Zenith Suspension/Zenith OD Suspension Use In Pregnancy & Lactation

Zenith Suspension: Pregnancy: There are no adequate data from the use of azithromycin in pregnant women. In reproduction toxicity studies in animals, azithromycin was shown to pass the placenta, but no teratogenic effects were observed (see Pharmacology: Toxicology: Preclinical safety data under Actions). The safety of azithromycin has not been confirmed with regard to the use of the active substance during pregnancy. Therefore, azithromycin should only be used during pregnancy if the benefit outweighs the risk.
Breastfeeding: Azithromycin has been reported to be secreted into human breast milk, but there are no adequate and well-controlled clinical studies in breastfeeding women that have characterised the pharmacokinetics of azithromycin excretion into human breast milk.
Serious adverse effects of azithromycin on breast-fed infants have not been observed. A decision needs to be made as to whether breastfeeding should be interrupted or whether the azithromycin therapy should be dispensed with or the treatment interrupted. In this context, both the benefits of breastfeeding for the child and the therapeutic benefits for the woman should be taken into account.
Zenith OD Suspension: Pregnancy: Pregnancy Category B.
Reproduction studies have been performed in rats and mice at doses up to moderately maternally toxic levels (200 mg/kg/day). These doses, based on a mg/m² basis, are estimated to be 4 and 2 times, respectively, the human daily dose of 500 mg. No evidence of harm to the fetus has been observed in these animal studies.
However, there are no adequate and controlled studies using azithromycin in pregnant women. Since animal studies are not always predictive of human response, azithromycin should be used in pregnancy only when the potential benefit justifies the potential risk to the fetus.
Lactation: Azithromycin is distributed in human milk and may cause diarrhea, fungal infection of the mucous membrane and sensitization in the breastfed infant. It is recommended to discard the milk during treatment and up to 2 days after discontinuation of treatment. Breastfeeding may be resumed thereafter.