Metrogyl vaginal gel 1%, 30g with applicator

• bacterial vaginosis of various etiologies, confirmed by clinical and microbiological data;

• urogenital trichomoniasis.

Intravaginally. The recommended dose is 5 g (1 full applicator) 2 times / day (morning and evening). The course of treatment is 5 days.

Active substance:

metronidazole 10 mg

Excipients:

propyl hydroxybenzoate,

propylene glycol,

carbomer-940,

disodium edetat,

sodium hydroxide,

purified water.

• leukopenia (including history);

• impaired coordination of movements;

• organic lesions of the central nervous system (including epilepsy);

• liver failure;

• pregnancy - I trimester;

• hypersensitivity (including to nitroimidazole derivatives).

Dosage form:

Vaginal gel 10 mg / 1 g: tube 30 g 1 pc. in set with applicator

Description : Homogeneous vaginal gel , from colorless to light yellow.

Composition:

Active substance:

metronidazole 10 mg

Excipients:

propyl hydroxybenzoate,

propylene glycol,

carbomer-940,

disodium edetat,

sodium hydroxide,

purified water.

Clinical and pharmacological group: Drug with antiprotozoal and antibacterial action for local use in gynecology

Pharmaco-therapeutic group: Antimicrobial and antiprotozoal agent

pharmachologic effect

Metronidazole is highly active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, as well as the obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides viilgatus), Fusobacterium spp., Veillonela spp., Prevotella (P. bivia, P. buccae, P..dismpositive microorganisms. and P..dismpositive microorganisms. Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp., Mobiluncus spp.). The minimum inhibitory concentration for these strains is 0.125Ц6.25 µg / ml.

The mechanism of action of Metrogyl 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 bacteria.

Pharmacokinetics

After a single intravaginal injection of 5 g of Metrogyl, the average Cmax of the drug in serum is 237 ng / ml, which is 2% of the average Cmax of metronidazole when taken orally at a dose of 500 mg. The time to reach Cmax is 6-12 hours after intravaginal administration of a single dose of 5 g and 1-3 hours after oral administration of metronidazole at a dose of 500 mg.

After intravaginal administration, the drug undergoes systemic absorption (about 56%). It penetrates into breast milk and most tissues, passes through the blood-brain barrier and the placenta. Plasma protein binding 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.

The relative bioavailability of the vaginal gel is 2 times higher than the bioavailability of a single dose (500 mg) of vaginal metronidazole tablets, which is due to the high penetration of the drug into the vaginal fluid. Therefore, the therapeutic effect after intravaginal administration is achieved even at low concentrations of metronidazole.

It is excreted by the kidneys - 60-80% of the dose of the systemic drug (20% - unchanged), by the intestines - 6-15% of the dose of the systemic drug.

Indications:

• bacterial vaginosis of various etiologies, confirmed by clinical and microbiological data;

• urogenital trichomoniasis.

Dosage regimen

Intravaginally. The recommended dose is 5 g (1 full applicator) 2 times / day (morning and evening). The course of treatment is 5 days.

Side effect

Local reactions: burning sensation or frequent urination, vulvitis; a sexual partner - a burning sensation or irritation of the penis. After discontinuation of the drug - the development of vaginal candidiasis.

Systemic effects may develop: dizziness, headache, dry mouth, changes in taste, including metallic taste, nausea, vomiting, loss of appetite, spastic abdominal pain, constipation or diarrhea, dark urine staining, leukopenia or leukocytosis.

Allergic reactions: skin rash, urticaria.

In case of any unwanted side effects, it is necessary to stop treatment and consult a doctor.

Contraindications for use

• leukopenia (including history);

• impaired coordination of movements;

• organic lesions of the central nervous system (including epilepsy);

• liver failure;

• pregnancy - I trimester;

• hypersensitivity (including to nitroimidazole derivatives).

Application during pregnancy and lactation

It is possible to use the drug in the II and III trimesters of pregnancy. When prescribing the drug during lactation, it is recommended to stop breastfeeding.

Application for violations of liver function

Contraindicated in liver failure.

special instructions

During the period of treatment, alcohol intake is contraindicated (a disulfiram-like reaction may develop: spastic abdominal pain, nausea, vomiting, headache, sudden flushing of the face).

MetrogylЃ can immobilize treponemas and lead to a false positive Nelson's test.

During the course of treatment, it is necessary to abstain from sexual activity.

Avoid contact with eyes.

Overdose

There were no cases of drug overdose when prescribed in recommended doses.

Drug interactions

Similar to disulfiram, it causes intolerance to ethanol.

Enhances the action of indirect aitncoagulants, it is not recommended to combine it with non-depolarizing muscle relaxants (vecuronium).

When taken simultaneously with lithium preparations, the concentration of lithium in the blood plasma may increase.

Phenobarbital accelerates the metabolism of metronidazole due to the induction of microsomal liver enzymes, cimetidine - reduces.

Storage conditions

List B. Store at a temperature not exceeding 25 ? C in places inaccessible to children.

Shelf life

Shelf life is 2 years.

Do not use beyond the expiration date stated on the label.

Terms of sale

The drug is available with a prescription.