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Isoniazid Injection Generic Name & Formulations
Legal Class
Rx
General Description
Isoniazid 100mg/mL; soln for IM inj; contains chlorobutanol.
Pharmacological Class
Isonicotinic acid.
How Supplied
Vial (10mL)—1
Manufacturer
Isoniazid Injection Indications
Indications
Treatment and prophylaxis of susceptible tuberculosis.
Isoniazid Injection Dosage and Administration
Adult
Treatment: 5mg/kg up to 300mg daily in a single dose; or 15mg/kg up to 900mg/day, 2 or 3 times/week. See literature for regimens in patients with pulmonary TB without HIV, pulmonary TB with HIV, patients with extra pulmonary TB, pregnant women with TB, and patients with multi-drug resistant TB. Prevention: >30kg: 300mg/day in a single dose. Malnourished, predisposed to neuropathy: give concomitant pyridoxine.
Children
Treatment: 10–15mg/kg up to 300mg daily in a single dose; or 20–40mg/kg up to 900mg/day, two or three times/week. See literature for regimens in patients with pulmonary TB without HIV, pulmonary TB with HIV, patients with extra pulmonary TB, pregnant women with TB, and patients with multi-drug resistant TB. Prevention: 10mg/kg (up to 300mg daily) in a single dose. Malnourished, predisposed to neuropathy: give concomitant pyridoxine.
Isoniazid Injection Contraindications
Contraindications
Drug-induced hepatitis. Previous isoniazid-associated hepatic injury. Severe adverse reactions to isoniazid (eg, drug fever, chills, arthritis). Acute liver disease of any etiology.
Isoniazid Injection Boxed Warnings
Not Applicable
Isoniazid Injection Warnings/Precautions
Warnings/Precautions
Increased risk of severe or fatal hepatitis; monitor, discontinue if signs of hepatic damage detected. Defer in acute hepatic disease. Alcoholics. Chronic liver disease. Perform LFTs prior to therapy, then periodically as needed. Severe renal dysfunction. >35yrs old. Peripheral neuropathy or conditions predisposing to neuropathy. Injection drug use. Women belonging to minority groups, particularly in the post-partum period. HIV seropositive. Perform eye exams if visual symptoms occur. Neonates. Pregnancy (Cat.C). Nursing mothers.
Isoniazid Injection Pharmacokinetics
See Literature
Isoniazid Injection Interactions
Interactions
Concomitant hepatotoxic agents: may cause fatal liver dysfunction. Concomitant alcohol may be associated with higher incidence of isoniazid hepatitis. Monitor prothrombin time with concomitant anticoagulants. May potentiate phenytoin, carbamazepine, theophylline, valproate (adjust dose). May antagonize ketoconazole. May inhibit assays for serum folate and Vit. B12 (consider alternative methods).
Isoniazid Injection Adverse Reactions
Adverse Reactions
Peripheral neuropathy (esp. in slow acetylators), elevated serum transaminases (SGOT; SGPT), bilirubinemia, bilirubinuria, jaundice, hepatitis (may be fatal), nausea, vomiting, epigastric distress, pancreatitis, blood dyscrasias, hypersensitivity reactions (eg, skin eruptions, TEN, DRESS), pyridoxine deficiency, hyperglycemia, pellagra, metabolic acidosis, gynecomastia, rheumatic syndrome, SLE-like syndrome, inj site reactions.
Isoniazid Injection Clinical Trials
See Literature
Isoniazid Injection Note
Not Applicable
Isoniazid Injection Patient Counseling
See Literature
