국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Cosette Pharmaceuticals, Inc.
Fluticasone Propionate
Fluticasone Propionate 0.05 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Fluticasone propionate ointment, USP 0.005% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. Fluticasone propionate ointment, 0.005% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, fluticasone propionate ointment, 0.005% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic embryofetal development studies were conducted in mice, rats and rabbits. Subcutaneous doses of 15, 45 and 150 μg/kg/day of fluticasone propionate were administered to pregnant female mice from gestation days 6 to 15. A teratogenic effect characteristic of corticosteroids (cleft palate) was noted after administration of 45 and 150 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in
Fluticasone Propionate Ointment, USP 0.005% is a white to off-white translucent ointment supplied as follows: 15 g tubes (NDC 0713-0632-15) 30 g tubes (NDC 0713-0632-31) 60 g tubes (NDC 0713-0632-60) Store between 2° and 30°C (36° and 86°F).
Abbreviated New Drug Application
FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE OINTMENT COSETTE PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUTICASONE PROPIONATE OINTMENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUTICASONE PROPIONATEOINTMENT. FLUTICASONE PROPIONATE OINTMENT, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1990 INDICATIONS AND USAGE Fluticasone propionate ointment, USP 0.005% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. ( 1) DOSAGE AND ADMINISTRATION Apply a thin film to affected skin areas twice daily. ( 2) DOSAGE FORMS AND STRENGTHS Ointment, 0.005%, supplied in 15 g, 30 g, and 60 g tubes. ( 3) CONTRAINDICATIONS Fluticasone propionate ointment, 0.005% is contraindicated in those patients with a history of serious hypersensitivity to any of the components in the preparation. ( 4) WARNINGS AND PRECAUTIONS Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: Reversible HPA axis suppression and resulting clinical glucocorticoid insufficiency can occur during or after withdrawal of treatment. Risk factors include use over large surface area, prolonged use, use under occlusion, altered skin barrier, liver failure, and young age. Modify use if HPA axis suppression is suspected. ( 5.1) ADVERSE REACTIONS The most common adverse reactions (<1%) were pruritus, burning, hypertrichosis, increased erythema, urticaria, irritation, and lightheadedness. ( 6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT COSETTE PHARMACEUTICALS,INC. AT 1-800- 922-1038 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 10/2022 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 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse 전체 문서 읽기