MOMETASONE FUROATE - mometasone furoate solution

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 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 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 Topical Solution USP, 0.1% (Lotion) 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 dysto

Product summary:

Mometasone Furoate Topical Solution, 0.1% (Lotion) is supplied in 30-mL (27.5 g) (NDC 67405-275-30) and 60-mL (55 g) (NDC 67405-275-60) bottles; boxes of one. Store Mometasone Furoate Topical Solution, 0.1% (Lotion) 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 SOLUTION
HARRIS PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE TOPICAL SOLUTION USP,
0.1% (LOTION) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MOMETASONE FUROATE TOPICAL
SOLUTION USP, 0.1% (LOTION).
MOMETASONE FUROATE TOPICAL SOLUTION USP, 0.1% (LOTION) FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Mometasone Furoate Topical Solution USP, 0.1% (Lotion) 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 few drops to the affected skin areas once daily and
massage lightly until it disappears. (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) (2)
DOSAGE FORMS AND STRENGTHS
• Topical Solution, 0.1% (Lotion). (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 included are acneiform reaction,
burning, itching and folliculitis. (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.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2