Metronidazole solution 5 percent instructions. How does Metronidazole interact with other medicines? When administered intravenously

A drug: METRONIDAZOLE

Active substance: metronidazole
ATX code: J01XD01
KFG: Antiprotozoal drug with antibacterial activity
ICD-10 codes (indications): A04.7, A06, A40, A41, A59, G00, G06, I33, J15, J85, J86, J90, K25, K26, K29, K65.0, K75.0, K81.0, M00, M86, N70, N71, N72, N73.0, Z29.8
Reg. number: P N002063/02
Registration date: 07/31/08
Owner reg. cred.: MOSKHIMPHARMPREPARATY im. N.A. Semashko OJSC (Russia)

DOSAGE FORM, COMPOSITION AND PACKAGING

Solution for infusion transparent, slightly yellow with a greenish tint.

Excipients: sodium chloride 900 mg, sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted 2-water) 300 mg, water for injection (up to 100 ml).

100 ml - polyethylene bottles (1) - plastic bags.

INSTRUCTIONS FOR USE FOR SPECIALISTS.
The description of the drug was approved by the manufacturer in 2009.

PHARMACHOLOGIC EFFECT

Antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-nitro group of intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group interacts with the DNA of the microbial cell, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

Active regarding Trichomonas vaginalis, Entamoeba histolytica, as well as obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., some gram-positive microorganisms (Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp.).

The minimum inhibitory concentration for these strains is 0.125-6.25 μg/ml.

In combination with amoxicillin, it is active against Helicobacter pylori (amoxicillin suppresses the development of resistance to metronidazole).

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 common aerobes.

Increases the sensitivity of tumors to radiation, causes sensitization to alcohol (disulfiram-like effect).

PHARMACOKINETICS

It 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, penetrates through blood-brain and placental barrier.

V d: adults - approximately 0.55 l/kg, newborns - 0.54-0.81 l/kg. Communication with plasma proteins - 10-20%.

With intravenous administration of 500 mg over 20 minutes, Cmax in blood serum after 1 hour is 35.2 μg/ml. The concentration of the drug in the blood after 4 hours is 33.9 mcg/ml, after 8 hours - 25.7 mcg/ml; C min upon subsequent administration - 18 μg/ml. Tmax - 30-60 min. The therapeutic concentration is maintained for 6-8 hours. With normal bile formation, the concentration of metronidazole in bile after intravenous administration can significantly exceed the concentration in plasma.

About 30-60% of metronidazole is metabolized in the body by hydroxylation. oxidation and glucuronidation. The main metabolite (2-oxymetronidazole) also has antiprotozoal and antimicrobial effects.

T1/2 with normal liver function - 8 hours (from 6 to 12 hours), with alcoholic liver damage - 18 hours (from 10 to 29 hours), in newborns born at a gestational age of 28-30 weeks - approximately 75 hours, 32 -35 weeks - 35 hours, 36-40 weeks - 25 hours. 60-80% is excreted by the kidneys (20% unchanged), through the intestines - 6-15%. In case of severe renal impairment (creatinine clearance less than 10 ml/min), after repeated administration, patients may experience accumulation of metronidazole in the blood serum, and therefore the dose of the drug should be halved.

Metronidazole and its main metabolites are quickly removed from the blood during hemodialysis (T1/2 is reduced to 2.6 hours). During peritoneal dialysis, it is excreted in small quantities.

INDICATIONS

Protozoal infections;

Extraintestinal amebiasis, including amoebic liver abscess;

Intestinal amebiasis (amebic dysentery);

Trichomoniasis;

Trichomonas vaginitis;

Trichomonas urethritis;

Infections caused by Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus);

Bone and joint infections;

CNS infections, incl. meningitis;

Brain abscess;

Bacterial endocarditis;

Pneumonia;

Empyema;

Lung abscess;

Infections caused by Clostridium spp., Peptococcus niger and Peptostreptococcus spp.;

Abdominal infections (peritonitis, liver abscess);

Infections of the pelvic organs (endometritis, abscess of the fallopian tubes and ovaries, infections of the vaginal vault);

Pseudomembranous colitis (associated with antibiotic use);

Gastritis or duodenal ulcer associated with Helicobacter pylori;

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

Radiation therapy for patients with tumors - as a radiosensitizing drug, in cases where tumor resistance is due to hypoxia in tumor cells.

DOSING REGIME

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

For adults and children over 12 years old a single dose is 500 mg, the rate of continuous (jet) or drip intravenous administration is 5 ml/min. 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, a transition to maintenance therapy with oral forms of metronidazole is carried out.

