CLOBETASOL PROPIONATE .5 mg/mL
CLOBETASOL PROPIONATE · SOLUTION · Glenmark Pharmaceuticals Inc., USA
Clobetasol propionate is a strong topical steroid used to reduce inflammation and itching of the skin. It comes as a liquid solution that is applied directly to affected areas of the skin.
Key Facts
- Brand Name
- CLOBETASOL PROPIONATE
- Generic Name
- CLOBETASOL PROPIONATE
- NDC Code (Product)
68462-532- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Strength
- .5 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA210190
- Marketing Start
- 04/18/2018
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Taro Pharmaceuticals U.S.A., Inc.
Failed Content Uniformity Specifications
Taro Pharmaceuticals U.S.A., Inc.
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn Inc
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Taro Pharmaceuticals U.S.A., Inc.
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Oxalis Labs
Defective Container; complaints of leakage.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Preferred Pharmaceuticals, Inc.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE .) Clobetasol propionate ointment are super- high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks , and amounts greater than 50 g per week should not be used . As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol propionate ointment should not be used with occlusive dressings . Geriatric Use : In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with clobetasol propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Contraindications
CONTRAINDICATIONS Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is CLOBETASOL PROPIONATE used for?
Clobetasol propionate is a strong topical steroid used to reduce inflammation and itching of the skin. It comes as a liquid solution that is applied directly to affected areas of the skin.
Is CLOBETASOL PROPIONATE a controlled substance?
CLOBETASOL PROPIONATE is not classified as a controlled substance by the DEA.
What is the generic name for CLOBETASOL PROPIONATE?
The generic name for CLOBETASOL PROPIONATE is CLOBETASOL PROPIONATE. There are 7 other brand versions of CLOBETASOL PROPIONATE.
What is the NDC code for CLOBETASOL PROPIONATE .5 mg/mL?
The NDC (National Drug Code) for CLOBETASOL PROPIONATE .5 mg/mL is 68462-532, listed by Glenmark Pharmaceuticals Inc., USA.
Other Clobetasol Brands
See all →- Clobetasol Propionate.05 g/100mL51672-1347
- Clobetasol Propionate.5 mg/g63629-8638
- Clobetasol Propionate.5 mg/g63629-8639
- Clobetasol Propionate.5 mg/g70700-109
- Clobetasol Propionate.5 mg/g71335-2837
- Clobetasol Propionate.5 mg/g13668-569
- Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%.5 mg/g21922-016
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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