MOMETASONE FUROATE solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Bryant Ranch Prepack

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Mometasone Furoate Topical Solution 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. Mometasone Furoate Topical Solution, 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 Topical Solution 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 l

Povzetek izdelek:

Mometasone Furoate Topical Solution USP, 0.1% is colorless, clear to translucent and supplied in 30-mL (27.5 gram) (NDC 63629-8685-1) bottles; boxes of one. Store Mometasone Furoate Topical Solution, 0.1% at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MOMETASONE FUROATE- MOMETASONE FUROATE SOLUTION
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE
TOPICAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR MOMETASONE
FUROATE TOPICAL SOLUTION.
MOMETASONE FUROATE TOPICAL SOLUTION, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Warnings and Precautions
INDICATIONS AND USAGE
Mometasone Furoate Topical Solution 0.1% is a corticosteroid indicated
for the relief of the inflammatory
and pruritic manifestations of corticosteroid-responsive dermatoses in
patients ≥ 12 years of age. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions included are acneiform reaction,
burning, itching and folliculitis. (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: 2/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
Ophthalmic Adverse Reactions (5.2) 05/2018
Apply a few drops to the affected skin areas once daily and massage
lightly until it disappears. (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)
Solution, 0.1%. (3)
Mometasone Furoate Topical Solution, 0.1% is contraindicated in those
patients with a history of
hypersensitivity to any of the components in the preparation. (4)
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 evide