Ginekit

General characteristics. Structure:

Active ingredient of a tablet A: 1 g of azithromycin.

Tablet A excipients: the tselyulloza is microcrystallic, starch, Natrium benzoicum, magnesium stearate, sodium krokhmalglikolit, aerosil, talc, a gidroksimetilpropiltselyulloz, propylene glycol, titanium dioxide, starch soluble.

Active ingredient of a tablet B: 1 g of a seknidazol.

Tablet B excipients: the tselyulloza is microcrystallic, starch, Natrium benzoicum, magnesium stearate, sodium krokhmalglikolit, aerosil, talc, a gidroksimetilpropiltselyulloz, propylene glycol, titanium dioxide, starch soluble.

Active ingredient of a tablet C: 150 mg of a flukonazol.

Tablet C excipients: starch, lactose, a tselyulloza microcrystallic, Natrium benzoicum, magnesium stearate, sodium krokhmalglikolit, aerosil, talc.

The antimicrobic, antifungal and antiseptic drug used in gynecology.

Pharmacological properties:

Pharmacodynamics. Azithromycin depending on concentration shows bacteriostatic or bactericidal action concerning aerobic gram-positive microorganisms (Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes), aerobic gram-negative microorganisms (Haemophilus ducreyi, Haemophilus influenzae, Moraxella cataerhalis, Neisseria gonoroeae; Chlamidia pneumoniae, Chlamidia trachomatis, Mycoplasma pneumoniae). Shows cross resistance to eritromitsinrezistentny gram-negative microorganisms, and also Enterococcus faecalis and the majority of metitsillinustoychivy strains. Works by linkng with a 50S-ribosome subunit and thus slows down protein synthesis in cells of microorganisms. Synthesis of nucleic acids at the same time does not change. Collects in phagocytes and fibroblasts that facilitates its receipt in the inflammation center.

Seknidazol, like other derivatives of a nitroimidazole, affects bakteritsidno the majority of anaerobic bacteria and protozoa. Interacts with DNA of microbic cells, breaks its helical structure, causes a rupture of threads and reduces synthesis of nucleic acids. Oppresses recovery reactions in microbic cells.

Flukonazol is effective concerning Criptococcus neoformans and mushrooms of the sort Candida spp. Has selective effect on P450 cytochrome and as the result, oppresses synthesis of sterol in cells of mushrooms.

Pharmacokinetics. Azithromycin. It is steady in acid medium, has lipophilic properties, it is quickly soaked up in a GIT. After a single dose in a dose of 500 mg bioavailability makes about 37% (effect of the first passing). _Cmax in blood is reached in 2–3 h and makes 0,4 mg/l. Contacts proteins in inverse proportion to concentration in blood. Linkng with proteins makes 7–50%. Time of semi-removal makes 68 h.

Azithromycin easily gets through gistogematichesky barriers. Gets through membranes of cells therefore it is active rather intracellular causative agents of infections. Concentration in cells and fabrics 10-50 times higher that in a blood plasma, and in the inflammation center — is 24-30% higher, than in healthy fabrics. Meal significantly changes pharmacokinetics. It Demetilirutsya in a liver. With bile and urine respectively about 50 and 6% of drug in not changed look are removed.

Seknidazol. After intake rather well (about 80%) it is soaked up. _Cmax in a blood plasma is reached in 4 h after reception. Is exposed to biotransformation in a liver. Semi-removal time — about 20 h. Gets through a placental barrier and into breast milk. It is allocated slowly, preferential with urine.

Flukonazol. _Cmax in blood is reached in 0,5–1,5 h after reception on an empty stomach. Linkng with proteins of a blood plasma makes 11–12%. 80% of drug are allocated with kidneys in not changed look. The clearance is proportional to clearance of creatinine. Semi-removal time — 30 h.

Indications to use:

Ginekit apply to treatment and prevention (preventive treatment) of diseases, the sexually transmitted, caused by the sensitive to drug mixed microflora (mikst-infection), in particular, Neisseria gonoroeae, Trichomonas vaginalis, Chlamidia trachomatis, Micoplasma at Ureaplasma urealiticum and other causative agents of a bacterial vaginosis, vaginit, a cervicitis, urethritis, prostatitis, etc. (Gardnerella vaginalis, Leptothrix and other anaerobic bacteria, Candida albicans, Haemophylus ducreyi).

Ginekit also appoint for prevention of infectious complications at small invasive interventions on bodies of a small pelvis (abortion, introduction and removal of intrauterine system, a diagnostic and medical scraping of walls of a uterus and the channel of a neck of uterus, diathermocoagulation, a cryolysis).

