Clindamycin phosphate precautions
| Clindamycin phosphate |
|---|
| CLEOCIN PHOSPHATE®, EVOCLIN®, CLEOCIN T®, CLEOCIN DERM®, CLINDA GEL®, CLINDAMAX® FDA Package Insert |
| Description |
| Clinical Pharmacology |
| Microbiology |
| Indications and Usage |
| Contraindications |
| Warnings |
| Precautions |
| Adverse Reactions |
| Overdosage |
| Dosage and Administration |
| How Supplied |
| Labels and Packages |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
PRECAUTIONS
General
CLEOCIN T Topical Solution contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.
CLEOCIN T should be prescribed with caution in atopic individuals.
Drug Interactions
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.
Pregnancy
Teratogenic effects—Pregnancy Categoty B
Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus due to clindamycin, except at doses that caused maternal toxicity. Animal reproduction studies are not always predictive of human response.
In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities.
Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.
Nursing Mothers
It is not known whether clindamycin is excreted in human milk following use of CLEOCIN T. 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.
Pediatric Use
Safety and effectiveness in pediatric patients under the age of 12 have not been established.
Geriatric Use
Clinical studies for Cleocin T did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
References
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf