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Naproxen
Overview
What is SALLUS Pain Relief Collection with Naproxen?
Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti- inflammatory drugs.The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2- naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively:
What does SALLUS Pain Relief Collection with Naproxen look like?
What are the available doses of SALLUS Pain Relief Collection with Naproxen?
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What should I talk to my health care provider before I take SALLUS Pain Relief Collection with Naproxen?
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How should I use SALLUS Pain Relief Collection with Naproxen?
Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen or naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).Naproxen as naproxen tablets or naproxen sodium tablets are indicated:• For the relief of the signs and symptoms of rheumatoid arthritis• For the relief of the signs and symptoms of osteoarthritis• For the relief of the signs and symptoms of ankylosing spondylitis• For the relief of the signs and symptoms of juvenile arthritisNaproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.Naproxen as naproxen tablets and naproxen sodium tablets are also indicated:• For relief of the signs and symptoms of tendonitis• For relief of the signs and symptoms of bursitis• For relief of the signs and symptoms of acute gout• For the management of pain• For the management of primary dysmenorrhea
Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen tablets and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).After observing the response to initial therapy with naproxen or naproxen sodium, the dose and frequency should be adjusted to suit an individual patients needs.
Although naproxen and naproxen sodium circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen.The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see ).
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see ).
During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary.In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see ).
The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (ie, 5 mg/kg given twice a day).
The recommended starting dose is 550 mg of naproxen sodium as naproxen sodium tablet followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1375 mg of naproxen sodium. Thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium. Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium tablets are recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Naproxen may also be used for initial treatment of acute pain because absorption of naproxen is delayed compared to other naproxen-containing products (see ).
The recommended starting dose is 750 mg of naproxen followed by 250 mg every 8 hours until the attack has subsided. Naproxen sodium may also be used at a starting dose of 825 mg followed by 275 mg every 8 hours.
What interacts with SALLUS Pain Relief Collection with Naproxen?
Naproxen and naproxen sodium are contraindicated in patients with known hypersensitivity to naproxen and naproxen sodium.Naproxen and naproxen sodium 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 ).Naproxen and naproxen sodium are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).
What are the warnings of SALLUS Pain Relief Collection with Naproxen?
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What are the precautions of SALLUS Pain Relief Collection with Naproxen?
General
Naproxen-containing products such as naproxen tablets, naproxen sodium tablets, ALEVE®, and other naproxen products should not be used
concomitantly since they all circulate in the plasma as the naproxen anion.
Hepatic Effects
Hematological Effects
Preexisting Asthma
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What are the side effects of SALLUS Pain Relief Collection with Naproxen?
Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen (see ).In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis
headache*, dizziness*, drowsiness*, lightheadedness, vertigo
pruritus (itching)*, skin eruptions*, ecchym oses*, sweating, purpura
tinnitus*, visual disturbances, hearing disturbances
edema*, palpitations
dyspnea*, thirst*Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.
flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting
abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashesThe following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.
In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.
fever, infection, sepsis, anaphylactic reactions, appetite changes, death
hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction
dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation
hepatitis, liver failure
rectal bleeding, lymphadenopathy, pancytopenia
weight changes
anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations
asthma, respiratory depression, pneumonia
exfoliative dermatitis
blurred vision, conjunctivitis
cystitis, dysuria, oliguria/polyuria, proteinuria
What should I look out for while using SALLUS Pain Relief Collection with Naproxen?
Naproxen and naproxen sodium are contraindicated in patients with known hypersensitivity to naproxen and naproxen sodium.Naproxen and naproxen sodium 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 ).Naproxen and naproxen sodium are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).
