MOMETASONE FUROATE cream

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)

זמין מ:

Preferred Pharmaceuticals Inc.

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27 H30 Cl2 O6 , a molecular weight of 521.43 and the following structural formula: Mometasone furoate, USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of Mometasone Furoate Cream USP, 0.1% contains: 1 mg mometasone furoate, USP in a cream base of aluminum starch octenyl succinate (Dry-Flo Plus (Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax.

leaflet_short:

Mometasone furoate cream USP, 0.1% is a white to off-white, uniform and smooth cream and is supplied in 45 g (NDC 68788-8345-4) tubes. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59 to86°F) [see USP Controlled Room Temperature]. Avoid excessive heat.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

MOMETASONE FUROATE- MOMETASONE FUROATE CREAM
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE
CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOMETASONE FUROATE
CREAM.
MOMETASONE FUROATE CREAM, 0.1% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Warnings and Precautions
INDICATIONS AND USAGE
Mometasone furoate cream, 0.1% is a corticosteroid indicated for the
relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses in
patients ≥ 2 years of age. (1)
DOSAGE AND ADMINISTRATION
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•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Mometasone furoate cream, 0.1% is contraindicated in those patients
with a history of hypersensitivity to
any of the components in the preparation. (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions are: burning, pruritus, and skin
atrophy. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
Ophthalmic Adverse Reactions (5.2) 05/2018
Apply a thin film to the affected skin areas once daily. (2)
Discontinue therapy when control is achieved. (2)
If no improvement is seen within 2 weeks, reassess diagnosis. (2)
Do not use with occlusive dressings unless directed by a physician.
(2)
Cream, 0.1%. (3)
Reversible HPA axis suppression with the potential for
glucocorticosteroid insufficiency after withdrawal
of treatment, Cushing’s syndrome, and hyperglycemia may occur due to
systemic absorption.
Patients applying a topical steroid to a large surface area or to
areas under occlusion should be
evaluated periodically for evidence of HPA axis suppression. Modify
use should HPA axis