Econazol (econazole) pessary 150 mg. №3

Description

Econazol Storage
active substance: esonazole;

1 pessary contains 150 mg of econazole nitrate (in terms of 100% dry matter);

Econazolxcipient: solid fat.

Econazol Dosage form
Pessaries.

Main physical and chemical properties: smooth pessaries of white or almost white color, torpedo-shaped. On a longitudinal section there are no impregnations, existence of a funnel-shaped deepening and an air core is allowed.

Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. ATX code G01A F05.

Pharmacological properties

Pharmacodynamics.

The drug is a triazole fungicide. Shows antifungal activity against dermatophytes, yeasts and molds. Active against some gram-positive and gram-negative bacteria. The effect of econazole nitrate is to damage the cell membranes of fungi by increasing the permeability of fungal cells and damage to intracellular membranes in the cytoplasm. The site of action is likely to be acyl residues of unsaturated fatty acids of membrane phospholipids.

Pharmacokinetics.

After vaginal administration of econazole nitrate is slightly absorbed.

Maximum concentrations of econazole and / or its metabolites were observed within 1–2 days after administration and were 65 ng / ml.

Econazole and / or its metabolites are predominantly bound to serum proteins (> 98%). Econazole is preferably metabolized by oxidation, deamination and / or O-dealkylation, its metabolites are excreted in the urine and feces.

Indication
Vulvovaginal mycoses caused by fungal pathogens sensitive to econazole.

Contraindication
Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction
Econazole-Farmex should not be combined with other gynecological drugs for intravaginal or topical use based on mineral oil, vegetable oil or Vaseline.

Relevant studies were not performed. Because econazole is chemically similar to imidazole derivatives, there is a possibility of competitive interaction of econazole nitrate with substances metabolized by CYP3A / 2C29 enzymes. However, due to the fact 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, acenocoumarol, and phenprocoumon should exercise caution and monitor blood clotting parameters. Dose adjustment of oral anticoagulants may be required during and after econazole treatment.

Concomitant use of diaphragms or condoms with Econazole-Pharmex should be avoided. This interaction reduces the effectiveness of the drug and weakens the strength of barrier contraceptives.