Drugs Details

Drugs Info of Acanya, BenzaClin, BenzaClin with pump, Duac, Z-Clinz 10, Z-Clinz 5
Drugs Details
  • Drugs Type  : FDA
  • Date : 16th Jan 2015 06:00 am
  • Brand Name : Acanya, BenzaClin, BenzaClin with pump, Duac, Z-Clinz 10, Z-Clinz 5
  • Generic Name : benzoyl peroxide and clindamycin topical (Pronunciation: BEN zoyl per OX ide and clin da MYE sin)
Descriptions

BenzaClin® Topical Gel (clindamycin and benzoyl peroxide) contains clindamycin phosphate, (7(S)-chloro-7deoxylincomycin-2-phosphate). 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.

Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below:

 

Clindamycin phosphate Structural Formula Illustration

Clindamycin phosphate has 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-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate).

BenzaClin (clindamycin and benzoyl peroxide) Topical Gel also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula:

 

Benzoyl peroxide Structural Formula Illustration

Benzoyl peroxide has a molecular weight of 242.23.

Each gram of BenzaClin (clindamycin and benzoyl peroxide) Topical Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water.

What are the possible side effects of benzoyl peroxide and clindamycin topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have any of these serious side effects:

  • severe redness, burning, stinging, or peeling of treated skin areas; or
  • diarrhea that is watery or bloody.

Less serious side effects may include:

  • mild burning or stinging;
  • itching or tingly feeling;
  • dryness or peeling of treated skin;...

Read All Potential Side Effects and See Pictures of BenzaClin »

What are the precautions when taking clindamycin and benzoyl peroxide (BenzaClin)?

Before using this medication, tell your doctor or pharmacist if you are allergic to benzoyl peroxide; or to clindamycin; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: intestinal disorders (e.g., regional enteritis, ulcerative colitis, antibiotic-associated colitis, Clostridium difficile-associated diarrhea).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when...

Read All Potential Precautions of BenzaClin »

This monograph has been modified to include the generic and brand name in many instances.

Indications

BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is indicated for the topical treatment of acne vulgaris.

Dosage Administration

BenzaClin (clindamycin and benzoyl peroxide) Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

How Supplied

How Supplied And Compounding Instructions

 

Size
(Net Weight)
NDC 0066- Benzoyl Peroxide Gel Active Clindamycin Powder (In vial) Purified plastic Water To Be Added to each vial
25 grams 0494-25 19.7g 0.3g 5 mL
50 grams 0494-50 39.4g 0.6 g 10 mL
50 grams (pump) 0494-55 39.4g 0.6 g 10 mL

Prior to dispensing, tap the vial until powder flows freely. Add indicated amount of purified water to the vial (to the mark) and immediately shake to completely dissolve clindamycin. If needed, add additional purified water to bring level up to the mark. Add the solution in the vial to the gel and stir until homogenous in appearance (1 to 1½ minutes). For the 50 gram pump only, reassemble jar with pump dispenser. BenzaClin (clindamycin and benzoyl peroxide) Topical Gel (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.

Store at room temperature up to 25°C (77°F) {See USP}.

Do not freeze. Keep tightly closed. Keep out of the reach of children.

Prescribing Information as of June 2009. Dermik Laboratories, a business of sanofi-aventis U.S. LLC Bridgewater, NJ 08807.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

During clinical trials, the most frequently reported adverse event in the BenzaClin (clindamycin and benzoyl peroxide) treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the BenzaClin (clindamycin and benzoyl peroxide) and vehicle groups.

Local Adverse Events - all causalities in > /= 1% of patients

  BenzaClin
n = 420
Vehicle
n = 168
Application site reaction 13 (3%) 1 ( < 1%)
Dry skin 50 (12%) 10 (6%)
Pruritus 8 (2%) 1 ( < 1%)
Peeling 9 (2%) -
Erythema 6 (1%) 1 ( < 1%)
Sunburn 5 (1%) -

The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.

Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. 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.

Read the BenzaClin (clindamycin and benzoyl peroxide) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

Read the BenzaClin Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA, BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC CLINDAMYCIN. 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. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTURE FOR Clostridium Difficile AND STOOL ASSAY FOR C. difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

Precautions

General

For dermatological use only; not for ophthalmic use. 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.

The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi. If this occurs, discontinue use of this medication and take appropriate measures.

Avoid contact with eyes and mucous membranes.

Clindamycin and erythromycin containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. The clinical significance of this is unknown.

Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment.

In a 52 week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of BenzaClin (clindamycin and benzoyl peroxide) Topical Gel with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation).

In a 2-year dermal carcinogenicity study in rats, treatment with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel at doses of 100, 500 and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats. The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g BenzaClin (clindamycin and benzoyl peroxide) Topical Gel, based on mg/m²) was statistically significantly higher than that in the sham- and vehicle-controls.

Genotoxicity studies were not conducted with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test.

Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamycin phosphate and benzoyl peroxide, was not clastogenic in a mouse micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. 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 BenzaClin (clindamycin and benzoyl peroxide) Topical Gel 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 BenzaClin (clindamycin and benzoyl peroxide) Topical Gel, based on mg/m²) revealed no effects on fertility or mating ability.

Pregnancy

Teratogenic Effects

Pregnancy Category C:Animal reproductive/developmental toxicity studies have not been conducted with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel or benzoyl peroxide. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times 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.

There are no well-controlled trials in pregnant women treated with BenzaClin (clindamycin and benzoyl peroxide) Topical Gel . It also is not known whether BenzaClin (clindamycin and benzoyl peroxide) Topical Gel can cause fetal harm when administered to a pregnant woman.

Nursing Women

It is not known whether BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is excreted in 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.

Pediatric Use

Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

An in vitro percutaneous penetration study comparing BenzaClin (clindamycin and benzoyl peroxide) Topical Gel and topical 1% clindamycin gel alone, demonstrated there was no statistical difference in penetration between the two drugs. Mean systemic bioavailability of topical clindamycin in BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is suggested to be less than 1%.

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. It is suggested that the lipophilic nature of benzoyl peroxide acts to concentrate the compound into the lipid-rich sebaceous follicle.

Microbiology

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 activity against P. acnes was not examined in clinical trials with this product.

Clinical Studies

In two adequate and well controlled clinical studies of 758 patients, 214 used BenzaClin (clindamycin and benzoyl peroxide) , 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. BenzaClin (clindamycin and benzoyl peroxide) applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; weeks 2, 4, 6, 8 and 10. The primary efficacy measures were the lesion counts and the investigator's global assessment evaluated at week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face. Non-medicated make-up could be applied at one hour after the BenzaClin (clindamycin and benzoyl peroxide) application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure. Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below:

 

Study 1
BenzaClin
n=120
Benzoyl
peroxide
n=120
Clindamycin
n=120
Vehicle
n=120
Mean percent reduction in inflammatory lesion counts
46% 32% 16% + 3%
Mean percent reduction in non-inflammatory lesion counts
22% 22% 9% +1%
Mean percent reduction in total lesion counts
36% 28% 15% 0.2%
Study 2
BenzaClin
n=95
Benzoyl
peroxide
n=95
Clindamycin
n=49
Vehicle
n=48
Mean percent reduction in inflammatory lesion counts
63% 53% 45% 42%
Mean percent reduction in non-inflammatory lesion counts
54% 50% 39% 36%
Mean percent reduction in total lesion counts
58% 52% 42% 39%

The BenzaClin (clindamycin and benzoyl peroxide) group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients using BenzaClin (clindamycin and benzoyl peroxide) Topical Gel should receive the following information and instructions:

