Trichopolum

General characteristics. Structure:

Active agent: metronidazole of 250 mg

Other ingredients: potato starch, gelatin, starch syrup, magnesium stearate.

Active agent: metronidazole of 500 mg

Other ingredients: cellulose microcrystallic, povidone, кросповидон, stearic acid, silicon dioxide colloid anhydrous.

Pharmacological properties:

Pharmacodynamics. Metronidazole belongs to derivatives of a nitro-5-imidazole and possesses a broad spectrum of activity. Are sensitive to drug: Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp., Prevotella spp., Veilonella. Metronidazole slows down development of protozoa — Trichomonas vaginalis, Giardia intestinalis (Lamblia intestinalis), Entamoebahistolytica.
Are changeably sensitive to drug: Bifidobacterium spp., Eubacterium spp. Strains of microorganisms are insensitive: Propionibacterium, Actinomyces, Mobiluncus.

Pharmacokinetics. After vaginal introduction system penetration is minimum. T½ makes 8–10 h. Linkng with proteins of a blood plasma insignificant (<20%). The Bystry and expressed diffusion in lungs, kidneys, a liver, bile, SMZh, skin, saliva and a vaginal secret. Gets through a placental barrier and into breast milk. Metabolism happens mainly in a liver: are formed 2 not conjugated oxidized active a metabolite (5–30% of activity).
Excretion — preferential kidneys: 35–65% of the accepted dose are removed with urine in the form of metronidazole and its oxidized metabolites.

Indications to use:

Mecotic vaginitis; nonspecific vaginitis.

Route of administration and doses:

Drug is used only at adults.
Mecotic vaginitis. To appoint on 1 vaginal tablet of 1 times a day within 10 days. Before introduction to a vagina the tablet should be moistened slightly in the cooled boiled water. Treatment needs to be carried out with concomitant oral administration of the tablets Trichopolum. It is not necessary to stop treatment in the period of periods.
Nonspecific vaginita. To enter 1 vaginal tablet deeply into a vagina of 1 times a day within 7 days. If necessary it is possible to appoint the tablets Trichopolum orally.
Simultaneous treatment of the sexual partner of the patient, even in the absence of infection symptoms at it is recommended.
The maximum duration of treatment should not exceed 10 days, quantity of courses of treatment — 2–3 in a year.

Features of use:

Prolonged use of drug demands laboratory control of blood. If at the patient the leukopenia develops, it is important to estimate carefully a ratio of the expected advantage of continuation of treatment and possible risk. It is necessary to remember risk of deterioration in the neurologic status at patients with a serious, chronic or acute neurologic illness at treatment by metronidazole.
Patients with the permanent or progressing neyropatiya should appoint Trichopolum very carefully.
It is necessary to stop treatment at emergence of an ataxy, dizziness, hallucinations and at deterioration in the neurologic status of the patient. Metronidazole is capable to immobilize treponemas that leads to the false positive test of Nelson.
Drug should be used with care at patients with hepatic encephalopathy. At patients with hepatic encephalopathy the dose needs to be lowered on a third and it is possible to apply 1 time a day. At patients to whom carry out a hemodialysis metronidazole and its metabolites are removed during 8 h carrying out a hemodialysis therefore metronidazole should be accepted at once after carrying out a hemodialysis. Patients have no need for change of a dose with a renal failure by which carry out peritoneal dialysis.
There is a possibility of a persistirovaniye of a gonococcal infection after elimination of a mecotic infection.
During treatment by metronidazole it is necessary to avoid alcohol intake as developing of tachycardia, vomiting, feeling of heat is possible.
At use of a vaginal tablet along with use of condom or a vaginal diaphragm the risk of a rupture of latex can increase.
Use during pregnancy and feeding by a breast
Use in the I trimester of pregnancy and during feeding by a breast contraindicated.
Children. Drug is used only at adults.

