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Temovate Scalp Application Recall
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
TEMOVATE® Scalp Application is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis.
This product is not recommended for use in pediatric patients under 12 years of age.
History
There is currently no drug history available for this drug.
Other Information
TEMOVATE® (clobetasol propionate scalp application) Scalp Application, 0.05% contains 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 (11β,16β)-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 C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.
TEMOVATE® Scalp Application contains clobetasol propionate 0.5 mg/g in a base of purified water, isopropyl alcohol (39.3%), carbomer 934R and sodium hydroxide.
Sources
Temovate Scalp Application Manufacturers
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Pharmaderm, A Division Of Fougera Pharmaceuticals Inc.
Temovate Scalp Application | Pharmaderm, A Division Of Fougera Pharmaceuticals Inc.
TEMOVATE® Scalp Application should be applied to the affected scalp areas twice daily, once in the morning and once at night.
TEMOVATE® Scalp Application is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.
TEMOVATE® Scalp Application is not to be used with occlusive dressings.
Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with TEMOVATE® Scalp Application, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
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