GINOFORT

Active material: Butokonazol
When ATH: G01AF15
CCF: The drug with the antifungal activity for topical application in gynecology
ICD-10 codes (testimony): B37.3
When CSF: 08.03.01
Manufacturer: RICHTER RICHTER Ltd. (Hungary)

Pharmaceutical form, composition and packaging

Vaginal Cream soft, homogeneous, from white to almost white, free from foreign particles and without visible separation.

1 g
butoconazole nitrate20 mg

Excipients: sorbitol, mineral oil, glycerol monostearate, polyglyceryl-3 oleate, wax, colloidal silicon dioxide, disodium эdetat, metilparagidroksiʙenzoat, propilparagidroksibenzoat, propylene glycol, water.

5 g – applicators polypropylene (1) – cupboards polisterolovye (1) – Laminated bags (1) – packs cardboard.

 

Pharmacological action

Antifungal agent, imidazole. It has fungicidal effect.

It is active against fungi of the genus Candida, Trichophyton, Microsporum, Epidermophyton and some gram-positive bacteria.

By blocking the cell membrane of the fungus formation of ergosterol from lanosterol, It increases the permeability of the membrane, which leads to cell lysis fungus.

Vaginal Cream is highly bioadhesive. Butoconazole in intravaginal application is on the vaginal mucosa for 4-5 days.

 

Pharmacokinetics

Absorption

When intravaginal application of systemic absorption 1.7% of the administered dose. Cmax achieved through 13 h and is 2-18.6 ng / ml.

Metabolism and excretion

Subjected to intensive metabolism, partly excreted in the urine and the bile.

 

Testimony

- Vaginal candidiasis, caused by Candida albicans.

 

Dosage regimen

The drug is administered vaginally once. The contents of one applicator (about 5 g cream) injected deep into the vagina. The preparation can be applied at any time.

 

Side effect

Local reactions: burning, itch, soreness and swelling of the vaginal wall.

Other: pain and / or spasm in the lower abdomen.

 

Contraindications

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

 

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

 

Cautions

In the case of preservation of clinical symptoms of the infection after completion of treatment should be repeated microbiological examination to confirm the diagnosis.

Irritation of the vaginal mucosa or pain is an indication to stop the drug.

Cream Ginofort® It comprises a mineral oil, damaging products of latex or rubber (incl. condoms or intravaginal aperture), however for 72 h after treatment should not use these contraceptives.

 

Overdose

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

 

Drug Interactions

Data on drug interactions drug Ginofort® no.

 

Conditions of supply of pharmacies

The drug prescription.

 

Conditions and terms

The drug should be stored out of reach of children at temperature from 15 ° to 30 ° C. Shelf life – 2 year.

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