Clindamycin phosphate/Benzoyl peroxide

Clindamycin phosphate/Benzoyl peroxide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]; Turky Alkathery, M.D. [3]

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Overview

Clindamycin phosphate/Benzoyl peroxide is a lincosamide that is FDA approved for the treatment of inflammatory acne vulgaris. Common adverse reactions include dry skin.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Inflammatory Acne Vulgaris

• Dosing information

• 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.

Limitations of Use

• Dosing information

• 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of clindamycin phosphate/benzoyl peroxide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of clindamycin phosphate/benzoyl peroxide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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.

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.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Clindamycin phosphate/Benzoyl peroxide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Clindamycin phosphate/Benzoyl peroxide in pediatric patients.

Contraindications

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%.

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.

Warnings

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. If significant diarrhea occurs, clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% 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 a 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.

Ultraviolet Light and Environmental Exposure

Benzoyl peroxide, a component of clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%, may cause increased sensitivity to sunlight. Minimize sun exposure (including use of tanning beds or sun lamps) following drug application.Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution.

Adverse Reactions

Clinical 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, 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.

This image is provided by the National Library of Medicine.

(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%).

Postmarketing Experience

The following adverse reactions have been identified during post approval 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 post marketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%.

Drug Interactions

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.

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.

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): 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/kg/day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clindamycin phosphate/Benzoyl peroxide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Clindamycin phosphate/Benzoyl peroxide during labor and delivery.

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.

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.

Geriatic 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.

Gender

There is no FDA guidance on the use of Clindamycin phosphate/Benzoyl peroxide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Clindamycin phosphate/Benzoyl peroxide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Clindamycin phosphate/Benzoyl peroxide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Clindamycin phosphate/Benzoyl peroxide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Clindamycin phosphate/Benzoyl peroxide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Clindamycin phosphate/Benzoyl peroxide in patients who are immunocompromised.

Administration and Monitoring

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.

Monitoring

FDA package insert for clindamycin phosphate/benzoyl peroxide contains no information regarding Drug Monitoring.

IV Compatibility

There is limited information about the IV compatibility.

Overdosage

FDA Package Insert for clindamycin phosphate/benzoyl peroxide contains no information regarding Drug overdosage.

Pharmacology

Clindamycin phosphate/Benzoyl peroxide
Combination of
Benzoyl peroxide	Antiseptic
Clindamycin phosphate	Antibiotic
Identifiers
CAS number	?
ATC code	D10AE51
PubChem	?
Therapeutic considerations
Licence data	US
Pregnancy cat.	C
Legal status	Template:Unicode Prescription only
Routes	Topical

Mechanism of Action

Clindamycin: clindamycin is a lincosamide antibacterial.

Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects, but the precise mechanism of action is unknown.

Structure

Clindamycin phosphate and Benzoyl peroxide gel, 1.2%/5% is a fixed combination product with two active ingredients in a white to slightly yellow, opaque, aqueous gel formulation.

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

Clindamycin phosphate is C 18 H 34 ClN 2 O 8 PS. The structural formula for clindamycin phosphate is represented below:

This image is provided by the National Library of Medicine.

Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).

Benzoyl peroxide is C14H10O4. It has the following structural formula:

This image is provided by the National Library of Medicine.

Benzoyl peroxide has a molecular weight of 242.23.

Each gram of clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% contains 10 mg (1%) clindamycin, as clindamycin phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type C), dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide.

Pharmacodynamics

There is limited information regarding Clindamycin phosphate/Benzoyl peroxide Pharmacodynamics in the drug label.

Pharmacokinetics

A comparative trial of the pharmacokinetics of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and 1% clindamycin solution alone in 78 subjects indicated that mean plasma clindamycin levels during the 4 week dosing period were <0.5 ng/mL for both treatment groups.

Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Less than 2% of the dose enters systemic circulation as benzoic acid.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. The clinical significance of this is unknown.

In a 2-year dermal carcinogenicity study in mice, treatment with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% at doses up to 8,000 mg/kg/day (16 times the highest recommended adult human dose of 2.5 g Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, based on mg/m2) did not cause an increase in skin tumors. However, topical treatment with another formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, or 2,000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2‑year dermal carcinogenicity study in rats.

In a 52-week photocarcinogenicity study in hairless mice (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical treatment with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and exposure to ultraviolet radiation.

Genotoxicity studies were not conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in Salmonella typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.

Studies have not been performed with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, based on mg/m2) revealed no effects on fertility or mating ability.

Clinical Studies

In five randomized, double-blind clinical trials of 1,319 subjects, 397 used clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%, 396 used benzoyl peroxide, 349 used clindamycin and 177 used vehicle. Subjects were instructed to wash the face, wait 10 to 20 minutes, and then apply medication to the entire face, once daily in the evening before retiring. Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% applied once daily for 11 weeks was significantly more effective than vehicle, benzoyl peroxide, and clindamycin in the treatment of inflammatory lesions of moderate to moderately severe facial acne vulgaris in three of the five trials (Trials 1, 2, and 5).

Subjects were evaluated and acne lesions counted at each clinical visit at Weeks 2, 5, 8, 11. The primary efficacy measures were the lesion counts and the investigator’s global assessment evaluated at Week 11. Percent reductions in inflammatory lesion counts after treatment for 11 weeks in these 5 trials are shown in Table 2.

This image is provided by the National Library of Medicine.

The group treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% showed greater overall improvement in the investigator’s global assessment than the benzoyl peroxide, clindamycin and vehicle groups in three of the five trials (Trials 1, 2, and 5).

Clinical trials have not adequately demonstrated the effectiveness of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% versus benzoyl peroxide alone in the treatment of non-inflammatory lesions of acne.

How Supplied

Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is a white to slightly yellow, opaque gel. It is supplied as follows:

• 45 gram tube NDC 66993-949-45

Storage

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.

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

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Patient Counseling Information

See FDA-approved patient labeling (Patient Information)

• Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately.
• Clindamycin phosphate and benzoyl peroxide Gel, 1.2%/5% may cause irritation such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies.
• Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn. Sunscreen may also be used.
• Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% may bleach hair or colored fabric.

Manufactured for: Prasco Laboratories.

Mason, OH 45040 USA

DUG:4PI

PHARMACIST - DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

Precautions with Alcohol

Alcohol-Clindamycin phosphate/benzoyl peroxide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Clindamycin phosphate/benzoyl peroxide

Look-Alike Drug Names

There is limited information regarding Clindamycin phosphate/Benzoyl peroxide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.