Clobetasol Propionate Solution

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Clobetasol Propionate Solution Recall

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Side Effects & Adverse Reactions

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Legal Issues

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/wk because of the potential for the drug to suppress the HPA axis.

This product is not recommended for use in children under 12 years of age.

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History

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Other Information

Clobetasol propionate topical solution 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 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:

Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water.

Clobetasol propionate topical solution contains clobetasol propionate 0.05% (0.5 mg/g) in a base composed of purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium hydroxide. It may also contain hydrochloric acid to adjust pH.

Sources

Clobetasol Propionate Solution Manufacturers

Rebel Distributors Corp

Clobetasol Propionate Solution | Rebel Distributors Corp

Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night.

Clobetasol propionate topical solution is potent; therefore, treatment must be limited to two consecutive weeks, and amounts greater than 50 mL/wk should not be used.

Clobetasol propionate topical solution is not to be used with occlusive dressings.

No Recall
Physicians Total Care, Inc.

Clobetasol Propionate Solution | Physicians Total Care, Inc.

Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night.

Clobetasol propionate topical solution is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.

Clobetasol propionate topical solution 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 clobetasol propionate topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

No Recall
Hi-tech Pharmacal Co., Inc.

Clobetasol Propionate Solution | Hi-tech Pharmacal Co., Inc.

Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night.

Clobetasol propionate topical solution is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.

Clobetasol propionate topical solution 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 clobetasol propionate topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

No Recall
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Clobetasol Propionate Solution | Woonsocket Prescription Center,incorporated

do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years: do not use

No Recall
Morton Grove Pharmaceuticals, Inc.

Clobetasol Propionate Solution | Morton Grove Pharmaceuticals, Inc.

Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night.

Clobetasol propionate topical solution is potent; therefore, treatment must be limited to two consecutive weeks, and amounts greater than 50 mL/week should not be used.

Clobetasol propionate topical solution 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 clobetasol propionate topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Clobetasol Propionate Solution | Taro Pharmaceuticals U.s.a., Inc.

Clobetasol Propionate Topical Solution USP, 0.05% should be applied to the affected scalp areas twice daily, once in the morning and once at night.

Clobetasol propionate topical solution is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.

Clobetasol propionate topical solution 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 clobetasol propionate topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

No Recall