Product Name：Ibuprofen tablet
Nombre del Producto: Ibuprofeno tableta
Specification: 400mg, 600mg
Package: 10tablets/blister/box, 1blister/box, 10blister/box
Standard: USP& BP & CP
Ibuprofen tablet 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.
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.
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 tablet should be administered with care in patients with asthma, especially those who have developed bronchospasm with other non-steroidal agents.
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.
Pregnancy and lactation
Ibuprofen tablet should not be administered during pregnancy and is not recommended for use by breast-feeding women.
Regular use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.
Side-effects and special precautions
Ibuprofen tablet 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. Abnormalities of liver function tests and impairment of renal function has been observed. Acute reversible renal failure has been reported. Ibuprofen should be used with care in patients with impaired renal function.
In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
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