Mometasone Furoate
Generic: MOMETASONE FUROATE
Basic Information
Manufacturer
Torrent Pharmaceuticals Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
18ef90de-f74d-492f-a125-49da1875bd29
Indications & Usage
1 INDICATIONS AND USAGE Mometasone Furoate Ointment 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 Ointment 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.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions are burning, pruritus, skin atrophy, tingling/stinging and furunculosis.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc.
at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience 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 812 subjects, the incidence of adverse reactions associated with the use of Mometasone Furoate Ointment was 4.8%.
Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis.
Cases of rosacea associated with the use of Mometasone Furoate Ointment have been reported.
The following adverse reactions were reported to be possibly or probably related to treatment with Mometasone Furoate Ointment during a clinical study in 5% of 63 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 1; an unspecified skin disorder, 1; and a bacterial skin infection, 1.
The following signs of skin atrophy were also observed among 63 subjects treated with Mometasone Furoate Ointment in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; and thinness,1.
6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae and miliaria.
These adverse reactions may occur more frequently with the use of occlusive dressings.
Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc.
at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience 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 812 subjects, the incidence of adverse reactions associated with the use of Mometasone Furoate Ointment was 4.8%.
Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis.
Cases of rosacea associated with the use of Mometasone Furoate Ointment have been reported.
The following adverse reactions were reported to be possibly or probably related to treatment with Mometasone Furoate Ointment during a clinical study in 5% of 63 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 1; an unspecified skin disorder, 1; and a bacterial skin infection, 1.
The following signs of skin atrophy were also observed among 63 subjects treated with Mometasone Furoate Ointment in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; and thinness,1.
6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae and miliaria.
These adverse reactions may occur more frequently with the use of occlusive dressings.
Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.