Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation

Pregnancy
Page 2 of 7
2014-0004758
Use of clindamycin is not recommended during the first trimester, as there are no adequate and well-controlled studies in pregnant women over this period.

In clinical trials, intravaginal use of clindamycin vaginal products in pregnant women during second trimester and systemic use of clindamycin phosphate during the second and third trimester has not been associated with congenital abnormalities.

Clindamycin may be used to treat pregnant women if clearly necessary during the second and third trimester of pregnancy.

Reproduction studies performed in rats and mice using oral and parenteral doses of clindamycin, ranging from 100 to 600 mg/kg/day, have revealed no evidence of harm to the fetus due to clindamycin (see section 5.3). In one mouse strain, cleft palates were observed in species treated fetuses; this response was not produced in other mouse strains or in other species, and is therefore considered to be a strain specific effect. Animal reproduction studies are not always predictive of human response.

In a clinical trial in pregnant women during the second trimester, Dalacin® 2% Vaginal Cream was effective in treating bacterial vaginosis, and no drug-related medical events were reported in the neonates. However, as with any drug used during pregnancy, a careful risk-benefit assessment should take place beforehand.

Breast-feeding
It is not known if clindamycin is excreted in human breast milk following the use of vaginally administered clindamycin vaginal cream. Clindamycin has been reported to appear in human breast milk in ranges from <0.5 to 3.8 µg/ml following systemic use. Clindamycin has the potential to cause adverse effects on the breastfed infant’s gastrointestinal flora such as diarrhoea or blood in the stool, or rash. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

Fertility
Fertility studies in rats treated orally with clindamycin revealed no effects on fertility or mating ability. No animal fertility studies have been performed using the vaginal route of administration.