Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Clindamycin phosphate topical solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter are clear solution with characteristics odor free from particulate matter. Filled in white HDPE bottle fitted with white PP cap and is available in the following sizes: Clindamycin phosphate topical solution USP, 1% is NDC 68788-7990-6 in applicator bottle of 60 mL Storage Conditions Store at 20°C to 25°C (68°F to 77°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.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68788-7990-6 Clindamycin phosphate topical solution USP, 1% Rx only Clindamycin Phosphate Topical Solution 1%
- HOW SUPPLIED Clindamycin phosphate topical solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter are clear solution with characteristics odor free from particulate matter. Filled in white HDPE bottle fitted with white PP cap and is available in the following sizes: Clindamycin phosphate topical solution USP, 1% is NDC 68788-7990-6 in applicator bottle of 60 mL Storage Conditions Store at 20°C to 25°C (68°F to 77°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.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68788-7990-6 Clindamycin phosphate topical solution USP, 1% Rx only Clindamycin Phosphate Topical Solution 1%
Overview
Clindamycin phosphate topical solution USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. 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 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). Clindamycin phosphate topical solution USP, 1% contains isopropyl alcohol, 50% v/v; propylene glycol and purified water. Sodium hydroxide or hydrochloric acid may be added to adjust pH between 4.0 to 7.0. Image
Indications & Usage
Clindamycin phosphate topical solution USP, 1% 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 topical solution, twice daily to affected area. Keep all liquid dosage forms in 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 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 topical solution 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]. # not recorded * of 126 subjects Treatment Emergent Adverse Event Number of Patients Reporting Events 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) 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.
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