Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Clindamycin phosphate gel USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram are a transparent gel free from lumps and foreign matter without any separation and is supplied as follows: NDC 72578-118-01 in tube of 30 g NDC 72578-118-02 in tube of 60 g Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from freezing. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088. For more information, go to Viona Pharmaceuticals Inc. at 1-888-304-5011.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Clindamycin Phosphate Gel USP, 1% 30 g NDC 72578-118-01 Rx only Zydus image 1 image 2
- HOW SUPPLIED Clindamycin phosphate gel USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram are a transparent gel free from lumps and foreign matter without any separation and is supplied as follows: NDC 72578-118-01 in tube of 30 g NDC 72578-118-02 in tube of 60 g Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from freezing. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088. For more information, go to Viona Pharmaceuticals Inc. at 1-888-304-5011.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Clindamycin Phosphate Gel USP, 1% 30 g NDC 72578-118-01 Rx only Zydus image 1 image 2
Overview
Clindamycin phosphate gel, USP contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. 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 gel contains following inactive ingredient: allantoin, carbopol, methyl paraben, polyethylene glycol, propylene glycol, purified water and sodium hydroxide. The structural formula is 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). Image
Indications & Usage
Clindamycin phosphate gel 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 ).
Dosage & Administration
Apply a thin film of clindamycin phosphate gel twice daily to affected area. Keep containers 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. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile . The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 days to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro . If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug. 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 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 18 clinical studies of various formulations of 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) # (–) # (–) 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, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.
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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.