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:

NuCare Pharmaceuticals,Inc.

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. 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 prod

Product summary:

Mometasone furoate cream 0.1% is supplied in 45g NDC 68071-4637-5 boxes of one. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive heat.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOMETASONE FUROATE- MOMETASONE FUROATE CREAM
NUCARE 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
• 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)
DOSAGE FORMS AND STRENGTHS
• Cream, 0.1%. ( 3)
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
• 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)
• Pediatric patients may be more susceptible to systemic toxicity. (
5.1, 8.4)
• May increase the risk of cataracts and glaucoma. If visual
symptoms occur, consider referral to an
ophthalmologist. ( 5.2)
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-F