Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ)
Fougera Pharmaceuticals Inc.
CICLOPIROX
CICLOPIROX 10 mg in 0.96 mL
TOPICAL
PRESCRIPTION DRUG
Ciclopirox Shampoo 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. None. Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, Ciclopirox Shampoo 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 13, 42, 54 and 26 times the maximum recommended human dose based on body surface area comparisons, respectively). Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox olamine was topically administered
Ciclopirox Shampoo 1% is supplied in 120 mL plastic bottles (NDC 0168-0449-04). Discard unused product after initial treatment duration. Store between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.
Abbreviated New Drug Application
CICLOPIROX- CICLOPIROX SHAMPOO FOUGERA PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CICLOPIROX SHAMPOO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CICLOPIROX SHAMPOO. CICLOPIROX SHAMPOO 1% FOR TOPICAL USE INITIAL U.S. APPROVAL: 1982 INDICATIONS AND USAGE • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FOUGERA PHARMACEUTICALS INC. AT 1-800-645-9833 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 7/2017 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Local Effects 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Ciclopirox Shampoo is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. (1) Apply approximately 1 teaspoon of Ciclopirox Shampoo to the scalp twice per week for 4 weeks. (2) For topical use only. Not for ophthalmic, oral, or intravaginal use. (2) Shampoo, 1% (3) None (4) If signs of irritation occur, discontinue use. (5.1) Avoid contact with eyes. (5.1) Hair discoloration has been reported with Ciclopirox use. (5.1) The most frequently reported adverse reactions are pruritus, burning, and erythema. (6.1) 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 12.4 Microbiology 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Ciclopirox Shampoo 1% is indicated for the topica Lesen Sie das vollständige Dokument