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ANODYNE ILE
Overview
What is ANODYNE ILE?
The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (CHNOS)Mg x 3 HO with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:
The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.
Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac.
What does ANODYNE ILE look like?
What are the available doses of ANODYNE ILE?
What should I talk to my health care provider before I take ANODYNE ILE?
How should I use ANODYNE ILE?
Esomeprazole magnesium is supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in Table 1. Esomeprazole magnesium delayed-release capsules should be taken at least one hour before meals. The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the prescribing information, and individual patient medical needs. Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.
Table 1: Recommended Dosage Schedule for Esomeprazole Magnesium Delayed-Release Capsules
Clinical Studies. .
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Drug Interactions
Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.
What interacts with ANODYNE ILE?
Ibuprofen Oral Suspension is contraindicated in patients with known hypersensitivity to ibuprofen.
Ibuprofen Oral Suspension should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see and ).
Ibuprofen Oral Suspension is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
What are the warnings of ANODYNE ILE?
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, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the 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, such as ibuprofen, increases the risk of serious gastrointestinal (GI) events (see ).
Status Post Coronary Artery Bypass Graft (CABG) Surgery
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. NSAIDs are contraindicated in the setting of CABG (see ).
Post-MI Patients
Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of Ibuprofen Oral Suspension in patients with a recent MI unless the benefits are expected to outweigh the risks of recurrent CV thrombotic events. If Ibuprofen Oral Suspension is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Hypertension
NSAIDs, including Ibuprofen Oral Suspension, can lead to onset of new hypertension or worsening of pre-existing 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 Ibuprofen Oral Suspension, 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.
Heart Failure and Edema
The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.
Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of ibuprofen may blunt the CV effects of several therapeutic agents used to treat these medical conditions [e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)] (see ).
Avoid the use of Ibuprofen Oral Suspension in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If Ibuprofen Oral Suspension is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
NSAIDs, including Ibuprofen Oral Suspension, 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 who use NSAIDs have a greater than 10-fold 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
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 flow, 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 Ibuprofen Oral Suspension in patients with advanced renal disease. Therefore, treatment with Ibuprofen Oral Suspension is not recommended in these patients with advanced renal disease. If Ibuprofen Oral Suspension therapy must be initiated, close monitoring of the patient’s renal function is advisable.
Anaphylactoid Reactions
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Ibuprofen Oral Suspension. Ibuprofen Oral Suspension 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 and ). Emergency help should be sought in cases where an anaphylactoid reaction occurs.
Skin Reactions
NSAIDs, including Ibuprofen Oral Suspension, 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, ibuprofen should be avoided because it may cause premature closure of the ductus arteriosus.
What are the precautions of ANODYNE ILE?
General
Ibuprofen Oral Suspension 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 Ibuprofen Oral Suspension in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Hepatic Effects
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Ibuprofen Oral Suspension. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Ibuprofen Oral Suspension. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Ibuprofen Oral Suspension should be discontinued.
Hematological Effects
Anemia is sometimes seen in patients receiving NSAIDs, including Ibuprofen Oral Suspension. 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 Ibuprofen Oral Suspension, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
In two postmarketing clinical studies the incidence of a decreased hemoglobin level was greater than previously reported. Decrease in hemoglobin of 1 gram or more was observed in 17.1% of 193 patients on 1600 mg ibuprofen daily (osteoarthritis), and in 22.8% of 189 patients taking 2400 mg of ibuprofen daily (rheumatoid arthritis). Positive stool occult blood tests and elevated serum creatinine levels were also observed in these studies.
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 Ibuprofen Oral Suspension 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, Ibuprofen Oral Suspension should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
Aseptic Meningitis
Aseptic meningitis, with fever and coma, has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease.
Diabetics
Ibuprofen Oral Suspension contains 270 mg high fructose corn syrup and 0.83 calories per mL, or 1350 mg high fructose corn syrup and 4.15 calories per teaspoonful, which should be taken into consideration when treating diabetic patients with this product.
Information for Patients:
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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. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile 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, Ibuprofen Oral Suspension should be discontinued.
Drug Interactions
ACE-inhibitors
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
Aspirin
As with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential of increased adverse effects.
Diuretics
Clinical studies, as well as post marketing observations, have shown that ibuprofen oral suspension can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.
Lithium
Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)
Methotrexate
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Warfarin
Several short-term controlled studies failed to show that ibuprofen significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on warfarin-type anticoagulants. However, because bleeding has been reported when ibuprofen and other NSAIDs have been administered to patients on warfarin-type anticoagulants, the physician should be cautious when administering ibuprofen to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
Pregnancy
Teratogenic Effects - Pregnancy Category C
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. Ibuprofen should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects
Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.
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 ibuprofen suspension on labor and delivery in pregnant women are unknown. Therefore, administration of Ibuprofen Oral Suspension is not recommended during labor and delivery.
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 Ibuprofen Oral Suspension, 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 of ibuprofen oral suspension in pediatric patients below the age of 6 months have not been established (see ). Dosing of Ibuprofen Oral Suspension in children 6 months or older should be guided by their body weight (see ).
Geriatric Use
As with any NSAID, caution should be exercised in treating the elderly (65 years and older).
What are the side effects of ANODYNE ILE?
