Drug Catalog - Product Detail
CLOBETASOL PROPIONATE OINTMENT OINT 0.0005 45GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50383-0268-45 | AKORN | 45 | 0.05% | OINTMENT |
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Description
DESCRIPTION Clobetasol Propionate Cream and Ointment USP, 0.05% contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25 H 32 CIFO 5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH. Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g in an ointment base composed of propylene glycol, sorbitan sesquioleate, and white petrolatum. Chemical Structure
How Supplied
HOW SUPPLIED Clobetasol Propionate Cream, USP, 0.05% is supplied in 15-g tubes (NDC 50383-267-15), 30-g tubes (NDC 50383-267-30), 45-g tubes (NDC 50383-267-45), and 60-g tubes (NDC 50383-267-60). Clobetasol Propionate Ointment, USP, 0.05% is supplied in 15-g tubes (NDC 50383-268-15), 30-g tubes (NDC 50383-268-30), 45-g tubes (NDC 50383-268-45), and 60-g tubes (NDC 50383-268-60). Store cream between 15° and 30° C (59° and 86° F). Store ointment at controlled room temperature 20°-25° C (68°-77° F). Clobetasol propionate cream and ointment should not be refrigerated. Rx only Rev. 267/268:05 09/22 Distributed by: Akorn Operating Company LLC Gurnee, IL 60031
Indications & Usage
INDICATIONS AND USAGE Clobetasol propionate cream and ointment are 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 and Administration
DOSAGE AND ADMINISTRATION Apply a thin layer of clobetasol propionate cream or ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE ). Clobetasol propionate cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/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 cream and 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 cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.