MOMETASONE FUROATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

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

INN (International Name):

MOMETASONE FUROATE

Composition:

MOMETASONE FUROATE 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mometasone furoate ointment USP, 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. 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/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. In

Product summary:

Mometasone Furoate Ointment USP, 0.1% is supplied as follows: NDC 0168-0271-15, 15 gram tube NDC 0168-0271-46, 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOMETASONE FUROATE- MOMETASONE FUROATE OINTMENT
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 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 USP, 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 ointment 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, skin atrophy,
tingling/stinging and furunculosis. (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
5 WARNINGS AND PRECAUTIONS
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)
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