Glevate

Clobetasol Propionate (Glevate) cream contains Clobetasol Propionate, a highly active topical corticosteroid.
Each g cream contains: Clobetasol Propionate 0.5 mg.

Clobetasol Propionate (Glevate) is of particular value when used in short courses for the treatment of more resistant dermatoses such as psoriasis (excluding widespread plaque psoriasis), recalcitrant eczema, lichen planus, discoid lupus erythematosus and other skin conditions which do not respond satisfactorily to less active corticosteroids.

Apply sparingly to the affected area once or twice daily until improvement occurs. Therapy should be stopped when control is achieved. In the more responsive conditions, this may be within a few days. If longer course is necessary, it is recommended that treatment should not be continued for more than 2 weeks and the total dosage should not exceed 50 grams per week without the patient's condition being reviewed because of the potential for the drug to suppress the hypothalamus pituitary adrenal (HPA) axis. Repeated short courses of these formulations can be used to treat exacerbations. A less potent steroid should be used if continuous steroid treatment is necessary. In resistant lesions, especially with hyperkeratosis, the anti-inflammatory effects of these preparations can be enhanced, if required, by occluding the treatment area with polythene film. Overnight occlusion is generally adequate for satisfactory response. Thereafter, improvement can usually be maintained by application without occlusion. Or as directed by the physician.

These products are not recommended for children under 12 years of age. They are contraindicated in patients who are hypersensitive to any of the ingredients contained in them.
As with other topical corticosteroids, these products should not be used in rosacea, acne, perioral dermatitis, primary cutaneous viral infections (herpes simplex, chickenpox), fungal infections (candidiasis, tinea) and bacterial infections.

Clobetasol Propionate is a highly potent topical corticosteriod that has been shown to suppress the HPA axis at doses as low as 2 grams per day. Systemic absorption of topical corticosteriods has resulted in reversible hypothalamic pituitary adrenal (HPA) axis suppression, manifestations of Cushing's Syndrome, hyperglycaemia and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. 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 steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur requiring supplement systemic corticosteroids.
If applied to the eyelids, care is required to ensure that the preparation does not enter the eye, as glaucoma might result.
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings and the affected area should be cleansed before a fresh dressing is applied. Certain areas of the body such as the face, groin and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Frequent observation of the patient is important when these areas are to be treated. Topical steroids should not be used extensively in pregnancy i.e. in large amounts or prolonged periods.

The most frequent adverse reactions reported for Clobetasol Cream have been local and have included burning sensation and stinging sensation. Less frequent adverse reactions were itching, skin atrophy, cracking and fissuring of the skin.
The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions, listed in an approximately decreasing order of occurrence are burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestation of Cushing's Syndrome, hyperglycaemia and glycosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have provoked the pustular form of the disease.

For external use only.

Store at temperatures not exceeding 25°C. Protect from light.

Information for Patients: Patients should receive the following information and instructions: 1. These medications should be used as directed by the Physician and should not be used longer than the prescribed time period. They are for external use only. Avoid contact with the eyes.
2. These medications should not be used for any disorders other than those for which they were prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.
4. Any signs of adverse reactions should be reported to your Physician.

Topical Corticosteroids

D07AD01 - clobetasol ; Belongs to the class of very potent (group IV) corticosteroids. Used in the treatment of dermatological diseases.

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