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What is Temovate?
TEMOVATE (clobetasol propionate cream and ointment) Cream and Ointment, 0.05% contain 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 (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:
Clobetasol propionate has the molecular formula CHCIFO 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 stearate, 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.
What does Temovate look like?
What are the available doses of Temovate?
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What should I talk to my health care provider before I take Temovate?
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How should I use Temovate?
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.
Apply a thin layer of TEMOVATE Cream or Ointment to the affected skin areas twice daily and rub in gently and completely (see ).
TEMOVATE Cream and Ointment are super-high potency topical corti-costeroids; therefore,
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.
What interacts with Temovate?
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What are the warnings of Temovate?
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What are the precautions of Temovate?
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What are the side effects of Temovate?
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What should I look out for while using Temovate?
TEMOVATE (clobetasol propionate cream and ointment) Cream and Ointment, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
What might happen if I take too much Temovate?
Topically applied TEMOVATE Cream and Ointment can be absorbed in sufficient amounts to produce systemic effects (see ).
How should I store and handle Temovate?
Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) .TEMOVATE (clobetasol propionate cream) Cream, 0.05% is supplied in:30-g tubes (NDC 10337-163-30), and60-g tubes (NDC 10337-163-60). TEMOVATE (clobetasol propionate ointment) Ointment, 0.05% is supplied in:15-g tubes (NDC 10337-162-15), and30-g tubes (NDC 10337-162-30). TEMOVATE (clobetasol propionate cream) Cream, 0.05% is supplied in:30-g tubes (NDC 10337-163-30), and60-g tubes (NDC 10337-163-60). TEMOVATE (clobetasol propionate ointment) Ointment, 0.05% is supplied in:15-g tubes (NDC 10337-162-15), and30-g tubes (NDC 10337-162-30).
Chemical StructureNo Image found
Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.
Non-Clinical ToxicologyTEMOVATE (clobetasol propionate cream and ointment) Cream and Ointment, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
The vasodilating effects of isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Concomitant use of isosorbide dinitrate with phosphodiesterase inhibitors in any form is contraindicated (see ).
Concomitant use of isosorbide dinitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see ).
Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing 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 should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur that require supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see ).
If irritation develops, TEMOVATE Cream and Ointment should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of TEMOVATE Cream and Ointment should be discontinued until the infection has been adequately controlled.
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 fissuring 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 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.
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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