Each gram of Clobetasol 0.05% ointement contains:

active ingredient: clobetasol propionate – 0.5 mg;
excipients: liquid paraffin, propylparaben, petrolatum white (vaseline), ethanol 96%.

Corticosteroid for topical use; D07AD01.

Following topical application, Clobetasol produce anti-inflammatory, antipruritic, anti-exudate, antiallergic and vasoconstrictor actions. The activity of the drug is thought to result at least in part from binding with a steroid receptor. Clobetasol decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown.

Absorption

Following topical application of Clobetasol propionate to most areas of normal skin, only small amounts of the drug appear to reach the dermis and subsequently the systemic circulation with the usual dosage; however, systemic absorption may be increased when the usual dosage is exceeded or when the skin is inflamed or diseased.

Elimination

Following percutaneous penetration of Clobetasol propionate, drug that is systemically absorbed probably follows the metabolic pathways of systemically administered corticosteroids. However, systemic metabolism of Clobetasol has not been fully characterized or quantified. Clobetasol and its metabolites are excreted in bileand in urine in animals.

Adminsitration

Topical Clobetasol is applied sparingly in thin films and are rubbed gently into the affected area twice daily, preferably in the morning and evening, some patients may respond initially to once-daily.

If clinical improvement does not occur after 2 weeks of treatment, the diagnosis should be reevaluated.

Treatment of patients with facial lesions by Clobetasol applications should not exceed 5 days.

Local Effects

Burning, itching, irritation, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, the accession of secondary infections, skin atrophy, striae, miliaria, cracked skin.

Local adverse Clobetasol effects occur most frequently with occlusive dressings, especially with prolonged therapy, and may require discontinuing the occlusive dressing.

Prolonged use at high doses may cause symptoms of Cushing, especially in children.

Adverse dermatologic effects of Clobetasol usually improve when the drug is discontinued but may persist for long periods; atrophic striae may be permanent.

Long-term use of Clobetasol and its application under occlusive dressings may suppress the hypothalamic-pituitary-adrenal (HPA) axis. Itmay occur when using 2 g of drug (1 mg of clobetasol propionate per day).

If irritation or sensitization occurs following topical application of Clobetasol , the drug should be discontinued.

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dressings.

It should avoid applying the product on injured skin or open wounds

If irritation develops, Clobetasol should be discontinued and appropriate therapy instituted.

Pediatric Use
Safety and efficacy of Clobetasol have not been established in pediatric patients. Therefore, use of Clobetasol in children younger than 17 years of age is not recommended.

Pregnancy
Clobetasol should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. The drug should not be used on extensive areas, in large amounts, or for prolonged periods in pregnant women.

Lactation
Clobetasol should not be used during breast-feeding.

None well documented.

Symptoms: excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency and produce manifestations of hypercorticism.

Treatment: appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised. Adminster oral sodium bicarbonate to alkalinize the urine and force diuresis.

White odorless ointment.(Clobetasol 0.05% ointment).

Clobetasol 0.05% ointment
15 g 0.05% of ointment is filled into aluminum tubes (inside package).
The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).

3 years. Do not use after the expiration date.

Store in a cool and dry place, out of the reach of children. Protect from light.

To be dispensed with prescription.