CUTIVATE- fluticasone propionate lotion

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

PharmaDerm a division of Fougera Pharmaceuticals Inc.

INN (Algemene Internationale Benaming):

fluticasone propionate

Samenstelling:

fluticasone propionate 0.5 mg in 1 mL

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

CUTIVATE® 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, CUTIVATE® 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 comparisons). Subcutaneous dos

Product samenvatting:

CUTIVATE® (fluticasone propionate) Lotion USP, 0.05% is white to off-white in color, and supplied as follows: 120 mL bottle NDC 10337-434-04 Store between 15° and 30°C (59° and 86° F). Do not refrigerate, and keep container tightly closed.

Autorisatie-status:

New Drug Application

Productkenmerken

CUTIVATE- FLUTICASONE PROPIONATE LOTION
PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CUTIVATE LOTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR CUTIVATE LOTION.
CUTIVATE (FLUTICASONE PROPIONATE) LOTION, 0.05%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
CUTIVATE 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
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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 CUTIVATE® 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 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 , 8.4)
Skin Irritation and Sensi