Diclofenac Sodium D/R

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Overview

What is Diclofenac Sodium D/R?

Diclofenac, as the sodium salt, is a benzene-acetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula:

Each enteric-coated tablet for oral administration contains 25 mg, 50 mg or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients; black iron oxide, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

What does Diclofenac Sodium D/R look like?

What are the available doses of Diclofenac Sodium D/R?

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What should I talk to my health care provider before I take Diclofenac Sodium D/R?

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How should I use Diclofenac Sodium D/R?

INDICATIONS AND USAGE

Carefully consider the potential bene ts and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Diclofenac is indicated:

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with diclofenac, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of osteoarthritis, the recommended dosage is 100 to 150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).

For the relief of rheumatoid arthritis, the recommended dosage is 150 to 200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).

For the relief of ankylosing spondylitis, the recommended dosage is 100 to 125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.

Different formulations of diclofenac (diclofenac sodium delayed-release tablets; diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.

What interacts with Diclofenac Sodium D/R?

Diclofenac sodium delayed-release tablets is contraindicated in patients with known hypersensitivity to diclofenac.

Diclofenac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma).

Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

What are the warnings of Diclofenac Sodium D/R?

Safe use of robaxinand robaxin-750 has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, robaxinand robaxin-750 should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see ).

Cardiovascular Effects

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocar-dial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS, GI Effects).

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).

Hypertension

NSAIDs, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including diclofenac sodium delayed-release tablets, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure and Edema Renal Effects

Fluid retention and edema have been observed in some patients taking NSAIDs. Diclofenac should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal (GI) Effects: Risk of GI Ulceration, Bleeding, and Perforation

NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3–6 months, and in about 2%–4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Caution should be used when initiating treatment with diclofenac in patients with considerable dehydration.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood ow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of diclofenac in patients with advanced renal disease. Therefore, treatment with diclofenac is not recommended in these patients with advanced renal disease. If diclofenac therapy must be initiated, close monitoring of the patient's renal function is advisable.

Hepatic Effects

Elevations of one or more liver tests may occur during therapy with diclofenac. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continued therapy. Borderline elevations (i.e., less than 3 times the ULN [ULN = the upper limit of the normal range]) or greater elevations of transaminases occurred in about 15% of diclofenac-treated patients. Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury.

In clinical trials, meaningful elevations (i.e., more than 3 times the ULN) of AST (GOT) (ALT was not measured in all studies) occurred in about 2% of approximately 5,700 patients at some time during diclofenac treatment. In a large, open-label, controlled trial of 3,700 patients treated for 2-6 months, patients were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of patients and included marked elevations (i.e., more than 8 times the ULN) in about 1% of the 3,700 patients. In that open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis.

Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. However, severe hepatic reactions can occur at any time during treatment with diclofenac.

If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), diclofenac should be discontinued immediately.

To minimize the possibility that hepatic injury will become severe between transaminase measurements, physicians should inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “ u-like” symptoms), and the appropriate action patients should take if these signs and symptoms appear.

To minimize the potential risk for an adverse liver related event in patients treated with diclofenac, the lowest effective dose should be used for the shortest duration possible. Caution should be exercised in prescribing diclofenac with concomitant drugs that are known to be potentially hepatotoxic (e.g., antibiotics, antiepileptics).

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to diclofenac. Diclofenac should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. (See CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma.) Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including diclofenac, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, as with other NSAIDs, diclofenac should be avoided because it may cause premature closure of the ductus arteriosus.

What are the precautions of Diclofenac Sodium D/R?

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What are the side effects of Diclofenac Sodium D/R?

ADVERSE REACTIONS

In patients taking diclofenac sodium delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%–10% of patients are:

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, atulence, gross bleeding/ perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.

Additional adverse experiences reported occasionally include:

Body as a Whole:

Cardiovascular System:

Digestive System:

Hemic and Lymphatic System

Metabolic and Nutritional

Nervous System:

Respiratory System

Skin and Appendages:

Special Senses:

Urogenital System:

Other adverse reactions, which occur rarely are:

Body as a Whole:

Cardiovascular System:

Digestive System

Hemic and Lymphatic System:

Metabolic and Nutritional:

Nervous System:

Respiratory System

Skin and Appendages:

Special Senses:

What should I look out for while using Diclofenac Sodium D/R?

Diclofenac sodium delayed-release tablets is contraindicated in patients with known hypersensitivity to diclofenac.

Diclofenac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma).

Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Cardiovascular Effects

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocar-dial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS, GI Effects).

