Clobetasol Propionate
Generic: CLOBETASOL PROPIONATE
Basic Information
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
91571297-03ad-441e-8ec6-f78c21fbe5e8
Indications & Usage
1 INDICATIONS AND USAGE Clobetasol propionate cream, 0.05% (emollient) is a super-high potency corticosteroid indicated for: Clobetasol propionate cream, 0.05% (emollient) 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.
( 1.1 ) The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older.
( 1.2 ) Limitations of Use Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
( 1.3 ) The total dosage should not exceed 50 grams per week.
( 1.3 ) Avoid use if skin atrophy is present at the treatment site.
( 1.3 ) 1.1 Corticosteriod-Responsive Dermatoses Clobetasol propionate cream, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older.
Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week.
1.2 Moderate to Severe Plaque-Type Psoriasis Clobetasol propionate cream, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis.
Treatment beyond 4 consecutive weeks is not recommended.
Use in pediatric patients under 16 years of age is not recommended.
1.3 Limitations of Use Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
The total dosage should not exceed 50 grams per week.
Avoid use if skin atrophy is present at the treatment site.
( 1.1 ) The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older.
( 1.2 ) Limitations of Use Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
( 1.3 ) The total dosage should not exceed 50 grams per week.
( 1.3 ) Avoid use if skin atrophy is present at the treatment site.
( 1.3 ) 1.1 Corticosteriod-Responsive Dermatoses Clobetasol propionate cream, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older.
Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week.
1.2 Moderate to Severe Plaque-Type Psoriasis Clobetasol propionate cream, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis.
Treatment beyond 4 consecutive weeks is not recommended.
Use in pediatric patients under 16 years of age is not recommended.
1.3 Limitations of Use Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
The total dosage should not exceed 50 grams per week.
Avoid use if skin atrophy is present at the treatment site.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reaction is burning/stinging (incidence 5%); common adverse reactions (incidence <2%) are pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 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 trials with clobetasol propionate formulations, the following adverse reactions have been reported: burning/stinging, pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia.
The incidence of local adverse reactions reported in the trials with clobetasol propionate cream, 0.05% (emollient) was less than 2% of patients treated with the exception of burning/stinging which occurred in 5% of treated patients.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 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 trials with clobetasol propionate formulations, the following adverse reactions have been reported: burning/stinging, pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia.
The incidence of local adverse reactions reported in the trials with clobetasol propionate cream, 0.05% (emollient) was less than 2% of patients treated with the exception of burning/stinging which occurred in 5% of treated patients.