Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 20 February 2017

Indication(s)

1 INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % 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, 1.2 %/5 % 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 Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % 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.

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Advisory information

contraindications

4 CONTRAINDICATIONS Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % 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, 1.2 %/5 % 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, 1.2 %/5 %.

[See Adverse Reactions (6.2).

] 4.2 Colitis/Enteritis Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1)].

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 Stiefel Laboratories, Inc. at 1-888-784-3335 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not 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, 1.2 %/5 % 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, 1.2 %/5 % Combined Results from Five Trials (n = 397) Symptom % of Subjects Using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % with Symptom Present Before Treatment (Baseline) During Treatment 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, 1.2 %/5 % with symptom score/number of enrolled subjects receiving Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 %).

6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 %.

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, 1.2 %/5 %.

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

Usage information

Dosing and administration

2 DOSAGE AND ADMINISTRATION Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % 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, 1.2 %/5 %.

Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin.

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % is not for oral, ophthalmic, or intravaginal use.

•Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % to the face once daily, in the evening.

(2) •Not for oral, ophthalmic, or intravaginal use.

(2)

Use in special populations

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 %.

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg per kg per day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg per m2, respectively) or subcutaneous doses of clindamycin up to 250 mg per kg per day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg per m2, respectively) revealed no evidence of teratogenicity.

8.3 Nursing Mothers It is not known whether Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % is excreted into human milk after topical application.

However, orally and parenterally administered clindamycin has been reported to appear in breast milk.

Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Because many drugs are excreted in human milk, caution should be exercised when Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % is administered to a nursing woman.

8.4 Pediatric Use Safety and effectiveness of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % in pediatric patients below the age of 12 have not been established.

8.5 Geriatric Use Clinical studies of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % did not include sufficient numbers of subjects ages 65 and over to determine whether they respond differently from younger subjects.

Pregnancy and lactation

8.3 Nursing Mothers It is not known whether Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % is excreted into human milk after topical application.

However, orally and parenterally administered clindamycin has been reported to appear in breast milk.

Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Because many drugs are excreted in human milk, caution should be exercised when Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % is administered to a nursing woman.

Interactions

7 DRUG INTERACTIONS •Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % 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, 1.2 %/5 % 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 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.

7.3 Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 %/5 % should be used with caution in patients receiving such agents.

7.4 Topical Sulfone Products Use of topical benzoyl-peroxide-containing preparations with topical sulfone products may cause skin and facial hair to temporarily change color (yellow/orange).

More information

Category Value
Authorisation number NDA050741
Orphan designation No
Product NDC 66993-949
Date Last Revised 15-04-2015
Type HUMAN PRESCRIPTION DRUG
RXCUI 1540241
Storage and handling 16.2 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.
Marketing authorisation holder Prasco Laboratories