Drug: Duac Topical Gel

DUAC (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is a fixed combination product with two active ingredients in a white to slightly yellow, opaque, aqueous gel formulation. 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. Clindamycin phosphate is C18H34ClN2O8PS. The structural formula for clindamycin phosphate is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thioL-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). Benzoyl peroxide is C14H10O4. It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of DUAC Gel contains 10 mg (1%) clindamycin, as clindamycin phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type C), dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide.

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The following adverse reaction is described in more detail in the WARNINGS AND PRECAUTIONS section of the label:
  • Colitis [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, 397 subjects used DUAC Gel once daily for 11 weeks for the treatment of moderate to moderately severe facial acne vulgaris. All subjects were graded for facial local skin reactions (erythema, peeling, burning, and dryness) on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The percentage of subjects that had symptoms present before treatment (at baseline) and during treatment is presented in Table 1. Table 1: Local Skin Reactions With Use of DUAC Gel Combined Results From Five Trials (n = 397)
Symptom % of Subjects Using DUAC Gel With Symptom Present Before Treatment (Baseline) During Treatment Mild Moderate Severe Mild Moderate Severe Erythema 28% 3% 0 26% 5% 0 Peeling 6% < 1% 0 17% 2% 0 Burning 3% < 1% 0 5% < 1% 0 Dryness 6% < 1% 0 15% 1% 0 (Percentages derived by number of subjects receiving DUAC Gel with symptom score/number of enrolled subjects receiving DUAC Gel). Postmarketing Experience The following adverse reactions have been identified during post approval use of DUAC Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Gel. Read the Duac Topical Gel (clindamycin benzoyl peroxide) Side Effects Center for a complete guide to possible side effectsLearn More »

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Apply a thin layer of DUAC Gel to the face once daily, in the evening or as directed by the physician. The skin should be gently washed, rinsed with warm water, and patted dry before applying DUAC Gel. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin. DUAC Gel is not for oral, ophthalmic, or intravaginal use.

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Erythromycin Avoid using DUAC Gel in combination with erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known. Concomitant Topical Medications Concomitant topical acne therapies should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists. Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. DUAC Gel should be used with caution in patients receiving such agents. Read the Duac Topical Gel Drug Interactions Center for a complete guide to possible interactions Learn More »

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Indication DUAC® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. Limitations Of Use DUAC Gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.

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Hypersensitivity DUAC Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Gel. [See Postmarketing Experience] Colitis/Enteritis DUAC Gel is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see WARNINGS AND PRECAUTIONS]. Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided.

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Dosage Forms And Strengths Gel, 1.2%/5% DUAC Gel is a white to slightly yellow, opaque gel. Each gram of DUAC Gel contains 12 mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide. DUAC Gel is a white to slightly yellow, opaque gel. It is supplied as follows: 45 gram tube NDC 0145-2371-05 Storage And Handling Pharmacist
  • Prior to Dispensing: Store in a cold place, preferably in a refrigerator, between 2°C and 8°C (36°F and 46°F). Do not freeze.
Dispensing Instructions For The Pharmacist
  • Dispense DUAC Gel with a 60-day expiration date.
  • Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”
  • Keep tube tightly closed.
  • Keep out of the reach of small children.
Stiefel Laboratories, Inc. Research Triangle Park, NC 27709. December 2013 Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. If significant diarrhea occurs, DUAC Gel should be discontinued. Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death. 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. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. Ultraviolet Light And Environmental Exposure Benzoyl peroxide, a component of DUAC Gel, may cause increased sensitivity to sunlight. Minimize sun exposure (including use of tanning beds or sun lamps) following drug application. [See Nonclinical Toxicology] Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Patient Counseling Information See FDA-approved patient labeling (PATIENT INFORMATION).
  • Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately.
  • DUAC Gel may cause irritation such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies.
  • Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn. Sunscreen may also be used.
  • DUAC Gel may bleach hair or colored fabric.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. The clinical significance of this is unknown. In a 2-year dermal carcinogenicity study in mice, treatment with DUAC Gel at doses up to 8,000 mg/kg/day (16 times the highest recommended adult human dose of 2.5 g DUAC Gel, based on mg/m²) did not cause an increase in skin tumors. However, topical treatment with another formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, or 2,000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In a 52-week photocarcinogenicity study in hairless mice (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical treatment with DUAC Gel and exposure to ultraviolet radiation. Genotoxicity studies were not conducted with DUAC Gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in Salmonella typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Studies have not been performed with DUAC Gel or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g DUAC Gel, based on mg/m²) revealed no effects on fertility or mating ability. Use In Specific Populations Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women treated with DUAC Gel. DUAC Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg/m², respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m², respectively) revealed no evidence of teratogenicity. Nursing Mothers It is not known whether DUAC Gel is excreted into human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Because many drugs are excreted in human milk, caution should be exercised when DUAC Gel is administered to a nursing woman. Pediatric Use Safety and effectiveness of DUAC Gel in pediatric patients below the age of 12 have not been established. Geriatric Use Clinical studies of DUAC Gel did not include sufficient numbers of subjects ages 65 and over to determine whether they respond differently from younger subjects. Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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