Clindagel® should be prescribed with caution in
Carcinogenesis, Mutagenesis, Impairment Of Fertility
The carcinogenicity of a 1% clindamycin phosphate gel
similar to Clindagel® was evaluated by daily application to mice for two
years. The daily doses used in this study were approximately 3 and 15 times higher
than the human dose of clindamycin phosphate from 5 milliliters of Clindagel®
, assuming complete absorption and based on a body surface area comparison. No
significant increase in tumors was noted in the treated animals.
A 1% clindamycin phosphate gel similar to Clindagel®
caused a statistically significant shortening of the median time to tumor onset
in a study in hairless mice in which tumors were induced by exposure to simulated
Genotoxicity tests performed included a rat micronucleus
test and an Ames Salmonella reversion test. Both tests were negative.
Reproduction studies in rats using oral doses of clindamycin hydrochloride and
clindamycin palmitate hydrochloride have revealed no evidence of impaired
Pregnancy Category B
Reproduction studies have been performed in rats and mice
using subcutaneous and oral doses of clindamycin phosphate, clindamycin
hydrochloride and clindamycin palmitate hydrochloride. These studies revealed
no evidence of fetal harm. The highest dose used in the rat and mouse
teratogenicity studies was equivalent to a clindamycin phosphate dose of 432
mg/kg. For a rat, this dose is 84 fold higher and for a mouse 42 fold higher,
than the anticipated human dose of clindamycin phosphate from Clindagel®
based on a mg/m comparison. There are, however, no adequate and well-controlled
studies in pregnant women. Because animal reproduction studies are not always
predictive of human response, this drug should be used during pregnancy only if
It is not known whether clindamycin is excreted in human
milk following use of Clindagel®. However, orally and parenterally
administered clindamycin has been reported to appear in breast milk. Because of
the potential for serious adverse reactions in nursing infants, a decision
should be made whether to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the mother.
Safety and effectiveness in children under the age of 12
have not been established.
The clinical study with Clindagel® did not include
sufficient numbers of patients aged 65 and over to determine if they respond
differently than younger patients.