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NAPROXEN is a brand name for Naproxen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Naproxen is indicated for the treatment of juvenile rheumatoid arthritis, rheumatoid arthritis, ankylosing spondylitis, osteoarthrosis (degenerative arthritis), acute gout, acute musculoskeletal disorders (for example sprains and strains, tenosynovitis, fibrositis, lumbosacral pain, direct trauma, and cervical…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Adults Naproxen gastro-resistant tablets should be swallowed whole and not broken or crushed. Therapy should be started at the lowest recommended dose, especially in the elderly. Rheumatoid arthritis, osteoarthrosis and ankylosing spondylitis The usual dose is 500 mg to 1 g per day taken in two divided doses at 12 hour intervals.
Where 1 g per day is needed either one 500 mg tablet twice daily or two 500 mg tablets in a single administration (morning or evening) is recommended. In the following cases a loading dose of 750 mg or 1 g per day for the acute phase is recommended: a) In patients reporting severe night-time pain/or morning stiffness.
b) In patients being switched to Naproxen from a high dose of another anti-rheumatic compound. c) In osteoarthrosis where pain is the predominant symptom. Acute gout 750 mg immediately, then 250 mg every 8 hours until the attack has passed.
Acute musculoskeletal disorders and dysmenorrhoea 500 mg initially, then 250 mg every 6 – 8 hours as needed. The maximum daily dose (after the first day) is 1250 mg.
Paediatric population Juvenile rheumatoid arthritis:
Normally, dosage is 10 mg/kg bodyweight daily taken in 2 doses at 12 hour intervals. The Elderly Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly.
The implication of this finding for Naproxen dosing is unknown. The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective does should be used and for the shortest possible duration.
The patient should be monitored regularly for GI bleeding during NSAID therapy. For the effect of reduced elimination in the elderly refer to Section
The following adverse events have been reported with NSAIDs and naproxen. Gastro-intestinal: the most commonly-observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, heartburn and epigastric distress.
4) and oesophagitis. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely. Immune system disorders: hypersensitivity reactions have been reported following treatment with NSAIDs in patients with, or without, a history of previous hypersensitivity reaction to NSAIDs.
These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis, erythema multiforme).
Metabolic and nutrition disorders: hyperkalaemia.
Psychiatric disorders:
Insomnia, dream abnormalities, depression, confusion and hallucinations.
Cardiac disorders:
Oedema, palpitations, cardiac failure and congestive heart failure have been reported in association with NSAID treatment. 4).
Vascular disorders:
Hypertension, vasculitis.
Renal and urinary disorders:
Including, but not limited to, glomerular nephritis, interstitial nephritis, nephrotic syndrome, haematuria, raised serum creatinine, renal papillary necrosis and renal failure.
4. Renal/hepatic impairment A lower dose should be considered in patients with renal or hepatic impairment. 3). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Method of administration For oral administration preferably with or after food.
3 Contraindications Hypersensitivity to naproxen or to any of the excipients. Active or history of peptic ulceration or active gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). g. asthma, rhinitis, nasal polyps, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs)/analgesic drugs as the potential exists for cross-sensitivity reactions.
These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients. 4). 6 – Pregnancy and lactation) History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine. 2, and GI and cardiovascular risks below). Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.
The antipyretic and anti-inflammatory activities of Naproxen may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs. As with other non-steroidal anti-inflammatory drugs, elevations of one or more liver function tests may occur.
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 nonsteroidal anti-inflammatory drugs.
Hypersensitivity to naproxen or to any of the excipients. Active or history of peptic ulceration or active gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). g. asthma, rhinitis, nasal polyps, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs)/analgesic drugs as the potential exists for cross-sensitivity reactions.
These reactions have the potential of being fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients. 4). 6 – Pregnancy and lactation) History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hepatobiliary disorders:
Abnormal liver function tests, fatal hepatitis and jaundice.
Nervous system disorders:
Convulsions, dizziness, retrobulbar optic neuritis, headaches, light-headedness, drowsiness, paraesthesia, inability to concentrate and cognitive dysfunction have been reported. 4).
Eye disorders:
Visual disturbances, corneal opacity, papillitis and papilloedema.
Ear and Labyrinth disorders:
Tinnitus, hearing disturbances including impairment and vertigo.
Respiratory, thoracic and mediastinal disorders:
Dyspnoea, asthma, eosinophilic pneumonitis and pulmonary oedema.
Blood and lymphatic system disorders:
Thrombocytopenia, neutropenia, granulocytopenia including agranulocytosis, eosinophilia, leucopenia, aplastic anaemia and haemolytic anaemia.
Skin and subcutaneous tissue disorders:
Bullous reactions including Steven Johnson Syndrome and Toxic Epidermal necrosis (very rare). Skin rashes including fixed drug eruption, itching (pruritus), urticaria, ecchymoses, purpura, sweating. Also alopecia, erythema multiforme, erythema nodosum, lichen planus, pustular reaction, SLE, epidermal necrolysis, photosensitivity reactions (including cases in which skin resembles porphyria cutanea tarda “pseudoporphyria”) or epidermolysis bullosa-like reactions which may occur rarely.
If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
Musculoskeletal and connective tissue disorders:
Myalgia and muscle weakness.
Reproductive system and breast disorders:
Female infertility.
General disorders and administration site conditions:
Thirst, pyrexia, fatigue and malaise. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Cross reactivity has been reported. Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac function may be at a greater risk when taking Naproxen.
5). 2). Prolonged use of NSAIDs in these patients is not recommended. Where prolonged therapy is required, patients should be reviewed regularly. Respiratory disorders Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma or allergic disease since NSAIDs have been reported to precipitate bronchospasm in such patients.
Cardiovascular, Hepatic Impairment and Renal failure linked to reduced prostaglandin production The administration of an NSAID may cause a dose dependant reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
3). Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Although data suggest that the use of naproxen (1000 mg daily) may be associated with a lower risk, some risk cannot be excluded. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Renal Effects There have been reports of impaired renal function, renal failure, acute interstitial nephritis, haematuria, proteinuria, renal papillary necrosis and occasionally nephrotic syndrome associated with naproxen.
Use in patients with impaired renal function As naproxen is eliminated to a large extent (95%) by urinary excretion via glomerular filtration, it should be used with great caution in patients with impaired renal function and the monitoring of serum creatinine and/or creatinine clearance is advised in these patients.
Naproxen is contraindicated in patients having a baseline creatinine clearance of less than 30ml/minute. Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree of protein binding. […]