Econazole (When ATH G01AF05)

When ATH:
G01AF05

Characteristic.

The antifungal agent for topical use. Imidazole.

Econazola nitrate is a white odourless crystals. Solubility in 20 °C (g / 100ml): water <0,1; ethanol (96%) 2,0; acetone 1,5; Molecular weight 444,70.

Pharmacological action.
Antifungal.

Application.

Mycosis of the skin (incl. defeat hairy areas) and mucous membranes.

Contraindications.

Hypersensitivity.

Pregnancy and breast-feeding.

Econazole nitrate showed no teratogenic properties when administered orally to mice, Krolik, floors. Fetotoksicheskie or embriotoksicskie effects observed in Segment I study in rats, treated with oral doses, exceed the dose for dermal use in humans 10-40 times. Similar effects were observed in studies II and III Segment Segment the mice, rabbits and rats, treated with oral doses, excess cutaneous human dose in 80 or 40 time.

Econazole nitrate should be used during pregnancy only in cases, when the intended benefits to the mother outweighs the potential risk to the fetus (adequate and well-controlled studies in humans have not held).

Category actions result in FDA - C. (The study of reproduction in animals has revealed adverse effects on the fetus, and adequate and well-controlled studies in pregnant women have not held, However, the potential benefits, associated with drugs in pregnant, may justify its use, in spite of the possible risk.)

Unknown, whether econazole nitrate is excreted in breast milk of women. Following oral administration of econazole nitrate to lactating rats, econazole and / or its metabolites are excreted into the milk and detected in breast-fed babies. In lactating rats, receiving high dose oral (in 40 or 80 cutaneous times the human dose), there was a decrease of viability and survival of newborn calves until weaning; however, at these high doses, the toxicity observed in females, which could be an unfavorable factor.

During treatment econazole nitrate should decide the issue of termination of breastfeeding.

Side effects.

Local reactions: irritation, burning sensation and itching, erythema, xerosis, rash; in the long-term use-and hyperpigmentation atroficskie skin lesions.

In clinical trials, approximately 3% patients, primenyavshih эkonazola nitrate Vide 1% cream, noted a burning sensation, itch, pricking, эritema. Marked 1 case of itchy rash.

Overdose.

Data on overdose of econazole nitrate in humans is not.

Dosing and Administration.

Outwardly, intravaginal. The dose and treatment regimen set individually depending on indications and dosage form. Outwardly: cream is applied to the affected skin and gently rub, procedure was carried out 1-2 times per day. When otomycosis cream applied to the skin of the external auditory passage 2-3 times a day for 5 Nights. The solution was diluted extemporaneously. Intravaginal: suppositories are administered deeply into the vagina, in the position of "lying" (before bedtime), daily.

Precautions.

To prevent recurrence of candidiasis and tinea of ​​feet and body treatment is required not less than 2 Sun, and when dermatofitia feet is not less 1 Months; in the absence of the effect of treatment within a specified time should stop and review diagnosis. In the case of lack of effectiveness of the standard 3-day course of vaginal candidiasis, it may be continued on 3 day and repeated course of conduct through 10 days. If no effect within a specified time therapy treatment should be discontinued, and specify the diagnosis.

When the first symptoms, evidence of increased sensitivity or irritation, econazole nitrate should be abolished.

Avoid contact with the eyes.

During menstruation drug is administered vaginally in the usual way.

When vulvovaginal mycosis necessarily treatment and sexual partner.