Azalia Use In Pregnancy & Lactation

Pregnancy: Azalia is not indicated during pregnancy. If pregnancy occurs during treatment with Azalia, further intake should be stopped.
According to animal data very high doses of progestogenic substances may cause masculinisation of female foetuses.
Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy nor a teratogenic effect when COCs were taken inadvertently during early pregnancy. Pharmacovigilance data collected with various desogestrel-containing COCs also do not indicate an increased risk.
Breast-feeding: Desogestrel does not influence the production or the quality (protein, lactose, or fat concentrations) of breast milk. However, small amounts of etonogestrel, (the metabolite of desogestrel) are excreted in the breast milk. As a result, 0.01-0.05 microgram etonogestrel per kg body weight per day may be ingested by the child (based on an estimated milk ingestion of 150 ml/kg/day).
According to limited long-term follow-up data on children, whose mothers started using Azalia during the 4th to 8th weeks post-partum, of growth and physical and psychomotor development did not indicate any differences in comparison to nursing infants, whose mother used a copper-IUD.
Based on the available data Azalia may be used during lactation. The development and growth of a nursing infant, whose mother uses Azalia, should, however, be carefully observed.
Fertility: Azalia is indicated for the prevention of pregnancy. For information on return to fertility (ovulation).