Pregnancy: There are no adequate data from the use of Duac Once Daily Gel in pregnant women. Animal reproductive/develomental studies have not been conducted with Duac Once Daily Gel or benzoyl peroxide. There are limited data on the use of clindamycin and benzoyl peroxide alone in pregnant women. Data from a limited number of pregnancies exposed in the first trimester to clindamycin indicate no adverse effects of clindamycin on pregnancy or on the health of the foetus/new-born child.
Reproduction studies in rats and mice, using subcutaneous and oral doses of clindamycin, revealed no evidence of impaired fertility or harm to the foetus due to clindamycin.
The safety of Duac Once Daily Gel in human pregnancy is not established. Therefore, Duac Once Daily Gel should only be prescribed to pregnant women after careful risk/benefit assessment by the physician in charge.
Breastfeeding: Use of Duac Once Daily Gel has not been studied during breastfeeding. Percutaneous absorption of clindamycin and benzoyl peroxide is low however; it is not known whether clindamycin or benzoyl peroxide is excreted in human milk following the use of Duac Once Daily Gel. Oral and parenteral administration of clindamycin has been reported to result in the appearance of clindamycin in breast milk. For this reason, Duac Once Daily Gel should be used during lactation only if the expected benefit justifies the potential risk to the infant.
To avoid accidental ingestion by the infant if used during lactation, Duac Once Daily Gel should not be applied to the breast area.
Fertility: There are no data on the effect of Duac Once Daily Gel on fertility in humans.