Looking for:- Clindamycin/benzoyl peroxide gel (BenzaClin): a review of its use in the management of acne
Clindamycin and Benzoyl Peroxide Topical: MedlinePlus Drug Information
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:. The BenzaClin group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator. BenzaClin 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.
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.
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. 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. Patients using BenzaClin Topical Gel should receive the following information and instructions:. 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 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 Topical Gel with exposure to ultraviolet radiation 40 weeks of treatment followed by 12 weeks of observation.
Genotoxicity studies were not conducted with BenzaClin 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. Studies have not been performed with BenzaClin Topical Gel or benzoyl peroxide to evaluate the effect on fertility.
There are no well-controlled trials in pregnant women treated with BenzaClin Topical Gel. It also is not known whether BenzaClin Topical Gel can cause fetal harm when administered to a pregnant woman.
It is not known whether BenzaClin 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.
Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established. The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies. BenzaClin 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.
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. For the 35 and 50 gram pumps only, reassemble jar with pump dispenser. Place a 3-month expiration date on the label immediately following mixing. Do not freeze. Keep tightly closed. Keep out of the reach of children.
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Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
Use clindamycin and benzoyl peroxide gel exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
Do not apply a double dose to make up for a missed one. Clindamycin and benzoyl peroxide may cause other side effects. Call your doctor if you have any unusual problems while using this medication. Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture not in the bathroom.
Dispose of any unused medication after 10 weeks. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet.
Instead, the best way to dispose of your medication is through a medicine take-back program. It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers are not child-resistant and young children can open them easily.
To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. Avoid getting clindamycin and benzoyl peroxide gel on your hair or clothing.
Clindamycin and benzoyl peroxide may bleach hair or colored fabric. Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements.
You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. Clindamycin and Benzoyl Peroxide Topical pronounced as klin da mye' sin ben' zoe ill per ox' ide. Why is this medication prescribed? How should this medicine be used?
Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow?