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These highlights do not include all the information needed to use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% safely and effectively. See full prescribing information for Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Clindamycin Pho | Clindamycin - Benzoyl Peroxide [Prasco Laboratories] | BioPortfolio

13:44 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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.

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.

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.

Gel, 1.2%/5%

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% contains 12 mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide.

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).]

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)].

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.

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 [See Nonclinical Toxicology (13.1).] 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.

The following adverse reaction is described in more detail in the Warnings and Precautions section of the label:

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.

(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%).

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

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.

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 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.

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

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 m, 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 m, respectively) revealed no evidence of teratogenicity.

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.

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.

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.

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 CHClNOPS. The structural formula for clindamycin phosphate is represented below:

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 CHO. It has the following structural formula:

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.

Clindamycin

Clindamycin is a lincosamide antibacterial [see Clinical Pharmacology (12.4)].

Benzoyl Peroxide

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

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 less than 0.5 ng per 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.

Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis.

In Vivo Activity

No microbiology studies were conducted in the clinical trials with this product.

In Vitro Activity

The clindamycin and benzoyl peroxide components individually have been shown to have in vitro activity against Propionibacterium acnes, an organism which has been associated with acne vulgaris; however, the clinical significance of this in vitro activity is not known.

Drug Resistance

There are reports of an increase of P. acnes resistance to clindamycin in the treatment of acne. In patients with P. acnes resistant to clindamycin, the clindamycin component may provide no additional benefit beyond benzoyl peroxide alone.

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 per kg per 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 per m) 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 per kg per 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 per kg per 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 per m) revealed no effects on fertility or mating ability.

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.

Table 2. Mean Percent Reduction in Inflammatory Lesion Counts

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.

Treatment Trial 1 (n = 120) Trial 2 (n = 273) Trial 3 (n = 280) Trial 4 (n = 288) Trial 5 (n = 358)
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% 65% 56% 42% 57% 52%
Benzoyl Peroxide 36% 37% 32% 57% 41%
Clindamycin 34% 30% 38% 49% 33%
Vehicle 19% -0.4% 29% 29%

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel. It is supplied as follows:

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Manufactured for:

Prasco Laboratories.

Mason, OH 45040 USA

DUG-PS:5PI

PHARMACIST - DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INFORMATION

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%

Read this Patient Information before you start using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a prescription medicine used on the skin (topical) to treat inflamed acne in people 12 years and older.

Who should not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% if you have:

What should I tell my healthcare provider before using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? Before using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, herbal supplements, and skin products you use. Using other topical acne products may increase the irritation of your skin when used with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%.

How should I use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

What should I avoid while using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

What are the possible side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% may cause serious side effects, including:

The most common side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% are skin reactions and may include redness, peeling, dryness, and burning. These are not all the possible side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Keep Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and all medicines out of the reach of children.

General information about Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% for a condition for which it was not prescribed. Do not give Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% to other people, even if they have the same symptoms you have. It may harm them.

If you would like more information, talk with your healthcare provider. You can also ask your pharmacist or healthcare provider for information about Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% that is written for health professionals.

For more information call 1-888-784-3335.

What are the ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Active ingredients: clindamycin phosphate 1.2% and benzoyl peroxide 5%

Inactive ingredients: carbomer homopolymer (type C), dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Prasco Laboratories.

Mason, OH 45040 USA

April 2015

DUG-PS:2PIL

Important: For use on the skin only (topical use). Do not get Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% in your mouth, eyes, vagina, or on your lips.

PRINCIPAL DISPLAY PANEL

NDC 66993-949-45

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%

45 grams

FOR EXTERNAL USE ONLY

Rx only

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

Manufactured by:

Stiefel Laboratories, Inc.

RTP, NC 27709

Made in Canada

Iss. 6/17

62000000015577

Manufacturer

Prasco Laboratories

Active Ingredients

Source

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