Metrovit (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

G01AF01 (Metronidazole)

Active Substance

Metronidazole (Rec.INN registered by WHO)

Dosage Form

Metrovit

Vaginal suppositories 500 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

5 pcs. – blisters (1) – carton packs.
5 pcs. – blisters (2) – carton packs.

Clinical-Pharmacological Group

A drug with antiprotozoal and antibacterial action for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial and antiprotozoal agent

Pharmacological Action

An antiprotozoal agent with antibacterial activity for topical use in gynecology. It belongs to nitro-5-imidazoles. The mechanism of action of metronidazole involves 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 microorganism cell, inhibiting the synthesis of their nucleic acids, which leads to the death of the microorganisms.

Metronidazole is an effective broad-spectrum antimicrobial and antiprotozoal agent. It exhibits high activity against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., as well as against obligate anaerobes – Bacteroides spp. (Bacteroides fragilis, Bacteroides ovatus, Bacteroides distasonis, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella disiens) and some gram-positive microorganisms (Clostridium spp., Peptostreptococcus spp., Peptococcus spp, Eubacterium spp., Mobiluncus spp.).

Pharmacokinetics

Metronidazole is well absorbed upon intravaginal application. It is biotransformed in the liver. It is 40-70% excreted by the kidneys (about 20% unchanged).

Indications

For the treatment of nonspecific vaginitis; bacterial vaginosis; trichomonal vaginitis.

ICD codes

Dosage Regimen

Administer one 500 mg vaginal suppository intravaginally, once daily, preferably at bedtime.

For the treatment of bacterial vaginosis, the typical course is 5 to 7 days.

For the treatment of trichomonal vaginitis, the typical course is 10 days.

Complete the full prescribed course of treatment, even if symptoms improve earlier.

Insert the suppository high into the vagina while lying on your back with knees bent.

Wash hands thoroughly before and after administration.

Concurrently treat the sexual partner with an appropriate systemic metronidazole regimen to prevent reinfection.

Abstain from sexual intercourse for the duration of the treatment.

During menstruation, continue treatment without interruption.

If symptoms persist after completing the course, consult a physician for reevaluation.

Adverse Reactions

Local reactions itching, burning, pain and irritation in the vagina; thick, white, mucous vaginal discharge (odorless or with a faint odor); frequent urination; after drug withdrawal – development of vaginal candidiasis.

From the digestive system nausea, altered taste sensations, metallic taste in the mouth, dry mouth, decreased appetite, cramping abdominal pain, nausea, vomiting, constipation or diarrhea.

From the CNS headache, dizziness.

From the hematopoietic system leukopenia or leukocytosis.

Allergic reactions urticaria, skin itching, rash.

Other rarely – red-brown discoloration of urine due to the presence of a water-soluble pigment formed as a result of metronidazole metabolism; burning sensation or irritation of the penis in the sexual partner.

Contraindications

Hypersensitivity to metronidazole or other nitroimidazole derivatives; blood diseases; leukopenia (including history); impaired coordination of movements; organic lesions of the CNS (including epilepsy); hepatic insufficiency (for use in high doses); first trimester of pregnancy, breastfeeding.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy. Thereafter, it should be used only if the potential benefit to the mother outweighs the possible risk to the fetus.

Metronidazole is excreted in breast milk. Breastfeeding should be discontinued during the use. Breastfeeding should be resumed no earlier than 48 hours after the end of use.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency (for use in high doses).

Geriatric Use

There are no specific instructions on restrictions for use in elderly patients.

Special Precautions

Simultaneous treatment of the sexual partner with metronidazole is recommended, regardless of whether they have manifestations of the disease.

It is recommended to refrain from sexual intercourse during the treatment period.

If there is a history of changes in the peripheral blood composition, as well as when using metronidazole in high doses and/or during long-term treatment, monitoring of the complete blood count is necessary.

Metronidazole can immobilize treponemes, leading to false-positive results of the Nelson test (TPI).

Effect on the ability to drive vehicles and operate machinery

The possibility of dizziness should be taken into account when prescribing the drug to patients engaged in potentially hazardous activities (especially drivers of vehicles).

Drug Interactions

Compatible with sulfonamides and antibiotics.

Metronidazole causes ethanol intolerance, so alcohol consumption should be avoided during treatment.

Metronidazole should not be combined with disulfiram, as the interaction of these drugs may lead to depression of consciousness and the development of mental disorders.

When used concomitantly with indirect anticoagulants (including warfarin), Metronidazole enhances their effect, leading to an increase in prothrombin time.

It is not recommended to use Metronidazole in combination with non-depolarizing muscle relaxants (vecuronium bromide).

Under the influence of barbiturates, a decrease in the effectiveness of metronidazole is possible due to the acceleration of its metabolism in the liver.

Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in its plasma concentration and an increased risk of adverse reactions.

When taken concomitantly with lithium preparations, an increase in its plasma concentration is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.