Clinda-derm Recall

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Questions & Answers

Side Effects & Adverse Reactions

Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Use of the topical formulation 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. Symptoms can occur after a few days, weeks or months following initiation of clindamycin therapy. They have also been observed to begin up to several weeks after cessation of therapy with clindamycin. Studies indicate a toxin(s) produced by Clostridium difficile 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.

When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered 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 mg to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days.

Mild cases of colitis may respond to discontinuance of clindamycin. Moderate to severe cases should be managed promptly with fluid, electrolyte, and protein supplementation as indicated. Cholestyramine and colestipol resins have been shown to bind the toxin 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. Systemic corticoids and corticoid retention enemas may help relieve the colitis. Other causes of colitis should also be considered. A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Clinda-Derm is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS.)


There is currently no drug history available for this drug.

Other Information

Chemical Structure

Clindamycin Phosphate C18H34ClN2O8PS

(MW = 504.96)

Clindamycin phosphate topical solution, for external use, contains clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per milliliter in a hydroalcoholic solution. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

The chemical name for clindamycin phosphate is 7(S)-chloro-7-deoxylincomycin-2-phosphate.

Each mL contains clindamycin phosphate equivalent to 10 mg clindamycin. In addition, each mL contains isopropyl alcohol (51.5% v/v), propylene glycol, sodium hydroxide and purified water.

Clinda-derm Manufacturers

  • Paddock Laboratoratories, Llc
    Clinda-derm (Clindamycin Phosphate) Solution [Paddock Laboratoratories, Llc]

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