Clindamycin Phosphate And Benzoyl Peroxide

2 DOSAGE AND ADMINISTRATION Before applying clindamycin phosphate and benzoyl peroxide gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. Apply a pea-sized amount of clindamycin phosphate and benzoyl peroxide gel to the face once daily.

Avoid the eyes, mouth, mucous membranes, or areas of broken skin. Use of clindamycin phosphate and benzoyl peroxide gel beyond 12 weeks has not been evaluated. 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.

Clindamycin phosphate and benzoyl peroxide gel is not for oral, ophthalmic, or intravaginal use. Apply a pea-sized amount of clindamycin phosphate and benzoyl peroxide gel to the face once daily. ( 2 ) Not for oral, ophthalmic, or intravaginal use.

( 2 )

1%). gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

1%). During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around Week 4 and continually decreased over time reaching near baseline levels by Week 12.

The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at Week 12 are shown in Table 1.

Table 1:

Percent of Subjects with Local Skin Reactions. Combined Results from the Two Phase 3 Trials (N = 773) Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12) Mild Mod. Mod. = Moderate Severe Mild Mod. Severe Mild Mod.

2 Postmarketing Experience 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 hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

5 WARNINGS AND PRECAUTIONS Colitis: Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

Clindamycin phosphate and benzoyl peroxide gel should be discontinued if significant diarrhea occurs. 1 ) Ultraviolet Light and Environmental Exposure: Minimize sun exposure following drug application. 1 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. When significant diarrhea occurs, clindamycin phosphate and benzoyl peroxide 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 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. 2 Ultraviolet Light and Environmental Exposure Minimize sun exposure including use of tanning beds or sun lamps following drug application.

3 Concomitant Topical Medications Concomitant topical acne therapy 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.

, anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. 1 ) Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. 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, or lincomycin.

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