Clindamycin Phosphate

Clindamycin Phosphate Topical Solution USP, 1% is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

• Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death.
• Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface.
• Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis ) have been reported with the use of topical and systemic clindamycin.
• Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis.
• The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus.
• Endoscopic examination may reveal pseudomembranous colitis .
• Stool culture for Clostridium difficile and s tool assay for C. difficile toxin may be helpful diagnos tically.
• When s ignificant diarrhea occurs, the drug should be discontinued.
• Large bowel end oscopy should be considered to es tablish a definitive diagnosis in cases of severe diarrhea.
• Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition.
• Vancomycin has been found to be effective in the treatment of antibiotic- associated pseudomembranous colitis produced by Clostridium difficile .
• The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days.
• Choles tyramine or coles tipol res ins bind vancomycin in vitro .
• If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.
• Diarrhea, colitis , and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.
• General Clindamycin Phosphate Topical Solution USP, 1% 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.
• Clindamycin Phosphate Topical Solution USP, 1% 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.
• Pregnancy Teratogenic effects 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.
• Nursing Mothers It is not known whether clindamycin is excreted in human breast milk following use of Clindamycin Phosphate Topical Solution.
• Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.
• Geriatric Use Clinical studies for Clindamycin Phosphate Topical Solution did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects.
• General Clindamycin Phosphate Topical Solution USP, 1% 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.
• Clindamycin Phosphate Topical Solution USP, 1% should be prescribed with caution in atopic individuals.

• Teratogenic effects 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.
• There are no adequate studies in pregnant women during the first trimester of pregnancy.
• Clindamycin should be used during the first trimester of pregnancy only if clearly needed.
• It is not known whether clindamycin is excreted in human breast milk following use of Clindamycin Phosphate Topical Solution.
• Clindamycin has been reported to appear in human breast milk in ranges from <0.5 to 3.8 µg/mL following systemic use.
• Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora.
• If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred.
• Monitor the infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

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.

Topically applied Clindamycin Phosphate Topical Solution can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).