METROGYL VAGINAL GEL 1% 30G

Release form, composition and packaging

 Vaginal gel 10 mg / 1 g: tube 30 g in set. with applicator
Reg. №: RK-LS-5-№ 004084 from 04/13/2011 - Current 

Vaginal gel colorless to pale yellow, uniform.

Description of the drugMETROGIL® vaginal gelbased on officially approved instructions for use of the drug and made in 2006.

pharmachologic effect

Drug with antiprotozoan and antibacterial action for local use in gynecology.

Possesseshigh activity towards anaerobes (Bacteroides spp., Fusobacter spp., Clostridium spp., anaerobic cocci), Trichomonas vaginalis, Entamoeba histolytica, Giardia.Active against most bacterial vaginosis microorganism strains: Gardnerella vaginalis, Bacteroides spp., Mobiluncus spp., Peptostreptococcus spp. Aerobic microorganisms are not sensitive to Metronidazole. The mechanism of action is the biochemical reduction of the 5-nitro group of metronidazole with intracellular transport proteins of anaerobic microorganisms and protozoa. The recovered 5-nitro group interacts with the DNA of microbial cells, inhibiting the synthesis of nucleic acids, which leads to the death of bacteria.

Pharmacokinetics

After a single intravaginal administration of Metrogyl vaginal gel at a dose of 5 g Cmax in the serum of healthy women is reached in 6-12 h and amounts to 237 ng / ml (2% of the average Cmax when taking metronidazole orally at a dose of 500 mg).The relative bioavailability of the vaginal gel is 2 times higher than the bioavailability of vaginal pills (with a single dose of 500 mg), due to the high penetrating ability of the drug in the vaginal fluid. Therefore, the therapeutic effect of the use of vaginal gel is achieved at low concentrations of metronidazole, which leads to a decrease in the number of side effects during the course of therapy.

Indications for use

- bacterial vaginosis of various etiologies, confirmed clinically and microbiologically.

Dosage and administration

The recommended dose is 5 g (one full applicator) 2 times / day (morning and evening). The course of therapy is 5 days.

The patient should be warned about the need to avoid sexual intercourse during treatment.

Side effect

From the reproductive system: symptomatic candidal cervicitis, vaginitis, itching and burning of the vagina and vulva; vaginal discharge, swelling of the vulva.

Gastrointestinal: metallic taste in the mouth, nausea, loss of appetite, cramped abdominal pain (including in the lower part), diarrhea, constipation.

From the side of the central nervous system: headache, dizziness.

Hemic and lymphatic: leukopenia, leukocytosis.

Other: increased urination, allergic reactions in the form of a skin rash.

Contraindications

- Hypersensitivity to other nitroimidazole derivatives;

- hypersensitivity and individual intolerance to metronidazole and other components of the drug.

Carefully used in patients with severe diseases of the central nervous system, liver and hematopoietic system.

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is not recommended and is possible only for health reasons and after careful assessment of the intended benefits to the mother and the potential risk to the fetus or child.

Application for violations of the liver

No data.

Application for violations of kidney function

No data.

special instructions

Against the background of the use of the drug should avoid alcohol.

Overdose

Cases of overdose of the drug Metrogyl vaginal gel when used according to indications and in recommended doses are not described.

Drug interaction

When using the drug Metrogyl vaginal gel, according to the indications and recommended doses, interaction with other drugs is unlikely.

It should be borne in mind that when combined, metronidazole enhances the effect of indirect anticoagulants, which leads to an increase in prothrombin time.

The simultaneous use of metronidazole with disulfiram can lead to the development of neurological symptoms (this combination is not recommended, and Metrogyl should not be prescribed to patients who received disulfiram during the last 2 weeks).

When combined, cimetidine inhibits the metabolism of metronidazole, which leads to an increase in the concentration of metronidazole in the blood serum and increases the risk of side effects.

Pharmacy sales terms

Terms and conditions of storage

The drug should be stored out of reach of children at a temperature not exceeding 25 ° C. Shelf life - 2 years.