DailyMed Label: Clindagel

DailyMed Label: Clindagel

2020

DailyMed Prescription

Clindagel

CLINDAMYCIN

Bausch Health US, LLC

NDC: 16781-462

NDC: 16781-462

NDC: 16781-462

NDC: 16781-462

CLINDAGEL (clindamycin phosphate) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. Chemically, clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chlorosubstitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin, and has the structural formula 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). chemstructure

In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used CLINDAGEL (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, CLINDAGEL applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table: Lesions CLINDAGEL QD N=162 Vehicle Gel QD N=82  Inflammatory  51% 40% P<0.05  Noninflammatory  25%  12%       Total  38%  27%    There was a trend in the investigator’s global assessment of the results, which favored  CLINDAGEL QD over the vehicle QD.  In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to CLINDAGEL. There was no signal for contact sensitization in the clinical trials under normal use conditions.

Apply a thin film of CLINDAGEL once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly. Keep container tightly closed.

CLINDAGEL 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.

General: CLINDAGEL 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. The carcinogenicity of a 1% clindamycin phosphate gel similar to CLINDAGEL was evaluated by daily application to mice for 2 years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 mL of CLINDAGEL , assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals. A 1% clindamycin phosphate gel similar to CLINDAGEL caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative. Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility. Teratogenic Effects: Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride, and clindamycin palmitate hydrochloride. These studies revealed no evidence of fetal harm. The highest dose used in the rat and mouse teratogenicity studies was equivalent to a clindamycin phosphate dose of 432 mg/kg. For a rat, this dose is 84-fold higher and for a mouse, 42-fold higher than the anticipated human dose of clindamycin phosphate from CLINDAGEL based on a mg/m 2 comparison. 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. It is not known whether clindamycin is excreted in human milk following use of CLINDAGEL . 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. Safety and effectiveness in children under the age of 12 have not been established. The clinical study with CLINDAGEL did not include sufficient numbers of patients aged 65 and over to determine if they respond differently than younger patients.

In the one well-controlled clinical study comparing

CLINDAGEL containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following size: 75 mL bottle - NDC 16781-462-75 Store at controlled room temperature 20°to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Do not store in direct sunlight. Retain in carton until contents are used. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada CLINDAGEL is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates 9706100 Rev. 01/20

Pharmacokinetics: In an open-label, parallel group study of 24 patients with acne vulgaris, once-daily topical administration of approximately 3 to 12 grams/day of CLINDAGEL for 5 days resulted in peak plasma clindamycin concentrations that were less than 5.5 ng/mL. Following multiple applications of C LINDAGEL less than 0.04% of the total dose was excreted in the urine. Microbiology: Although clindamycin phosphate is inactive in   vitro , rapid in   vitro hydrolysis converts this compound to clindamycin, which has antibacterial activity. Clindamycin inhibits bacteria protein synthesis at the ribosomal level by binding to the 50S ribosomal subunit and affecting the process of peptide chain initiation. In vitro studies indicated that clindamycin inhibited all tested Propionibacterium   acnes cultures at a minimum inhibitory concentration (MIC) of 0.4 mcg/mL. Cross-resistance has been demonstrated between clindamycin and erythromycin.

NDC 16781-462-75 Rx only Clindagel ® (clindamycin phosphate) topical gel equivalent to 1% clindamycin Topical Gel 1% For Topical Use Only 75 mL Ortho Dermatologics carton