Individual generic drug information

naproxen

Reference monograph

Part of registered formulation

NAPROXEN

Reference record: Naproxen
Source: BNF 80 (2020–2021)
Printed source pages: 1233, 1234
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Naproxen only.

Indications And Dose

Pain and inflammation in rheumatic disease ▶BY MOUTH ▶Adult: 0.5–1 g daily in 1–2 divided doses Pain and inflammation in musculoskeletal disorders | Dysmenorrhoea ▶BY MOUTH ▶Adult: Initially 500 mg, then 250 mg every 6–8 hours as required, maximum dose after the ﬁrst day 1.25 g daily Acute gout ▶BY MOUTH ▶Adult: Initially 750 mg, then 250 mg every 8 hours until attack has passed Acute migraine ▶BY MOUTH ▶Adult: 500 mg for 1 dose, to be taken in combination with sumatriptan as soon as migraine symptoms develop l UNLICENSED USE g Naproxen is used for the treatment of acute migraine in combination with sumatriptan, h but is not licensed for this indication.

Source page 1233

Contra Indications

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

Source page 1233

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. peripheral arterial disease. risk factors for cardiovascular events. uncontrolled hypertension

Source page 1233

Allergy And Cross Sensitivity

Contraindicated in patients with a history of hypersensitivity to aspirin or any other NSAID—which includes those in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by aspirin or any other NSAID.

Source page 1233

National Funding Access Decisions

Scottish Medicines Consortium (SMC) decisions SMC No. 1154/16 The Scottish Medicines Consortium has advised (June 2016) that naproxen effervescent tablets (Stirlescent ®) are accepted for restricted use within NHS Scotland for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhoea and acute gout in adults unable to swallow naproxen tablets.

Source pages 1233, 1234

Exceptions To Legal Category

Can be sold to the public for the treatment of primary dysmenorrhoea in women aged 15–50 years subject to max. single dose of 500 mg, max. daily dose of 750 mg for max. 3 days, and a max. pack size of 9 6 250 mg tablets.

Source page 1234

Safety

Extracted information for Naproxen only.

Interactions

→Appendix 1: NSAIDs

Source page 1233

Side Effects

Agranulocytosis. alopecia. angioedema. aplastic anaemia. asthma. cognitive impairment. concentration impaired. confusion. constipation. corneal opacity. depression. diarrhoea. dizziness. drowsiness. dyspnoea. erythema nodosum. fatigue. gastrointestinal discomfort. gastrointestinal disorders. glomerulonephritis . haemolytic anaemia. haemorrhage. hallucination. headache. hearing impairment. heart failure. hepatic disorders. hyperhidrosis. hyperkalaemia. hypersensitivity . hypertension. increased risk of arterial Musculoskeletal system thromboembolism. infertility female. inﬂammatory bowel disease. malaise. meningitis aseptic (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible). muscle weakness. myalgia. nausea. nephritis tubulointerstitial. nephropathy. neutropenia. oedema. optic neuritis. oral disorders. palpitations. pancreatitis. papillitis. papilloedema. paraesthesia. photosensitivity reaction. platelet aggregation inhibition. pulmonary oedema. rash pustular. renal failure (more common in patients with pre- existing renal impairment). renal papillary necrosis. respiratory disorders. seizure. severe cutaneous adverse reactions (SCARs). skin reactions. sleep disorders. thirst. thrombocytopenia. tinnitus. vasculitis. vertigo. visual impairment. vomiting 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. p. 1193

Source page 1233

Conception And Contraception

Caution—long-term use of some NSAIDs is associated with reduced female fertility, which is reversible on stopping treatment.

Source page 1233

Pregnancy

Avoid unless the potential beneﬁt outweighs the risk. Avoid during the third trimester (risk of closure of fetal ductus arteriosus in utero and possibly persistent pulmonary hypertension of the newborn); onset of labour may be delayed and duration may be increased.

Source page 1233

Breast Feeding

Use with caution during breast-feeding. Amount too small to be harmful but manufacturer advises avoid.

Source page 1233

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.

Source page 1233

Renal Impairment

Avoid if possible or use with caution. Avoid if eGFR less than 30 mL/minute/1.73 m2. Dose adjustments The lowest effective dose should be used for the shortest possible duration. Monitoring In renal impairment monitor renal function; sodium and water retention may occur and renal function may deteriorate, possibly leading to renal failure.

Source page 1233

Dose and formulations

Extracted information for Naproxen only.

