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Isoniazid / rifampin Pregnancy and Breastfeeding Warnings

Isoniazid / rifampin is also known as: IsonaRif, Rifamate

Isoniazid / rifampin Pregnancy Warnings

Isoniazid-rifampin has not been formally assigned to a pregnancy categoy by the FDA. Isoniazid-rifampin is only recommended for use during pregnancy when benefit outweighs risk. Isoniazid has been assigned to a pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality. There are no controlled data in human pregnancy; however, isoniazid is known to cross the placental barrier. Rifampin has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy; however, rifampin has been reported to cross the placental barrier and appear in cord blood. Isolated cases of fetal malformations have been reported. Postnatal hemorrhages in the mother and infant have been associated with the use of rifampin during the last few weeks of pregnancy, and administration of vitamin K may be indicated.

Isoniazid / rifampin Breastfeeding Warnings

Isoniazid and rifampin are excreted into human milk. Adverse effects in the nursing infant due to isoniazid are unlikely. The effects of rifampin in the nursing infant are unknown. Isoniazid is considered compatible with breast-feeding by the manufacturer; however, the manufacturer of rifampin recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Isoniazid and rifampin are considered compatible with breast-feeding by the American Academy of Pediatrics.

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