Medicell Pharma
Concise Prescribing Info
Treatment of pulmonary & extrapulmonary TB in combination w/ other anti-TB drugs. Monotherapy in the prophylaxis of TB.
Dosage/Direction for Use
Treatment of active TB Adult 5-10 mg/kg daily as a single dose. Max: 300 mg/day & rifampicin (10-20 mg/kg daily to a max of 600 mg daily) for 2-8 wk. Childn 10-20 mg/kg daily as a single dose, up to 300-500 mg daily. Prophylaxis Adult 300 mg daily as a single dose for 6-12 mth. Childn 10 mg/kg daily as a single dose for 6-12 mth. Max: 300 mg/day.
Should be taken on an empty stomach: Best taken 1 hr before or 2 hr after meals. May be taken w/ meals to reduce GI discomfort.
Hypersensitivity including drug-induced hepatitis; acute liver disease of any etiology. Pregnancy.
Special Precautions
Preexisting liver disease. Concurrent use of other hepatotoxic medications; excessive or chronic alcoholism. Defer preventive treatment in individual w/ acute hepatic diseases. Patients w/ convulsive disorders; severe renal dysfunction; renal TB. Periodic ophthalmoscopic exam is recommended if visual symptoms occur. Lactation. Elderly.
Adverse Reactions
Peripheral neuropathy, convulsion, toxic encephalopathy, optic neuritis & atrophy, toxic psychosis, nausea, vomiting, epigastric distress, elevated serum transaminases, bilirubinuria, hepatitis w/ or w/o jaundice, agranulocytosis, hemolytic, sideroblastic or aplastic anemia; thrombocytopenia, eosinophilia. Fever, skin eruptions, lymphadenopathy, vasculitis. Pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis, gynecomastia. Rheumatic syndrome, SLE-like syndrome.
Drug Interactions
Anticonvulsants eg phenytoin, carbamazepine. Al(OH)3 gel, disulfiram, oral anticoagulants, cycloserine, primidone, rifampin. Ketoconazole, acetaminophen, corticosteroids, diazepam, theophyllines.
MIMS Class
ATC Classification
J04AC01 - isoniazid ; Belongs to the class of hydrazides. Used in the systemic treatment of tuberculosis.
PDP-Isoniazid tab 300 mg
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