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benzoyl peroxide gel
|Study 1||Benzamycin® Pak
N = 119
N = 113
| Benzamycin® Pak
N = 38
N = 37
|Mean % Lesion Counts Reduction|
|Non Inflammatory *||46%||43%||24%||20%|
|Global Success *||28%||27%||3%||11%|
|Study 2||Benzamycin Pak
N = 109
N = 108
|Mean % Lesion Counts Reduction|
|Global Success *||36%||12%|
Erythromycin acts by inhibition of protein synthesis in susceptible organisms by reversibly binding to 50 S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between erythromycin, lincomycin, chloramphenicol and clindamycin.
Benzoyl peroxide has been shown to be effective in vitro against Propionibacterium acnes, an anaerobe found in sebaceous follicles and comedones. Benzoyl peroxide is believed to act by releasing active oxygen.
Benzamycin Pak® is contraindicated in those individuals who have shown hypersensitivity to any of its components.
For topical 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. If severe irritation develops, discontinue use and institute appropriate therapy.
The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms. If this occurs, discontinue use and take appropriate measures.
Avoid contact with eyes and all mucous membranes.
Patients using Benzamycin® Pak should receive the following information and instructions:
The combination of benzoyl peroxide and erythromycin in Benzamycin® Pak has not been evaluated for its carcinogenic or mutagenic potential or for its effects on 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.
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.
No animal studies have been performed to evaluate the carcinogenic potential or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin base and erythromycin ethylsuccinate and in rats and mice with erythromycin stearate did not provide evidence of tumorigenicity.
The genotoxicity of erythromycin stearate has been evaluated in the Salmonella typhimurium reverse mutation assay, the mouse L5178Y lymphoma cell assay, and for sister chromatid exchanges and chromosomal aberrations in CHO cells. These studies indicated that erythromycin stearate was not genotoxic.
There was no apparent effect on male or female fertility in rats fed erythromycin base at levels up to 0.25% of diet.
Animal reproduction studies have not been conducted with Benzamycin® Pak or benzoyl peroxide.
There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters.
There are no well-controlled trials in pregnant women with Benzamycin® Pak. It also is not known whether Benzamycin® Pak can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Benzamycin® Pak should be given to a pregnant woman only if clearly needed.
It is not known whether the ingredients of Benzamycin® Pak are excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman.
During clinical trials, 550 acne patients were studied. Of these patients, 236 were treated with Benzamycin® Pak. The most frequently reported adverse event considered at least possibly related was dry skin (7.6%) as compared to Vehicle (3.9%). Application site reactions (stinging, burning sensation, tingling, erythema) were reported in 2.5% of patients versus 1.3% for Vehicle patients. Blepharitis, pruritus and photosensitivity reactions were reported in <2% of patients who used the dual pouch product.
|Treatment Group Summaries
Number of Patients (%)
N = 236
N = 153
N = 121
Topical Gel Vehicle
N = 40
|DRY SKIN||18 (7.6%)||6 (3.9%)||6 (5.0%)||0|
|APPLICATION SITE REACTION
(stinging, erythema, and burning)
|6 (2.5%)||2 (1.3%)||1 (0.8%)||0|
|BLEPHARITIS||4 (1.7%)||1 (0.7%)||0||1 (2.5%)|
|PRURITUS||4 (1.7%)||2 (1.3%)||3 (2.5%)||0|
(Sunburn, stinging with sun exposure)
|PEELING||1 (0.5%)||1 (0.7%)||0||0|
Benzamycin® Pak requires thorough mixing by the patient immediately prior to each use. The medication should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry.
60 Pouches per carton NDC 0066-0577-60
Store at Room Temperature 20 to 25°C (68 to 77°F).
Keep away from heat and any open flame.
Keep out of the reach of children.
Prescribing Information as of July 2002.
A Division of Aventis Pharmaceuticals Inc.
Berwyn, PA 19312 USA
DPT Lakewood, Inc.
Lakewood, NJ 08701 USA
erythromycin and benzoyl peroxide gel
Revised: 03/2007 Dermik Laboratories
Reproduced with permission of U.S. National Library of Medicine
Copyright © 2018
|Over-the-counter (OTC) Drugs|