FLUTICASONE PROPIONATE lotion

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)

제공처:

Padagis Israel Pharmaceuticals Ltd

INN (국제 이름):

FLUTICASONE PROPIONATE

구성:

FLUTICASONE PROPIONATE 0.5 mg in 1 mL

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older. None. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, fluticasone propionate lotion 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 this study. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 15 μg/kg/day (less than the MRHD in adults based on body surface area comparis

제품 요약:

Fluticasone Propionate Lotion, 0.05% is white to off-white in color, and supplied as follows: 60 mL bottle NDC 45802-441 -02 Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Do not refrigerate, and keep container tightly closed.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE LOTION
PADAGIS ISRAEL PHARMACEUTICALS LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUTICASONE
PROPIONATE LOTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FLUTICASONE PROPIONATE LOTION.
FLUTICASONE PROPIONATE LOTION, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Fluticasone Propionate Lotion, 0.05% is a corticosteroid indicated for
the relief of the inflammatory and
pruritic manifestations of atopic dermatitis in patients 3 months of
age and older. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (2%) were burning/stinging at the
application site. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PADAGIS AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
Apply a thin film to the affected skin areas once daily. Rub in
gently. (2)
Discontinue use when control is achieved. (2)
Reassess diagnosis if no improvement in 2 weeks. (2)
The safety and efficacy of fluticasone propionate lotion have not been
established beyond four weeks
of use. (2)
Avoid use under occlusion or application to diaper area. (2)
Not for ophthalmic, oral, or intravaginal use. (2)
Lotion, 0.05%, supplied in 60 mL bottles. (3)
None. (4)
Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: Reversible HPA
axis suppression and
resulting glucocorticoid insufficiency can occur during or after
withdrawal of treatment. Risk factors
include the use of high-potency topical corticosteroids, use over
large surface area, prolonged use,
use under occlusion, concomitant use with other
corticosteroid-containing products, altered skin