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).

Hypertension

NSAIDs, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including diclofenac sodium delayed-release tablets, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure and Edema Renal Effects

Fluid retention and edema have been observed in some patients taking NSAIDs. Diclofenac should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal (GI) Effects: Risk of GI Ulceration, Bleeding, and Perforation

NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3–6 months, and in about 2%–4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Caution should be used when initiating treatment with diclofenac in patients with considerable dehydration.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood ow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of diclofenac in patients with advanced renal disease. Therefore, treatment with diclofenac is not recommended in these patients with advanced renal disease. If diclofenac therapy must be initiated, close monitoring of the patient's renal function is advisable.

Hepatic Effects

Elevations of one or more liver tests may occur during therapy with diclofenac. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continued therapy. Borderline elevations (i.e., less than 3 times the ULN [ULN = the upper limit of the normal range]) or greater elevations of transaminases occurred in about 15% of diclofenac-treated patients. Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury.

In clinical trials, meaningful elevations (i.e., more than 3 times the ULN) of AST (GOT) (ALT was not measured in all studies) occurred in about 2% of approximately 5,700 patients at some time during diclofenac treatment. In a large, open-label, controlled trial of 3,700 patients treated for 2-6 months, patients were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of patients and included marked elevations (i.e., more than 8 times the ULN) in about 1% of the 3,700 patients. In that open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis.

Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. However, severe hepatic reactions can occur at any time during treatment with diclofenac.

If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), diclofenac should be discontinued immediately.

To minimize the possibility that hepatic injury will become severe between transaminase measurements, physicians should inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “ u-like” symptoms), and the appropriate action patients should take if these signs and symptoms appear.

To minimize the potential risk for an adverse liver related event in patients treated with diclofenac, the lowest effective dose should be used for the shortest duration possible. Caution should be exercised in prescribing diclofenac with concomitant drugs that are known to be potentially hepatotoxic (e.g., antibiotics, antiepileptics).

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to diclofenac. Diclofenac should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. (See CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma.) Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including diclofenac, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, as with other NSAIDs, diclofenac should be avoided because it may cause premature closure of the ductus arteriosus.

What might happen if I take too much Diclofenac Sodium D/R?

OVERDOSAGE

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

How should I store and handle Diclofenac Sodium D/R?

ZERBAXA vials should be stored refrigerated at 2 to 8°C (36 to 46°F) and protected from light.The reconstituted solution, once diluted, may be stored for 24 hours at room temperature or for 7 days under refrigeration at 2 to 8° C (36 to 46°F).ZERBAXA vials should be stored refrigerated at 2 to 8°C (36 to 46°F) and protected from light.The reconstituted solution, once diluted, may be stored for 24 hours at room temperature or for 7 days under refrigeration at 2 to 8° C (36 to 46°F).Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.Diclofenac sodium delayed-release tablets50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000.75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000.Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured and Distributed by:Revised: February 2010 CTI-11 Rev. C Printed in USA Medication Guide for Non-SteroidalAnti-Inflammatory Drugs (NSAIDs)(See the end of this Medication Guide for a list of prescription NSAID medicines.)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:The chance of a person getting an ulcer or bleeding increases with:NSAID medicines should only be used:exactly as prescribedat the lowest dose possible for your treatmentfor the shortest time neededWhat are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine:Tell your healthcare provider:What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?Get emergency help right away if you have any of the following symptoms:Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NSAID medicines that need a prescription* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pharmacodynamics

Diclofenac sodium delayed-release tablets is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of diclofenac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

Pharmacokinetics

Absorption

Diclofenac is 100% absorbed after oral administration compared to IV administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available (see Table 1). Food has no significant effect on the extent of diclofenac absorption. However, there is usually a delay in the onset of absorption of 1 to 4.5 hours and a reduction in peak plasma levels of <20%.

Distribution

The apparent volume of distribution (V/F) of diclofenac sodium is 1.4 L/kg.

Diclofenac is more than 99% bound to human serum proteins, primarily to albumin. Serum protein binding is constant over the concentration range (0.15-105 μg/mL) achieved with recommended doses.

Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of diclofenac.

Metabolism

Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'hydroxy-4'-methoxy diclofenac. In patients with renal dysfunction, peak concentrations of metabolites 4'-hydroxy- and 5-hydroxy-diclofenac were approximately 50% and 4% of the parent compound after single oral dosing compared to 27% and 1% in normal healthy subjects. However, diclofenac metabolites undergo further glucuronidation and sulfation followed by biliary excretion.

