FLUTICASONE PROPIONATE ointment

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Fluticasone Propionate (UNII: O2GMZ0LF5W) (Fluticasone - UNII:CUT2W21N7U)

Dostupné z:

Taro Pharmaceuticals U.S.A., Inc.

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Fluticasone propionate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. Fluticasone propionate ointment 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 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 μg/kg/day, 45 μg/kg/day 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 μg/kg/day and 150 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) i

Prehľad produktov:

Fluticasone Propionate Ointment USP, 0.005% is a white to off-white translucent ointment supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE OINTMENT
TARO PHARMACEUTICALS U.S.A., 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 PROPIONATE OINTMENT.
FLUTICASONE PROPIONATE OINTMENT, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Fluticasone propionate ointment 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 5 g physician samples, 15 g, 30 g and 60
g tubes. (3)
CONTRAINDICATIONS
Fluticasone propionate ointment 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 TARO PHARMACEUTICALS
U.S.A., INC., AT 1-866-923-4914
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2020
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
A