Alclometasone Dipropionate label

Alclometasone Dipropionate

Alclometasone Dipropionate Recall

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Alclometasone Dipropionate Cream USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate cream have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

History

There is currently no drug history available for this drug.

Other Information

Alclometasone Dipropionate Cream USP, 0.05% contains alclometasone dipropionate (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

Chemically, alclometasone dipropionate is C28H37ClO7. It has the following structural formula:

Chemical Structure

Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol.

Each gram of alclometasone dipropionate cream contains 0.5 mg of alclometasone dipropionate in a hydrophilic, emollient cream base of Ceteth-20, cetyl alcohol, chlorocresol, glyceryl monostearate, monobasic sodium phosphate, PEG 100 stearate, phosphoric acid, propylene glycol, purified water, stearyl alcohol, and white petrolatum.

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Alclometasone Dipropionate Manufacturers

Taro Pharmaceuticals U.s.a., Inc.
No Recall
Alclometasone Dipropionate | The Kroger Co.
do not take more than the recommended dose adults and children 12 years and older take 2 caplets with water repeat every 6 hours, as needed do not take more than 6 caplets in 24 hours children under 12 years: consult a doctor
Physicians Total Care, Inc.
No Recall
Alclometasone Dipropionate | Physicians Total Care, Inc.
Apply a thin film of alclometasone dipropionate cream USP or alclometasone dipropionate ointment USP to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.

Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream or ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Alclometasone dipropionate cream or ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream or ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with alclometasone dipropionate cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.
No Recall
Alclometasone Dipropionate | E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.
Apply a thin film of alclometasone dipropionate cream to the affected skin areas two or three times daily; massage gently until the medication disappears. Alclometasone dipropionate cream may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Alclometasone dipropionate cream should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with alclometasone dipropionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Glenmark Generics Inc., Usa
No Recall
Alclometasone Dipropionate | Glenmark Pharmaceuticals Inc., Usa
Apply a thin film of alclometasone dipropionate cream USP or alclometasone dipropionate ointment USP to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.

Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream or ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Alclometasone dipropionate cream or ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream or ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with alclometasone dipropionate cream or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.