Fluderm (fluticasone propionate) cream 0.5 mg/g. 15 g. tube

Description

Fluderm (fluticasone propionate) Composition
active substance: fluticasone propionate;

1 g of the drug contains 0.5 mg of fluticasone propionate

auxiliary substances: mineral oil, propylene glycol, cetostearyl alcohol, isopropyl myristate, imidourea, sodium phosphate anhydrous, citric acid, polyethylene glycol cetostearyl ether, purified water.

Fluderm (fluticasone propionate) Dosage form
Cream.

Basic physical and chemical properties: homogeneous soft cream of white or almost white color.

Fluderm (fluticasone propionate) Pharmacological group
Corticosteroids for dermatological use. Active corticosteroids (group iii).

ATX code D07A C17.

Pharmacological properties

Pharmacological.

Fluticasone propionate is a glucocorticoid drug with high anti-inflammatory activity and a very low level of suppression of the hypothalamic-pituitary-adrenal system when applied topically, therefore its therapeutic index is one of the widest of all currently available GCS.

Fluticasone propionate has high systemic activity after subcutaneous administration, but very low activity after oral administration, possibly due to metabolic inactivation. In vitro studies have shown its high affinity for human corticosteroids receptors.

Fluticasone propionate does not exhibit an unpredictable hormonal effect and a noticeable effect on the central and peripheral nervous systems, gastrointestinal, cardiovascular or respiratory systems.

Pharmacokinetics.

Absorption.

With local and oral administration, the bioavailability is very low due to the limited absorption of the drug through the skin or from the gastrointestinal tract and due to the intensive metabolism of the first pass. Oral bioavailability approaches zero, so the systemic effect of fluticasone propionate with any internal use of the cream will be low.

Distribution.

Studies have shown that a very small amount of orally administered fluticasone propionate reaches the systemic circulation https://www.tabletki.info/ua/ru/fluderm, which is rapidly excreted in the bile and excreted in the feces. Fluticasone propionate is not retained in any tissues and does not bind to melanin.

Metabolism.

According to pharmacokinetic studies in animals, fluticasone propionate is rapidly excreted and is subject to extensive metabolic clearance. In humans, the metabolic clearance is wide and, accordingly, the output is fast. The penetration of the drug through the skin into the systemic circulation is rapidly inactivated. The main metabolic mechanism is hydrolysis to carboxylic acid, which has very low glucocorticoid and anti-inflammatory activity.

Output.

According to animal studies, the route of elimination does not depend on the method of administration of fluticasone propionate. It is excreted mainly in the feces, and this process is completely completed within 48 hours.

Clinical characteristics
Indications
Adults.

Dermatoses sensitive to corticosteroid treatment, such as:

– atopic dermatitis;

– numular dermatitis (discoid eczema);

– knotty itching

– psoriasis (with the exception of common plaque psoriasis)

– simple chronic lichen (neurodermatitis), lichen planus;

– seborrheic dermatitis;

– irritant or allergic contact dermatitis

– discoid lupus erythematosus,

– generalized erythroderma (as an additional remedy)

– reaction to insect bites;

– red prickly heat.

Children.

Treatment of atopic dermatitis in children aged 3 months, in the absence of the effect of treatment with less potent corticosteroids.

Contraindications
Hypersensitivity to the active substance or to any component of the drug.

Untreated skin infections.

Acne rosacea.

Acne vulgaris.

Perioral dermatitis.

Perianal and genital itching.

Itching without inflammation.

Dermatoses in children under 3 months of age, including dermatitis and diaper rash.