Composition, form of production and packaging
? Suppositories vaginal white, oval, waxy.
1 supp.
sertaconazole nitrate 300 mg
Auxiliary substances: Witepsol - 1.305 g, suppository - 1.305 g, silicon dioxide colloidal anhydrous - 0.09 g.
1 PC. - blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Antifungal drug, an imidazole derivative and benzothiophene. In therapeutic doses, it exerts a fungistatic and fungicidal action. The mechanism of action is to inhibit the synthesis of ergosterol and increase the permeability of the cell membrane, which leads to lysis of the fungal cell.
It is active against Candida spp. It also has antibacterial activity against Gram-positive bacteria (Streptococcus spp., Staphylococcus spp.).
PHARMACOKINETICS
When intravaginal application the drug is not absorbed.
INDICATIONS
- local treatment of infections of the mucous membrane of the vagina caused by fungi of the genus Candida (candidiasis vulvovaginitis).
DOSING MODE
The drug is used once. 1 vaginal suppository is injected deep into the vagina, lying on the back, before going to bed. If clinical symptoms persist, the drug can be re-used after 7 days.
Before using the drug, the external genitalia should be washed using neutral or alkaline soap.
SIDE EFFECT
Rarely: sensation of burning, itching in the vagina, which pass on their own during treatment and do not require drug withdrawal. These side effects are classic for topical preparations and reflect the effectiveness of the drug.
Possible: allergic reactions.
CONTRAINDICATIONS
- Hypersensitivity to derivatives of imidazole, benzotifen and other components of the drug.
PREGNANCY AND LACTATION
Sufficient data on the use of Zalain during pregnancy and during lactation there.
Considering the method of application of the drug (single administration), as well as the absence of systemic absorption, the use of Zalain during pregnancy and during lactation is possible if the prospective benefit to the mother exceeds the possible risk to the fetus or the child.
SPECIAL INSTRUCTIONS
With a simultaneous infection of the labia and adjacent areas (candidiasis vulvitis), additional local treatment with ZalainВ® cream should be performed.
Treatment can be done during menstruation.
When using the drug is recommended to abstain from sexual intercourse.
To prevent urogenital reinfection, it is recommended to consider the simultaneous treatment of the sexual partner.
The risk of damaging the means of barrier contraception (condom or diaphragm rupture) increases with their simultaneous use with Zalain.
Impact on the ability to drive vehicles and manage mechanisms
The use of Zalain does not affect the ability to perform potentially dangerous activities requiring a high concentration of attention and speed of psychomotor reactions (including driving vehicles).
OVERDOSE
Not installed.
If you accidentally take the drug inside, you must rinse the stomach and immediately consult a doctor.
DRUG INTERACTION
With the simultaneous use of Zalain В® with local contraceptives, there may be a weakening of the spermicidal effect of the latter.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 3 years.
