Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Clindamycin Phosphate Topical Solution, USP containing clindamycin phosphate, USP equivalent to 10 mg clindamycin per milliliter is available in a jar containing 60 single-use pledget applicators (NDC 80005-131-09) and a jar containing 69 single-use pledget applicators (NDC 80005-131-38). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from freezing. Clindamycin Phosphate Topical Solution, USP is flammable. Keep away from heat, sparks or open flames.; PRINCIPAL DISPLAY PANEL NDC 80005- 131 -09 Clindamycin Phosphate Topical Solution, USP 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin For Topical Use Only Rx Only 60 Pledgets Carnegie Pharma jar-label; PRINCIPAL DISPLAY PANEL NDC 80005- 131 -38 Clindamycin Phosphate Topical Solution, USP 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin For Topical Use Only Rx Only 69 Pledgets Carnegie Pharma jar-label
- HOW SUPPLIED Clindamycin Phosphate Topical Solution, USP containing clindamycin phosphate, USP equivalent to 10 mg clindamycin per milliliter is available in a jar containing 60 single-use pledget applicators (NDC 80005-131-09) and a jar containing 69 single-use pledget applicators (NDC 80005-131-38). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from freezing. Clindamycin Phosphate Topical Solution, USP is flammable. Keep away from heat, sparks or open flames.
- PRINCIPAL DISPLAY PANEL NDC 80005- 131 -09 Clindamycin Phosphate Topical Solution, USP 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin For Topical Use Only Rx Only 60 Pledgets Carnegie Pharma jar-label
- PRINCIPAL DISPLAY PANEL NDC 80005- 131 -38 Clindamycin Phosphate Topical Solution, USP 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin For Topical Use Only Rx Only 69 Pledgets Carnegie Pharma jar-label
Overview
Clindamycin Phosphate Topical Solution, USP contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Phosphate Topical Solution, USP pledget applicator contains approximately 1 mL of topical solution. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide pellets, and water. 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). structural formula
Indications & Usage
Clindamycin Phosphate Topical Solution 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
Use a Clindamycin Phosphate Topical Solution pledget for the application of Clindamycin Phosphate Topical Solution twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded. Clindamycin Phosphate Topical Solution is flammable. Avoid fire, flame, and smoking during and immediately following application. Pledget: Do not use if the seal is broken. Discard after single use. Keep the jar tightly closed after each use.
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 systemic absorption 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 Clostridioides 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 Clostridioides 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 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. To report SUSPECTED ADVERSE REACTIONS, contact Carnegie Pharmaceuticals, LLC at 1-732-783-7010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
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