Eumovate (Clobetasone 17-butyrate)

EUMOVATE®

Glaxo Wellcome

Clobetasone 17-butyrate

Topical Corticosteroid

Action And Clinical Pharmacology: The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasone are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, anti-puritic, and vasoconstrictive actions. However while the physiologic, pharmacologic and clinical effects of the corticosteroids are well known, the exact mechanism of their actions in each disease are uncertain. Clobetasone has been shown to have topical and systemic pharmacologic and metabolic effects characteristic of the corticosteroid class of drugs. tag_IndicationsIndications

Indications And Clinical Uses: Clobetasone, a fluorinated topical corticosteroid, is indicated for the treatment of milder forms of eczema, seborrheic dermatitis, and other corticosteroid responsive skin conditions, which do not require the use of a more potent topical corticosteroid.

Contra-Indications: Primarily infected skin lesions caused by infection with fungi or bacteria if no anti-infective agent is used simultaneously; primary cutaneous viral infections, including herpes simplex, vaccinia and varicella; tuberculous skin lesions; hypersensitivity to any of the components.

Manufacturers’ Warnings In Clinical States: This product should not be used in the eye and should be used with caution in lesions close to the eye as glaucoma may result. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids. When used under occlusive dressing, over extensive areas for prolonged periods, it is possible that sufficient absorption may take place to give rise to transient adrenal suppression. Long-term continuous topical corticosteroid therapy should be avoided where possible as adrenal suppression can occur even without occlusion.

Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

Precautions: Significant systemic absorption may result when corticosteroids are applied over large areas of the body. To minimize this possibility, treatment should be interrupted periodically or one area of the body should be treated at a time when long-term therapy is anticipated. In infants, the diaper may act as an occlusive dressing and increase absorption.

As with all corticosteroids, prolonged application to the face is undesirable.

Prolonged or extensive use of topical corticosteriod products may produce atrophy of the skin and s.c. tissue, particularly on flexor surfaces and on the face. If this is noted, the use of the drug should be discontinued.

Use with caution in patients with stasis dermatitis and other skin diseases associated with impaired circulation.

If a symptomatic response is not noted within a few days to a week, the local application should be discontinued and the patient re-evaluated.

In cases of bacterial infections of the skin, appropriate anti-bacterial agents should be used as primary therapy. If it is considered necessary, the topical corticosteroid may be used as an adjunct to control inflammation, erythema and itching. If a symptomatic response is not noted within a few days to a week, the local application of corticosteroid should be discontinued until the infection is brought under control.

During the use of topical corticosteroids, secondary infections may occur. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.

The safety and effectiveness of clobetasone when used under occlusive dressings has not been determined.

Although hypersensitivity reactions are rare with topically applied corticosteroids, the drug should be discontinued and appropriate therapy initiated if there are signs of hypersensitivity.

Pregnancy and Lactation: Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established. However, the administration of clobetasone topical preparations during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Drugs of this class should not be used extensively in pregnant patients in large amounts or for prolonged periods of time.

Adverse Reactions: When large areas of the body are being treated with clobetasone, it is possible that some patients will absorb sufficient steroid to cause transient adrenal suppression despite the low degree of systemic activity associated with clobetasone.

Local burning, irritation, itching, skin atrophy, dryness of the skin, atrophy of s.c. tissues, telangiectasia, striae, change in pigmentation, secondary infection, and hypertrichosis have been observed following topical corticosteroid therapy. Exacerbation of symptoms may occur.

Local atrophic changes could possibly occur in situations where moisture increases absorption of clobetasone, but only after prolonged use.

In the unlikely event of signs of hypersensitivity appearing, application should stop immediately.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercorticism may appear. As with any corticosteroid, discontinue therapy if the typical signs of hypercorticism appear.

Dosage: Apply thinly 2 or 3 times a day (according to the severity of the condition) to the affected area and rub gently into the skin. Maximum adult dosage should not exceed 100 g/week.

Availability And Storage: Cream: Each tube contains: clobetasone butyrate 0.05%. Nonmedicinal ingredients: beeswax substitute, cetostearyl alcohol, chlorocresol, citric acid anhydrous, dimethicone 20, glycerin, glyceryl monostearate, purified water and sodium citrate. Tubes of 15 and 30 g. Store below 30°C.

Ointment: Each tube contains: clobetasone butyrate 0.05%. Nonmedicinal ingredients: mineral oil and white petrolatum. Tubes of 15 and 30 g. Store below 30°C.

EUMOVATE® Glaxo Wellcome Clobetasone 17-butyrate Topical Corticosteroid

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Dermatitis, Seborrheic

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