FDA

Clindamycin Phosphate and Benzoyl Peroxide

Approved 5 Jun 2018TopicalGel

The FDA lists this product in 16 strengths and forms.

Indications

Clindamycin phosphate and benzoyl peroxide gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Clindamycin phosphate and benzoyl peroxide gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )

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. ( 4.1 ) Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. ( 4.2 )

4.1Hypersensitivity

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. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel [see Postmarketing Experience (6.2) ] .

4.2Colitis/Enteritis

Clindamycin phosphate and benzoyl peroxide gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1) ] .

Warnings and precautions

Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. Clindamycin phosphate and benzoyl peroxide gel should be discontinued if significant diarrhea occurs. ( 5.1 ) Ultraviolet Light and Environmental Exposure: Minimize sun exposure following drug application. ( 5.2 )

Indications

Contraindications

4.1Hypersensitivity

4.2Colitis/Enteritis

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on clindamycin phosphate and benzoyl peroxide gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes (see Data ). In limited published clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of major birth defects.

In animal reproduction studies, clindamycin did not cause malformations or embryo-fetal development toxicity in pregnant rats and mice when administered during the period of organogenesis at systemic doses up to 240 times the maximum recommended human dose (MRHD) of 2.5 g clindamycin phosphate and benzoyl peroxide gel, based on body surface area (BSA) comparisons (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data In limited published trials in pregnant women administered clindamycin during the first trimester of pregnancy, there was no difference in the rate of major birth defects reported among in utero exposed infants compared to unexposed infants.

These data cannot definitely establish or exclude any clindamycin-associated risk during pregnancy. Animal Data Animal reproductive/developmental toxicity studies have not been conducted with clindamycin phosphate and benzoyl peroxide gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in pregnant rats and mice administered during the period of organogenesis at oral doses of up to 600 mg/kg/day (240 and 120 times the MRHD for clindamycin, respectively, based on BSA comparisons) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the MRHD for clindamycin, respectively, based on BSA comparisons) revealed no malformations or embryo-fetal development toxicity.

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 adverse reactions are: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%). ( 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

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates observed in clinical trials of another drug and may not reflect the rates observed in clinical practice. These adverse reactions occurred in less than 0.5% of subjects treated with clindamycin phosphate and benzoyl peroxide gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).

During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions either were the same as baseline or increased and peaked around Week 4 and were near or improved from baseline levels by Week 12. The percentage of subjects that had symptoms present before treatment (at baseline), 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. Results from the Phase 3 Trial (N = 243) Before Treatment (Baseline) During Treatment End of Treatment (Week 12) Mild Mod. Mod. = Moderate Severe Mild Mod. Severe Mild Mod. Severe Erythema 20 6 0 28 5 <1 15 2 0 Scaling 10 1 0 19 3 0 10 <1 0 Itching 14 3 <1 15 3 0 7 2 0 Burning 5 <1 <1 7 1 <1 3 <1 0 Stinging 5 <1 0 7 0 <1 3 0 <1

6.2Postmarketing Experience

Because postmarketing adverse 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 phosphate/benzoyl peroxide.

Clindamycin Phosphate and Benzoyl Peroxide

Indications

Contraindications

4.1Hypersensitivity

4.2Colitis/Enteritis

Warnings and precautions

Two medicines in one question?

Clindamycin Phosphate and Benzoyl Peroxide

Indications

Contraindications

4.1Hypersensitivity

4.2Colitis/Enteritis

Warnings and precautions

Two medicines in one question?

5.1Colitis

5.2Ultraviolet Light and Environmental Exposure

5.3Concomitant Topical Medications

Interactions

7.1Erythromycin

7.2Neuromuscular Blocking Agents

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance