Naproxen, Oral

Anti-rheumatic, Systemic · Propionic acid

Indications

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, musculo-skeletal disorders including sprains, strains and lumbo-sacral pain. Acute gout. Dysmenorrhoea, migraine. Postoperative pain.

Dosage

The dosage are expressed as quantity of Naproxen. Adults: Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: Over 16 yr, 500 mg to 1000 mg daily in two divided doses or as a single dose morning or evening. Musculo-skeletal disorders: 500 mg initially then 250 mg six to eight hourly as required; max 1250 mg daily after first day. Dysmenorrhoea: Over 16 yr, usually 500 mg at once, then 250 mg every six to eight hr as required; max 1000 mg daily after first day. Migraine: Over 16 yr, 750 mg at once then 250 mg or 500 mg as needed; max 1250 mg daily. Post-operative pain: Over 16 yr, 500 mg twice daily. Gout: 750 mg initially then 250 mg every 8 hourly. Children: Not recommended for children under 5 yr for juvenile idiopathic arthritis; not recommended for children under 16 yr for musculoskeletal disorders or dysmenorrhoea. Pain and inflammation in musculoskeletal disorders,…

Adverse Effects

GI upset, bleeding and ulceration, abdominal pain. Skin and hypersensitivity reactions, headache, dizziness, tinnitus, vertigo, blood dyscrasias, altered LFTs, oedema, hypertension, cardiac failure, CNS disturbances, headache, fatigue, dyspnoea, impaired hearing, visual disturbances, thirst.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Aspirin/anti-inflammatory induced allergy. Active gastric or duodenal ulcer. Severe heart failure, haemorrhage, bleeding diathesis, hepatic and renal failure. Creatinine clearance <20 mL/min. Precautions: Renal or hepatic impairment, monitor on long-term therapy. Asthma, allergy. Cerebrovascular, coronary or peripheral vascular disease, cardiovascular risk factors, cardiac impairment, hypertension, congestive heart failure, hypovolaemia, mixed connective tissue disorders, porphyria, ulcerative colitis, visual disturbances, Crohn's disease, SLE. Elderly. Use lowest effective dose for shortest duration.

Interactions

Anticoagulants, antiplatelets, hydantoins, sulfonylureas, quinolones, sulphonamides, diuretics, lithium, beta-blockers, probenecid, methotrexate, cyclosporin, corticosteroids, SSRls, cardiac glycosides, mifepristone, tacrolimus, zidovudine, other NSAIDs, antihypertensives, bisphosphonates, methotrexate, digoxin, antacids, sulfinpyrazone.

Advice to Patient

Take immediately after meals. Do not crush, break or chew tablets, swallow whole with a glass of water. Do not lie down for 15-30 minutes after taking medication. Do not take for more than 10 days without consulting prescriber. Discontinue medication and inform prescriber immediately if there is constant stomach pain/cramps or blood in stool. Contact prescriber if there is unusual cough, difficulty in breathing, unusual bruising or bleeding, chest pain, palpitations, fast heartbeat, swelling in extremities, blood in urine, stool, mouth or vomitus, acute fatigue, skin rash, itching, blisters, fever, changes in hearing, ringing in ears, difficulty in speaking, changes in vision. Avoid alcohol during therapy. Take sufficient amount of fluids (2-3 litres per day) to maintain hydration, unless restricted by the prescriber. Do not take aspirin, aspirin containing medications,…

Pharmacokinetics

Onset of action: Analgesic: 30 to 60 minutes. Duration: Analgesic: <12 hours. Absorption: Oral: Almost 100%. Metabolism: Hepatic. Bioavailability: 95%. Half-life elimination: Children: Range: 8 to 17 hours. Children 8 to 14 hours: 8 to 10 hours. Adults: Normal renal function: 12 to 17 hours; Moderate to severe renal impairment: Approx. 15 to 21 hours. Time to peak, serum: Tablets, naproxen: 2 to 4 hours. Tablets, naproxen sodium: 1 to 2 hours. Tablets, delayed release (empty stomach): 4 to 6 hours; range: 2 to 12 hours. Tablets, delayed release (with food): 12 hours; range: 4 to 24 hours. Suspension: 1 to 4 hours. Suppository: 2 to 3 hours. Excretion: Urine (95%; primarily as metabolites); feces (=3%).

Brands with this active ingredient

Compiled by Healify Pharmacy from published drug references. How we compile it →

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