CLOBETASOL PROPIONATE CREAM EMOLLIENT 0.05% 30 G
Generic: Clobetasol Propionate
CLOBETASOL PROPIONATE CREAM EMOLLIENT 0.05% 30 G
Sign up to see pricing
Licensed pharmacies, clinics, doctor's offices, and veterinary practices get instant account approval
Sign Up — Instant ApprovalDrug Information
Identification
Clobetasol Propionate
Clobetasol Propionate
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
CREAM
TOPICAL
ANDA075633
Active Ingredients
| Ingredient | Strength |
|---|---|
| CLOBETASOL PROPIONATE | .5 mg/g |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply a thin layer of clobetasol propionate cream, 0.05% (emollient) to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application. Clobetasol propionate cream, 0.05% (emollient) is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used. In moderate to severe plaque-type psoriasis, clobetasol propionate cream, 0.05% (emollient) applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended. Clobetasol propionate cream, 0.05% (emollient) should not be used with occlusive dressings. Apply a thin layer of clobetasol propionate cream, 0.05% (emollient) to the affected skin areas twice daily and rub in gently and completely. ( 2 ) Treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used. ( 2 ) In moderate to severe plaque-type psoriasis, clobetasol propionate cream, 0.05% (emollient) applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefit of extending treatment should be weighed against the risk of HPA suppression. ( 2 )
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.
Information for Patients
17 PATIENT COUNSELING INFORMATION Inform patients using topical corticosteroids of the following information and instructions: Clobetasol propionate cream, 0.05% (emollient) is for external use only. Avoid contact with the eyes. Use as directed. Do not use clobetasol propionate cream, 0.05% (emollient) for any disorder other than that for which it was prescribed. Do not use longer than the prescribed time period. Do not use other corticosteroid-containing products while using clobetasol propionate cream, 0.05% (emollient) unless directed by the physician. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. Wash hands after applying the medication. Report any signs of local or systemic adverse reactions to the physician. Inform their physicians that they are using clobetasol propionate cream, 0.05% (emollient) if surgery is contemplated. If you go to another doctor for illness, injury or surgery, tell the doctor you are using clobetasol propionate cream, 0.05% (emollient). Do not use clobetasol propionate cream, 0.05% (emollient) on the face, underarms or groin areas. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. Use no more than 50 grams per week of clobetasol propionate cream, 0.05% (emollient). Store between 68°F and 77°F (20°C and 25°C). Do not refrigerate.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.