desoximetasone
Generic: DESOXIMETASONE
Basic Information
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
dc104fb8-4d7c-4bed-b2d8-8d9cfe8f0e5b
Indications & Usage
1 INDICATIONS AND USAGE Desoximetasone topical spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.
Desoximetasone topical spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older ( 1 ).
Desoximetasone topical spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older ( 1 ).
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (≥ 1%) are application site dryness, application site irritation and application site pruritus.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 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 practice.
In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied desoximetasone topical spray or vehicle spray twice daily for 4 weeks.
A total of 149 subjects applied desoximetasone topical spray.
Adverse reactions that occurred in ≥ 1% of subjects treated with desoximetasone topical spray are presented in Table 1.
Table 1.
Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Desoximetasone Topical Spray, 0.25% b.i.d.
(N = 149) Vehicle spray b.i.d.
(N = 135) Number of Subjects with Adverse Reactions 13 (8.7%) 18 (13.3%) Application site dryness 4 (2.7%) 7 (5.2%) Application site irritation 4 (2.7%) 5 (3.7%) Application site pruritus 3 (2.0%) 5 (3.7%) Another less common adverse reaction (<1% but >0.1%) was folliculitis.
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 included atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria.
Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported during use of topical corticosteroids.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 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 practice.
In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied desoximetasone topical spray or vehicle spray twice daily for 4 weeks.
A total of 149 subjects applied desoximetasone topical spray.
Adverse reactions that occurred in ≥ 1% of subjects treated with desoximetasone topical spray are presented in Table 1.
Table 1.
Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Desoximetasone Topical Spray, 0.25% b.i.d.
(N = 149) Vehicle spray b.i.d.
(N = 135) Number of Subjects with Adverse Reactions 13 (8.7%) 18 (13.3%) Application site dryness 4 (2.7%) 7 (5.2%) Application site irritation 4 (2.7%) 5 (3.7%) Application site pruritus 3 (2.0%) 5 (3.7%) Another less common adverse reaction (<1% but >0.1%) was folliculitis.
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 included atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria.
Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported during use of topical corticosteroids.