MOMETASONE FUROATE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

NORTHSTAR RX LLC

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 molecular formula C27 H30 Cl2 O6 , a molecular weight of 521.43 g/mol 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.

Produktbesonderheiten:

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

MOMETASONE FUROATE- MOMETASONE FUROATE CREAM
NORTHSTAR RX LLC
----------
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, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
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
•
•
•
•
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 NORTHSTAR RX LLC AT
1800-206-7821 OR
FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2020
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 Effects on Endocrine System
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 suppression
develop