Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Clindamycin phosphate gel USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following size: 75 mL bottle - NDC 73473-302-75 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. Manufactured for: Solaris Pharma Corporation Bridgewater, NJ 08807,USA Revised 08/2021; PACKAGE LABEL PRINCIPAL DISPLAY PANEL 75 mL Carton Label NDC 73473- 302 -75 Clindamycin Phosphate Gel USP, 1% For Topical Use Only. Rx only 75 mL carton
- HOW SUPPLIED Clindamycin phosphate gel USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following size: 75 mL bottle - NDC 73473-302-75 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. Manufactured for: Solaris Pharma Corporation Bridgewater, NJ 08807,USA Revised 08/2021
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL 75 mL Carton Label NDC 73473- 302 -75 Clindamycin Phosphate Gel USP, 1% For Topical Use Only. Rx only 75 mL carton
Overview
Clindamycin phosphate gel USP, 1%, a topical antibiotic, contains clindamycin phosphate, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 981, 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 -a-D- galacto -octopyranoside 2-(dihydrogen phosphate). structure
Indications & Usage
Clindamycin phosphate gel, 1% is indicated for topical application 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 .)
Dosage & Administration
Apply a thin film of clindamycin phosphate gel USP, 1% once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly. Keep container tightly closed.
Warnings & Precautions
WARNINGS Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. Studies indicate a toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea. Antiperistaltic agents, such as opiates and diphenoxylate with atropine, may prolong and/or worsen the condition. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.
Contraindications
Clindamycin phosphate gel, 1% 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.
Adverse Reactions
In the one well-controlled clinical study comparing clindamycin phosphate and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented below: Number (%) of Patients Body System/Adverse Event Clindamycin Phosphate QD N=168 Vehicle Gel QD N=84 Skin and appendages disorders Dermatitis 0 (0.0) 1 (1.2) Dermatitis contact 0 (0.0) 1 (1.2) Dermatitis fungal 0 (0.0) 1 (1.2) Folliculitis 0 (0.0) 1 (1.2) Photosensitivity reaction 0 (0.0) 1 (1.2) Pruritus 1 (0.6) 1 (1.2) Rash erythematous 0 (0.0) 0 (0.0) Skin dry 0 (0.0) 0 (0.0) Peeling 1 (0.6) 0 (0.0) 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. To report SUSPECTED ADVERSE REACTIONS, contact Solaris Pharma Corporation at 1-833-919-0527 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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