ZALAIN (Suppozitorii)

Active material: Sertaconazole
When ATH: G01AF
CCF: The drug with the antifungal activity for topical application in gynecology
ICD-10 codes (testimony): B37.3
When CSF: 08.03.01
Manufacturer: EGG PHARMACEUTICALS Plc (Hungary)

Pharmaceutical form, composition and packaging

Vaginal Suppositories white, oval, waxy.

Excipients: witepsol, suppocir, Colloidal anhydrous silica.

1 PC. – blisters (1) – packs cardboard.

Pharmacological action

Antifungal agent, imidazole derivative and benzothiophene. At therapeutic doses, has fungistatic and fungicidal activity. The mechanism of action is inhibition of the synthesis of ergosterol and an increase in the permeability of the cell membrane, which leads to cell lysis fungus.

It is active against Candida spp. (incl. Candida albicans). Also it possesses antibacterial activity against gram-positive bacteria (Streptococcus spp., Staphylococcus spp.).

Pharmacokinetics

When intravaginal application no systemic absorption. Unmodified sertaconazole not detected in any serum, audio in urine.

Testimony

- Infection of the vaginal mucosa, caused by fungi of the genus Candida (vulvovaginal candidiasis).

Dosage regimen

The drug is prescribed once. The vaginal suppository administered deeply into the vagina, Lying on your back before going to bed. In the case of preservation of clinical symptoms may re-use of the drug through 7 days.

Before intravaginal suppository should wash the vulva with neutral or alkaline soaps.

Side effect

Rarely: burning, itching of the vagina (are themselves, do not require discontinuation of the drug).

Maybe: allergic reactions.

Contraindications

- Hypersensitivity to sertaconazole, imidazole derivatives, benzotifena and other ingredients.

Pregnancy and lactation

Sufficient data on the use Zalain^® pregnancy and lactation No.

Given the way the drug (single), and the lack of systemic absorption application Zalain^® during pregnancy and lactation is possible in the case, if the expected benefit to the mother outweighs the potential risk to the fetus or child.

Cautions

In the absence of specific clinical symptoms alone detection of Candida in the vaginal mucosa can be an indication for prescribing. If candidiasis confirmed, it is recommended to identify and eliminate factors, conducive to the emergence and development of fungi.

When simultaneous infection of the labia and surrounding areas (Candida vulvitis) should be further carried out by local drug treatment Zalain^® cream.

The treatment can be carried out during menstruation.

In applying the drug to abstain from sex. To prevent reinfection urogenital encouraged to consider the simultaneous treatment of sexual partners.

Risk of damage of barrier contraception (condom breakage or diaphragm) increases in their simultaneous use with Zalain^®.

Effects on ability to drive vehicles and management mechanisms

Application Zalain does not affect the ability to perform potentially hazardous activities, require high concentration and speed of reaction psihomomtornyh (incl. driving vehicles).

Overdose

Currently, cases of drug overdose Zalain^® not reported. If you accidentally taking the drug orally is necessary to wash out the stomach and conduct symptomatic treatment.

Drug Interactions

With the simultaneous use of the drug Zalain^® local contraceptives may be a weakening of the spermicidal action of the past.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 30 ° C. Shelf life – 3 year.