Drug: Cleocin T

CLEOCIN T Topical Solution and CLEOCIN T Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. CLEOCIN T Topical Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each CLEOCIN T 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, and water. The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galactooctopyranoside 2-(dihydrogen phosphate).

Source: http://www.rxlist.com

In 18 clinical studies of various formulations of CLEOCIN T 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 Cleocin T (clindamycin topical) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Apply a thin film of CLEOCIN T Topical Solution, CLEOCIN T Topical Lotion, CLEOCIN T Topical Gel, or use a CLEOCIN T Topical Solution pledget for the application of CLEOCIN T twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded. Lotion: Shake well immediately before using. Pledget: Remove pledget from foil just before use. Do not use if the seal 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. Read the Cleocin T Drug Interactions Center for a complete guide to possible interactions Learn More »

Source: http://www.rxlist.com

CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion 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

CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion 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: 4/17/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Topically applied CLEOCIN T can be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

Source: http://www.rxlist.com

CLEOCIN T Topical Solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 30 mL applicator bottle - NDC 0009-3116-01
60 mL applicator bottle - NDC 0009-3116-02
Carton of 60 single-use pledget applicators - NDC 0009-3116-14 CLEOCIN T Topical Gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 60 gram tube - NDC 0009-3331-01
30 gram tube - NDC 0009-3331-02 CLEOCIN T Topical Lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL plastic squeeze bottle - NDC 0009-3329-01 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc., NY, NY 10017. Revised April 2014 Last reviewed on RxList: 4/17/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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. Pregnancy Teratogenic effects - Pregnancy Category B 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. 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. Last reviewed on RxList: 4/17/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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