MOMETASONE FUROATE ointment

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Padagis Israel Pharmaceuticals Ltd

INN (Internationale Bezeichnung):

MOMETASONE FUROATE

Zusammensetzung:

MOMETASONE FUROATE 1 mg in 1 g

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Mometasone Furoate Ointment, 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 or older. Mometasone Furoate Ointment, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. There are no adequate and well-controlled studies in pregnant women. Therefore, Mometasone Furoate Ointment, 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/

Produktbesonderheiten:

Mometasone Furoate Ointment USP, 0.1% is a white to off-white uniform ointment and supplied in 15-gram (NDC 45802-119 -37) and 45-gram (NDC 45802-119 -42) tubes; boxes of one. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

MOMETASONE FUROATE- MOMETASONE FUROATE OINTMENT
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE
OINTMENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOMETASONE
FUROATE OINTMENT.
MOMETASONE FUROATE OINTMENT, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Warnings and Precautions
INDICATIONS AND USAGE
Mometasone Furoate Ointment, 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
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions are burning, pruritus, skin atrophy,
tingling/stinging and furunculosis. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at
1-866-634-9120 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
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)
Ointment, 0.1%. (3)
Mometasone Furoate Ointment, 0.1% is contraindicated in those patients
with a history of
hypersensitivity to any of the components in the preparation.
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. (5.1, 8.4)
Pediatr