Ecodax (econazole) cream 1% 10 g.

Description

Ecodax Storage
active substance: econazole;

1 g of cream contains econazole nitrate 10 mg;

Ecodax Excipients: chlorocresol, sodium dihydrogen phosphate dihydrate, concentrated phosphoric acid, white soft paraffin, mineral oil, cetostearyl alcohol, cetomacrogol 1000, sodium hydroxide, purified water.

Ecodax Dosage form
Cream.

Basic physical and chemical properties: homogeneous homogeneous cream from white to yellowish-white color.

Pharmacotherapeutic group
Antifungal agents for topical use.

ATX code D01A C03.

Pharmacological properties

Pharmacodynamics.

Econazole, an imidazole derivative, is a broad-spectrum antifungal drug for external use. Has a fungicidal and bactericidal effect. The mechanism of action of econazole is due to inhibition of ergosterol biosynthesis, which regulates the permeability of cell walls of microorganisms. It is active against dermatophytes, yeasts and fungi: Trichophiton rubrum, Trichophiton mentagrophytes, Trichophiton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, Candida albicans, Torulopsis, Maladosorula, Rhodotorula Aspergillus, Cladosporium, Scopulariopsis brevicautus and some gram-positive bacteria (streptococci, staphylococci and Nocardia minutissima).

Pharmacokinetics.

Absorption

After topical application to the skin, the systemic absorption of econazole is extremely low. The mean peak concentration of econazole and / or its metabolites in plasma / serum was observed 1-2 days after dosing and was <1 ng / ml for 2% dermal cream applied to intact skin and 20 ng / ml for 2% dermal cream applied to damaged skin. Although most econazole remains on the skin surface (approximately 90%) after application of 1% cream, the concentrations of econazole found in the stratum corneum exceed the minimum inhibitory concentrations for dermatophytes, and inhibitory concentrations are reached in the middle of the dermis.

Distribution

Econazole and / or its metabolites are extensively bound (> 98%) to serum proteins in the systemic circulation.

Metabolism

Econazole, which reaches the systemic circulation, is extensively metabolized by oxidation of the imidazole ring, followed by O-dealkylation and glucuronidation.

Excretion

Econazole and metabolites are excreted in the urine and faeces in approximately equal amounts.

Indication
For the treatment of candidiasis of the skin, dermatomycosis and herpes zoster, including suspected comorbid infections caused by gram-positive bacteria.

Contraindication
Hypersensitivity to econazole or to any other component of the drug.

Interaction with other medicinal products and other forms of interaction
Econazole is a known inhibitor of CYP3A / 2C29. However, given that the drug is poorly absorbed into the systemic circulation, the occurrence of clinically significant interactions is unlikely.

Patients taking oral anticoagulants such as warfarin and acenocoumarol should exercise caution and monitor blood clotting parameters.

Dose adjustment of oral anticoagulants may be required during and after econazole treatment.