FLUTICON CREAM

Fluticasone Propionate 0.05% cream is one of a group of medicines known as corticosteroids, which have a high anti-inflammatory effect when used topically. Fluticasone is a potent corticosteroid that is applied to the skin to treat a wide variety of inflammatory skin diseases. It is used for the relief of inflamed skin, redness and itching in several skin problems not caused by germs and responsive to corticosteroids.

Pharmacokinetic data for the rat and the dog indicate rapid elimination and extensive metabolic clearance. Bioavailability is very low after topical or oral administration, due to limited absorption through the skin or from the gastrointestinal tract, and because of extensive first-pass metabolism. Distribution studies have shown that only minute traces of orally administered compound reach the systemic circulation, and that any systemically available radiolabel is rapidly eliminated in the bile and excreted in the faeces. Fluticasone propionate does not persist in any tissue, and does not bind to melanin. The major route of metabolism is hydrolysis of the S-fluoromethyl carbothioate group, to yield a carboxylic acid (GR36264), which has very weak glucocorticoid or anti-inflammatory activity. In all test animal species, the route of excretion of radioactivity is independent of the route of administration of radiolabelled fluticasone propionate. Excretion is predominantly faecal and is essentially complete within 48 hours. In man, too, metabolic clearance is extensive, and elimination is consequently rapid. Thus, drug entering the system circulation via the skin will be rapidly inactivated. Oral bioavailability approaches zero, due to poor absorption and extensive first-pass metabolism. Therefore, systemic exposure to any ingestion of the topical formulation will be low.

For adults and children aged 1 year and over, apply a thin film of fluticasone cream to the affected skin areas one to twice daily (see 4.4). Duration of use: Daily treatment should be continued until adequate control of the condition is achieved. Frequency of application should thereafter be reduced to the lowest effective dose. When fluticasone cream is used in the treatment of children, if there is no improvement within 7-14 days, treatment should be withdrawn and the child re-evaluated. Once the condition has been controlled (usually within 7-14 days) frequency of application should be reduced to the lowest effective dose for the shortest possible time. Continuous daily treatment for longer than 4 weeks is not recommended. An increase in the number of daily applications might aggravate side effects without improving the therapeutic effects. Method of administration: In adults and children, use the method of finger-tip unit to specify the quantity of cream applied to a given surface. The finger-tip unit corresponds to the amount of cream applied from the distal skin-crease to the tip of the index finger. This quantity permits to treat a skin surface corresponding to 2 hands of an adult (approximately 250 to 300 cm2). A finger-tip unit corresponds to approx. 0.5g of product. A tube of 30 grams contains 60 finger-tip unities.

FLUTICON Cream is available in 10 g of pack filled in laminated tube & packed in Carton.