One diclofenac metabolite 4'-hydroxy- diclofenac has very weak pharmacologic activity.

Excretion

Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Little or no free unchanged diclofenac is excreted in the urine. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites. Because renal elimination is not a significant pathway of elimination for unchanged diclofenac, dosing adjustment in patients with mild to moderate renal dysfunction is not necessary. The terminal half-life of unchanged diclofenac is approximately 2 hours.

Special Populations

Pediatric

Race

Hepatic Insufficiency

Renal Insufficienc

Non-Clinical Toxicology

Diclofenac sodium delayed-release tablets is contraindicated in patients with known hypersensitivity to diclofenac.

Diclofenac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma).

Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Cardiovascular Effects

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocar-dial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS, GI Effects).

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).

Hypertension

NSAIDs, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including diclofenac sodium delayed-release tablets, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure and Edema Renal Effects

Fluid retention and edema have been observed in some patients taking NSAIDs. Diclofenac should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal (GI) Effects: Risk of GI Ulceration, Bleeding, and Perforation

NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3–6 months, and in about 2%–4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Caution should be used when initiating treatment with diclofenac in patients with considerable dehydration.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood ow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of diclofenac in patients with advanced renal disease. Therefore, treatment with diclofenac is not recommended in these patients with advanced renal disease. If diclofenac therapy must be initiated, close monitoring of the patient's renal function is advisable.

Hepatic Effects

Elevations of one or more liver tests may occur during therapy with diclofenac. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continued therapy. Borderline elevations (i.e., less than 3 times the ULN [ULN = the upper limit of the normal range]) or greater elevations of transaminases occurred in about 15% of diclofenac-treated patients. Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury.

In clinical trials, meaningful elevations (i.e., more than 3 times the ULN) of AST (GOT) (ALT was not measured in all studies) occurred in about 2% of approximately 5,700 patients at some time during diclofenac treatment. In a large, open-label, controlled trial of 3,700 patients treated for 2-6 months, patients were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of patients and included marked elevations (i.e., more than 8 times the ULN) in about 1% of the 3,700 patients. In that open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis.

Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. However, severe hepatic reactions can occur at any time during treatment with diclofenac.

If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), diclofenac should be discontinued immediately.

To minimize the possibility that hepatic injury will become severe between transaminase measurements, physicians should inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “ u-like” symptoms), and the appropriate action patients should take if these signs and symptoms appear.

To minimize the potential risk for an adverse liver related event in patients treated with diclofenac, the lowest effective dose should be used for the shortest duration possible. Caution should be exercised in prescribing diclofenac with concomitant drugs that are known to be potentially hepatotoxic (e.g., antibiotics, antiepileptics).

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to diclofenac. Diclofenac should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. (See CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma.) Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including diclofenac, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, as with other NSAIDs, diclofenac should be avoided because it may cause premature closure of the ductus arteriosus.

See and for interaction with CNS drugs and alcohol.

Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

General

Diclofenac sodium delayed-release tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The pharmacological activity of diclofenac in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Hematological Effects

Anemia is sometimes seen in patients receiving NSAIDs, including diclofenac. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including diclofenac, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving diclofenac who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

Preexisting Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross-reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, diclofenac should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

Information for Patients

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.

Laboratory Tests

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. In patients on long-term treatment with NSAIDs, including diclofenac, the CBC and a chemistry profile (including transaminase levels) should be checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, diclofenac should be discontinued.

Drug Interactions

Aspirin

Methotrexate:

Cyclosporine:

ACE Inhibitors:

Furosemide:

Lithium:

Warfarin:

Pregnancy

Teratogenic Effects:

Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women.

Nonteratogenic Effects:

Labor and Delivery

In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of diclofenac on labor and delivery in pregnant women are unknown.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from diclofenac, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

ADVERSE REACTIONS

In patients taking diclofenac sodium delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%–10% of patients are:

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, atulence, gross bleeding/ perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.

Additional adverse experiences reported occasionally include:

Body as a Whole:

Cardiovascular System:

Digestive System:

Hemic and Lymphatic System

Metabolic and Nutritional

Nervous System:

Respiratory System

Skin and Appendages:

Special Senses:

Urogenital System:

Other adverse reactions, which occur rarely are:

Body as a Whole:

Cardiovascular System:

Digestive System

Hemic and Lymphatic System:

Metabolic and Nutritional:

Nervous System:

Respiratory System

Skin and Appendages:

Special Senses:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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