Metronidazole 0.5% 100ml bottle

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Metronidazole 0.5% 100ml vial

International non-proprietary name
Metronidazole

Farmgroup

Antimicrobial agents of different groups

Composition

Active ingredient: metronidazole - 5 mg. Excipients: sodium chloride - 8 mg; sodium hydrogen phosphate dodecahydrate (disubstituted sodium phosphate 12-water) - 0.6 mg; sodium dihydrogen phosphate (sodium phosphate monosubstituted) - 0.45 mg; 1M solution of hydrochloric acid to pH 4.5-6.0; water for injection - up to 1 ml.

Theoretical osmolarity - 286.3 Osm / l.

pharmachologic effect

Metronidazole is a broad-spectrum antiprotozoal and antibacterial agent.

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

Aerobic microorganisms and facultative anaerobes are not sensitive to metronidazole, but in the presence of mixed flora (aerobic and anaerobic) metronidazole acts synergistically with antibiotics that are effective against conventional aerobes.

Pharmacokinetics

With intravenous administration of 500 mg of metronidazole for 20 minutes to patients with an anaerobic infection, the serum concentration of the drug was 35.2 μg / ml after an hour, 33.9 μg / ml after 4 hours, 25.7 μg / ml after 8 hours .

The drug has a high penetrating ability, reaching bactericidal concentrations in most tissues and body fluids, including lungs, kidneys, liver, skin, cerebrospinal fluid, brain, bile, saliva, amniotic fluid, abscesses, vaginal secretions, semen, breast milk. Binding to blood proteins is weak and does not exceed 10-20%. In normal bile formation, the concentration of metronidazole in bile after intravenous administration may significantly exceed the concentration of metronidazole in the blood plasma.

Metronidazole is eliminated by the kidneys - 63% of the dose, 20% of the drug is excreted unchanged. The half-life of metronidazole is 6-7 hours. Renal clearance is 10.2 ml / min.

In patients with impaired renal function after repeated administration of the drug, cumulation of metronidazole in serum may be observed. Therefore, in patients with severe renal insufficiency, the frequency of metronidazole should be reduced.

Indications for use

Protozoal infections: extraintestinal amebiasis, including amebic liver abscess, intestinal amebiasis (amoebic dysentery), trichomoniasis (including trichomonas vaginitis, trichomonas urethritis).

Infections caused by Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, V. thetaiotaomicron, B. vulgatus): infections of bones and joints, infections of the central nervous system, including meningitis, brain abscess, bacterial endocarditis, pneumonia, empyema, and lung abscess, sepsis.

Infections caused by Clostridium spp., Peptococcus niger and Peptostreptococcus spp .: infections of the abdominal cavity (peritonitis, liver abscess), infections of the pelvic organs (endometritis, abscess of the fallopian tubes and ovaries, infection of the vaginal fornix).

Prevention of postoperative complications (especially interventions on the colon, pararectal area, appendectomy, gynecological surgery).

Contraindications

- hypersensitivity to metronidazole or other nitroimidazole derivatives;
- organic lesions of the central nervous system (including epilepsy);
- liver failure (in the case of the use of large doses);
- leukopenia (including in history);
- I trimester of pregnancy
- lactation period.

With caution prescribed for diseases of the kidneys, liver (renal / hepatic failure).

II and III trimesters of pregnancy - only for health reasons.

Use during pregnancy and during breastfeeding

Metronidazole should not be prescribed in the first trimester of pregnancy, in the future it should be used only if the potential benefit from the use of the drug for the mother exceeds the potential risk to the fetus.

Since metronidazole penetrates into breast milk, reaching concentrations in it that are close to plasma concentrations, it is recommended to stop breastfeeding during drug treatment.

special instructions

Long-term use of the drug is preferably carried out under the control of peripheral blood.

In / in the introduction of the solution for infusion is shown in patients in whom oral administration of the drug is impossible. In case of mixed infections, the infusion solution of metronidazole can be used in combination with parenteral antibiotics, without mixing the drugs with each other.

When IV drip should not be mixed with other drugs. When using the drug may be an exacerbation of candidiasis.

The use of alcoholic beverages during the course of therapy is strictly prohibited (a disulfiram-like reaction may develop: spastic abdominal pain, nausea, vomiting, headache, a sudden rush of blood to the face).

When using the drug, a slight leukopenia may be observed, therefore it is advisable to monitor the blood picture (the number of leukocytes) at the beginning and at the end of therapy.

In case of leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.

The appearance of ataxia, dizziness, and any other deterioration in the neurological status of patients requires discontinuation of treatment.

