No information provided.
BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
During clinical trials, the most frequently reported adverse event in the BenzaClin (clindamycin and benzoyl peroxide) treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the BenzaClin (clindamycin and benzoyl peroxide) and vehicle groups.
Local Adverse Events - all causalities in > /= 1% of patients
| BenzaClin n = 420 |
Vehicle n = 168 |
|
| Application site reaction | 13 (3%) | 1 ( < 1%) |
| Dry skin | 50 (12%) | 10 (6%) |
| Pruritus | 8 (2%) | 1 ( < 1%) |
| Peeling | 9 (2%) | - |
| Erythema | 6 (1%) | 1 ( < 1%) |
| Sunburn | 5 (1%) | - |
The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.
Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. 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.
BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is indicated for the topical treatment of acne vulgaris.
Pregnancy Category C:Animal reproductive/developmental toxicity studies have not been conducted with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel or benzoyl peroxide. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times 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.
There are no well-controlled trials in pregnant women treated with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel. It also is not known whether BenzaClin (clindamycin and benzoyl peroxide) Topical Gel can cause fetal harm when administered to a pregnant woman.
How Supplied And Compounding Instructions
| Size (Net Weight) |
NDC 0066- | Benzoyl Peroxide Gel | Active Clindamycin Powder (In vial) | Purified plastic Water To Be Added to each vial |
| 25 grams | 0494-25 | 19.7g | 0.3g | 5 mL |
| 50 grams | 0494-50 | 39.4g | 0.6 g | 10 mL |
| 50 grams (pump) | 0494-55 | 39.4g | 0.6 g | 10 mL |
Prior to dispensing, tap the vial until powder flows freely. Add indicated amount of purified water to the vial (to the mark) and immediately shake to completely dissolve clindamycin. If needed, add additional purified water to bring level up to the mark. Add the solution in the vial to the gel and stir until homogenous in appearance (1 to 1½ minutes). For the 50 gram pump only, reassemble jar with pump dispenser. BenzaClin (clindamycin and benzoyl peroxide) Topical Gel (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.
Store at room temperature up to 25°C (77°F) {See USP}.
Do not freeze. Keep tightly closed. Keep out of the reach of children.
Prescribing Information as of June 2009. Dermik Laboratories, a business of sanofi-aventis U.S. LLC Bridgewater, NJ 08807.
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. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
PRECAUTIONS GeneralFor dermatological use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.
The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use of this medication and take appropriate measures.
Avoid contact with eyes and mucous membranes.
Clindamycin and erythromycin containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.
Carcinogenesis, Mutagenesis, Impairment of FertilityBenzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. The clinical significance of this is unknown.
Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment.
In a 52 week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of BenzaClin (clindamycin and benzoyl peroxide) Topical Gel with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation).
In a 2-year dermal carcinogenicity study in rats, treatment with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel at doses of 100, 500 and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats. The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g BenzaClin (clindamycin and benzoyl peroxide) Topical Gel, based on mg/m²) was statistically significantly higher than that in the sham- and vehicle-controls.
Genotoxicity studies were not conducted with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test.
Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamycin phosphate and benzoyl peroxide, was not clastogenic in a mouse micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. 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 BenzaClin (clindamycin and benzoyl peroxide) Topical 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 BenzaClin (clindamycin and benzoyl peroxide) Topical Gel, based on mg/m²) revealed no effects on fertility or mating ability.
Pregnancy Teratogenic EffectsPregnancy Category C:Animal reproductive/developmental toxicity studies have not been conducted with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel or benzoyl peroxide. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times 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.
There are no well-controlled trials in pregnant women treated with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel. It also is not known whether BenzaClin (clindamycin and benzoyl peroxide) Topical Gel can cause fetal harm when administered to a pregnant woman.
Nursing WomenIt is not known whether BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is excreted in 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.
Pediatric UseSafety and effectiveness of this product in pediatric patients below the age of 12 have not been established.
BenzaClin (clindamycin and benzoyl peroxide) Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.
During clinical trials, the most frequently reported adverse event in the BenzaClin (clindamycin and benzoyl peroxide) treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the BenzaClin (clindamycin and benzoyl peroxide) and vehicle groups.
Local Adverse Events - all causalities in > /= 1% of patients
| BenzaClin n = 420 |
Vehicle n = 168 |
|
| Application site reaction | 13 (3%) | 1 ( < 1%) |
| Dry skin | 50 (12%) | 10 (6%) |
| Pruritus | 8 (2%) | 1 ( < 1%) |
| Peeling | 9 (2%) | - |
| Erythema | 6 (1%) | 1 ( < 1%) |
| Sunburn | 5 (1%) | - |
The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.
Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. 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.
DRUG INTERACTIONSNo information provided.
