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RIFIN FORTE

RIFAMPICIN, ISONIAZID, ETHAMBUTOL AND PYRAZINAMIDE · by PACIFIC PHARMA

ANTIMYCOBACTERIALS (ANTITUBERCULOSIS) Ethambutol/Isonicotinic acid derivative/Nicotinic acid derivative/Rifamycin PACIFIC PHARMA

Composition

Tab 120/60/225/300 mg: Rifampicin 120 mg, isoniazid 60 mg, ethambutol 225 mg, pyrazinamide 300 mg. Tab 150/75/275/400 mg: Rifampicin 150 mg, isoniazid 75 mg,ethambutol 275 mg, pyrazinamide 40

Indications & Dosage

Initial treatment of tuberculosis: Adult (body-weight 30-39 kg): 2 tabs daily for 2 months (initial phase); (body-weight 40-54 kg): 3 tabs daily for2 months (initial phase); (body-weight 55-69 kg): 4 tabs daily for2 months (initial phase); (body-weight 70 kg and above): 5 tabs daily for2 months (initial phase).

Contraindications

Liver disease, previous hypersensitivity to any rifamycin, patients with previous isoniazid associated hepatic injury or other severe adverse reactions with isoniazid, hypersensitivity to ethambutol, optic neuritis.

Precautions

Patients with active chronic liver disease or severe renal dysfunction. Isoniazid crosses the placental barrier and passes into maternal breast milk, observe neonates, breast fed infants of isoniazid treated mothers for any evidence of adverse effects. Not recommended for intermittent therapy, caution patients against intentional or accidental interruption of daily dosage regimen, since rare renal hypersensitivity reactions have been reported when therapy is resumed. Urine, faeces, saliva, sputum, sweat and tears may be coloured red-orange. Reduce dosage in patients with decreased renal functions. Not recommended in children under thirteen years age. Perform frequently liver function tests and blood uric acid determinations, history of gout or diabetes. Withdraw treatment if liver damage or hyperuricaemia accompanied by acute gouty arthritis occurs.

Interactions

Probenecid, sulfinpyrazone, oral typhoid vaccine. Rifampicin induces hepatic microsomal enzymes that metabolize a wide variety of drugs e.g. metoprolol, propranolol, quinidine, corticosteroids, contra-ceptives, oral anticoagulants, oral sulfonylureas. The effectiveness of isoniazid may be decreased when administered with corticosteroid. The effects of benzodiazepines may be increased. The hepatic toxicity of both isoniazid and/or rifampicin may be increased when administered concomitantly.The effectiveness may be decreased when taking concomitantly with aluminium salts.

Pregnancy

Risk cannot be ruled out.

Lactation

Caution advised or effect undetermined.

Side Effects

Anaphylactoid reactions, heartburn, epigastric dis-tress, anorexia, nausea, vomiting, diarrhoea, sore mouth, rash, pruritus, urticaria, eosinophilia, thrombocytopenia, muscular weakness, pain in extremities, visual disturbances, haemoglobinuria, hematuria, menstrual disturbances, peripheral neuropathy, elevated SGOT, SGPT, SGOPT, optic neuritis (related to dose and duration of treatment), abdominal distress, fever, malaise headache diz-ziness, elevated serum uric acid level, hepatitis which can be minimized by dose adjustment.