Description
Brand Name: Clindax- B Gel
Generic Name: Benzoyl Peroxide 5%/ Clindamycin 1% Gel.
DESCRIPTION.
CLINDAX-B Gel® (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-
Benzoyl peroxide is C14H10O4. It has the following structural formula:
Benzoyl peroxide has a molecular weight of 242.23. Each gram of CLINDAX-B 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.
INDICATIONS.
CLINDAX-B Gel® (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.
DOSAGE AND ADMINISTRATION
Apply a thin layer of CLINDAX-B 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 CLINDAX-B Gel®. Avoid the eyes, mouth, lips,
mucous membranes, or areas of broken skin. CLINDAX-B Gel® is not for oral, ophthalmic, or intravaginal use.
HOW ITS SUPPLIED
It’s supplied as a Gel, 1%/5% CLINDAX-B Gel® is a white to slightly yellow, opaque gel. Each gram of CLINDAX-B Gel® contains 12mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide.
CLINDAX-B Gel® is a white to slightly yellow, opaque gel. It is supplied as follows 10 gram
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 and keep tube tightly closed.
Keep out of the reach of small children.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of CLINDAX-B 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 CLINDAX-B Gel®.
DRUG INTERACTIONS
Erythromycin
Avoid using CLINDAX-B 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. CLINDAX-B Gel® should be used with caution in patients receiving such agents.
Warnings & Precautions
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, CLINDAX-B Gel® 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 CLINDAX-B Gel®, may cause increased sensitivity to sunlight. Minimize sun exposure (including use of tanning beds or sun lamps) following drug application. 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.
Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately 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.
CLINDAX-B 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 CLINDAX-B Gel®, at doses up to 8,000 mg/kg/day (16 times the highest recommended adult human dose of 2.5 g CLINDAX-B 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 CLINDAX-B Gel® and exposure to ultraviolet radiation .
Genotoxicity studies were not conducted with CLINDAX-B 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 CLINDAX-B Gel®, 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 CLINDAX-B Gel®, based on mg/m²) revealed no effects on fertility or mating ability.
Use In Specific Populations
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women treated with CLINDAX-B Gel®
