Generic

Naproxen

Therapeutic Class

Analgesic, Anti-Inflammatory

Pack Size

Naprosyn 250 mg tablets: Each box contains 50 tablets (5 x 10’s) in Alu-PVC / PVDC blister pack.
Naprosyn 500 mg tablets: Each box contains 50 tablets (5 x 10’s) in Alu-PVC / PVDC blister pack.
Naprosyn dry powder for Suspension: Each bottle contains dry powder for 50 ml (125 mg/5 ml) suspension.

Indications

Naprosyn® is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile rheumatoid arthritis. Naprosyn® is also indicated for the treatment of tendonitis, bursitis, acute gout, for the management of pain, primary dysmenorrhea, migraine treatment and prophylaxis.

Therapeutic Class

Analgesic, Anti-Inflammatory

Dosage & Administration

General Onset of pain relief can begin within 1 hour in patients taking naproxen. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients. Naprosyn® is not recommended in patients with baseline creatinine clearance less than 10 ml/minute because accumulation of naproxen metabolites has been seen in such patients. Naprosyn® may be given orally either in fasting state or with meals and/or antacids. Dose in adults Chronic conditions: Osteoarthritis / Rheumatoid arthritis / Ankylosing spondylitis / chronic pain states in which there is an inflammatory component: The recommended dose of naproxen is Naprosyn® 250 mg or 500 mg taken twice daily (morning and evening), or a single daily dose of 500-1000 mg given in the morning or evening, or 500 mg taken twice daily, or a single daily dose of 1000 mg given in the evening. 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. In patients who tolerate lower doses well, the dose may be increased to 1500 mg per day when a higher level of anti-inflammatory/analgesic activity is required. When treating patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefit to offset the potential increased risk (see Precautions). 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. Acute conditions: Analgesia / Dysmenorrhoea / Acute musculoskeletal conditions/Acute pain states in which there is an inflammatory component: The recommended starting dose is Naprosyn® 500 mg followed by Naprosyn® 250 mg every 6-8 hours as required.

Side Effects

Gastrointestinal: abdominal pain, constipation, diarrhea, dyspepsia, heartburn, nausea, stomatitis. Central nervous system: dizziness, drowsiness, headache, lightheadedness, vertigo. Dermatologic: ecchymoses, itching (pruritus), purpura, skin eruptions, sweating. Cheap for sale online, high quality louboutin. Special senses: hearing disturbances, tinnitus, visual disturbances. Cardiovascular: dyspnea, edema, palpitations. General: thirst.

Pregnancy & Lactation

Pregnancy: As with other drugs of this type, naproxen produces delay in parturition in animals and also affects the human fetal cardiovascular system (closure of ductus arteriosus). Therefore, naproxen should not be used during pregnancy unless clearly needed.

Precautions

Gastrointestinal ulceration, bleeding and perforation: Gastrointestinal mucosal injury may occur. Serious gastrointestinal toxicity, such as gastrointestinal irritation, bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAIDs including naproxen therapy. Studies to date have not identified any subset of patients not at risk of developing peptic ulcer and bleeding. In patients with a history of gastrointestinal disease, Naprosyn® should be given under close supervision.Open studies in patients with rheumatoid arthritis who had upper gastrointestinal dysfunction and/or were intolerant of other commonly used NSAIDs indicated that naproxen is generally well tolerated. Renal effects: There have been reports of impaired renal function, renal failure, acute interstitial nephritis, hematuria, proteinuria, renal papillary necrosis and occasionally nephrotic syndrome associated with naproxen. As with other NSAIDs, naproxen should be used with caution in patients with impaired renal function or a history of kidney disease because naproxen is an inhibitor of prostaglandin synthesis. Naproxen is not recommended in patients with baseline creatinine clearance less than 20 ml/min because accumulation of naproxen metabolites has been seen in such patients. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. Hematological: Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined. Patients who have coagulation disorders or are receiving drug therapy that interferes with hemostasis should be carefully observed if naproxen is administered. Patients at high risk of bleeding and those on full anticoagulation therapy (e.g. dicoumarol derivatives) may be at increased risk of bleeding if given naproxen concurrently. Anaphylactic reactions: Hypersensitivity reactions may occur in susceptible individuals. Anaphylactic (anaphylactoid) reactions may occur, both in patients with and without a history of hypersensitivity or exposure to aspirin, other non-steroidal anti-inflammatory drugs or naproxen . They may also occur in individuals with a history of angioedema, bronchospasticreactivity (e.g. asthma), rhinitis and nasal polyps. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome. Bronchospasm may be precipitated in patients suffering from, or with a history of, asthma or allergic disease or aspirin sensitivity. Hepatic effects: Hepatic abnormalities may be the result of hypersensitivity rather than direct toxicity. Severe hepatic reactions, including jaundice and hepatitis (some cases of hepatitis have been fatal) have been reported with this drug as with other non-steroidal anti-inflammatory drugs. Antipyretic effects: The antipyretic and anti-inflammatory activities of naproxen may reduce fever and inflammation, thus diminishing their utility as diagnostic signs. Steroids: If steroid dosage is reduced or eliminated during therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis. Ocular effects: Studies have not shown changes in the eye attributable to naproxen administration. In rare cases, adverse ocular disorders including papillitis, retrobulbar optic neuritis and papilledema, have been reported in users of NSAIDs including naproxen, although sodiuma caus sosodiumdium e-a nd-effect relationship cannot be established; accordingly, patients who develop visual disturbances during treatment with naproxen should have an ophthalmological examination. Driving and operating machinery: Some patients may experience drowsiness, dizziness, vertigo, insomnia or depression with the use of Naprosyn®. If patients experience these or similar undesirable effects, they should exercise caution in carrying out activities that require alertness. Precautions related to elderly patients: Elderly patients may be at a greater risk of experiencing undesirable effects than younger patients. In elderly patients the clearance is reduced. Use of the lower end of the dosage range is recommended (see Dosage and administration). Combination with other NSAIDs: The combination of other NSAIDs is not recommended, because of the cumulative risks of inducing serious NSAID-related adverse events.

Storage Conditions

Naprosyn® Store at below 35°C. The reconstituted suspension should be store in cool and dry place and used within 14 days after preparation. Keep out of reach of children.