Cardiovascular Effects
Cardiovascular Thrombotic Events
WARNINGS: Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
CONTRAINDICATIONS
Hypertension
Congestive Heart Failure and Edema
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
PRECAUTIONS - Drug Interactions
Renal Effects
WARNINGS: Advanced Renal Disease
Advanced Renal Disease
Anaphylactoid Reactions
CONTRAINDICATIONS and PRECAUTIONS: Preexisting Asthma
Skin Reactions
Pregnancy
What might happen if I take too much SALLUS Pain Relief Collection with Naproxen?
Symptoms and Signs
Treatment
How should I store and handle SALLUS Pain Relief Collection with Naproxen?
StorageStore Naftifine Hydrochloride Cream, 2% at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) .StorageStore Naftifine Hydrochloride Cream, 2% at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) .Naproxen Tablets USP:250 mg:375 mg:500 mg:Naproxen Sodium Tablets USP:275 mg:550 mg:Naproxen Tablets USP:250 mg:375 mg:500 mg:Naproxen Sodium Tablets USP:275 mg:550 mg:Naproxen Tablets USP:250 mg:375 mg:500 mg:Naproxen Sodium Tablets USP:275 mg:550 mg:Naproxen Tablets USP:250 mg:375 mg:500 mg:Naproxen Sodium Tablets USP:275 mg:550 mg:Naproxen Tablets USP:250 mg:375 mg:500 mg:Naproxen Sodium Tablets USP:275 mg:550 mg:Naproxen Tablets USP:250 mg:375 mg:500 mg:Naproxen Sodium Tablets USP:275 mg:550 mg:Naproxen Tablets USP:250 mg:375 mg:500 mg:Naproxen Sodium Tablets USP:275 mg:550 mg:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pharmacodynamics
Pharmacokinetics
Immediate Release
PRECAUTIONS, Nursing Mothers)
WARNINGS: Renal Effects
Pediatric Patients
DOSAGE AND ADMINISTRATION
Geriatric Patients
Race
Hepatic Insufficiency
Renal Insufficiency
Renal Effects
Non-Clinical Toxicology
Naproxen and naproxen sodium are contraindicated in patients with known hypersensitivity to naproxen and naproxen sodium.Naproxen and naproxen sodium 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 ).Naproxen and naproxen sodium are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).Cardiovascular Effects
Cardiovascular Thrombotic Events
WARNINGS: Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
CONTRAINDICATIONS
Hypertension
Congestive Heart Failure and Edema
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
PRECAUTIONS - Drug Interactions
Renal Effects
WARNINGS: Advanced Renal Disease
Advanced Renal Disease
Anaphylactoid Reactions
CONTRAINDICATIONS and PRECAUTIONS: Preexisting Asthma
Skin Reactions
Pregnancy
Alcohol, Ethyl: Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.
Anticholinergics: The onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics.
Oral Contraceptives: Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.
Charcoal (Activated): Reduces acetaminophen absorption when administered as soon as possible after overdose.
Beta Blockers (Propanolol): Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased.
Loop Diuretics: The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.
Lamotrigine: Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.
Probenecid: Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.
Zidovudine: The pharmacologic effects of zidovudine may be decreased because of enhanced non-hepatic or renal clearance of zidovudine.
General
Naproxen-containing products such as naproxen tablets, naproxen sodium tablets, ALEVE®, and other naproxen products should not be used
concomitantly since they all circulate in the plasma as the naproxen anion.
Hepatic Effects
Hematological Effects
Preexisting Asthma
Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen (see ).In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis headache*, dizziness*, drowsiness*, lightheadedness, vertigo pruritus (itching)*, skin eruptions*, ecchym oses*, sweating, purpura tinnitus*, visual disturbances, hearing disturbances edema*, palpitations dyspnea*, thirst*Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients. flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashesThe following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized. In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients. fever, infection, sepsis, anaphylactic reactions, appetite changes, death hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation hepatitis, liver failure rectal bleeding, lymphadenopathy, pancytopenia weight changes anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations asthma, respiratory depression, pneumonia exfoliative dermatitis blurred vision, conjunctivitis cystitis, dysuria, oliguria/polyuria, proteinuria
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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