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Manufacturer: Teva (Teva) Israel
Code ATC: G01AF16
Pharm group: Antiseptics and antimicrobials for the treatment of gynecological diseases
Release form: Solid dosage forms. Vaginal suppositories.
Indications for use:
Common characteristics. Composition:
Active substance: omoconazole nitrate micronized 150 mg, 300 mg, 900 mg excipient: hard fat (Witepsol W 25) - 2500 mg
Description: white or almost White homogeneous suppositories cylindrical shape
Active substance - nitrate omoconazole is a derivative of imidazole, has antifungal and antibacterial properties. Exhibits fungistatic activity against the major pathogenic fungi, such as yeast fungi (Candida albicans, Candida glabrata and other Candida species), dermatophytes (Trichophyton, Epludermophyton, Microsporam), Pityrosporum orbiculare, Pityrosporum ovale and Aspergilus species. According to studies in vilro the drug is effective against some hymnological bacteria.
The mechanism of action is based on blocking biosynthetic processes.
The pharmacokinetics. When using a vaginal suppository 150 mg once a day (course 6 days) measurement of plasma concentrations, conducted after the first, third and sixth day of treatment, not reached the level of detection of the drug (25 ng/ml), which corresponds to about 2-3 % of the drug. When applying high doses of omoconazole can accumulate. The degree of suction in inflammation of the mucous membrane can be increased. Research, both animal and human have shown that entered into omoconazole quickly and largely metabolized. Most of the metabolites kongugiruut with glucuronide or sulfate.
Indications for use:
It is recommended for the treatment of vulvovaginitis, caused by the fungus Candida (acute, chronic and recurrent), and candidiasis in pregnancy.
Way of application and dose:
Vaginal suppositories 150 mg:
for 6 consecutive days in the evening before bedtime to enter 1 suppository deep into the vagina. Vaginal suppositories 300 mg:
for 3 days in a row in the evening before bedtime to enter 1 suppository deep into the vagina. Vaginal suppositories 900 mg:
before going to sleep to enter 1 suppository deep into the vagina.
It is necessary to strictly observe the duration of treatment.
To use the drug during menstruation is forbidden. It is advisable to start the treatment after menstruation.
Oily components vaginal suppositories change in the quality of condoms, so you should avoid their simultaneous application and to consider replacement of contraception. During the course of treatment and during the week after should be avoided hygiene of the vagina. For body wash, you should use a neutral or slightly alkaline soap. During treatment underwear, towel and sponge for washing should be cleaned and changed daily.
In case of defeat mushrooms labia and surrounding areas, it is recommended to apply the antifungal cream.
Pregnancy and lactation
The use of vaginal suppositories in the first trimester of pregnancy and during lactation is possible only after a careful individual assessment by a physician ratio benefits/risk.
Animal studies have shown that used in therapeutic doses omoconazole has no embryotoxic action, and does not harm postnatal development.
Controlled clinical trials with pregnant and nursing mothers have not been conducted. To these holes do not have data that would indicate the ingress of omoconazole in breast milk.
The drug is generally well tolerated. In some cases, the treatment can be local burning or itching. In most cases, these symptoms are temporary and do not require discontinuation of treatment.
Interaction with other drugs:
Hypersensitivity to the drug components. With caution during pregnancy and lactation.
It was not observed.
At temperatures from 15 °C to 25 °C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date.
Vaginal suppositories 150 mg, 300 mg, 900 mg
Suppositories 150 mg - 6 suppositories in buzyakova outline package (stripe) of the aluminum foil coated with polyethylene. Suppositories 300 mg - 3 suppository in basiacally outline package (stripe) of the aluminum foil coated with polyethylene.
Suppositories 900 mg - 1 suppository in basiacally contour package
(the stripe) of the aluminum foil coated with polyethylene.
One strip together with instructions for use in the carton.