Fluderm (fluticasone propionate) ointment 0.05 mg/g. 15 g. tube

Description

Fluderm Storage
active substance: fluticasone propionate;

1 g of the drug contains fluticasone propionate 0.5 mg;

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

Fluderm Dosage form
Cream.

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

Fluderm Pharmacotherapeutic group
Corticosteroids for use in dermatology. Active corticosteroids (group III). ATX code D07A C17.

Pharmacological properties

Pharmacodynamics.

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, so its therapeutic index is one of the broadest currently available topical steroids.

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

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

Pharmacokinetics.

Absorption.

When applied topically and orally, bioavailability is very low due to limited absorption of the drug through the skin or from the gastrointestinal tract and due to intensive first-pass metabolism. Oral bioavailability is close to zero, so the systemic effects of fluticasone propionate with any internal application of the cream will be low.

Distribution.

Studies have shown that a very small amount of orally administered fluticasone propionate reaches the systemic circulation, which is rapidly excreted in bile and excreted in faeces. Fluticasone propionate is not retained in any tissue and does not bind to melanin.

Metabolism.

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

Breeding.

According to animal studies, the route of excretion does not depend on the method of application of fluticasone propionate. Excreted mainly in the feces, and this process is complete within 48 hours.

Indication
Adults.

Dermatoses sensitive to corticosteroid treatment, such as:

atopic dermatitis;
numular dermatitis (discoid eczema);
nodular itching;
psoriasis (except for common plaque psoriasis);
simple chronic herpes (neurodermatitis), herpes zoster;
seborrheic dermatitis;
irritant or allergic contact dermatitis;
discoid lupus erythematosus;
generalized erythroderma (as an adjunct);
reaction to insect bites;
red Friday.
Children.

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

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

Untreated skin infections.

Pink acne.

Common acne.

Perioral dermatitis.

Perianal and genital itching.

Itching without inflammation.

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