MOMETASONE FUROATE- mometasone furoate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Mometasone Furoate (UNII: 04201GDN4R) (Mometasone - UNII:8HR4QJ6DW8)

Available from:

Harris Pharmaceutical, 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 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. None. 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 measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when

Product summary:

Mometasone Furoate Cream 0.1% is supplied in 15 g (NDC 67405-100-15) and 45 g (NDC 67405-100-45) tubes; boxes of one. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOMETASONE FUROATE- MOMETASONE FUROATE CREAM
HARRIS PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE CREAM 0.1% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MOMETASONE FUROATE
CREAM 0.1%.
MOMETASONE FUROATE CREAM 0.1% 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 ≥12 years of
age. (1) (1)
DOSAGE AND ADMINISTRATION
• 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)
• The safety and efficacy of Mometasone Furoate Cream 0.1% in
pediatric patients for more than 3 weeks of use have not
been established. (2)
• Do not use with occlusive dressings unless directed by a
physician. (2) (2)
DOSAGE FORMS AND STRENGTHS
• Cream, 0.1%. (3) (3)
CONTRAINDICATIONS
• None. (4) (4)
WARNINGS AND PRECAUTIONS
• 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. Pediatric patients may
be more susceptible to systemic toxicity. (5.1,
8.4) (5)
ADVERSE REACTIONS
Most common adverse reactions are: burning, pruritus, and skin
atrophy. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT G&W LABORATORIES, INC.
AT 1-800-922-1038 OR FDA AT
1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_. (6)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FOR