Data from FDA - Curated by EPG Health - Last updated 05 July 2018

Indication(s)

INDICATIONS AND USAGE 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).

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Advisory information

contraindications
CONTRAINDICATIONS 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.
Special warnings and precautions
PRECAUTIONS 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. 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 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. 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. 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.
Adverse reactions
ADVERSE REACTIONS 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(%) # not recorded 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) 12of 126 subjects (10) Peeling 61 (11) # ( – ) 11 ( 7) 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 gastrointestinal disturbances gram-negative folliculitis eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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.
Pregnancy and lactation
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. 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.

Interactions

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.

More information

Category Value
Authorisation number NDA050537
Agency product number EH6D7113I8
Orphan designation No
Product NDC 0009-3331,0009-3116,0009-3329
Date Last Revised 01-06-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 797274
Storage and handling Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP]. Protect from freezing.
Marketing authorisation holder Pharmacia and Upjohn Company LLC