displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical name for naproxen is (+)-(S)-6-Methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula:
Naproxen is a practically odorless, white to off-white, crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.Each tablet for oral administration contains 250 mg, 375 mg or 500 mg of naproxen. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, povidone, synthetic black iron oxide (375 mg only), synthetic red iron oxide (375 mg only) and synthetic yellow iron oxide (375 mg only).
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Naproxen tablets are indicated:
- For relief of mild to moderate pain
- For relief of signs and symptoms of juvenile arthritis
- For relief of the signs and symptoms of rheumatoid arthritis
- For relief of the signs and symptoms of osteoarthritis
- For treatment of primary dysmenorrhea
- For acute or long-term use in the relief of signs and symptoms of the following:
- Ankylosing spondylitis
- Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)
- Acute gouty arthritis
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Naproxen tablets are contraindicated in patients with known hypersensitivity to naproxen.Naproxen 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 WARNINGS – Anaphylactoid Reactions, and PRECAUTIONS – Preexisting Asthma).Naproxen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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 CLINICAL PHARMACOLOGY).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:Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, and stomatitisCentral Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigoDermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpuraSpecial Senses: tinnitus*, visual disturbances, hearing disturbancesCardiovascular: edema*, palpitationsGeneral: 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.Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomitingGeneral: 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 post-marketing reports. Those adverse reactions observed through post-marketing reports are italicized.Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)Cardiovascular: congestive heart failure, vasculitisGastrointestinal: gastrointestinal bleeding and/or perforation, hematemesis, jaundice, pancreatitis, vomiting, colitis, abnormal liver function tests, nonpeptic gastrointestinal ulceration, ulcerative stomatitis Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemiaMetabolic and Nutritional: hyperglycemia, hypoglycemiaNervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunctionRespiratory: eosinophilic pneumonitisDermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored. Special Senses: hearing impairmentUrogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosisIn patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, deathCardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarctionGastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, hepatitis, eructation, liver failureHemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopeniaMetabolic and Nutritional: weight changesNervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinationsRespiratory: asthma, respiratory depression, pneumoniaDermatologic: exfoliative dermatitisSpecial Senses: blurred vision, conjunctivitisUrogenital: cystitis, dysuria, oliguria/polyuria, proteinuria
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Significant naproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting. 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. Because naproxen sodium may be rapidly absorbed, high and early blood levels should be anticipated. A few patients have experienced convulsions, but it is not clear whether or not these were drug-related. It is not known what dose of the drug would be life threatening. The oral LD50 of the drug is 543 mg/kg in rats, 1234 mg/kg in mice, 4110 mg/kg in hamsters, and greater than 1000 mg/kg in dogs.Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. 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. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high protein binding.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen. 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 naproxen, the dose and frequency should be adjusted to suit an individual patient’s needs.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Naproxen Tablets USP are supplied as follows:250 mg tablets: White to off-white, round, convex tablet debossed WATSON in an arc around the top edge and 821 across the bottom on one side and plain on the other side, in bottles of 100.375 mg tablets: Gray, capsule-shaped tablet debossed WATSON over 822 on one side and plain on the other side, in bottles of 100 and 500.500 mg tablets: White to off-white, capsule-shaped tablet debossed WATSON over 791 on one side and plain on the other side, in bottles of 100 and 500.Store at 20o-25oC (68o-77o F). [See USP controlled room temperature.] Dispense in a well-closed, light-resistant container as defined in USP/NF.Manufactured for:
Watson Laboratories, Inc.
Corona, CA 92880 USAManufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45237 USARevised: August 2005