ACANYA(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% For topical - America[美国药品]

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ACANYA(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% For topical

2016-11-23 07:44:14 来源: 作者: 【大中小】浏览:397次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACANYA Gel safely and effectively. See full prescribing information for ACANYA Gel. ACANYA ®(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% For topical use Initial U.S. Approval: 2000 INDICATIONS AND USAGE ACANYA Gel is a lincosamide antibiotic and benzoyl peroxide indicated for the topical treatment of acne vulgaris. (1) DOSAGE AND ADMINISTRATION •Apply a pea-sized amount of ACANYA Gel to the face once daily. ( 2) •Not for oral, ophthalmic, or intravaginal use. ( 2) DOSAGE FORMS AND STRENGTHS ACANYA Gel contains clindamycin phosphate 1.2% and benzoyl peroxide 2.5% in a topical gel in 50 gram pumps. (3) CONTRAINDICATIONS ACANYA Gel is contraindicated in: •Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. ( 4) •Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. ( 4) WARNINGS AND PRECAUTIONS •Colitis: Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. ACANYA Gel should be discontinued if significant diarrhea occurs. ( 5.1) •Ultraviolet Light and Environmental Exposure: Minimize sun exposure following drug application. ( 5.2) ADVERSE REACTIONS The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch DRUG INTERACTIONS •ACANYA Gel should not be used in combination with erythromycin-containing products because of its clindamycin component. ( 7.1) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 2/2014 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4.1Hypersensitivity 4.2Colitis/Enteritis 5 WARNINGS AND PRECAUTIONS 5.1Colitis 5.2Ultraviolet Light and Environmental Exposure 6 ADVERSE REACTIONS 6.1Clinical Studies Experience 6.2Postmarketing Experience 7 DRUG INTERACTIONS 7.1Erythromycin 7.2Neuromuscular Blocking Agents 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanisms of Action 12.3 Pharmacokinetics 12.4Microbiology 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1How Supplied 16.2Dispensing Instructions for the Pharmacist 16.3Storage and Handling 17PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE ACANYA® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. 2 DOSAGE AND ADMINISTRATION Apply a pea-sized amount of ACANYA Gel to the face once daily. Use of ACANYA Gel beyond 12 weeks has not been eva luated. 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. ACANYA Gel is not for oral, ophthalmic, or intravaginal use. 3 DOSAGE FORMS AND STRENGTHS Gel, 1.2%/2.5% Each gram of ACANYA Gel contains 10 mg (1%) clindamycin as phosphate, and 25 mg (2.5%) benzoyl peroxide in a white to off-white, opaque, smooth gel. 4 CONTRAINDICATIONS 4.1Hypersensitivity ACANYA Gel 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 ACANYA Gel [see Postmarketing Experience (6.2)]. 4.2Colitis/Enteritis ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1)]. 5 WARNINGS AND PRECAUTIONS 5.1Colitis 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. When significant diarrhea occurs, ACANYA Gel 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 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. 5.2Ultraviolet Light and Environmental Exposure Minimize sun exposure including use of tanning beds or sun lamps following drug application [see Nonclinical Toxicology (13.1)]. 6 ADVERSE REACTIONS
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