Drug: Clindets

Clindets® (Clindamycin Phosphate Pledgets) contain clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per milliliter in a vehicle of isopropyl alcohol 52% v/v, propylene glycol and water. Each Clindets® (clindamycin) pledget applicator contains approximately 1 mL of Clindamycin Phosphate Topical Solution. Clindamycin Phosphate Topical Solution has a pH range between 4.0 and 7.0. 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. It occurs as a white to off-white, hygroscopic, crystalline powder. It is freely soluble in water, slightly soluble in dehydrated alcohol, very slightly soluble in acetone and practically insoluble in chloroform, benzene, and ether. Clindamycin phosphate is odorless or practically odorless, and has a bitter taste. Chemically, clindamycin phosphate is C 18 H 34 ClN 2 O 8 PS. It has the following structural formula:

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In 18 clinical studies of various topical formulations of clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatological events (see table below).   Number of patients reporting events Treatment Emergent
Adverse Event

Source: http://www.rxlist.com

Apply a thin film using a Clindets applicator for the application of Clindamycin Phosphate Topical Solution twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then discarded. Remove pledget from foil just before use. Do not use if the seal is broken. Discard after single use.

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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. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Clindets (clindamycin) are 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.)

Source: http://www.rxlist.com

Clindets (clindamycin) are 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.Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Topically applied Clindamycin Phosphate formulations can be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

Source: http://www.rxlist.com

Clindets® (Clindamycin Phosphate Pledgets) 1%* * equivalent to 1% clindamycin (10 mg/mL) is available in the following size: 69 pledget container - NDC 0145-2472-80 Store at controlled room temperature, 15°-30°C (59°-86°F). Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Clindets (clindamycin) contain an alcohol base which will cause burning and irritation of the eyes. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucuous 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. Clindets (clindamycin) should be prescribed with caution to 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 Category B Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to clindamycin. 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 clearly needed. Nursing Mothers It is not known whether clindamycin is excreted in human milk following use of Clindets. 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 the pediatric population under the age of 12 has not been established. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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