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Drug Resistance
Mild cases of pseudomembranous colitis usual y respond to drug discontinuation Nursing Women: It is not known whether Duac Topical Gel is secreted into human
There are reports of an increase of P. acnes resistance to clindamycin in the alone. In moderate to severe cases, consideration should be given to management milk after topical application. However, oral y and parenteral y administered treatment of acne. In patients with P. acnes resistant to clindamycin, the with fluids and electrolytes, protein supplementation and treatment with an clindamycin has been reported to appear in breast milk. Because of the potential for clindamycin component may provide no additional benefit beyond benzoyl peroxide antibacterial drug clinical y effective against Clostridium difficile colitis.
serious adverse reactions in nursing infants, a decision should be made whether to (clindamycin, 1% - benzoyl peroxide, 5%)
discontinue nursing or to discontinue the drug, taking into account the importance PRECAUTIONS
CLINICAL STUDIES
General: For dermatological use only; not for ophthalmic use. Concomitant topical
In five randomized, double-blind clinical studies of 1,319 patients, 397 used Duac, acne therapy should be used with caution because a possible cumulative irritancy Pediatric Use: Safety and effectiveness of this product in pediatric patients below
396 used benzoyl peroxide, 349 used clindamycin and 177 used vehicle. Duac effect may occur, especial y with the use of peeling, desquamating, or abrasive the age of 12 have not been established.
applied once daily for 11 weeks was significantly more effective than vehicle, benzoyl peroxide, and clindamycin in the treatment of inflammatory lesions of ADVERSE REACTIONS
moderate to moderately severe facial acne vulgaris in three of the five studies The use of antibiotic agents may be associated with the overgrowth of During clinical trials, al patients were graded for facial erythema, peeling, burning, DESCRIPTION
nonsusceptible organisms, including fungi. If this occurs, discontinue use of this and dryness on the fol owing scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = Duac® Topical Gel contains clindamycin phosphate, (7(S)-chloro-7- medication and take appropriate measures.
severe. The percentage of patients that had symptoms present before treatment (at deoxylincomycin-2-phosphate), equivalent to 1% clindamycin, and 5% benzoyl Patients were evaluated and acne lesions counted at each clinical visit: weeks 2, 5, baseline) and during treatment were as fol ows: 8, 11. The primary efficacy measures were the lesion counts and the investigator’s global assessment evaluated at week 11. Patients were instructed to wash the face, Avoid contact with eyes and mucous membranes.
Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic wait 10 to 20 minutes, and then apply medication to the entire face, once daily, in Clindamycin and erythromycin containing products should not be used in Local reactions with use of Duac Topical Gel
produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent the evening before retiring. Percent reductions in inflammatory lesion counts after combination. In vitro studies have shown antagonism between these two % of patients using Duac Topical Gel with symptom present
treatment for 11 weeks in these five studies are shown in the fol owing table: antimicrobials. The clinical significance of this in vitro antagonism is not known.
Combined results from 5 studies (n = 397)
Mean percent reduction in inflammatory lesion counts
18H34ClN2O8PS. The structural formula for clindamycin Information for Patients: Patients using Duac Topical Gel should receive the
1. Duac Topical Gel is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and al mucous C—NH—C—H
membranes, as this product may be irritating.
2. This medication should not be used for any disorder other than that for which it 3. Patients should not use any other topical acne preparation unless otherwise (Percentages derived by # subjects with symptom score/# enrol ed Duac subjects, The Duac group showed greater overal improvement in the investigator’s global assessment than the benzoyl peroxide, clindamycin and vehicle groups in three of 4. Patients should report any signs of local adverse reactions to their physician.
Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is the five studies (Studies 1, 2, and 5).
DOSAGE AND ADMINISTRATION
methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2- 5. Duac Topical Gel may bleach hair or colored fabric.
Duac Topical Gel should be applied once daily, in the evening or as directed by the pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen Clinical studies have not adequately demonstrated the effectiveness of Duac versus physician, to affected areas after the skin is gently washed, rinsed with warm water benzoyl peroxide alone in the treatment of non-inflammatory lesions of acne.
6. Duac Topical Gel can be stored at room temperature up to 25°C (77°F) for INDICATIONS AND USAGE
up to 2 months. Do not freeze. Keep tube tightly closed. Keep out of the reach Benzoyl peroxide is C14H10O4. It has the fol owing structural formula: Duac Topical Gel is indicated for the topical treatment of inflammatory acne of smal children. Discard any unused product after 2 months.
