Naproflam 500

Rx

Indications

• Rheumatoid arthritis,
• Osteoarthrosis,
• Ankylosing spondylitis,
• Juvenile rheumatoid arthritis,
• Acute gout,
• Acute musculoskeletal disorders,
• Dysmenorrhoea.

Dosage

Adults

• Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
  500 mg to 1 g taken in 2 doses at 12-hour intervals or alternatively, as a single administration.
  In the following cases a loading dose of 750 mg or 1 g per day for the acute phase is recommended:
  – In patients reporting severe night-time pain/or morning stiffness.
  – In patients being switched to naproxen from a high dose of another anti-rheumatic compound.
  – In osteoarthrosis where pain is the predominant symptom.
• Acute gout
  750 mg at once then 250 mg every 8 hours until the attack has passed.
• Acute musculoskeletal disorders and dysmenorrhoea
  500 mg initially followed by 250 mg at 6 – 8 hour intervals as needed, with a maximum daily dose after the first day of 1250 mg.

Older people should use the lowest effective dose and for the shortest duration possible.

Paediatric population (over 5 years)

• For juvenile rheumatoid arthritis: 10 mg/kg/day taken in 2 doses at 12-hour intervals.
• Naproxen is not recommended for use in any other indication in children under 16 years of age.

Renal/hepatic impairment

• A lower dose should be considered in patients with renal or hepatic impairment.
• Naproxen is contraindicated in patients with baseline creatinine clearance less than 30 ml/minute.

Usage

• Naproflam 500 is administered orally, to be taken preferably with or after food.

• Peptic ulceration or active gastrointestinal bleeding,
• Hypersensitivity to naproxen, naproxen sodium, or to any of the excipients,
• Naproxen should not be given to patients in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis, nasal polyps or urticaria,
• Severe renal, hepatic or heart failure,
• The last trimester of pregnancy.

Very common

• Heartburn, nausea, vomiting, constipation, diarrhoea, flatulence, dyspepsia, abdominal discomfort and epigastric distress,
• Dyspnoea,
• Rashes of various types, pruritus, urticarial, angio-oedema,
• Insomnia, dizziness, headache.

• Older people and/or debilitated patients are particularly susceptible to the adverse effects of NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Prolonged use of NSAIDs in these patients is not recommended.
• The antipyretic and anti-inflammatory activities of naproxen may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs.
• Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.
• Severe hepatic reactions, including jaundice and hepatitis(some cases of hepatitis have been fatal) have been reported with this drug as with other non-steroidal anti-inflammatory drugs.
• Naproxen decreases platelet aggregation and prolongs bleeding time.
• 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. 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. Naproxen is contraindicated in patients having a baseline creatinine clearance of less than 30 ml/minute.
• Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis should be carefully observed if naproxen-containing products are administered.
• Patients at high risk of bleeding or those on full anti-coagulation therapy (e.g. dicoumarol derivatives) may be at increased risk of bleeding if given naproxen-containing products concurrently.
• Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or exposure to aspirin, other non-steroidal anti-inflammatory drugs or naproxen-containing products.
• If steroid dosage is reduced or eliminated during therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.
• Patients who develop visual disturbances during treatment with naproxen-containing products should have an ophthalmological examination.
• 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.
• In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
• Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Naproxen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• The combination of naproxen-containing products and other NSAIDs is not recommended.
• To minimize the risk for an adverse cardiovascular event in patients treated with naproxen, prescribe the lowest effective daily dose for the shortest duration possible.
• Use of naproxen in the last trimester of pregnancy is contraindicated. NSAIDs should not be used during the first two trimesters of pregnancy, unless the potential benefit to the patient outweighs the potential risk to the foetus.
• The use of naproxen should be avoided in patients who are breast-feeding.
• Some patients may experience drowsiness, dizziness, vertigo, insomnia, fatigue, visual disturbances or depression with the use of naproxen. If patients experience these or similar undesirable effects, they should not drive or operate machinery.