P-Fen

Symptomatic treatment of juvenile RA. Reduction of fever, including post-immunization pyrexia. Symptomatic relief of colds & flu, & mild to moderate pain eg, sore throat, teething pain, toothache, earache, headache, minor aches & sprains.

Dose should be given approx every 6-8 hr (or w/ a min of 4 hr between each dose if required). Childn 10-12 yr 15 mL dose may be taken 3 times in 24 hr, 7-9 yr 10 mL dose may be taken 3 times in 24 hr, 4-6 yr 7.5 mL dose may be taken 3 times in 24 hr, 1-3 yr 5 mL dose may be taken 3 times in 24 hr. Infant 6-12 mth 2.5 mL dose may be taken 3-4 times in 24 hr, 3-6 mth weighing >5 kg 2.5 mL dose may be taken 3 times in 24 hr. Juvenile RA 30-40 mg/kg/day in 3-4 divided doses. Post-immunization pyrexia One 2.5 mL dose followed by one further 2.5 mL dose 6 hr later if necessary. No more than two 2.5 mL dose in 24 hr.

Should be taken with food.

Hypersensitivity. Patients w/ severe heart failure. Treatment of peri-operative pain in CABG surgery setting. History of GI bleeding or perforation, related to previous NSAIDs therapy. Active or history of recurrent peptic ulcer/haemorrhage. 3rd trimester of pregnancy.

Use at the lowest effective dose for the shortest possible time. Increased risk of serious CV thrombotic events, MI, & stroke; serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines. Risk of renal papillary necrosis & other renal injury w/ long-term administration. Risk of renal toxicity in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Not recommended in patients w/ advanced renal disease. Associated w/ serious liver injury in rare cases. Avoid 2,400 mg daily dose in patients w/ ischemic heart disease, cerebrovascular disease, CHF, or risk factors for CV disease. Avoid concomitant use of ≥2 NSAIDs. Concomitant administration w/ ASA is not recommended. Risks of premature closure of the ductus arteriosus & potential to prolong parturition during the 3rd trimester of pregnancy. Caution during the 1st & 2nd trimesters of pregnancy, particularly from middle to end of 2nd trimester (onset at approx 20 wk) due to possible fetal renal dysfunction leading to oligohydramnios &, in some cases, neonatal renal impairment or failure.

Short-term use: Hypersensitivity reactions; non-specific allergic reactions & anaphylaxis, resp tract reactivity eg, asthma, aggravated asthma, bronchospasm, dyspnea; various skin reactions eg, pruritus, urticaria, angioedema & more rarely exfoliative & bullous dermatoses (including epidermal necrolysis & erythema multiforme). Long-term use: Hypersensitivity reactions w/ urticaria & pruritus, abdominal pain, nausea, dyspepsia, headache, acute renal failure, papillary necrosis associated w/ increased serum urea & oedema, various skin rashes.

Enhanced effects of anticoagulants eg, warfarin. Increased risk of nephrotoxicity w/ diuretics; ciclosporin; tacrolimus. Increased risk of GI ulceration or bleeding w/ corticosteroids; antiplatelet agents & SSRIs. NSAIDs may exacerbate cardiac failure, reduce GFR & increase plasma glycoside levels when used in combination w/ cardiac glycosides. Reduced effect of mifepristone. Increased risk of haematological toxicity w/ zidovudine. Increased risk of haemarthroses & haematoma in HIV+ haemophiliacs receiving concurrent treatment w/ zidovudine & ibuprofen.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

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