It can immobilize treponema and lead to a false-positive Nelson test. When treating Trichomonas vaginitis in women and Trichomonas urethritis in men, it is necessary to abstain from sex. Necessarily simultaneous treatment of sexual partners. After treatment of trichomoniasis, control tests should be carried out for 3 consecutive cycles before and after menstruation.

When conducting therapy for more than 10 days - only in justified cases, with strict observation of the patient and regular monitoring of laboratory blood parameters. If a longer course of therapy is required due to the presence of chronic diseases, the ratio between the expected effect and the potential risk of complications should be carefully weighed.

Dosage and administration

Intravenous infusion.

Intravenous administration of metronidazole is indicated for severe infections, as well as in the absence of the possibility of taking the drug inside.

For adults and children over 12 years of age, a single dose is 500 mg, the rate of continuous intravenous (jet) or drip is 5 ml per minute. The interval between injections is 8 hours. The duration of treatment is determined individually. The maximum daily dose is no more than 4 g. According to indications, depending on the nature of the infection, they are switching to maintenance therapy with oral forms of metronidazole.

Children under the age of 12 years metronidazole injected 7.5 mg / kg body weight in 3 doses at a speed of 5 ml per minute.

For the prevention of anaerobic infection before planned surgery on the pelvic organs and urinary tract in adults and children over 12 years old, metronidazole is prescribed in the form of infusions at a dose of 500-1000 mg, on the day of surgery and the next day at a dose of 1500 mg / day (500 mg every 8 ocloc'k). After 1-2 days, they usually switch to maintenance therapy with oral forms of metronidazole.

For patients with severe impaired renal function (creatinine clearance less than 30 ml / min) and / or liver, the daily dose of metronidazole is 1000 mg; (multiplicity of reception 2 times).
Side effect
On the part of the gastrointestinal tract: nausea, vomiting, diarrhea, constipation, lack of appetite, unpleasant "metallic" taste in the mouth, dryness of the oral mucosa, glossitis, stomatitis; epigastric pain; cholestatic hepatitis sometimes with jaundice, increased activity of liver transaminases.

On the part of the central nervous system: with prolonged use - headache, dizziness, ataxia, peripheral sensory neuropathy, irritability, irritability, depression, sleep disturbance, weakness; confusion, hallucinations, convulsions.

On the part of the urogenital system: a burning sensation in the urethra, dysuria, cystitis, polyuria, urinary incontinence, candidiasis.

Allergic reactions: skin rash, itching, urticaria, nasal congestion, fever, angioedema, anaphylactic shock.

On the part of the skeletal system: arthralgia.

From the hematopoietic system: leukopenia.

Local reactions: thrombophlebitis (pain, hyperemia or swelling at the injection site).

Other: flattening of the T wave on the electrocardiogram (ECG),

During the application of metronidazole, red-brown urine staining may occur.
Interaction with other drugs
Metronidazole for intravenous infusion is not recommended to be mixed with other drugs!

When using metronidazole for injection, the interaction with other drugs is negligible, but caution should be exercised when used simultaneously with certain drugs.

Warfarin and other indirect anticoagulants. Metronidazole enhances the effect of indirect anticoagulants, which leads to an increase in the time of formation of prothrombin.

Disulfiram The simultaneous use can lead to the development of various neurological symptoms, so do not appoint metronidazole to patients who have taken disulfiram in the last two weeks.

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

The simultaneous use of drugs that stimulate the enzymes of microsomal oxidation in the liver (phenobarbital, phenytoin) can accelerate the elimination of metronidazole, as a result of which its concentration in plasma decreases.

In patients receiving long-term treatment with lithium preparations in high doses, the use of metronidazole may increase the concentration of lithium in the blood plasma and the development of symptoms of intoxication.

The antimicrobial action of metronidazole is enhanced in combination with sulfonamides and antibiotics.

With the combined use of metronidazole and cyclosporine, an increase in plasma concentration of cyclosporine may be observed.

Metronidazole reduces the clearance of fluorouracil, which can cause an increase in the toxicity of the latter.

With simultaneous use, metronidazole may increase plasma concentrations of busulfan.

It is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide).

Metronidazole is incompatible with ethanol (when used together, disulfira-like reactions develop).

Release form

Infusion solutions in bottles
Dosage: 5 mg / ml.

100 ml in a glass bottle with a sealed cork made of rubber and compressed with an aluminum cap.

The bottle together with the instruction for application is placed in a pack from a cardboard.

For hospitals: 56 bottles with an equal number of instructions for use are placed in group packaging - boxes made of corrugated cardboard.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Shelf life
2 years


It is a drug. Consultation with a doctor is required.