Drug: Clindamycin Phosphate Topical Solution

Clindamycin Phosphate Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Phosphate Topical Solution pledget applicator contains approximately 1 mL of topical 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 solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide (to adjust the pH to between 4.0 – 7.0) and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C18H34CIN2O8PS. Flash Point 75° F.Last reviewed on RxList: 1/7/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

In 18 clinical studies of various formulations of topical Clindamycin Phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below]. Number of Patients Reporting Events
Treatment Emergent
Adverse Event Solution
n=553 (%) Gel
n=148 (%) Lotion
n=160 (%) Burning 62 (11) 15 (10) 17 (11) Itching 36 ( 7 ) 15 (10) 17 (11) Burning/Itching 60 (11) # (-- ) # (-- ) Dryness 105 (19) 34 (23) 29 (18) Erythema 86 (16) 10 ( 7 ) 22 (14) Oiliness/Oily Skin 8 ( 1 ) 26 (18) 12*(10) Peeling 61 (11) # (-- ) 11 ( 7 ) # not recorded
* of 126 subjects Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS). Abdominal pain and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin. Read the Clindamycin Phosphate Topical Solution (clindamycin phosphate topical solution) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Apply a thin film of Clindamycin Phosphate Topical Solution or use a Clindamycin Phosphate Topical Solution pledget for the application of Clindamycin Phosphate twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded. Pledget: Remove pledget from jar just before use. Do not use if the seal under the cap is broken. Discard after single use. Keep all liquid dosage forms in containers tightly closed.

Source: http://www.rxlist.com

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: 1/7/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Clindamycin Phosphate Topical Solution 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.)

Source: http://www.rxlist.com

Clindamycin Phosphate Topical Solution 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. Last reviewed on RxList: 1/7/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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

Source: http://www.rxlist.com

Clindamycin Phosphate Topical Solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 30 mL applicator bottle, 60 mL applicator bottle. Clindamycin Phosphate Pledgets contains Clindamycin Phosphate Topical Solution. The solution contains Clindamycin Phosphate equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Pledgets is available in a Jar of 60 single-use pledget applicators and a Jar of 69 single-use pledget applicators. Store at controlled room temperature 15° to 30° C (59° to 86° F) [See USP]. Protect from freezing. Flash Point 75° F. Distributed By Perrigo, Allegan, MI 49010. FDA revision date: 11/1/2002 Last reviewed on RxList: 1/7/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Clindamycin Phosphate 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. Clindamycin Phosphate Topical Solution should be prescribed with caution in atopic individuals. 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 Clindamycin Phosphate Topical Solution. 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. Last reviewed on RxList: 1/7/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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