Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Clindacin ® ETZ (Clindamycin Phosphate Topical Solution USP, 1% (Pledgets)) is available as follows: A carton containing 60 individually wrapped single-use pledget applicators (NDC 43538-172-60) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing.; PRINCIPAL DISPLAY PANEL - 60 Pledget Carton NDC 43538-172-60 For Topical Use Only R x Only Clindacin ® ETZ Clindamycin Phosphate Topical Solution USP, 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin 60 Individual Pledgets MEDIMETRIKS PHARMACEUTICALS, INC. Principal Display Panel - 60 Pledget Carton; PRINCIPAL DISPLAY PANEL - Kit Carton NDC 43538-173-60 R x Only Clindacin ® ETZ KIT Clindamycin Phosphate Topical Solution USP, 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin CONTENTS: Clindacin ® ETZ Clindamycin Phosphate Topical Solution USP, 1% (Pledgets) 1 - Carton (60 Pledgets) AcuWash ® Moisturizing Daily Cleanser 1 - Bottle (16 fl. oz.) MEDIMETRIKS PHARMACEUTICALS, INC. Principal Display Panel - Kit Carton
- HOW SUPPLIED Clindacin ® ETZ (Clindamycin Phosphate Topical Solution USP, 1% (Pledgets)) is available as follows: A carton containing 60 individually wrapped single-use pledget applicators (NDC 43538-172-60) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing.
- PRINCIPAL DISPLAY PANEL - 60 Pledget Carton NDC 43538-172-60 For Topical Use Only R x Only Clindacin ® ETZ Clindamycin Phosphate Topical Solution USP, 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin 60 Individual Pledgets MEDIMETRIKS PHARMACEUTICALS, INC. Principal Display Panel - 60 Pledget Carton
- PRINCIPAL DISPLAY PANEL - Kit Carton NDC 43538-173-60 R x Only Clindacin ® ETZ KIT Clindamycin Phosphate Topical Solution USP, 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin CONTENTS: Clindacin ® ETZ Clindamycin Phosphate Topical Solution USP, 1% (Pledgets) 1 - Carton (60 Pledgets) AcuWash ® Moisturizing Daily Cleanser 1 - Bottle (16 fl. oz.) MEDIMETRIKS PHARMACEUTICALS, INC. Principal Display Panel - Kit Carton
Overview
Clindacin ® ETZ contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindacin ® ETZ pledget applicator contains approximately 1 mL of topical solution. 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 solution contains isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0). 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). Chemical Structure
Indications & Usage
Clindacin ® ETZ 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
Do not use if the unit-dose pouch seal is broken. Remove pledget just before use. Use pledget to apply a thin film of Clindamycin Phosphate Topical Solution to the affected area twice daily. More than one pledget may be used. Each pledget should be used only once and then discarded.
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
Clindacin ® ETZ 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 topical 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) not recorded (-) (-) Dryness 105 (19) 34 (23) 29 (18) Erythema 86 (16) 10 (7) 22 (14) Oiliness/Oily Skin 8 (1) 26 (18) 12 of 126 subjects (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. To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512 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.
Storage & Handling
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing.
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