Mycogen

Active material: Omokonazol
When ATH: D01AC13
CCF: Antifungal agents for external use
When CSF: 08.02.01
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Cream for external application 1% white, uniform, without smell.

Excipients: paraffin sverhzhidky, polysorbate 40, carbomer 934R, benzoic acid, Sodium hydroxide (30% water solution), лабрафил М-2130-CS (macrogol glycerides and palm oil esters), water distillirovannaya.

20 g – aluminum tuba (1) – packs cardboard.

Pharmacological action

Antifungal drug for topical application in gynecology. Has antibacterial and fungistatic. The mechanism of action based on inhibition of fungal ergosterol biosynthesis, which leads to disorganization of the membrane of the fungus. Active against yeasts (incl. Candida albicans, Candida glabrata), Orbicular Pityrospores, Pityrosporum ovale и Aspergilus spp. Studies, проведенных in vitro, It shows the activity omokonazola against some Gram-positive bacteria.

Pharmacokinetics

When used for 6 days 1 Vaginal suppozytoryyu (150 mg) in daily concentrations of plasma omokonazola, measured after 1 th, 3-th and 6 th day of application, We did not reach the defined value (25 ng / ml, corresponding absorbance values 2-3% administered dose). In applying the drug in high doses possible cumulation omokonazola. The degree of absorption can be increased when applied to inflamed mucous membranes of the vagina.

Omokonazol, got into the systemic circulation, rapidly and largely biotransformed to form metabolites, which is conjugated to a glucuronide or sulphate. Omokonazol is mainly excreted in the bile and excreted in the feces.

Testimony

Treatment of vulvovaginitis, caused by fungi of the genus Candida (incl. with Gram-positive bacterial microflora joined):

• acute candidiasis;
• Chronic candidiasis;
• recurrent candidiasis;
• candidiasis in pregnancy.

Dosage regimen

Heading dose of Mikogal 900 mg. Effective therapy for the duration of treatment 1, 3 and 6 equivalent days. Suppozitorii 150 mg is used for 6 on consecutive days 1 suppository / day. Suppozitorii 300 mg is used for 3 on consecutive days 1 suppository / day. Suppozitorii 900 mg used once. The suppository is administered deeply into the vagina, 1 time / day. in the evening, before bedtime.

Side effect

In some cases,: burning or itching at the site of application.

Preparation, usually, well tolerated, side effects are transient and do not require discontinuation of the drug.

Contraindications

• Hypersensitivity to the drug.

Pregnancy and lactation

Use of the drug Mikogal I trimester of pregnancy and lactation is possible only in the case, if the expected benefit to the mother outweighs the potential risk to the fetus or child. Adequate clinical safety studies of drugs in pregnancy have not been conducted.

These allocation omokonazola breast milk are absent. In experimental studies found, omokonazol that does not have embryotoxic action and not affect the postnatal development of the child.

Cautions

The drug should not be used during menstruation. The course of treatment it is advisable to start after menstruation. During therapy and during the week after the end of the vagina should not squirt. To wash should use a neutral or slightly alkaline soap. It should be changed or disinfected daily underwear, towel and sponge for washing.

With concomitant lesions of the labia and the surrounding areas, we recommend further apply an antifungal cream. Fat-based vaginal suppositories alters the properties of mechanical contraceptives (condoms and pessaries), so avoid their simultaneous use.

Overdose

So far, cases of drug overdose were reported Mikogal.

Drug Interactions

Not found clinically significant drug interactions Mikogal with other drugs.

Conditions and terms

The drug should be stored at room temperature (from 15° to 25°C). Shelf life – 2 year.