BALGIL V. I.

Instructions for use

BALGILV.I.

Registration number: B-250-95 60105/11

Trade name of the drug: Balgil V.I.

International nonproprietary name:metronidazole.

Dosage form:solution for infusion.

Composition:100 ml solution for infusion contains 500 mg metronidazole.

Description:transparent, colorless or slightly yellowish solution.

Pharmacotherapeutic group:antiprotozoal agents.

CodeATX: J01EE01.

Pharmacologicalical properties

Pharmacodynamics

Metronidazole is a synthetic antiprotozoal and antimicrobial agent derived from 5-nitroimidazole. The drug is active against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as against obligate anaerobes (spore- and non-spore-forming) — Bacteroides spp. (B.fragilis, B.ovatus, B.distasonis, B.thetaiotaomicron, B.vulgatus), Fusobacterium spp., Clostridum spp., Peptostreptocpccus spp., Peptococcus spp., sensitive strains of Eubacterium. Aerobic microorganisms and facultative anaerobes are sensitive to metronidazole, but in the presence of mixed flora (aerobes and anaerobes), metronidazole acts synergistically with antibiotics that are effective against common aerobes.

The mechanism of action of metronidazole is the biochemical restoration 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 microbial cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

Pharmacokinetics

After intravenous drip administration, the concentration of the drug in the blood serum after an hour is 35.2 μg/ml, after 4 hours — 33.9 μg/ml, after 8 hours — 25.7 μg/ml. Metonidazole 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, abscess cavities, vaginal secretions, seminal fluid, breast milk . Binding to blood plasma proteins is weak and does not exceed 10-20%. With 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 excreted 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, accumulation of metronidazole in the blood serum may occur. Therefore, in patients with severe renal failure, the frequency of taking metronidazole should be reduced.

Indications for use

Metronidazole solution for infusion is used to treat infections caused by microorganisms sensitive to the drug:

• prevention and treatment of anaerobic infections during surgical interventions, mainly on the abdominal organs and urinary tract;
• combination therapy of severe mixed aerobic-anaerobic infections;
• severe form of intestinal and hepatic amebiasis;
• sepsis;
• peritonitis
• osteomyelitis;
• gynecological diseases;
• abscesses of the pelvis and brain;
• abscess pneumonia;
• gas gangrene;
• infections of the skin and soft tissues, bones and joints.

Method of administration and dosage

Balgil V.I. solution for infusion is used intravenously by drip for adults and children over 12 years of age, 100 ml (500 mg), which is administered over 20 minutes at a rate of 5 ml per minute every 8 hours.

For children under 12 years of age, the duration of treatment can be determined by the doctor depending on the results of a clinical examination. Depending on the child’s weight, the amount of liquid infused is determined at a rate of 7.5 mg/kg. The order and frequency of infusions remain the same as for adults: 5 ml/min over 20 minutes. every 8 hours.

As soon as possible, you should switch from intravenous infusions to taking the drug orally (200-400 mg three times a day).

Side effects

Digestive system:nausea, vomiting, diarrhea, lack of appetite, dry mouth, unpleasant metallic taste in the mouth, epigastric pain, glossitis, stomatitis, pancreatitis.

From the central nervous system:headache, dizziness, increased excitability, depression, sleep disturbance, weakness; in some cases — confusion, hallucinations, convulsions, peripheral neuropathy.

On the part of the urinary system:burning sensation in the urethra, dysuria, cystitis, polyuria, urinary incontinence, excessive development of fungal flora of the vagina (candidiasis), red-brown coloring of urine.

On the part of the musculoskeletal system:arthralgia.

On the part of the hematopoietic system:leukopenia, neutropenia.

Allergieschemicalreactionsand: skin rashes, hives, itching, redness of the skin, nasal congestion, fever.

Localse reactions:thrombophlebitis, pain, redness and swelling at the site of drug administration.

Contraindications

• hypersensitivity to metronidazole or other nitroimidazole derivatives;
• leukopenia (including history);
• organic lesions of the central nervous system (including epilepsy);
• liver failure;
• I trimester of pregnancy;
• II and III trimesters of pregnancy — only for health reasons;
• breastfeeding mothers — according to indications, with simultaneous cessation of breastfeeding.

Overdose

Symptoms of metronidazole overdose are nausea, vomiting, diarrhea, itching, metallic taste in the mouth, ataxia, dizziness, parasthesia, convulsions, leukopenia, dark urine color. There is no specific antidote. Symptomatic and supportive treatment is provided. Metronidazole and its metabolites are well eliminated by hemodialysis.

Interaction with other drugs

When using metronidazole solution for infusion, interaction with other drugs is negligible, but caution should be exercised when coadministered with other drugs.

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

The simultaneous use of metronidazole and disulfiram can lead to the development of various neurological symptoms, so metronidazole should not be prescribed to patients who have taken disulfiram within the last two weeks.

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

The simultaneous administration of drugs that stimulate microsomal oxidation enzymes in the liver (phenobarbital, phenytoin) can accelerate the elimination of metronidazole, resulting in a decrease in its concentration in the blood.

In patients receiving long-term treatment with lithium drugs in high doses, when taking metronidazole, an increase in the concentration of lithium in the blood plasma and the development of symptoms of intoxication are possible.

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

Special instructions

Metronidazole is prescribed with caution for liver and kidney diseases.

In children and adolescents under 18 years of age, the combined use of metronidazole with amoxicillin is not recommended.

While using metronidazole, it is necessary to avoid drinking alcohol, since as a result of impaired oxidation of alcohol, reactions characteristic of disulfiram may be observed (cramping abdominal pain, nausea, headache, sudden flushing of the face).

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

Metronidazole solution for intravenous infusion should not be mixed with other medications.

Even invisible damage to the bottle during transportation or storage can lead to contamination of the drug. The drug should not be used if a leak is detected when pressing the bottle, or the contents are opaque.

Issue form

Solution for infusion, 100 ml in plastic bottles. 1 bottle along with instructions for use in a cardboard box.

Storage conditions

Store in a cool, dark place at temperatures below 30ºC.

Keep out of the reach of children.

Expiration date

3 years. Do not use after the expiration date!

Conditions for dispensing from pharmacies

Dispensed with a doctor’s prescription.

Manufacturer:BAL PHARMA LTD, India.