Clindamycin Phosphate, Benzoyl Peroxide

FDA Drug Information • Also known as: Clindamycin Phosphate And Benzoyl Peroxide

Brand Names: Clindamycin Phosphate And Benzoyl Peroxide
Route: TOPICAL
Dosage Form: GEL
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2 - pyrrolidinecarboxamido)-1-thio-L-threo - α - Dgalacto-octopyranoside 2 -(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below: Clindamycin phosphate: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below: Benzoyl peroxide: Molecular Formula: C 14 H 10 O 4 Molecular Weight: 242.23 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% contains the following inactive ingredients: purified water, carbomer 980, propylene glycol, and potassium hydroxide. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin. structure1 structure2

What Is Clindamycin Phosphate, Benzoyl Peroxide Used For?

1 INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, 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, 1.2%/2.5% to the face once daily. Avoid the eyes, mouth, mucous membranes, or areas of broken skin. Use of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% 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, 1.2%/2.5% is not for oral, ophthalmic, or intravaginal use.

Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the face once daily. (2)

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

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 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 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. The following selected adverse reactions occurred in less than 0.2% of subjects treated with clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). 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.* Severe Mild Mod.* Severe Mild Mod.* Severe Erythema 22 4 0 25 5 < 1 15 2 0 Scaling 8 < 1 0 18 3 0 8 1 0 Itching 10 2 0 15 2 0 6 < 1 0 Burning 3 < 1 0 8 2 0 2 < 1 0 Stinging 2 < 1 0 6 1 0 1 < 1 0 *Mod. = Moderate 6.2 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.

Drug Interactions

7 DRUG INTERACTIONS

Avoid using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% in combination with topical or oral erythromycin-containing products because of its clindamycin component. (7.1) 7.1 Erythromycin Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% should not be used in combination with topical or oral 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 Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% should be used with caution in patients receiving such agents.

Contraindications

4 CONTRAINDICATIONS Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is contraindicated in:

Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. (4.1)

Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. (4.2) 4.1 Hypersensitivity Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/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%/2.5%. [ See Postmarketing Experience (6.2) . ] 4.2 Colitis/Enteritis Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. [ See Warnings and Precautions (5.1) . ]

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary There are no available data on Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% 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, 1.2%/2.5%, 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 2-4% and 15-20%, 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, 1.2%/2.5% or benzoyl peroxide. Developmental toxicity...

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a white to off-white smooth gel supplied as: NDC 45802- 597 -0150 g pump 16.2 Dispensing Instructions for the Pharmacist

Dispense Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% with a 10-week expiration date.

Specify “Store at room temperature up to 25°C (77°F). Do not freeze.” 16.3 Storage and Handling

PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2°C to 8°C (36°F to 46°F).

PATIENT: Store at room temperature at or below 25°C (77°F).

Protect from freezing.

Store pump upright.

Keep out of the reach of children.

Keep container tightly closed.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.