Product Description.:
TEMOVATE (clobetasol propionate cream and ointment) Cream and Ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Ciobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.
Clobetasol propionate has the empirical formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.
TEMOVATE Cream contains clobetasol propionate 0.5 mg/g in a cream base of propylene glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate, PEG 100 stearale, white wax, chlorocresol, sodium citrate, citric acid monohydrate, and purified water.
TEMOVATE Ointment contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.
INDICATIONS
TEMOVATE Cream and Ointment 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 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).
TEMOVATE Cream and Ointment are super-high potency topical corticosteroids 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.
SIDE EFFECTS
In controlled clinical trials, the most frequent adverse reactions reported for TEMOVATE Cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and Assuring of the skin.
In controlled clinical trials, the most frequent adverse events reported for TEMOVATE Ointment were burning sensation,.irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia.
Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.
The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.
PRECAUTIONS
General: TEMOVATE Cream and Ointment should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for giucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma Cortisol, and urinary free Cortisol tests. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time, and only small areas should be treated at any one time due to the increased risk of HPA suppression.
TEMOVATE Cream and Ointment produced HPA axis suppression when used at doses as low as 2 g/day for 1 week in patients with eczema.
If HPA axis suppression is noted, an attempt shoul
