Isoniazid
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- ISONIAZID DESCRIPTION
- CLINICAL PHARMACOLOGY
- MICROBIOLOGY
- INDICATIONS & USAGE
- ISONIAZID CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- LABORATORY TESTS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- ISONIAZID ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- REFERENCES
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
ISONIAZID DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of Action
Isoniazid resistant Mycobacterium tuberculosis bacilli develop rapidly when isoniazid monotherapy is administered.
MICROBIOLOGY
INDICATIONS & USAGE
ISONIAZID CONTRAINDICATIONS
WARNINGS
See boxed warningPRECAUTIONS
GeneralLABORATORY TESTS
DRUG INTERACTIONS
FoodAcetaminophen
Carbamazepine
Ketoconazole
Phenytoin
Theophylline
Valproate
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
Teratogenic EffectsPregnancy Category C
Isoniazid has been shown to have an embryocidal effect in rats and rabbits when given orally during pregnancy. Isoniazid was not teratogenic in reproduction studies in mice, rats, and rabbits. There are no adequate and well-controlled studies in pregnant women. Isoniazid should be used as a treatment for active tuberculosis during pregnancy because the benefit justifies the potential risk to the fetus. The benefit of preventative therapy also should be weighed against a possible risk of exposure; the low levels of isoniazid in breast milk do not threaten the neonate. Since isoniazid is known to cross the placenta barrier, neonates of isoniazid treated mothers should be carefully observed for any evidence of adverse effects.
Nonteratogenic Effects
Since isoniazid is known to cross the placenta barrier, neonates of isoniazid-treated mothers should be carefully observed for any evidence of adverse effects.
NURSING MOTHERS
ISONIAZID ADVERSE REACTIONS
Nervous System Reactions
Hepatic Reactions
See boxed warning
Gastrointestinal Reactions
Nausea, vomiting, and epigastric distress.
Hematologic Reactions
Hypersensitivity Reactions
Fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy, and vasculitis.
Metabolic and Endocrine Reactions
Pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis, and gynecomastia.
Miscellaneous Reactions
Rheumatic syndrome and systemic lupus erythematosus-like syndrome.
OVERDOSAGE
Signs and SymptomsTreatment
For the Asymptomatic Patient
For the Symptomatic Patient
General
Rapid Control of Metabolic Acidosis
Dialysis
DOSAGE & ADMINISTRATION
(See also INDICATIONS0.)For Treatment of Tuberculosis
Patients with Pulmonary Tuberculosis Without HIV Infection
(see also Directly Observed Therapy
Patients with Pulmonary Tuberculosis and HIV Infection
Patients with Extra Pulmonary Tuberculosis
Pregnant Women with Tuberculosis
Treatment of Patients with Multi-Drug Resistant Tuberculosis (MDRTB)
Directly Observed Therapy (DOT)
For Preventative Therapy of Tuberculosis
HOW SUPPLIED
STORAGE AND HANDLING
REFERENCES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
IsoniazidIsoniazid TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
