MOMETASONE FUROATE cream

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (nume internaţional):

MOMETASONE FUROATE

Compoziție:

MOMETASONE FUROATE 1 mg in 1 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 or older. Mometasone furoate cream, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate cream 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 measur

Rezumat produs:

Mometasone furoate cream USP, 0.1% is supplied as follows: NDC 0168-0270-15, 15 gram tube NDC 0168-0270-46, 45 gram tube Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

MOMETASONE FUROATE- MOMETASONE FUROATE CREAM
E. FOUGERA & CO. 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
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
RECENT MAJOR CHANGES
Warnings and Precautions
Ophthalmic Adverse Reactions (5.2) 05/2018
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 FOUGERA PHARMACEUTICALS
INC. AT 1-800-645-9833 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2018
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