Mometasone Furoate
Generic: MOMETASONE FUROATE
Basic Information
Manufacturer
Proficient Rx LP
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
47a60763-671e-413b-b962-f7f11ba2f4d7
Indications & Usage
1 INDICATIONS AND USAGE Mometasone furoate cream USP, 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 USP, 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 )
Mometasone furoate cream USP, 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 )
Adverse Reactions
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of mometasone furoate cream was 1.6%.
Reported reactions included burning, pruritus, and skin atrophy.
Reports of rosacea associated with the use of mometasone furoate cream have also been received.
In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of mometasone furoate cream was approximately 7%.
Reported reactions included stinging, pruritus, and furunculosis.
The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate cream during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1.
The following signs of skin atrophy were also observed among 97 subjects treated with mometasone furoate cream in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1.
The following additional local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings.
These reactions are: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.
Most common adverse reactions are: burning, pruritus, and skin atrophy.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Generics Inc., USA at 1 (888)721-7115] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of mometasone furoate cream was 1.6%.
Reported reactions included burning, pruritus, and skin atrophy.
Reports of rosacea associated with the use of mometasone furoate cream have also been received.
In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of mometasone furoate cream was approximately 7%.
Reported reactions included stinging, pruritus, and furunculosis.
The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate cream during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1.
The following signs of skin atrophy were also observed among 97 subjects treated with mometasone furoate cream in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1.
The following additional local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings.
These reactions are: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.
Most common adverse reactions are: burning, pruritus, and skin atrophy.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Generics Inc., USA at 1 (888)721-7115] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.