MOMETASONE FUROATE cream

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

REMEDYREPACK INC.

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

- 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 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,

Ապրանքի ամփոփագիր:

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59 to86°F) [see USP Controlled Room Temperature]. Avoid excessive heat.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

MOMETASONE FUROATE- MOMETASONE FUROATE CREAM
REMEDYREPACK 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, 0.1% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Warnings and Precautions
1. 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 GLENMARK
PHARMACEUTICALS INC., USA AT 1 (888)721-
7115 OR FDA AT 1-800-FDA-1088 OR www.f