Clindamycin phosphate and benzoyl peroxide is the generic equivalent of the brand-name drug Clindamycin Phosphate and Benzoyl Peroxide. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Clindamycin phosphate and benzoyl peroxide through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Clindamycin phosphate and benzoyl peroxide gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. ( 1.1 ) Limitation of Use: Clindamycin phosphate and benzoyl peroxide 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. ( 1.2 ) 1.1 Indication 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. 1.2 Limitations of Use Clindamycin phospha…
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Clindamycin Clindamycin is a lincosamide antibacterial [see Clinical Pharmacology (12.4) ]. Benzoyl Peroxide Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects, but the precise mechanism of action is unknown. 12.3 Pharmacokinetics A comparative trial of the pharmacokinetics of clindamycin phosphate and benzoyl peroxide gel and 1% clindamycin solution alone in 78 subjects indicated that mean plasma clindamycin levels during the 4-week dosing period were less than 0.5 ng/mL for both treatment groups. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Less than 2% of t…
Contraindications & Precautions
4 CONTRAINDICATIONS Clindamycin phosphate and benzoyl peroxide gel is contraindicated in: Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. ( 4 ) Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis). ( 4 ) 4.1 Hypersensitivity Clindamycin phosphate and benzoyl peroxide gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation,…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reaction is described in more detail in the Warnings and Precautions section of the label: Colitis [see Warnings and Precautions (5.1) ] . The most common local adverse reactions (≥5%) are erythema, peeling, dryness, and burning. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted un…
Drug Interactions
7 DRUG INTERACTIONS Clindamycin phosphate and benzoyl peroxide gel should not be used in combination with erythromycin-containing products because of its clindamycin component. ( 7.1 ) 7.1 Erythromycin Avoid using clindamycin phosphate and benzoyl peroxide 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. 7.2 Con…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply a thin layer of clindamycin phosphate and benzoyl peroxide 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 clindamycin phosphate and benzoyl peroxide gel. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin. Clindamycin phosphate and benzoyl peroxide gel is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of cli…
Patient Counseling Information
17 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. Clindamycin phosphate and benzoyl peroxide 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. Clind…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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