Pharmacological properties

Metronidazole belongs to nitro-5-imidazoles and has a wide spectrum of action. Sensitive to the drug: Peptostreptococcusspp., Clostridiumspp., Bacteroidesspp., Fusobacteriumspp., Prevotellaspp., Veilonella. Metronidazole delays the development of protozoa – Trichomonasvaginalis, Giardia intestinalis (Lambliaintestinalis), Entamoebahistolytica. The drug is intermittently sensitive: Bifidobacterium spp., Eubacterium spp. Microorganism insensitive strains: Propionibacterium, Actinomyces, Mobiluncus.

Pharmacokinetics

When used for local treatment in the form of vaginal suppositories, the systemic absorption of the drug is minimal.

Indications for use

Topical treatment of trichomonas vaginitis, bacterial vaginosis and non-specific vaginitis caused by microorganisms sensitive to metronidazole.

Dosage and administration

The drug is allowed to be used to treat only adult patients.

Metronidazole, vaginal suppositories, are usually used with metronidazole in tablet form.

Trichomonas vaginitis. Assign 1 vaginal suppository 1 time per day for 10 days. The suppository is injected deep into the vagina. Treatment should be carried out with the simultaneous oral administration of metronidazole tablets: 1 tablet (250 mg) twice a day for 10 days.

Nonspecific vaginitis. 1 vaginal suppository is administered deep into the vagina 1 time per day for 7 days.

The maximum duration of treatment should not exceed 10 days, and the number of courses of treatment should not exceed 3 per year.

The method of application of suppositories.

Suppositories are administered intravaginally. Suppositories should not be cut into parts, since such changes can lead to a violation of the distribution of the active substance.

Side effects

Gastrointestinal disorders: epigastric pain, nausea, vomiting, diarrhea, inflammation of the oral mucosa, taste disorders, anorexia, exceptional cases of pancreatitis, which are reversible.

Changes in skin condition: rash, itching, redness, urticaria, fever, angioedema; very rarely – exceptional cases of anaphylactic shock; in isolated cases – a pustular rash.

Disorders from the central and peripheral nervous system: peripheral sensory neuropathy, headache, cramps, dizziness, very rarely – cases of encephalopathy (for example, confusion) and subacute cerebellar syndrome (for example, ataxia, dysarthria, impaired gait, nystagmus, tremor), which may occur after discontinuation of the drug.

Mental disorders: psychotic disorders, including confusion, hallucinations.

Visual impairment: temporary visual impairment, such as diplopia, myopia.

Hematology: in isolated cases – agranulocytosis, neutropenia and thrombocytopenia.

Violation of liver function: in isolated cases – a deviation from the norm tests of liver function, which are reversible, cholestatic hepatitis.

During treatment, urine may acquire a red-brown color, which is due to the presence of water-soluble pigments, which are a product of metronidazole metabolism.

Contraindications

Hypersensitivity to metronidazole or other nitroimidazole derivatives; blood diseases, leukopenia (including a history); impaired coordination of movements, diseases of the central nervous system (including epilepsy); liver failure (when prescribing large doses); pregnancy (I trimester), lactation, children under 18 years of age.

Precautions: pregnancy (II-III trimesters).

Drug interactions

When used simultaneously with indirect anticoagulants (e.g. warfarin), metronidazole enhances their action, which leads to an increase in prothrombin time. It is not recommended to combine with non-depolarizing muscle relaxants (for example, vecuronium bromide).

Like disulfiram, it causes intolerance to ethanol.

The simultaneous use of metronidazole with disulfiram can lead to the development of various neurological syndromes (depression of consciousness, the development of mental disorders).

Under the influence of barbiturates (for example, phenobarbital), the effectiveness of metronidazole decreases due to the acceleration of its inactivation in the liver.

With simultaneous use with cimetidine, serum metronidazole levels may increase and the risk of adverse reactions increases.

With simultaneous administration with lithium preparations, the concentration of the latter in plasma may increase.

Special instructions

Use in individuals with impaired liver function:

With caution is prescribed for liver diseases.

Use in pediatrics: The drug is contraindicated in children.

Pregnant and lactating women: In the first trimester of pregnancy and during lactation, the drug is contraindicated.

In the second and third trimesters of pregnancy, the drug can be used only if the expected benefit to the mother outweighs the potential risk to the fetus and under the supervision of a doctor.

Influence on the ability to drive a car or machinery: the attention of drivers of vehicles and persons driving other potentially dangerous machinery should be drawn to the possibility of dizziness associated with the use of the drug.

The drug should not be used after the expiration date and should be stored out of the reach of children.

Overdose

Symptoms: leukopenia, neuropathy, ataxia, vomiting.

Since the specific antidote of metronidazole is not known, symptomatic therapy is recommended.

Release form

Vaginal suppositories of 250 mg or 500 mg.

5 suppositories in blister strip packaging. 2 blister strip packaging along with instructions for use in a cardboard box.

Storage conditions

Store in a dry, dark place at a temperature of no higher than 25 ° C.

Do not freeze.

Shelf life

3 years.

Conditions of release from pharmacies

On prescription