Side effects:

From blood: agranulocytosis, neutropenia and thrombocytopenia, pancytopenia, leukopenia.
From mentality: mental disorders, including confusion of consciousness, the suppressed mood.
From a nervous system: an ataxy, drowsiness, a headache, spasms, dizziness, encephalopathy (for example confusion of consciousness, the increased body temperature, hypersensitivity to light, a wryneck, hallucinations, paralysis, visual disturbances and the movements); aseptic meningitis.
From an organ of sight: temporary vision disorders, such as diplomiya, myopia, decrease in visual acuity, change in perception of flowers, optical neuropathy / neuritis.
From a musculoskeletal system and connecting fabric: mialgiya, arthralgia.
From a GIT: pain in epigastriums, nausea, vomiting, diarrhea, an inflammation of a mucous membrane of an oral cavity (a glossitis with dryness in a mouth, stomatitis, a coated tongue), flavoring frustration, anorexia, isolated cases of pancreatitis which have reversible character.
From a liver: hepatitis of the mixed etiology and defeat of cells of a liver, sometimes with jaundice; it was reported about cases of a liver failure which demanded transplantation of a liver from the patients treated by metronidazole and other antibiotics.
From skin and its derivatives: rash, an itch, a dermahemia, urticaria, fever, a Quincke's disease, an acute anaphylaxis, pustular rash, inflows with a hyperemia, a multiformny erythema.
Other side reactions: hyperthermia.
During treatment urine can get red-brown coloring that is caused by presence of soluble pigments in water which are a metronidazole metabolism product.

Interaction with other medicines:

Disulfiramum: it was reported about cases of mental reactions (a delirium, confusion of consciousness) at the patients who were at the same time accepting metronidazole and Disulfiramum.
Alcohol: it is not necessary to take alcoholic beverages and to accept the drugs containing alcohol during treatment and during at least 1 more day after its termination because of possible emergence of disulfiramopodobny reaction (a hyperemia, vomiting, tachycardia).
Peroral therapy by anticoagulants (warfarin): strengthening of anticoagulating action and the increased risk of bleedings caused by decrease in a hepatic catabolism. In case of simultaneous use the thicket should control a prothrombin time and to adjust anticoagulating therapy at treatment by metronidazole.
Lithium: lithium level in a blood plasma at reception of metronidazole can increase. It is necessary to control concentration of lithium in a blood plasma, creatinine and electrolytes at the patients accepting lithium and metronidazole at the same time.
Cyclosporine: risk of increase in level of cyclosporine in a blood plasma. If drugs need to be accepted at the same time, it is necessary to control levels of cyclosporine and creatinine carefully.
Phenytoinum or phenobarbital: causes decrease in level of metronidazole in a blood plasma.
Fluorouratsil: decrease in clearance of a fluorouratsil causes increase in its toxicity.
Busulfan: metronidazole can increase levels of a busulfan in a blood plasma that it is capable to lead to considerable toxic influence of a busulfan.
Change of the international normalized relation (INR): at the patients receiving antibacterial therapy numerous cases of increase in activity of peroral anticoagulants were registered. At the same time existence of infections or the expressed inflammation, age and the general state of health acts as the risk factors causing tendency to such complication. Under these circumstances it is difficult to define as far as disturbance of balance of MNO is influenced by an infection or its treatment. However some classes of antibiotics play at the same time a large role, in particular: ftorkhinolona, macroleads, tsiklina, тримоксазол and some cephalosporins.

Contraindications:

Hypersensitivity to metronidazole or to other components of drug, the I trimester of pregnancy, the feeding period a breast. Hypersensitivity to imidazole derivatives. It is not recommended to appoint this medicine in a combination with Disulfiramum or to accept along with alcohol (see INTERACTIONS).

Overdose:

The leukopenia, neuropathy, ataxy, vomiting can be noted. As the specific antidote of metronidazole is unknown, it is recommended to perform symptomatic therapy.

Storage conditions:

At a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

Tab. of 250 mg, No. 20.
Tab. vaginal. 500 mg, No. 10.