Clobetasol Propionate
Generic: CLOBETASOL PROPIONATE
Basic Information
Manufacturer
INA Pharmaceutics Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
1b0e9eb5-71eb-44b4-894a-094a9f325dc8
Indications & Usage
INDICATIONS AND USAGE Clobetasol Propionate Cream is a corticosteroid indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older.
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Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reaction (incidence ≥ 1%) is application site discoloration.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact INA Pharmaceutics, Inc.
at 1-866-835-0469 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.
Clobetasol Propionate Cream was evaluated in two randomized, multicenter, prospective, vehicle-controlled clinical trials in subjects with moderate to severe plaque psoriasis.
Subjects applied Clobetasol Propionate Cream or vehicle cream twice daily for 14 days.
A total of 354 subjects applied Clobetasol Propionate Cream and 178 subjects applied vehicle.
The adverse reaction that occurred in at least 1% of subjects treated with Clobetasol Propionate Cream and at a higher incidence than in subjects treated with vehicle cream was application site discoloration (2% versus 1%).
Less common local adverse events occurring in < 1% of subjects treated with Clobetasol Propionate Cream were application site atrophy, telangiectasia and rash.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of clobetasol propionate: striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis and miliaria.
Because these 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.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact INA Pharmaceutics, Inc.
at 1-866-835-0469 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.
Clobetasol Propionate Cream was evaluated in two randomized, multicenter, prospective, vehicle-controlled clinical trials in subjects with moderate to severe plaque psoriasis.
Subjects applied Clobetasol Propionate Cream or vehicle cream twice daily for 14 days.
A total of 354 subjects applied Clobetasol Propionate Cream and 178 subjects applied vehicle.
The adverse reaction that occurred in at least 1% of subjects treated with Clobetasol Propionate Cream and at a higher incidence than in subjects treated with vehicle cream was application site discoloration (2% versus 1%).
Less common local adverse events occurring in < 1% of subjects treated with Clobetasol Propionate Cream were application site atrophy, telangiectasia and rash.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of clobetasol propionate: striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis and miliaria.
Because these 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.