Luixol

White, smooth semisolid preparation without any gritty particles and foreign materials.
Each gram contains: Clobetasol Propionate 0.5 mg.

Topical Corticosteroid.
Pharmacology: Pharmacodynamics: Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase allergic reactions including decreasing the density of mast cells, decreasing chemotaxis and activation of eosinophils, decreasing cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibiting the metabolism of arachidonic acid.
Pharmacokinetics: Absorption: Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.
Mean peak plasma clobetasol propionate concentrations of 0.63 ng/ml occurred in one study eight hours after the second application (13 hours after an initial application) of 30 g clobetasol propionate 0.05% ointment to normal individuals with healthy skin. Following the application of a second dose of 30 g clobetasol propionate cream 0.05% mean peak plasma concentrations were slightly higher than the ointment and occurred 10 hours after application.
In a separate study, mean peak plasma concentrations of approximately 2.3 ng/ml and 4.6 ng/ml occurred respectively in patients with psoriasis and eczema three hours after a single application of 25 g clobetasol propionate 0.05% ointment.
Distribution: The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection.
Metabolism: Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolised, primarily in the liver.
Elimination: Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Short-term treatment of more resistant dermatoses e.g. psoriasis (excluding widespread plaque psoriasis), recalcitrant eczema & other conditions which do not respond satisfactorily to less active steroids.

Apply sparingly to the affected area once or twice daily until improvement occurs. As with other highly active topical steroid preparations, therapy should be discontinued when control is achieved. If a longer course is necessary, it is recommended that treatment should be continued for more than four weeks without the patient's condition being observed. Repeated short courses of Clobetasol propionate may be used to control exacerbations. If continuous steroid treatment is necessary a less potent preparation should be used. In very resistant lesions, especially where there is hyperkeratosis, the anti-inflammatory effects of Clobetasol propionate can be enhanced, if necessary, by occluding the treatment area with polythene film. Only overnight occlusion is usually adequate to bring about a satisfactory response. Thereafter, improvement can usually be maintained by application without occlusion. Or as directed by the physician.

Acute overdose is very unlikely to occur. However, in case of chronic overdosage or misuse, the features of hypercorticisms may appear and in this situation topical steroids should be discontinued.

Clobetasol Propionate is contraindicated in: Cutaneous infections such as impetigo, tinea corporis and herpes simplex; Infestations such as scabies; Neonates; Acne Vulgaris; Rosacea; Gravitational ulceration.
Long term continuous therapy with Clobetasol Propionate should be avoided, particularly in infants and children, in whom adrenal suppression occurs readily. If Clobetasol propionate is required for use in children, it is recommended that the treatment should be reviewed on weekly basis. It should be noted that the infants' napkin might act as occlusive dressing. The face more than other area of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating facial conditions which warrants use of Clobetasol Propionate and frequent observations of the patient is important.

Clobetasol Propionate should be avoided in pregnant women. Mothers using large amounts of the drug should be aware of the potential excretion in milk.

Provided the weekly dosage is less than 50 g in adults, any pituitary adrenal suppression is likely to be transient with a rapid return to normal values once the short course of steroid therapy has ceased. The same applies to children given proportionate dosage. Use of occlusive dressings increases the absorption of topical corticosteroids. Prolonged and intensive treatment with a highly active corticosteroid preparation may cause atrophic changes, such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or where skin folds are involved.

Special Precautions for Handling and Disposal: Any unused medicine should be disposed of properly. Consult a pharmacist or local waste management center for more details about how to safely discard expired or unused medicines.

Store at temperatures not exceeding 30°C.

Topical Corticosteroids

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

Rx