In patients taking ibuprofen or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are: abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, fluid retention, gastrointestinal experiences (including abdominal pain, bloating, constipation, diarrhea, dyspepsia, epigastric pain, flatulence, heartburn, nausea, vomiting), headaches, increased bleeding time, nervousness, pruritus, rashes (including maculopapular) and tinnitus.
Additional adverse experiences reported occasionally include:
| Body as a whole - | fever, infection, sepsis |
| Cardiovascular system - | congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, syncope |
| Digestive system - | dry mouth, duodenitis, esophagitis, gastric or duodenal ulcer with bleeding and/or perforation, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding |
| Hemic and lymphatic system - | ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, thrombocytopenia |
| Metabolic and nutritional - | weight changes |
| Nervous system - | anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, vertigo |
| Respiratory system - | asthma, dyspnea |
| Skin and appendages - | alopecia, photosensitivity, sweat |
| Special senses - | blurred vision |
| Urogenital system - | cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, acute renal failure in patients with pre-existing significantly impaired renal function | Other adverse reactions, which occur rarely are: |
| Body as a whole - | anaphylactic reactions, anaphylactoid reactions, appetite changes |
| Cardiovascular system - | arrhythmia, cerebrovascular accident, hypotension, myocardial infarction, palpitations, vasculitis |
| Digestive system - | eructation, gingival ulcer, hepatorenal syndrome, liver necrosis, liver failure, pancreatitis |
| Hemic and lymphatic system - | agranulocystosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, pancytopenia |
| Metabolic and nutritional - | hyperglycemia |
| Nervous system - | convulsions, coma, emotional lability, hallucinations, aseptic meningitis |
| Respiratory - | apnea, respiratory depression, pneumonia, rhinitis |
| Skin and appendages - | angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens Johnson syndrome, urticaria, vesiculobullous eruptions |
| Special senses - | amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision), conjunctivitis, dry eyes, hearing impairment |
| Urogenital - | azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, tubular necrosis |
What should I look out for while using ANODYNE ILE?
Esomeprazole magnesium is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions ()].
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole magnesium, refer to the CONTRAINDICATIONS section of their package inserts.
What might happen if I take too much ANODYNE ILE?
A single oral dose of esomeprazole at 510 mg/kg (about 124 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions.
The symptoms described in connection with deliberate esomeprazole magnesium overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of esomeprazole were uneventful. Reports of overdosage with omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert – Adverse Reactions). No specific antidote for esomeprazole is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive.
As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose contact Dr. Reddy's at 1-888-375-3784.
How should I store and handle ANODYNE ILE?
Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-509-30Bottles of 90 NDC 43598-509-90Bottles of 1000 NDC 43598-509-10Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-510-30Bottles of 90 NDC 43598-510-90Bottles of 1000 NDC 43598-510-10Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided. Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-509-30Bottles of 90 NDC 43598-509-90Bottles of 1000 NDC 43598-509-10Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-510-30Bottles of 90 NDC 43598-510-90Bottles of 1000 NDC 43598-510-10Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided. Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-509-30Bottles of 90 NDC 43598-509-90Bottles of 1000 NDC 43598-509-10Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-510-30Bottles of 90 NDC 43598-510-90Bottles of 1000 NDC 43598-510-10Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided. Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-509-30Bottles of 90 NDC 43598-509-90Bottles of 1000 NDC 43598-509-10Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-510-30Bottles of 90 NDC 43598-510-90Bottles of 1000 NDC 43598-510-10Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided. Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-509-30Bottles of 90 NDC 43598-509-90Bottles of 1000 NDC 43598-509-10Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-510-30Bottles of 90 NDC 43598-510-90Bottles of 1000 NDC 43598-510-10Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided. Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-509-30Bottles of 90 NDC 43598-509-90Bottles of 1000 NDC 43598-509-10Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-510-30Bottles of 90 NDC 43598-510-90Bottles of 1000 NDC 43598-510-10Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided. Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-509-30Bottles of 90 NDC 43598-509-90Bottles of 1000 NDC 43598-509-10Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-510-30Bottles of 90 NDC 43598-510-90Bottles of 1000 NDC 43598-510-10Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided. Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-509-30Bottles of 90 NDC 43598-509-90Bottles of 1000 NDC 43598-509-10Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-510-30Bottles of 90 NDC 43598-510-90Bottles of 1000 NDC 43598-510-10Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided. Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-509-30Bottles of 90 NDC 43598-509-90Bottles of 1000 NDC 43598-509-10Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's.Bottles of 30 NDC 43598-510-30Bottles of 90 NDC 43598-510-90Bottles of 1000 NDC 43598-510-10Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H/K-ATPase in the gastric parietal cell. The S- and R-isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion.
Non-Clinical Toxicology
Esomeprazole magnesium is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions ()].For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole magnesium, refer to the CONTRAINDICATIONS section of their package inserts.
Ibuprofen Oral Suspension 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 Ibuprofen Oral Suspension in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
The following serious adverse reactions are described below and elsewhere in labeling:
• Acute Interstitial Nephritis [see Warnings and Precautions
• Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ]
• Bone Fracture [see Warnings and Precautions ]
• Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ]
• Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ]
• Hypomagnesemia [see Warnings and Precautions ]
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. 315.72Tips
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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).