Ilosone 200/Ilosone DS

Ilosone 200/Ilosone DS Use In Pregnancy & Lactation

erythromycin

Manufacturer:

Aspen

Distributor:

Distriphil
Full Prescribing Info
Use In Pregnancy & Lactation
Ilosone DS: Use in Pregnancy: Reproduction studies have been performed in rats, mice and rabbits, using erythromycin and its various salts and esters of doses several times the usual human dose. No evidence of impaired fertility or harm to the fetus that appeared to be related to erythromycin was reported in these studies. There are however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.
Ilosone 200: Pregnancy: Pregnancy Category B. There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base by oral gavage at 350 mg/kg/day (approximately twice the maximum recommended human dose on a body surface area) prior to and during mating, during gestation, and through weaning. No evidence of teratogenicity or embryotoxicity was observed when erythromycin base was given by oral gavage to pregnant rats and mice at 700 mg/kg/day and to pregnant rabbits at 125 mg/kg/day (approximately 1-3 times the maximum recommended human dose).
Labor and Delivery: The effect of erythromycin estolate on labor and delivery is unknown.
Nursing Mothers: Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is administered to nursing women.