FDA

Clindamycin Phosphate and Benzoyl Peroxide

Approved 28 Dec 2018TopicalGel

The FDA lists this product in 16 strengths and forms.

Indications

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 )

1.1Indication

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.

1.2Limitations 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.

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 )

4.1Hypersensitivity

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 Adverse Reactions ( 6.2 ).]

4.2

Indications

( 1.2 )

1.1Indication

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.

1.2Limitations of Use

Contraindications

4.1Hypersensitivity

4.2

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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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 the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, 397 subjects used clindamycin phosphate and benzoyl peroxide gel once daily for 11 weeks for the treatment of moderate to moderately severe facial acne vulgaris.

All subjects were graded for facial local skin reactions (erythema, peeling, burning, and dryness) on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The percentage of subjects that had symptoms present before treatment (at baseline) and during treatment is presented in Table 1. Table 1 Local Skin Reactions with Use of Clindamycin Phosphate and Benzoyl Peroxide Gel Combined Results from Five Trials (n = 397) % of Subjects Using Clindamycin Phosphate and Benzoyl Peroxide Gel with Symptom Present Before Treatment (Baseline) During Treatment Symptom Mild Moderate Severe Mild Moderate Severe Erythema 28% 3% 0 26% 5% 0 Peeling 6% <1% 0 17% 2% 0 Burning 3% <1% 0 5% <1% 0 Dryness 6% <1% 0 15% 1% 0 (Percentages derived by number of subjects receiving clindamycin phosphate and benzoyl peroxide gel with symptom score/number of enrolled subjects receiving clindamycin phosphate and benzoyl peroxide gel).

6.2Post-marketing Experience

The following adverse reactions have been identified during post-approval use of clindamycin phosphate and benzoyl peroxide 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 clindamycin phosphate and benzoyl peroxide gel.

Urticaria, application site reactions, including discoloration have been reported.

Clindamycin Phosphate and Benzoyl Peroxide

Indications

1.1Indication

1.2Limitations of Use

Contraindications

4.1Hypersensitivity

4.2

Two medicines in one question?

Clindamycin Phosphate and Benzoyl Peroxide

Indications

1.1Indication

1.2Limitations of Use

Contraindications

4.1Hypersensitivity

4.2

Two medicines in one question?

Warnings and precautions

5.1Colitis

5.2Ultraviolet Light and Environmental Exposure

Interactions

7.1Erythromycin

7.2Concomitant Topical Medications

7.3Neuromuscular Blocking Agents

7.4Topical Sulfone Products Use

Pregnancy and breastfeeding

8.1Pregnancy Pregnancy Category C.

Adverse reactions

6.1Clinical Trials Experience

6.2Post-marketing Experience

Composition

Strengths and forms

Official product information

At a glance