  1. BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating.
  2. This medication should not be used for any disorder other than that for which it was prescribed.
  3. Patients should not use any other topical acne preparation unless otherwise directed by physician.
  4. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using BenzaClin (clindamycin and benzoyl peroxide) Topical Gel. To minimize exposure to sunlight, a wide-brimmed hat or other protective clothing should be worn, and a sunscreen with SPF 15 rating or higher should be used.
  5. Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue BenzaClin (clindamycin and benzoyl peroxide) Topical Gel and contact their physician immediately. In addition, patients should report any signs of local adverse reactions to their physician.
  6. BenzaClin (clindamycin and benzoyl peroxide) Topical Gel may bleach hair or colored fabric.
  7. BenzaClin (clindamycin and benzoyl peroxide) Topical Gel can be stored at room temperature up to 25°C (77°F) for 3 months. Do not freeze. Discard any unused product after 3 months.
  8. Before applying BenzaClin (clindamycin and benzoyl peroxide) Topical Gel to affected areas wash the skin gently, then rinse with warm water and pat dry.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

CLINDAMYCIN/BENZOYL PEROXIDE - TOPICAL

 

(klin-duh-MY sin/BEN-zoh-ill per-OX-ide)

 

COMMON BRAND NAME(S): Benzaclin, Duac

 

USES: This combination medication is used to treat a certain type of acne (inflammatory acne vulgaris). It helps to decrease the number of acne pimples. Clindamycin is an antibiotic that stops the growth of acne-causing bacteria. Benzoyl peroxide can also stop the growth of bacteria as well as reduce oil production in the skin, helping keep your pores open.

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using clindamycin/benzoyl peroxide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before using this medication, wash the affected skin gently with mild, non-medicated cleanser, rinse with warm water, and pat dry. Apply a thin layer of this medication to the affected areas of the skin as directed by your doctor. Be careful to avoid your eyes, mouth, inside your nose, and any areas of broken skin. Wash your hands after each use.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It may take up to 6 weeks to see a decrease in acne and up to 12 weeks to see the full benefit of the medication.

Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Dry skin, redness, burning, itching, or skin peeling may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

You can use skin moisturizing creams or lotions to help reduce many of the side effects listed above.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may be absorbed into your bloodstream and very rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to resistant bacteria. This condition may occur weeks after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the BenzaClin (clindamycin and benzoyl peroxide) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to benzoyl peroxide; or to clindamycin; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: intestinal disorders (e.g., regional enteritis, ulcerative colitis, antibiotic-associated colitis, Clostridium difficile-associated diarrhea).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication may bleach hair or colored fabric. Avoid contact with hair or clothing.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other acne medications used on the skin (e.g., products that contain erythromycin).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Different brands/strengths of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Protect from light and moisture. Keep the container tightly closed, and do not store in the bathroom. This medication is good for a limited time after you receive it. Discard any unused medication by the expiration date your pharmacist provides.

Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised September 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Acanya, BenzaClin, BenzaClin with pump, Duac, Z-Clinz 10, Z-Clinz 5

Generic Name: benzoyl peroxide and clindamycin topical (Pronunciation: BEN zoyl per OX ide and clin da MYE sin)

  • What is benzoyl peroxide and clindamycin topical (BenzaClin)?
  • What are the possible side effects of benzoyl peroxide and clindamycin topical?
  • What is the most important information I should know about benzoyl peroxide and clindamycin topical?
  • What should I discuss with my healthcare provider before using benzoyl peroxide and clindamycin topical?
  • How should I use benzoyl peroxide and clindamycin topical?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking benzoyl peroxide and clindamycin topical?
  • What other drugs will affect benzoyl peroxide and clindamycin topical?
  • Where can I get more information?

What is benzoyl peroxide and clindamycin topical (BenzaClin)?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect that allows excess oil and dirt to be washed away.

Clindamycin is an antibiotic that prevents bacteria from growing on the skin.

The combination of benzoyl peroxide and clindamycin topical are used to treat acne.

