Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**DOSAGE** Orally as a single daily dose, preferably on an empty stomach. Absorption may be reduced with food but isoniazid may be taken with meals if gastrointestinal irritation occurs. May be given i.m. (if oral administration is not possible). For treatment of active tuberculosis, adults, 5 to 10mg/kg daily in a single dose (maximum of 300mg daily) and rifampin (10 to 20mg/kg daily to a maximum of 600mg daily) which are administered for an initial phase lasting from 2 to 8 weeks. Children inactivate isoniazid faster than adults and may be given 10 to 20 mg/kg daily in a single dose (up to 300 to 500mg daily). For prophylactic use, isoniazid is generally used alone and preventive therapy generally should be continued for 6 months to 12 months. Adults: 300 mg daily in a single dose. Children: 10 mg/kg daily in a single dose (maximum 300 mg daily). **Supplied:** White tablet scored on one side, pms on the other side in 50, 100 and 300 mg. Bottles of 100.
ORAL
Medical Information
**INDICATIONS** Used in conjunction with other antituberculosis drugs in the treatment of pulmonary and extrapulmonary tuberculosis and alone in the prophylaxis of tuberculosis.
**CONTRAINDICATIONS** Patients who develop severe hypersensitivity reactions to isoniazid, included drug induced hepatitis; acute liver disease of any etiology, pregnancy (preventive treatment with isoniazid should be started after delivery).
J04AC01
isoniazid
Manufacturer Information
MEDICELL PHARMACEUTICAL (S) PTE. LTD.
Pharmascience Inc.
Active Ingredients
Documents
Package Inserts
PDP-Isoniazid Tablet PI.pdf
Approved: April 10, 2023