Journal of Clinical and Aesthetic Dermatology

DEC 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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Page 11 of 59

BRIEF SUMMARY OF PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to use AKTIPAK ™ safely and effectively. See full prescribing information for AKTIPAK ™ . AKTIPAK ™ (erythromycin and benzoyl peroxide) Gel, 3%/5% - For Dermatological Use Only – Not for Ophthalmic Use INDICATIONS AND USAGE Aktipak ™ is indicated for the topical treatment of acne vulgaris. CONTRAINDICATIONS Aktipak ™ is contraindicated in those individuals who have shown hypersensitivity to any of its components. PRECAUTIONS General: 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. Information for Patients: Patients using Aktipak ™ should receive the following information and instructions: 1. Patients should be informed that they will need to mix this medication prior to use. The medication will be dispensed in one foil pouch which contains medication in two separated compartments. 2. The contents must be mixed thoroughly by the patient (in the palm of the hand), prior to application. 3. Patients should apply the product immediately after mixing, then the hands should be washed. &QPQVOKZQTCRRN[PGCTCPQRGPƃCOG 5. Aktipak ™ may bleach hair or colored fabric. 6. Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn. 7. This medication is to be used as directed by a physician. It is for external use only. Avoid contact with the eyes, mouth, and all mucous membranes as this product may be irritating. 8. Patients should report to their physician any signs of local adverse reactions. 9. This medication should not be used for any disorder other than that for which it was prescribed. 10. Patients should not use any other topical acne preparation unless otherwise directed by physician. 11. Patients should be instructed to review the instructions for use on the product carton. 12. This medication should be stored at r oom temperature away from heat and CP[QRGPƃCOG Carcinogenesis, Mutagenesis, Impairment of Fertility: T he combination of benzoyl peroxide and erythromycin in Aktipak ™ 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 UKIPKƂECPEGQHVJKUKUWPMPQYP 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. Pregnancy: Teratogenic Effects: Pregnancy CATEGORY C: Animal reproduction studies have not been conducted with Aktipak ™ 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 Aktipak ™ . It is also not known whether Aktipak ™ can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Aktipak ™ should be given to a pregnant woman only i f clearly needed. Nursing Women: It is not known whether the ingredients of Aktipak ™ 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. Pediatric Use: Safety and effectiveness of this product in pediatric patients below 12 years of age have not been established. ADVERSE REACTIONS During clinical trials, 550 acne patients were studied. Of these patients, 236 were treated w ith Aktipak ™ . 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% of Vehicle patients. Blepharitis, pruritus and photosensitivity reactions were reported in <2% of patients who used the dual pouch product. Treatment Groups Summaries Number of Patients (%) Aktipak ™ (erythromycin and benzoyl peroxide) Gel, 3%/5% Manufactured for: Cutanea Life Sciences, Inc. Wayne, PA 19087 Revised: December 2016 ©2016 Cutanea Life Sciences, Inc. AKT013 You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Aktipak ™ Aktipak ™ Vehicle Benzamycin Topical Gel Benzamycin Topical Gel V ehicle COSTART Term N = 236 N = 153 N = 121 N = 40 D RY 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 PHOTO- SENSITIVITY REACTION (Sunburn, stinging with sun exposure) 3 (1.3%) 0 0 0 PEELING 1 (0.5%) 1 (0.7%) 0 0

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