HOW SUPPLIED
Duac® (clindamycin, 1% - benzoyl peroxide, 5%) Topical Gel is available in a 45 7. Before applying Duac Topical Gel to affected areas, wash the skin gently, Duac Topical Gel has not been demonstrated to have any additional benefit when compared to benzoyl peroxide alone in the same vehicle when used for the Prior to Dispensing: Store in a cold place, preferably in a refrigerator, between 2°C
8. Excessive or prolonged exposure to sunlight should be limited. To minimize and 8°C (36°F and 46°F). Do not freeze. Benzoyl peroxide has a molecular weight of 242.23.
CONTRAINDICATIONS
exposure to sunlight, a hat or other clothing should be worn.
Dispensing Instructions for the Pharmacist: Dispense Duac Topical Gel with a 60
Each gram of Duac Topical Gel contains 10 mg (1%) clindamycin, as phosphate, Duac Topical Gel is contraindicated in those individuals who have shown Carcinogenesis, Mutagenesis, Impairment of Fertility: Benzoyl peroxide has been
day expiration date and specify “Store at room temperature up to 25°C (77°F). Do and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer 940, hypersensitivity to any of its components or to lincomycin. It is also contraindicated shown to be a tumor promoter and progression agent in a number of animal studies. dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, silicon in those having a history of regional enteritis, ulcerative colitis, The clinical significance of this is unknown.
dioxide, methylparaben, poloxamer, purified water, and sodium hydroxide.
pseudomembranous colitis, or antibiotic-associated colitis.
Keep tube tightly closed. Keep out of the reach of smal children.
Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week CLINICAL PHARMACOLOGY
WARNINGS
induced squamous cel skin tumors in transgenic TgAC mice in a study using 20 U.S. Patent Nos. 5,466,446, 5,446,028, 5,767,098, and 6,013,637 A comparative study of the pharmacokinetics of Duac Topical Gel and 1% ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN
clindamycin solution alone in 78 patients indicated that mean plasma clindamycin ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH.
levels during the four week dosing period were < 0.5 ng/ml for both treatment USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN
Genotoxicity studies were not conducted with Duac Topical Gel. Clindamycin ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA,
phosphate was not genotoxic in Salmonel a typhimurium or in a rat micronucleus BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS)
test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of Benzoyl peroxide has been shown to be absorbed by the skin where it is converted mammalian cel types, to be mutagenic in Salmonel a typhimurium tests by some but to benzoic acid. Less than 2% of the dose enters systemic circulation as benzoic HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC
not al investigators, and to cause sister chromatid exchanges in Chinese hamster CLINDAMYCIN. STUDIES INDICATE A TOXIN(S) PRODUCED BY CLOSTRIDIA IS
ovary cel s. Studies have not been performed with Duac Topical Gel or benzoyl ONE PRIMARY CAUSE OF ANTIBIOTIC-ASSOCIATED COLITIS. THE COLITIS IS
peroxide to evaluate the effect on fertility. Fertility studies in rats treated oral y with Microbiology:
USUALLY CHARACTERIZED BY SEVERE PERSISTENT DIARRHEA AND SEVERE
up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of ABDOMINAL CRAMPS AND MAY BE ASSOCIATED WITH THE PASSAGE OF BLOOD
clindamycin in the highest recommended adult human dose of 2.5 g Duac Topical Mechanism of Action
Gel, based on mg/m2) revealed no effects on fertility or mating ability.
Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS
prevents elongation of peptide chains by interfering with peptidyl transfer, thereby COLITIS. STOOL CULTURE FOR Clostridium difficile AND STOOL ASSAY FOR
Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction
Clostridium difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN
studies have not been conducted with Duac Topical Gel or benzoyl peroxide. It is also SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED.
not known whether Duac Topical Gel can cause fetal harm when administered to a Benzoyl peroxide is a potent oxidizing agent.
LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A
pregnant woman or can affect reproduction capacity. Duac Topical Gel should be given to a pregnant woman only if clearly needed.
In Vivo Activity
DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA. ANTIPERISTALTIC
No microbiology studies were conducted in the clinical trials with this product.
AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY
Developmental toxicity studies performed in rats and mice using oral doses of PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS AND
clindamycin up to 600 mg/kg/day (240 and 120 times the amount of clindamycin in In Vitro Activity
PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO
the highest recommended adult human dose based on mg/m2, respectively) or The clindamycin and benzoyl peroxide components individual y have been shown to subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the have in vitro activity against Propionibacterium acnes, an organism which has been SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL
amount of clindamycin in the highest recommended adult human dose based on associated with acne vulgaris; however, the clinical significance of this is not THERAPY WITH CLINDAMYCIN.
mg/m2, respectively) revealed no evidence of teratogenicity.

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