Drug profile
Isoniazid
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Adults over 30 Kg: 300 mg per day in a single dose.
Source: US FDA label for isoniazid (isoniazid), section 'dosage and
administration', retrieved 2026-08-29
- In situations where adherence with daily preventative therapy cannot be assured,
20 mg/kg to 30 mg/kg (not to exceed 900 mg) twice weekly under the direct
observation of a health care worker at the time of administration 8 .
Source: US FDA label for isoniazid (isoniazid), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Infants and Children 10 mg/kg (up to 300 mg daily) in a single dose.
Source: US FDA label for isoniazid (isoniazid), section 'dosage and
administration', retrieved 2026-08-29
- In situations where adherence with daily preventative therapy cannot be assured,
20 mg/kg to 30 mg/kg (not to exceed 900 mg) twice weekly under the direct
observation of a health care worker at the time of administration 8 .
Source: US FDA label for isoniazid (isoniazid), section 'dosage and
administration', retrieved 2026-08-29
RENAL IMPAIRMENT
- No kidney-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for isoniazid (isoniazid),
retrieved 2026-08-29
HEPATIC IMPAIRMENT
- No liver-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for isoniazid (isoniazid),
retrieved 2026-08-29
PREGNANCY
- Teratogenic Effects Pregnancy Category C Isoniazid has been shown to have an
embryocidal effect in rats and rabbits when given orally during pregnancy.
Source: US FDA label for isoniazid (isoniazid), section 'pregnancy', retrieved
2026-08-29
- Isoniazid was not teratogenic in reproduction studies in mice, rats and rabbits.
Source: US FDA label for isoniazid (isoniazid), section 'pregnancy', retrieved
2026-08-29
- There are no adequate and well-controlled studies in pregnant women.
Source: US FDA label for isoniazid (isoniazid), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- The small concentrations of isoniazid in breast milk do not produce toxicity in
the nursing newborn; therefore, breast feeding should not be discouraged.
Source: US FDA label for isoniazid (isoniazid), section 'nursing mothers',
retrieved 2026-08-29
- However, because levels of isoniazid are so low in breast milk, they can not be
relied upon for prophylaxis or therapy of nursing infants.
Source: US FDA label for isoniazid (isoniazid), section 'nursing mothers',
retrieved 2026-08-29