Metronidazole-Altpharm - instructions for use, dose, side effects, contraindications

Antiprotozoal and antibacterial drug, refers to the derivatives of 5-nitroimidazole. The mechanism of action 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 reacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

Metronidazole active against protozoa: Trichomonas vaginalis, Entamoeba histolytica, as well as against gram-negative anaerobes: Bacteroides spp. (B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp., and some Gram-positive anaerobes Clostridium spp., Peptostreptococcus spp., Peptococcus spp., sensitive strains Eubacterium.

The minimum limit concentration (MIC) for these strains is 0.125-6.25 μg / ml.

To Metronidazole insensitive aerobic microorganisms and facultative anaerobes, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against conventional aerobes.

Pharmacokinetics:

Suction: After intravaginal administration metronidazole is subject to systemic absorption (about 56%).

Distribution: 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%.

Metabolism: Metabolized in the liver by hydroxylation, oxidation and glucuronation. Activity of the main metabolite (2-hydroxymethonidazole) - 30% of the activity of the starting compound.

Excretion: It is excreted by the kidneys - 60-80% of the dose of the systemic action drug (20% of this quantity in the unchanged form), the intestine - 6-15% of the dose of the systemic action drug.

Indications:

Urogenital trichomoniasis (including urethritis, vaginitis), nonspecific vaginitis of various etiologies, confirmed by clinical and microbiological data.

Contraindications:

Hypersensitivity to metronidazole or other nitroimidazole derivatives; leukopenia, impaired coordination of movements, organic lesions of the central nervous system (including epilepsy), liver failure (in the case of high doses), pregnancy, the period of breastfeeding.

Carefully:Leukopenia in the anamnesis.

Pregnancy and lactation:

Do not use (see section "Contraindications").

Dosing and Administration:

The drug is used intravaginally, i.e. injected into the vagina.

The suppository is inserted into the vagina with a pointed end, as far as possible deeper.

For the treatment of trichomonas vaginitis apply a suppository at a dose of 250 mg twice a day (morning and evening) or 1 suppository at a dose of 500 mg once a day for 10 days.

For the treatment of nonspecific vaginitis apply 1 suppository in a dose of 500 mg twice a day for 7 days.

During the course of treatment, sexual intercourse should be avoided.

Side effects:

Often - 1-10%; infrequently, 0.1-1%; rarely - 0,01-0,1%; very rarely - less than 0.01%, including individual cases.

Local reactions: infrequently - vulvitis (itching, burning pain or hyperemia of the mucous membrane in the region of the external genitalia); thick, white mucous discharge from the vagina without smell or with a faint smell; sensation of burning or irritation of the penis in the sexual partner;

Allergic reactions: infrequently - hives, itching, rash;

From the urinary system: rarely - frequent urination; In rare cases, the color of urine can be observed in the red-brown color, due to the presence of a water-soluble pigment,formed as a result of metronidazole metabolism.

From the gastrointestinal tract: infrequently - a change in taste sensations, including a "metallic" aftertaste, a decrease in appetite; rarely - nausea, vomiting, spastic pain in the abdominal cavity; often - constipation or diarrhea, dryness of the oral mucosa;

From the nervous system: rarely - dizziness, headache;

On the part of the organs of hematopoiesis and the system of hemostasis: very rarely - leukopenia or leukocytosis.

After cancellation of the drug, the development of candidiasis of the vagina is possible.

Overdose:

Symptoms: nausea, vomiting, ataxia.

Treatment: there is no specific antidote, symptomatic and supportive therapy.

Interaction:

Compatible with sulfonamides and antibiotics.

When treating metronidazole, you should avoid drinking alcohol (causes alcohol intolerance).

Do not combine metronidazole with disulfiram, since the interaction of these drugs may inhibit the consciousness, the development of neurological symptoms. Do not assign metronidazole patients who took disulfiram in the last two weeks.

When used concomitantly with warfarin and other indirect anticoagulants metronidazole intensifies their action, which leads to an increase in prothrombin time.

It is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide).

Under the influence of barbiturates, the effect of metronidazole may decrease, since its inactivation in the liver is accelerated.

Cimetidine depresses the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and an increased risk of side effects.

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

Special instructions:

Treatment with metronidazole should not last more than 10 days and should be repeated more than 2-3 times a year.

Simultaneous treatment of sexual partners is recommended.

When treating trichomonas vaginitis in women and trichomoniasis in men, it is necessary to abstain from sexual intercourse.

With vaginitis caused by Trichomonas vaginalis, it is advisable to simultaneously treat the sexual partner metronidazole for oral administration.

In the case of using the drug in conjunction with metronidazole for oral administration, especially in the second course, control of the picture of peripheral blood (danger of leukopenia) is necessary.With leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.

During the period of treatment, alcohol intake is contraindicated (development of disulfiram-like reactions is possible: spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face).

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, as the drug may cause dizziness.

Form release / dosage:Vaginal suppositories, 250 mg and 500 mg.

Packaging:

There are 5 suppositories in a contiguous cell package.

2 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000852

Date of registration:24.10.2011

Expiration Date:Unlimited

The owner of the registration certificate:ALTFARM, LLC ALTFARM, LLC Russia

Manufacturer: & nbsp

ALTFARM, LLC Russia

Representation: & nbspALTFARM LLC ALTFARM LLC Russia

Information update date: & nbsp25.04.2018

Illustrated instructions

Instructions

Metronidazole-Altpharm (Metronidazole-Altpharm)