Formulary
Naproxen: Indications, Dosing, Side Effects and Interactions
Naproxen clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 4 min read
Naproxen: Indications, Dosing, Side Effects and Interactions
Naproxen clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Pain and inflammation in rheumatic disease**
- **Adult** (By Mouth): 0.5-1 g daily in 1-2 divided doses.
**Pain and inflammation in musculoskeletal disorders ,Dysmenorrhoea**
- **Adult** (By Mouth): Pain and inflammation in musculoskeletal disorders , Dysmenorrhoea Initially 500 mg for 1 dose, then 250 mg every 6-8 hours as required.
**Acute gout**
- **Adult** (By Mouth): Initially 750 mg for 1 dose, then 250 mg every 8 hours until attack has passed.
**Acute migraine**
- **Adult** (By Mouth): 500 mg for 1 dose, to be taken in combination with sumatriptan as soon as migraine symptoms develop.
**Pain and inflammation in musculoskeletal disorders , Dysmenorrhoea for naproxen**
- **Child** (By mouth): 5 mg/kg twice daily (max. per dose 500 mg).
**Pain and inflammation in juvenile idiopathic arthritis for naproxen**
- **Child 2-17 years** (By mouth): 5-7.5 mg/kg twice daily (max. per dose 500 mg).
Cautions
Allergic disorders; cardiac impairment (NSAIDs may impair renal function); cerebrovascular disease; coagulation defects; connective-tissue disorders; dehydration (risk of renal impairment); elderly (risk of serious side-effects and fatalities); heart failure; history of gastro-intestinal disorders (e.g. ulcerative colitis, Crohn's disease); ischaemic heart disease; may mask symptoms of infection; peripheral arterial disease; risk factors for cardiovascular events; uncontrolled hypertension
Contraindications
Active gastro-intestinal bleeding; active gastro-intestinal ulceration; history of gastro-intestinal bleeding related to previous NSAID therapy; history of gastro-intestinal perforation related to previous NSAID therapy; history of recurrent gastro-intestinal haemorrhage (two or more distinct episodes); history of recurrent gastro-intestinal ulceration (two or more distinct episodes); severe heart failure
Side effects
Common or very common Constipation; diarrhoea; dizziness; fatigue; gastrointestinal discomfort; headache; hearing impairment; heart failure; hyperhidrosis; nausea; skin reactions; stomatitis; tinnitus; visual impairment; vomiting Uncommon Cognitive impairment; concentration impaired; depression; fluid retention; gastrointestinal disorders; haemorrhage; hepatic disorders; hyperkalaemia; inflammatory bowel disease; menstrual disorder; mood altered; palpitations; seizure; sleep disorders; thirst Rare or very rare Agranulocytosis; alopecia; angioedema; asthma; bone marrow disorders; eosinophilia; erythema nodosum; glomerulonephritis; haemolytic anaemia; hypersensitivity; increased risk of infection; leucopenia; lupus erythematosus; meningitis aseptic (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible); muscle weakness; myalgia; nephritis tubulointerstitial; nephropathy; pancreatitis; Parkinson's disease exacerbated; photosensitivity reaction; pneumonia eosinophilic; pulmonary oedema; renal failure (more common in patients with pre-existing renal impairment); renal papillary necrosis; severe cutaneous adverse reactions (SCARs); thrombocytopenia; vasculitis Frequency not known Confusion; corneal opacity; drowsiness; dyspnoea; hallucination; hypertension; infertility female; malaise; neutropenia; oedema; optic neuritis; papillitis; papilloedema; paraesthesia; proteinuria; renal impairment; vertigo Side-effects, further information For information about cardiovascular and gastrointestinal side-effects, and a possible exacerbation of symptoms in asthma, see Non-steroidal anti-inflammatory drugs
Interactions
**Other interactions (23):**
- Concomitant administration of antacid or colestyramine 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.
- It is considered unsafe to take NSAIDs in combination with anti-coagulants such as warfarin or heparin unless under direct medical supervision, as NSAIDs may enhance the effects of anti-coagulants...
- Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (see Section 4.4).
- Acetylsalicylic acid Clinical pharmacodynamic data suggest that concomitant naproxen usage for more than one day consecutively may inhibit the effect of low-dose acetylsalicylic acid on platelet...
- The clinical relevance of this interaction is not known Due to the high plasma protein binding of naproxen, patients simultaneously receiving hydantoins, anticoagulants, other NSAIDs, aspirin or a...
Pregnancy
Important safety information For naproxen MHRA/CHM advice: NSAIDs: potential risks following prolonged use after 20 weeks of pregnancy (June 2023) See Non-steroidal anti-inflammatory drugs .
Breast feeding
Use with caution during breast-feeding. Amount too small to be harmful but manufacturer advises avoid.
Hepatic impairment
Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment. Dose adjustments Manufacturer advises consider dose reduction in mild to moderate impairment.
Renal impairment
In general, for NSAIDs the MHRA advises to avoid where possible; if necessary, use with caution (risk of fluid retention and further renal impairment, including renal failure). For naproxen , avoid if creatinine clearance less than 30 mL/minute (risk of accumulation). M Dose adjustments Consider dose reduction if creatinine clearance 30 mL/minute or more. M See Prescribing in renal impairment .
Medicinal forms
Suspension,Tablet,Tablet,Tablet,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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