Trichopol vaginal tablets 500mg, No. 10

Local treatment of Trichomonas and nonspecific vaginitis, bacterial vaginosis.

Intravaginal in adults.
Trichomonas vaginitis:
1 vaginal tablet per day for 7-10 days in combination with taking the drug metronidazole tablets.
Nonspecific vaginitis, bacterial vaginosis:
1 vaginal tablet per day for 7 days, if necessary in combination with taking the drug metronidazole tablets.
Metronidazole treatment should not last more than 10 days and be repeated more often than 2 to 3 times a year.
Having previously freed the tablet from the contour packaging using scissors (cut the film along the contour of the tablet), moisten the tablet with boiled chilled water and insert it deep into the vagina.

1 tablet contains:
Active ingredient: metronidazole 500 mg
Excipients: microcrystalline cellulose, povidone, crospovidone, colloidal silicon dioxide, stearic acid.

• Hypersensitivity to metronidazole or other nitroimidazole derivatives;

• blood diseases, leukopenia (including a history);

• impaired coordination of movements, organic lesions of the central nervous system (including epilepsy);

• hepatic impairment (in the case of large doses),

• pregnancy (I trimester), lactation period.

With care: pregnancy (II - III trimesters), history of leukopenia.

Trade name of the drug:

TrichopolЃ

International non-proprietary name:

metronidazole

Dosage form:

vaginal pills

Composition:

1 tablet contains:
Active ingredient: metronidazole 500 mg
Excipients: microcrystalline cellulose, povidone, crospovidone, colloidal silicon dioxide, stearic acid.

Description: oblong, biconvex tablets, white with a yellowish sheen.

Pharmacotherapeutic group:

antimicrobial and antiprotozoal agent.

MS code: G01AF01

Pharmacological properties
Pharmacodynamics
Metronidazole belongs to 5-nitroimidazoles and is a DNA-tropic drug with a bactericidal type of action.
The mechanism of action of metronidazole is the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with the DNA of the cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.
Metronidazole is an effective broad-spectrum antimicrobial and antiprotozoal agent.
The drug is highly active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., As well as obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella (Prevotella bivia, Prevotella. spp., Peptococcus spp., Peptostreptococcus spp., Mobiluncus spp.)

Pharmacokinetics
After intravaginal administration, metronidazole in the form of tablets undergoes systemic absorption (about 56%).
It penetrates into breast milk and most tissues, passes through the blood-brain barrier and the placenta.
The connection with plasma proteins is less than 20%.
It is metabolized in the liver by hydroxylation, oxidation and glucuronidation. The activity of the main metabolite (2-oxymetronidazole) is 30% of the activity of the parent compound. TCmax is 6 - 12 hours.
It is excreted by 40-70% (about 20% in unchanged form) through the kidneys.

Indications for use

Local treatment of Trichomonas and nonspecific vaginitis, bacterial vaginosis.

Contraindications

• Hypersensitivity to metronidazole or other nitroimidazole derivatives;

• blood diseases, leukopenia (including a history);

• impaired coordination of movements, organic lesions of the central nervous system (including epilepsy);

• hepatic impairment (in the case of large doses),

• pregnancy (I trimester), lactation period.

With care: pregnancy (II - III trimesters), history of leukopenia.

Application during pregnancy and lactation
Metronidazole crosses the placenta, therefore, the drug should not be prescribed in the first trimester of pregnancy, in the future it should be used only if the potential benefit from using the drug in the mother outweighs the possible risk to the fetus.
Metronidazole passes into breast milk. Breastfeeding during the period of taking the drug should be canceled. Breastfeeding should be resumed no earlier than 48 hours after the end of the drug.

Method of administration and dosage

Intravaginal in adults.
Trichomonas vaginitis:
1 vaginal tablet per day for 7-10 days in combination with taking the drug metronidazole tablets.
Nonspecific vaginitis, bacterial vaginosis:
1 vaginal tablet per day for 7 days, if necessary in combination with taking the drug metronidazole tablets.
Metronidazole treatment should not last more than 10 days and be repeated more often than 2 to 3 times a year.
Having previously freed the tablet from the contour packaging using scissors (cut the film along the contour of the tablet), moisten the tablet with boiled chilled water and insert it deep into the vagina.

Side effect

When used topically, the following side effects may occur:

• itching, burning, pain, and irritation in the vagina; thick, white, mucous vaginal discharge, odorless or faint, frequent urination; after discontinuation of the drug - the development of vaginal candidiasis;

• a burning sensation or irritation of the penis in a sexual partner;

• from the gastrointestinal tract: nausea, change in taste, metallic taste in the mouth, dry mouth, decreased appetite, cramping abdominal pain, nausea, vomiting, constipation or diarrhea;

• allergic reactions: urticaria, itching of the skin, rash;

• headache, dizziness;

• leukopenia or leukocytosis;

In rare cases, urine may turn reddish-brown due to the presence of a water-soluble pigment resulting from the metabolism of metronidazole.

Interaction with other medicinal products

Compatible with sulfonamides and antibiotics. When treating with metronidazole, alcohol should be avoided (similar to disulfiram, it causes alcohol intolerance). You should not combine metronidazole with disulfiram, since the interaction of these drugs may lead to depression of consciousness, the development of mental disorders.
When used simultaneously with warfarin and other indirect anticoagulants, metronidazole enhances their effect, which leads to an increase in prothrombin time. It is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide).
Under the influence of barbiturates, a decrease in the effect of metronidazole is possible, since its inactivation in the liver is accelerated.
Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and an increased risk of adverse reactions. When taken simultaneously with lithium preparations, the concentration of the latter in plasma may increase.

Special instructions
In the case of trichomoniasis, simultaneous treatment of the sexual partner with the drug is recommended, regardless of whether he has manifestations of the disease.
During the period of drug treatment, it is recommended to refrain from sexual intercourse.
If there is a history of changes in the composition of peripheral blood, as well as when using the drug in high doses and / or with its long-term use, it is necessary to control the general blood test.
Metronidazole can immobilize treponemas, resulting in a false positive TPI test (Nelson's test).
The attention of patients, especially drivers of vehicles and persons operating other mechanisms, should be drawn to the possibility of dizziness associated with taking the drug.

Release form:

Vaginal tablets 500 mg.
5 or 10 tablets in PVC / Al foil blister. 1 or 2 blisters, together with instructions for medical use, are placed in a cardboard box.

Storage conditions
In a dry, dark place at temperatures below 25 ? C. Keep out of the reach of children.

Shelf life is 3 years.
Do not use after the expiration date printed on the package.

Terms of dispensing from pharmacies On prescription.