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Temovate ointment prescribing information

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Clobetasol propionate has greater teratogenic potential than steroids that are less potent. A division of Fougera Pharmaceuticals Inc. Cream and Ointment in pediatric patients have not been established.

Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. This medication should not be used for any disorder other than that for which it was prescribed.

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Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. We market a growing portfolio of FDA-approved medicines, including several generic alternatives, in the United States. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. PEG 100 stearate, white wax, chlorocresol, sodium citrate, citric acid monohydrate, and purified water.

Abnormalities seen included cleft palate and skeletal abnormalities. This medication is to be used as directed by the physician. 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.

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Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088. Our Quality employees in Buena, New Jersey release all of our products before they are delivered to pharmacies and hospitals.

It is a white to cream-colored crystalline powder insoluble in water. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Temovate Consumer information is supplied by First Databank, Inc.

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Ointment were burning sensation, irritation, and itching in 0. Cream and Ointment should not be used with occlusive dressings. Use in pediatric patients under 12 years of age is not recommended.

Pregnancy Teratogenic Effects Pregnancy Category C. This is not a complete list of side effects and others may occur. 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. Cream and Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.

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Temovate Patient Information is supplied by Cerner Multum, Inc. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. Search for generic or brand product names using this interactive page. Our products include both injectable and topical prescription medicines.

The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions to the physician. Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Cortico-steroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Our Canadian business markets a portfolio of injectable products that have been approved by Health Canada.

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Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin. 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. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Sandoz in the US also publishes a generic-to-brand pocket guide which is available via mail.

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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. Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. CLINICAL PHARMACOLOGY Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Ointment were burning sensation, irritation, and itching in 0.

Although the risk of serious side effects is low when clobetasol topical is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream. Call your doctor for medical advice about side effects. For all other inquiries, visit Contact Us.

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Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous cor-ticosteroid production, or cause other untoward effects. Please note, only pocket guide requests with the required information above can be received at this automated e-mail address. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. This should disappear in a few days as your body adjusts to Temovate.

If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing syndrome when they are treated with topical corticosteroids. Cream and Ointment should be discontinued and appropriate therapy instituted. Include your name, address, phone number, and number of copies requested. 1 week in patients with eczema. This may be done by using the ACTH stimulation, A.

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Cream and Ointment indicate that they are in the super-high range of potency as compared with other topical corticosteroids. Although the risk of serious side effects is low when clobetasol topical is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream. It is for external use only. At Sandoz, we discover new ways to improve and extend people’s lives. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients.

At Sandoz, we discover new ways to improve and extend people’s lives. Include your name, address, phone number, and number of copies requested. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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Although the risk of serious side effects is low when clobetasol topical is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream. Pregnancy Teratogenic Effects Pregnancy Category C. Please note, only pocket guide requests with the required information above can be received at this automated e-mail address. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Ointment were burning sensation, irritation, and itching in 0.

Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. Tell your doctor about any unusual or bothersome side effect. This medication is to be used as directed by the physician.