Data from FDA - Curated by EPG Health - Last updated 05 December 2017

Indication(s)

INDICATIONS AND USAGE Clindacin ® ETZ 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 ).

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Advisory information

contraindications
CONTRAINDICATIONS Clindacin ® ETZ 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.
Special warnings and precautions
PRECAUTIONS General Clindacin ® ETZ 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 products 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 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 Clindacin ® ETZ. 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 clindamycin phosphate topical solution USP, 1% 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 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) not recorded (-) (-) 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 Do not use if the unit-dose pouch seal is broken. Remove pledget just before use. Use pledget to apply a thin film of Clindamycin Phosphate Topical Solution to the affected area twice daily. More than one pledget may be used. Each pledget should be used only once and then discarded.
Pregnancy and lactation
Nursing Mothers It is not known whether clindamycin is excreted in human milk following use of Clindacin ® ETZ. 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.

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 ANDA065049
Agency product number EH6D7113I8
Orphan designation No
Product NDC 43538-173,43538-172
Date Last Revised 15-11-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 797274
Storage and handling STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing.
Marketing authorisation holder Medimetriks Pharmaceuticals, Inc.