Route of administration and doses:

Pill from set is taken as follows:
in the morning a tablet B of a seknidazol (1 g), at noon — the second tablet B of a seknidazol (1 g), in the afternoon — a tablet In a flukonazol (150 mg), in the evening — a tablet A of azithromycin (1,0).

Azithromycin is accepted on 1 g once in 2 h after food. Seknidazol accept 1 g during food twice to prevent its irritant action on a mucous membrane of a digestive tract.

Flukonazol accept once 150 mg irrespective of food.

Use of several sets of drug for treatment of diseases, sexually transmitted is possible. The doctor selects the number of receptions of Ginekit and the scheme of treatment individually.

The recommended scheme of treatment of a mikst-infection if in structure there is Chlamidia: Ginekit's reception in the 1-, 2-, 7-, 14-, 21 day.

The recommended scheme of treatment of a mikst-infection as a part of which there is no Chlamidia (Micoplasma/Ureaplasma urealiticum/Trichomonas vaginalis, etc. are allocated): reception of Ginekit in the 1-, 3-, 5-, 7-, 14 day.

Features of use:

Before an initiation of treatment Ginekit needs to be made crops and to define sensitivity of microflora to drugs which are a part of this set.

Patients with infectious uretrita and tservitsita before an initiation of treatment with Ginekit have to pass the corresponding serological tests concerning syphilis.

Ginekit's use is not recommended during pregnancy, especially in its first trimester.

Ginekit it is not recommended for use for mothers who feed груддю. In case of need uses of set during a lactation, feedings of the child during treatment it has to be stopped.

Ginekit's uses for children and teenagers given relatively are absent therefore his use at these categories of patients is not recommended.

Considering that at sensitive patients at Ginekit's use can arise drowsiness, the lack of coordination of movements, for the period of administration of drug is better to refrain from control of vehicles and mechanisms, performance of other works which demand concentration of attention.

It is impossible to apply alcoholic beverages during treatment through reliability of development of nervous breakdowns and abnormal liver functions.

Side effects:

At the recommended use mode side reactions arise seldom and have preferential allergic character (skin rash, a Quincke's disease, an eosinophilia).

From other side reactions at sensitive patients can note digestion disturbances, metal smack in a mouth, nausea, vomiting, diarrhea, a lock, a meteorism, an abdominal pain, a melena, a glossitis, stomatitis, cholestatic jaundice and other abnormal liver functions, a stethalgia, heartbeat, weakness, a headache, dizziness, drowsiness, a lack of coordination of movements, an ataxy, paresthesia, polyneuropathy, nephrite, a vaginitis, a leukopenia, a neutropenia or a neutrophilia, thrombocytopenia (at persons with the weakened immunity), pseudomembranous colitis, an alopecia.

Interaction with other medicines:

When using set it is necessary to remember interaction of the drugs which are its part with other medicines, in particular: the antiacid drugs containing a hydroxide of aluminum and magnesium; a levodopa, tricyclic antidepressants, MAO inhibitors, fluoxetine, peroral hypoglycemic drugs — sulphonylurea derivatives, anticoagulants of a coumarinic row, cyclosporine, rifampicin, a hydrochlorothiazide, Phenytoinum, theophylline, terfenadiny.

So, the antiacid drugs containing a hydroxide of aluminum and magnesium reduce azithromycin absorption.

Seknidazol increases effects of a levodopa. At simultaneous use of a seknidazol with tricyclic antidepressants, MAO inhibitors and fluoxetine there can be toxic reactions — a hyperthermia, muscle tension, a myoclonus, coma.

Flukonazol increases effect of peroral hypoglycemic drugs (sulphonylurea derivatives), anticoagulants of a coumarinic row, allocation with urine of cyclosporine and rifampicin. At simultaneous use with a hydrochlorothiazide concentration of a flukonazol increases by 40%. Flukonazol increases concentration in a blood plasma of Phenytoinum and theophylline.
Simultaneous use with terfenadiny can lead to serious violations of a heart rhythm.

Contraindications:

Hypersensitivity to azithromycin, a seknidazol, a flukonazol and other derivatives of a nitroimidazole, azoles, antibiotics macroleads, and also to any of the excipients which are a part of tablets.

Pathological changes from a blood count (including in the anamnesis), heavy abnormal liver functions, organic diseases of TsNS (an active stage), the period of pregnancy and feeding of a breast (for the period of treatment feeding is stopped).

Overdose:

At the correct mode of use cases of overdose were not registered.

Storage conditions:

To store in the place, unavailable to children, dry, at a temperature not above 30 degrees Celsius.

Issue conditions:

According to the recipe

Packaging:

On 4 tablets in a strip, on 1 strip in separate external packaging, on 5 separate packagings in a cardboard box.