March 23, 2017
Recommended Topic Related To:

Temovate

"The U.S. Food and Drug Administration today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections.

Sivextro is approved to treat patients with acute bacterial skin and skin structure infecti"...

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Temovate




Indications
Dosage
How Supplied

INDICATIONS

TEMOVATE® Cream and Ointment are super-high potency corticos-teroid formulations indicated for the relief of the inflammatory and pru-ritic 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

Apply a thin layer of TEMOVATE® Cream or Ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

TEMOVATE® Cream and Ointment are super-high potency topical corti-costeroids; 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.

TEMOVATE® 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 TEMOVATE® Cream or Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

TEMOVATE® (clobetasol propionate cream) Cream, 0.05% is supplied in:

30-g tubes (NDC 10337-163-30), and
60-g tubes (NDC 10337-163-60).

TEMOVATE® (clobetasol propionate ointment) Ointment, 0.05% is supplied in:

15-g tubes (NDC 10337-162-15), and
30-g tubes (NDC 10337-162-30).

Store between 15° and 30°C (59° and 86°F). TEMOVATE® Cream should not be refrigerated. PharmaDerm

A division of Fougera Pharmaceuticals Inc., Melville, NY 11747 USA. Revised: Jan 2012

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/19/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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