MOMETASONE FUROATE ointment

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Harris Pharmaceutical, Inc.

ИНН (Международная Имя):

Mometasone Furoate

состав:

Mometasone Furoate 1 mg in 1 g

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

MOMETASONE FUROATE - MOMETASONE FUROATE OINTMENT
HARRIS PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE, USP OINTMENT 0.1%
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOMETASONE FUROATE, USP OINTMENT 0.1%.
MOMETASONE FUROATE, USP OINTMENT 0.1% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Mometasone Furoate, USP Ointment 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, USP Ointment 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
• Ointment, 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, skin atrophy,
tingling/stinging and furunculosis. (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 INFORMAT