FLUTICASONE PROPIONATE ointment

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Cosette Pharmaceuticals, Inc.

INN (International ime):

Fluticasone Propionate

Sastav:

Fluticasone Propionate 0.05 mg in 1 g

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

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).

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

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