| INDICATIONS
Clobetasol propionate ointment and emollient cream 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 grams per week because of
the potential for the drug to suppress the hypothalamic-pituitary-adrenal
(HPA) axis. Use in children under 12 years of age is not
recommended.
Temovate & Emollient: In the treatment of moderate
to severe plaque-type psoriasis, TEMOVATE Emollient applied
to 5% to 10% of body surface area can be used up to 4
consecutive weeks. The total dosage should not exceed
50 g/week. When dosing for more than 2 weeks, any additional
benefits of extending treatment should be weighed against
the risk of HPA suppression. Treatment beyond 4 consecutive
weeks is not recommended. Patients should be instructed
to use TEMOVATE Emollient for the minimum amount of time
necessary to achieve the desired results (see PRECAUTIONS).
Use in pediatric patients under 16 years of age has not
been studied.
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
Ointment and Emollient Cream: Apply a thin layer of Clobetasol
Propionate USP to the affected skin areas twice daily
and rub in gently and completely.
Clobetasol Propionate Ointment and Emollient Cream are
super-high potency topical corticosteroids; therefore,
treatment should be limited to 2 consecutive weeks, and
amounts greater than 50 grams per 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 Ointment
USP and Clobetasol Propionate Emollient Cream USP should
not be used with occlusive dressings.
Temovate & Emollient (only): In moderate to severe
plaque-type psoriasis, TEMOVATE & Emollient applied
to 5% to 10% of body surface area can be used up to 4
weeks. The total dosage should not exceed 50 g/week. When
dosing for more than 2 weeks, any additional benefits
of extending treatment should be weighed against the risk
of HPA suppression.
HOW SUPPLIED
Ointment: Clobetasol Propionate Ointment
USP, 0.05% is supplied in 15 g, 30 g, and 45 g tubes.
Temovate & Emollient: Temovate & Emollient, 0.05%
is supplied in 15-g (NDC 0173-0454-01), 30-g (NDC 0173-0454-02),
and 60-g (NDC 0173-0454-03) tubes.
STORAGE
Store at controlled room temperature 15°-30°
C( 59°-86° F). Clobetasol Propionate Ointment
and Emollient Cream should not be refrigerated.
CAUTION: Federal law prohibits dispensing
without prescription.
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