Benzoyl peroxide and clindamycin topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of benzoyl peroxide and clindamycin topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have any of these serious side effects:

  • severe redness, burning, stinging, or peeling of treated skin areas; or
  • diarrhea that is watery or bloody.

Less serious side effects may include:

  • mild burning or stinging;
  • itching or tingly feeling;
  • dryness or peeling of treated skin; or
  • redness or other irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the BenzaClin (clindamycin and benzoyl peroxide) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about benzoyl peroxide and clindamycin topical?

Use benzoyl peroxide and clindamycin topical exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use this medication for longer than your doctor has prescribed.

Avoid getting this medication in your eyes, mouth, or nose (or in the creases of your nose), or on your lips. If it does get into any of these areas, wash with water. Do not apply this medicine to sunburned, windburned, dry, chapped, irritated, or broken skin.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Although this medicine is applied to the skin, your body may absorb enough clindamycin to cause serious side effects. You may not be able to use this medication if you have inflammation of your intestines (also called enteritis), ulcerative colitis, or if you have ever had severe diarrhea caused by antibiotic medicine.

Avoid exposure to sunlight or tanning beds. This medication can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Side Effects Centers
  • BenzaClin
  • Duac
  • Acanya

Patient Detailed How Take

What should I discuss with my healthcare provider before using benzoyl peroxide and clindamycin topical?

Do not use this medication if you are allergic to benzoyl peroxide or clindamycin (Cleocin, Clina-Derm, Clindets).

Although this medicine is applied to the skin, your body may absorb enough clindamycin to cause serious side effects. You may not be able to use this medication if you have:

  • inflammation of your intestines (also called enteritis);
  • ulcerative colitis; or
  • if you have ever had severe diarrhea caused by antibiotic medicine.

FDA pregnancy category C. It is not known whether benzoyl peroxide and clindamycin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether benzoyl peroxide and clindamycin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using benzoyl peroxide and clindamycin.

How should I use benzoyl peroxide and clindamycin topical?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.

Wash your hands before and after applying this medication.

Wash your face with a mild cleanser (not soap) and pat the skin dry with a clean towel.

Benzoyl peroxide and clindamycin topical is usually applied twice daily, in the morning and evening.

Avoid getting this medication in your eyes, mouth, or nose (or in the creases of your nose), or on your lips. If it does get into any of these areas, wash with water. Do not apply this medicine to sunburned, windburned, dry, chapped, irritated, or broken skin.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

If you receive more than one supply of Acanya or Duac gel, store the unopened container in a refrigerator until you are ready to start using it. Do not freeze.

Once in use, store the gel at room temperature away from moisture and heat. Do not freeze. Throw away any unused medicine after the expiration date on the label has passed. Duac has an expiration date of 60 days. Acanya has an expiration date of 10 weeks. BenzaClin has an expiration date of 3 months.

Side Effects Centers
  • BenzaClin
  • Duac
  • Acanya

Patient Detailed Avoid Taking

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms include bloody or watery diarrhea, which may result if you absorb this medicine through your skin by applying too much.

What should I avoid while taking benzoyl peroxide and clindamycin topical?

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid exposure to sunlight or tanning beds. This medication can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using sunscreen containing PABA on the same skin treated with benzoyl peroxide and clindamycin topical, or skin discoloration may occur.

Benzoyl peroxide can bleach hair or fabrics. Do not let this medicine come into contact with clothing, hair, or colored towels or bed linens.

What other drugs will affect benzoyl peroxide and clindamycin topical?

Tell your doctor about all other medicines you use, especially:

  • erythromycin topical (Akne-Mycin, Emcin Clear, Eryderm, Erygel, Erythra-Derm, Ery-Sol, and others); or
  • erythromycin taken by mouth (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole, and others).

This list is not complete and other drugs may interact with benzoyl peroxide and clindamycin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about benzoyl peroxide and clindamycin topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 8.03. Revision date: 4/13/2012.

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