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension Gastro-resistant tablet CAUTIONARY AND ADVISORY LABELS 5, 25 ▶Naproxen (Non-proprietary) Naproxen 250 mg Naproxen 250mg gastro-resistant tablets | 56 tablet P £11.69 DT = £9.73 Musculoskeletal system Naproxen 375 mg Naproxen 375mg gastro-resistant tablets | 56 tablet P £27.78 DT = £27.77 Naproxen 500 mg Naproxen 500mg gastro-resistant tablets | 56 tablet P £23.79 DT = £19.54 ▶Naprosyn EC (Atnahs Pharma UK Ltd) Naproxen 250 mg Naprosyn EC 250mg tablets | 56 tablet P £4.29 DT = £9.73 Naproxen 375 mg Naprosyn EC 375mg tablets | 56 tablet P £6.42 DT = £27.77 Naproxen 500 mg Naprosyn EC 500mg tablets | 56 tablet P £8.56 DT = £19.54 ▶Nexocin EC (Noumed Life Sciences Ltd) Naproxen 250 mg Nexocin EC 250mg gastro-resistant tablets | 56 tablet P s DT = £9.73 Naproxen 375 mg Nexocin EC 375mg gastro-resistant tablets | 56 tablet P s DT = £27.77 Naproxen 500 mg Nexocin EC 500mg gastro-resistant tablets | 56 tablet P s DT = £19.54 Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Naproxen (Non-proprietary) Naproxen 250 mg Naproxen 250mg tablets | 28 tablet P £5.35 DT = £2.91 | 56 tablet P £10.70 Naproxen 500 mg Naproxen 500mg tablets | 28 tablet P £8.14 DT = £2.47 | 56 tablet P £14.30 ▶Naprosyn (Atnahs Pharma UK Ltd) Naproxen 250 mg Naprosyn 250mg tablets | 56 tablet P £4.29 Naproxen 500 mg Naprosyn 500mg tablets | 56 tablet P £8.56 Oral suspension ▶Naproxen (Non-proprietary) Naproxen 25 mg per 1 ml Naproxen 25mg/ml oral suspension sugar free sugar-free | 100 ml P £110.00 DT = £119.00 Naproxen 125mg/5ml oral suspension sugar free sugar-free | 100 ml P £110.00–£128.00 DT = £119.00 Naproxen 50 mg per 1 ml Naproxen 50mg/ml oral suspension | 100 ml P £45.01 DT = £45.01 Effervescent tablet ▶Stirlescent (Stirling Anglian Pharmaceuticals Ltd) Naproxen 250 mg Stirlescent 250mg effervescent tablets sugar-free | 20 tablet P £52.72 DT = £52.72

Source page 1234

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

0.5–1 g daily in 1–2 divided doses

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1233

Adults

First line only; read the complete Indications and dose section above.

Initially 500 mg, then 250 mg every 6–8 hours as

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1233

Adults

First line only; read the complete Indications and dose section above.

Initially 750 mg, then 250 mg every 8 hours until

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1233

Adults

First line only; read the complete Indications and dose section above.

500 mg for 1 dose, to be taken in combination

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1233

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

naproxen

Reference monograph

Part of registered formulation

NAPROXEN

Reference record: Naproxen
Source: BNF 80 (2020–2021)
Printed source pages: 1233, 1234
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Naproxen only.

Indications And Dose

Source page 1233

Contra Indications

Source page 1233

Cautions

Source page 1233

Allergy And Cross Sensitivity

Source page 1233

National Funding Access Decisions

Source pages 1233, 1234

Exceptions To Legal Category

Source page 1234

Safety

Extracted information for Naproxen only.

Interactions

→Appendix 1: NSAIDs

Source page 1233

Side Effects

Source page 1233

Conception And Contraception

Caution—long-term use of some NSAIDs is associated with reduced female fertility, which is reversible on stopping treatment.

Source page 1233

Pregnancy

Source page 1233

Breast Feeding

Use with caution during breast-feeding. Amount too small to be harmful but manufacturer advises avoid.

Source page 1233

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.

Source page 1233

Renal Impairment

Source page 1233

Dose and formulations

Extracted information for Naproxen only.

Medicinal Forms

Source page 1234

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

0.5–1 g daily in 1–2 divided doses

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1233

Adults

First line only; read the complete Indications and dose section above.

Initially 500 mg, then 250 mg every 6–8 hours as

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1233

Adults

First line only; read the complete Indications and dose section above.

Initially 750 mg, then 250 mg every 8 hours until

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1233

Adults

First line only; read the complete Indications and dose section above.

500 mg for 1 dose, to be taken in combination

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1233

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.