FLUTICASONE PROPIONATE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

fluticasone propionate (UNII: O2GMZ0LF5W) (fluticasone - UNII:CUT2W21N7U)

Available from:

Fougera Pharmaceuticals Inc.

INN (International Name):

fluticasone propionate

Composition:

fluticasone propionate 0.5 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 compar

Product summary:

Fluticasone propionate lotion USP, 0.05% is white to off-white in color, and supplied as follows: 60 mL bottle NDC 0168-0434-60 120 mL bottle NDC 0168-0434-04 Store between 15° and 30°C (59° and 86° F). Do not refrigerate, and keep container tightly closed.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE LOTION
FOUGERA PHARMACEUTICALS INC.
----------
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, 0.05%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
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 and older. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
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 and 120 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 barrier,
liver failure, and use in pediatric patients. Minimize
risk by mitigating the risk factors and use product as recommended.
Modify use if HPA axis suppression is suspected.
(5.1, 8.