Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation

Pregnancy
Studies in animals have shown reproductive toxicity (see section 5.3).

Use of Dalacin 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 Dalacin Vaginal products in pregnant women during the second trimester and systemic use of clindamycin phosphate during the second and third trimester has not been associated with congenital abnormalities.

Dalacin may be used to treat pregnant women if clearly necessary during the second and third trimester of pregnancy. Digital application of the vaginal ovule is recommended during pregnancy.

Breast-feeding
It is unknown whether clindamycin is excreted in human breast milk following vaginal administration, but it is used in much lower doses than systemic clindamycin, and approximately 30% (range: 6% to 70%) is systemically absorbed. Following systemic administration, clindamycin has been reported to appear in human breast milk in ranges from < 0.5 to 3.8 µg/mL.

If clindamycin is administered systemically to a breastfeeding mother, there is a risk of adverse reactions on the breastfed infant’s gastrointestinal flora such as diarrhoea or blood in the stool, or rash.
Use of Dalacin vaginal ovules in a breastfeeding woman can be considered if the expected benefit to the mother outweighs the risks for the child.


Fertility
Studies in animals revealed no effect on fertility.