Rimactazid-300/Rimactazid-450 Use In Pregnancy & Lactation

Rifampicin: In mice and rats, rifampicin proved teratogenic in daily doses of >150 mg/kg, insofar as an increased occurrence of spina bifida and cleft palate was observed. In rabbits, it had no teratogenic effect. In all 3 animal species, unspecific embryotoxic effects occurred after doses >150 mg/kg.
In humans, no significant increase in malformation rate was observed in the offspring of >300 women exposed to rifampicin during pregnancy.
Administration of rifampicin during the last few weeks of pregnancy can cause postnatal hemorrhage in the mother and newborn infant, which may necessitate treatment with vitamin K preparations.
Isoniazid: Teratogenic effects have been noted in animal models.
Nevertheless, isoniazid has been found to entail relatively little risk during pregnancy in humans. Congenital malformations are no greater than those expected for the normal population. Since it is theoretically possible that the drug might exert neurotoxic effects on the child, it is recommended that the mother should take pyridoxine during pregnancy.
Rimactazid/CombiPack should not be given during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Although rifampicin and isoniazid pass into the breast milk, no adverse effects on breastfed infants have been observed. It is therefore not absolutely necessary to wean the infant. However, in view of the theoretical possibility of neurotoxic effects due to isoniazid, breastfed infants should be kept under careful surveillance. Prophylactic administration of pyridoxine to mother and child is recommended.
Pyrazinamide: There is no experience upon which to judge the safety of pyrazinamide in human pregnancy, nor is there evidence from animal work that it is free from either teratogenic potential or other adverse effects on the embryo and/or fetus relevant to the safety assessment of the product. It is unknown whether pyrazinamide passes through the placenta. Pyrazinamide also passes into the breast milk; the adverse effects on the infant are unknown. Therefore, the benefits and risks of nursing the infant should be carefully considered.