Naprosyn 500

Indications of Naprosyn 500

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.

 

Pharmaceutical Name

Radiant Pharmaceuticals Ltd.

 

Pharmacology

Naprosyn® (naproxen) is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic properties. Naproxen is a propionic acid derivative related to the arylacetic acid class of drugs. The chemical name of naproxen is (+)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid. 

 

Dosage & Administration of Naprosyn 500

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 whichthere is an inflammatory component: The recommended starting dose is Naprosyn® 500 mg followed by Naprosyn® 250 mg every 6-8 hours as required.

Acute gout: The recommended starting dose is of 750 mg Naprosyn®, followed by 250 mg every 8 hours until the attack has subsided.

Migraine: For treatment of acute migraine headache, the dose is Naprosyn® 750 mg at the first symptom of an impending attack. An additional dose of Naprosyn® 250 mg to 500 mg can be taken throughout the day, if necessary, but not before half an hour after the initial dose. For prophylaxis of migraine headache, the dose of Naprosyn® is 500 mg twice daily. If no improvement is seen within 4-6 weeks, the drug should be discontinued.

 

Interaction of Naprosyn 500

With medicine: Concomitant administration of antacid or cholestyramine can delay the absorption of naproxen, but does not affect its extent. Concomitant administration of food can delay the absorption of naproxen, but does not affect its extent. Naproxen is highly bound to plasma albumin; Patients simultaneously receiving the drug and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required. No significant interactions have been observed in clinical studies with naproxen and coumarin-type anticoagulants, however caution is advised since interactions have been seen with other nonsteroidal agents of this class, the free fraction of warfarin may increase substantially in some subjects and naproxen interferes with platelet function. Caution is advised when probenecid is administered concurrently, since increases in naproxen plasma concentrations and increased half-life of naproxen have been reported with this combination. Caution is advised when methotrexate is administered concurrently, since naproxen and other prostaglandin synthesis-inhibiting drugs have been reported to reduce the clearance of methotrexate, and thus possibly enhance its toxicity. Naproxen can reduce the
anti-hypertensive effect of beta-blockers. As with other non-steroidal anti-inflammatory drugs, naproxen may inhibit the natriuretic effect of frusemide. Inhibition of renal lithium clearance leading to increases in plasma lithium concentrations has been reported. Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.With food & others: Naprosyn® may be given orally either in fasting state or with meals and/or antacids. 

 

Contraindications

Naprosyn® is contraindicated in patients who have had allergic reactions to naproxen. It is also contraindicated in patients in whom aspirin or other nonsteroidal anti inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis and nasal polyps. Naproxen is contraindicated in patients with active peptic ulceration or active gastrointestinal bleeding. Naproxen is contraindicated in children under 2 years of age since safety in this age group has not been established.

 

Side Effects of Naprosyn 500

The following are the most often reported adverse effects: 

• Gastrointestinal: heartburn, abdominal discomfort, nausea, diarrhea, dyspepsia.
  Headache, vertigo, and sleepiness are symptoms of the Central Nervous System.
• Dermatological conditions include pruritus (itching) and purpura.
• Cardiovascular symptoms include edema and palpitation.
• Other symptoms include visual and auditory problems.

 

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.

Labour and delivery: Naproxen is not recommended in labour and delivery because, through its prostaglandin synthesis inhibitory effect, naproxen may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.

Nursing mothers: The naproxen anion has been found in the milk of lactating women at a concentration of approximately 1% of that found in plasma. Because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates, use in nursing mothers is not recommended.

 

Precautions & Warnings

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.

 

Therapeutic Class

Rheumatoid Arthritis Drugs, Osteoarthritis Drugs, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

 

Storage Conditions

Do not store above 30ºC, protect from light & moisture.
Keep out of reach of children.

 

Generic Name of Naprosyn 500

Naproxen Sodium

 

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