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Application during pregnancy

The results of a large study involving pregnant women who received clindamycin during the first trimester of pregnancy (approximately 650 newborns received clindamycin exposure) did not demonstrate an increase in the incidence of malformations in newborns. However, the available data on the safety of clindamycin use during pregnancy are insufficient.

The results of experimental studies in animals do not suggest the presence of a direct or indirect harmful effect on the course of pregnancy, embryo / fetal development, the course of labor or postnatal development.

Clindamycin crosses the placenta. It is assumed that a therapeutic, effective concentration is achieved in the fetus. When using the preparation during pregnancy, the benefits and possible risks associated with treatment should be carefully weighed.

Clindamycin is excreted in breast milk. It has been reported that clindamycin is present in human breast milk at concentrations of <0.5 to 3.8 μg / ml with systemic use. Therefore, in breastfed newborns, it is impossible to exclude the appearance of such undesirable effects on the microflora of the gastrointestinal tract such as diarrhea or blood in the feces, sensitization, rashes and colonization of mucous membranes by yeast fungi. Clindamycin should not be used due to the risk of severe adverse reactions in breastfed or breastfeeding infants.

Reproductive function.

The results of animal studies showed no signs of reproductive dysfunction. There are no data on the effect of clindamycin on human reproductive function.

The ability to influence the reaction rate when driving or driving other mechanisms.

Clindamycin has a mild to moderate effect on the ability to drive vehicles or operate machinery. Some adverse reactions can affect the ability to concentrate and the speed of the reaction; therefore, they can affect the ability to drive vehicles or operate machinery.

So far, no overdose symptoms have been observed. If necessary, gastric lavage is indicated. Hemodialysis and peritoneal dialysis are ineffective in removing clindamycin from serum. The specific antidote is unknown.

The adverse reactions below have been identified in clinical trials and post-market surveillance. In each category, adverse reactions are listed by frequency and by clinical significance.

In terms of frequency, adverse reactions are divided into the following categories: very often (≥ 1/10), often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1000 to <1/100), rarely (from ≥ 1/10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from available data). Adverse reactions are listed in each category for decreasing severity.

Infections and infestations.

Often pseudomembranous colitis.

Frequency not known: Clostridium difficile colitis, vaginal infections.

On the part of the blood and lymphatic system.

Often agranulocytosis, neutropenia, thrombocytopenia, leukopenia, eosinophilia.

From the immune system.

Rarely preparation-induced fever.

Anaphylactic reactions are very rare.