Гинокапс
Producer: Minskinterkaps Unitary Enterprise Republic of Belarus
Code of automatic telephone exchange: G01AF20
Release form: Firm dosage forms. Capsules are vaginal.
General characteristics. Structure:
Active ingredients: 100 mg of metronidazole, 100 mg of Miconazolum of nitrate.
Vspomogatelna of substance: the lecithin purified beeswax, the water purified sunflower oil.
Structure of a cover of the capsule: gelatin, глицерол, methylparahydroxybenzoate, пропилпарагидроксибензоат, the water purified titanium dioxide, dye a sunset yellow (E110).
The combined drug used in gynecology having antifungal, antiprotozoan and antibacterial effect.
Pharmacological properties:
Pharmacodynamics. Pharmacological activity of medicine of Ginokaps is caused by complex action of its components – metronidazole and Miconazolum of nitrate. Drug has antifungal, antiprotozoan and antibacterial effect.
Metronidazole - antimicrobic and antiprotozoan means, derivative 5 nitroimidazoles. The mechanism of action consists in biochemical recovery 5 nitrogroups of metronidazole intracellular transport proteins of anaerobic microorganisms and protozoa.
The recovered 5 nitrogroup of metronidazole interacts with DNA of a cell of microorganisms, inhibiting synthesis of their nucleic acids that leads to death of bacteria. Gagdnerella vaginalis, Giardia intes-tinalis, Entamoeba histolyca, Lamblia spp is active concerning Trichomonas vaginalis., and also strict anaerobes of Bacter-oides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella (Prevotella bivia, Prevotella buccae, Prevotella disiens) and some gram-positive microorganisms (Eubacter spp. Clostridium spp., Peptococ-cus spp., Peptostreptococcus spp., Mobiluncus spp.).
To metronidazole aerobic microorganisms are insensitive. Miconazolum - the antifungal means inhibiting synthesis of ergosterol of a cellular membrane. It is active concerning dermatophytes, barmy and some other mushrooms. Shows antimicrobic activity concerning gram-positive microorganisms. Does not change structure of microflora and pH of a vagina. Quickly eliminates an itch which usually accompanies fungal infections. At intravaginalny use it is active generally concerning Candida albicans.
Pharmacokinetics. After intravaginalny introduction metronidazole is exposed to system adsorption (about 56%). Gets into breast milk and the majority of fabrics, passes through GEB and a placenta. Communication with proteins of plasma – less than 20%. It is metabolized in a liver by a hydroxylation, oxidation and a glyukuronirovaniye.
Activity of the main metabolite (2 oxymetronidazole) of-30% of activity of initial connection. System absorption of Miconazolum at intravaginalny use is very low. Miconazolum breaks Gistogematichesky barriers badly, practically does not get into SMZh.
Indications to use:
Гинокапс it is applied to topical treatment of the infectious diseases of a vagina caused by trichomonads and/or kandida:
- mycotic vulvovaginitis.
Route of administration and doses:
Гинокапс apply intravaginalno. The capsule is entered deeply into a vagina.
At trichomoniasis appoint on 1 капс. 1 time in the evening before going to bed within 10 days in combination with metronidazole reception inside.
At a bacterial vaginosis or a mycotic vulvovaginitis appoint on 1 капс. 1-2 within 10 days, if necessary – in combination with metronidazole reception inside.
At insufficient efficiency the course of treatment can be continued within 10 days.
Features of use:
In the course of treatment it is recommended to refrain from sex life.
During treatment ethanol reception is contraindicated (possibly development of disulfiramopodobny reactions: abdominal pain of spastic character, nausea, vomiting, a headache, sudden rush of blood to the person).
It is reasonable to appoint vaginal capsules in a combination with peroral forms of metronidazole.
In case of use of drug together with metronidazole for intake, especially at a repeated course, control of a picture of peripheral blood (danger of a leukopenia) is necessary.
With care: pregnancy (the II-III trimesters), a leukopenia in the anamnesis.
Not influence on a possibility of driving of the car, work with the equipment.
Side effects:
Allergic reactions: urticaria, skin rash. Local: itch, irritation of a mucous membrane of a vagina. Development of system effects is possible: change of flavoring feelings, including "metal" smack, dizziness, a headache, dryness in a mouth, nausea, vomiting, a loss of appetite, spastic an abdominal cavity pains, locks or diarrhea, coloring of urine in dark color, a leukopenia or a leukocytosis. In case of side effects of treatment by Ginokaps it is necessary to stop.
Interaction with other medicines:
In need of joint reception with other medicines previously consult with the doctor. (Warfarin), peroral hypoglycemic medicines, Phenytoinum strengthens action of indirect antigoagulyant, it is not recommended to combine with not depolarizing muscle relaxants (vekuroniya). Simultaneous use of metronidazole with Disulfiramum can lead to development of neurologic symptoms (it is not necessary to appoint metronidazole sick which accepted Disulfiramum during the last 2 weeks). At simultaneous use with drugs of lithium concentration of the last in plasma can increase. Phenobarbital accelerates metabolism of metronidazole due to induction of microsomal enzymes of a liver; Cimetidinum – reduces that can lead to increase in its concentration in blood serum and to increase in risk of development of by-effects.
Contraindications:
- liver and/or renal failure;
- lack of coordination of movements;
- organic lesions of TsNS (including epilepsy);
- I trimester of pregnancy, lactation period;
- intolerance of derivatives of a nitroimidazole;
- hypersensitivity to drug components
Overdose:
Cases of overdose of drug in the recommended doses at intravaginalny use were not observed.
Storage conditions:
Drug should be stored in the unavailable to children, protected from moisture and light place at a temperature from 15 °C to 25 °C. A period of validity - 1,5 years.
Issue conditions:
According to the recipe
Packaging:
On 5 vaginal capsules in strip packagings, on 2 strip packagings in a cardboard box.