Ibumax

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (anti-inflammatory agents).
PHARMACOLOGICAL ACTION:
Ibumax contains ibuprofen, a propionic acid derivative, which is non-steroidal compound. Ibuprofen is an anti-inflammatory agent and also has analgesic and antipyretic properties.
Ibuprofen is absorbed following oral administration, and peak serum concentrations are observed after 1 to 2 hours. The half-life in plasma is about 2 hours. Ibuprofen is extensively bound to plasma proteins (99%). It passes slowly into the synovial spaces and remains there in higher concentrations as the concentrations in plasma decline.
The excretion of ibuprofen is rapid and complete. Greater than 90% of an ingested dose is excreted in the urine as metabolites or their conjugates, and no ibuprofen by itself is found in the urine. The major metabolites are a hydroxylated and carboxylated compound.
INDICATIONS:
Ibumax is indicated in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis and osteoarthritis; and acute gouty arthritis, the treatment of nonarticular rheumatism, including fibrositis; the treatment of musculoskeletal pain, swelling and inflammation due to trauma. Ibumax is indicated for the relief of mild to moderate pain such as dysmenorrhoea, dental, post episiotomy and post-partum pain, headache, back pain and pain associated with migraine. Ibumax may be used as an antipyretic.
CONTRA-INDICATIONS:
Ibumax should not be administered during pregnancy and is not recommended for use by breastfeeding women. It should not be given to patients with bleeding disorders, cardiovascular disease, peptic ulceration or a history of such ulceration.
Caution is advised in those patients who are receiving coumarin anticoagulants.
Ibumax should not be given to patients who are sensitive to aspirin.
Ibumax should be prescribed with caution for those with asthma and especially for patients who have developed bronchospasm with other non-steroidal agents.
DOSAGE AND DIRECTIONS FOR USE:
Rheumatoid arthritis and osteoarthritis:
Acute: 1 200 to 2 400 mg per day in divided doses.
(6 x 200 mg tablets or 3 x 400 mg tablets up to 12 x 200 mg tablets or 6 x 400 mg tablets).
Maintenance: 600 mg to 1 200 mg per day in divided doses.
Children: Juvenile Rheumatoid Arthritis - 20 mg/kg of body mass in divided doses daily. Safety in children under one year of age has not been established.
Pain: Initial dose: 5 mg/kg of body weight. After 2 hours a second dose of 5 mg/kg may be given and thereafter if pain is not controlled 5 mg/kg every 4-6 hours. Do not exceed 20 mg/kg of bodyweight per day. Consult a doctor if pain persists more than 7 days.
Fever: 5 mg/kg of body weight every 4-6 hours. Do not exceed 20 mg/kg of bodyweight per day. Consult a doctor if fever persists more than 3 days.
The tablets may be taken with food to minimise gastro-intestinal side-effects. If gastro-intestinal disturbances occur, Ibumax should be given with food or milk.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Dyspepsia, nausea, gastro-intestinal intolerance and bleeding may occur. Skin rashes of various types have been observed.
Bronchospasm, thrombocytopenia and agranulocytosis have been reported.
Toxic amblyopia has occurred.
Headache, dizziness, nervousness and other central effects, vomiting, diarrhoea, oedema and tinnitus may occur. Abnormalities of liver function tests and impairment of renal function have been observed. Acute allergic reactions have been reported. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
The action of furosemide and the anti hypertensive effects of thiazide diuretics, beta-adrenergic antagonists, prazosin and captopril may be reduced when taken concomitantly with ibuprofen.
Acute reversible renal failure has been reported. Ibumax should be used with care in patients with impaired renal failure.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The most likely symptoms of overdosage are nausea and epigastric pain. Gastric lavage could be performed if recently taken. Further treatment is supportive and symptomatic.

STORAGE INSTRUCTIONS:
Store below 25°C, in a dry place. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

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