Ibuprofen Coated Tablets Antipyretic - analgesic Medicines, BP/USP/CP standard

Ibuprofen Tablet

COMPOSITION:

Each sugar-coated tablet contains 400 mg Ibuprofen.

PHARMACOLOGICAL ACTION:

Ibuprofen, which is a non-steroidal, anti-inflammatory, antipyretic and analgesic agent. It inhibits the synthesis of prostaglandins. Ibuprofen is absorbed from the gastro-intestinal tract producing peak plasma concentrations after one to two hours.

INDICATIONS:

Ibuprofen is indicated in the treatment of rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis, Still's disease (juvenile rheumatoid arthritis), fibrositis, musculoskeletal pain, swelling and inflammation due to trauma.

CONTRA-INDICATIONS:

It should be given with care to patients with peptic ulceration or a history of such ulceration, bleeding disorders, cardiovascular disease and those on oral anticoagulants. It should not be given to patients who are sensitive to aspirin. Ibuprofen should be administered with care in patients with asthma, especially those who have developed bronchospasm with other non-steroidal agents.

WARNINGS:

Contains tartrazine, which may cause allergic type reactions (including bronchial asthma) in certain individuals. The overall incidence of tartrazine sensitivity is low; it is however frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:

Adults:
600 mg - 1 200 mg daily in divided doses.
Children:
20 mg/kg body mass per day but not to exceed 500 mg per day in children weighing less than 30 kg.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Ibuprofen may cause nausea, vomiting, dyspepsia, diarrhoea, stomatitis, or gastrointestinal haemorrhage. Headache, dizziness, nervousness and other central nervous system effects, skin rash, thrombocytopenia, agranulocytosis, toxic amblyopia, bronchospasm, oedema, tinnitus, pruritus, depression, drowsiness, insomnia and blurred vision may occur.