Children under 12 years of age Metronidazole is administered 7.5 mg/kg body weight in 3 doses at a rate of 5 ml/min.

For prevention of anaerobic infection before planned surgery on the gastric organs and urinary tractadults and children over 12 years old Metronidazole is prescribed as an infusion 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 hours). After 1-2 days, they usually switch to maintenance therapy with oral forms of metronidazole.

For patients with severe renal impairment (creatinine clearance less than 30 ml/min) and/or liver The maximum daily dose of metronidazole is 1000 mg (taken twice a day).

IN as a radiosensitizing drug administered intravenously at a rate of 160 mg/kg or 4-6 g/sq.m of body surface 0.5-1 hour before the start of irradiation. Apply before each irradiation session for 1-2 weeks. During the remaining period of radiation treatment, metronidazole is not used. The maximum single dose should not exceed 10 g. The course dose is 60 g. To relieve intoxication caused by radiation, drip administration of a 5% dextrose solution, hemodez or 0.9% sodium chloride solution is used.

At cancer of the cervix and uterine body, skin cancer used in the form of local applications (3 g dissolved in a 10% solution of dimethyl sulfoxide, moisten tampons, which are used locally, 1.5-2 hours before irradiation). In case of poor tumor regression, applications are carried out throughout the entire course of radiation therapy. If the dynamics of tumor cleansing from necrosis is positive - during the first 2 weeks of treatment.

SIDE EFFECT

From the digestive system: nausea, vomiting, loss of appetite, intestinal colic, diarrhea, constipation, coated tongue, bitter, metallic taste in the mouth, stomatitis, dry mouth, glossitis, pancreatitis.

From the hematopoietic system: reversible neutropenia (leukopenia).

From the side of the central nervous system: peripheral neuropathy (feeling of numbness in the limbs), headaches, convulsions, drowsiness, dizziness, incoordination, ataxia, confusion, depression, increased excitability, weakness, insomnia, hallucinations, irritability.

Allergic reactions: skin rash, urticaria, itching, erythema multiforme, angioedema and anaphylactic reaction, skin flushing, nasal congestion, fever, arthralgia.

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

From the hepatobiliary system: increased activity of liver enzymes, cholestasis, jaundice.

From the genitourinary system: dysuria, cystitis, polyuria. urinary incontinence, candidiasis of the vaginal mucosa, red-brown coloration of urine (causes a metabolite of metronidazole, has no clinical significance).

Others: increased body temperature, flattening of the T wave on the ECG.

CONTRAINDICATIONS

Leukopenia (including history);

Organic lesions of the central nervous system (including epilepsy);

Liver failure (in case of high doses);

Pregnancy (first trimester);

Lactation period;

Increased sensitivity.

WITH caution

Pregnancy (II and III trimesters) only for health reasons, renal/liver failure.

PREGNANCY AND LACTATION

Contraindicated in the first trimester of pregnancy and lactation. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Pregnancy (II and III trimesters) only for health reasons.

SPECIAL INSTRUCTIONS

IV administration of a solution for infusion is indicated for patients in whom oral administration of the drug is impossible. For mixed infections, metronidazole infusion solution can be used in combination with parenteral antibiotics without mixing the drugs with each other.

When administered intravenously, it should not be mixed with other drugs. When using the drug, an exacerbation of candidiasis may occur.

The consumption of alcoholic beverages during the course of therapy is strictly prohibited.

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

With 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 cessation of treatment.

May immobilize treponemes 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 sexual activity. Simultaneous treatment of sexual partners is mandatory. After treatment for trichomoniasis, control tests should be carried out during 3 consecutive cycles before and after menstruation.

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

Impact on the ability to drive vehicles and operate machinery

If side effects from the central nervous system occur, you should refrain from driving a car or working with potentially dangerous mechanisms.

OVERDOSE

Symptoms: nausea, vomiting, ataxia; when taken as a radiosensitizing agent - convulsions, peripheral neuropathy.

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

DRUG INTERACTIONS

Strengthens the effect of indirect anticoagulants, which leads to an increase in prothrombin time.

Similar to disulfiram, it causes ethanol intolerance.

The simultaneous use of metronidazole with disulfiram can lead to the development of various neurological symptoms (the interval between prescriptions is at least 2 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. as a result of which its concentration in plasma decreases.

When taken simultaneously with lithium preparations, the concentration of lithium in the plasma may increase and the development of symptoms of intoxication.

Sulfonamides enhance the antimicrobial effect of metronidazole.

CONDITIONS OF VACATION FROM PHARMACIES

The drug is available with a prescription.

CONDITIONS AND DURATION OF STORAGE

List B. Store out of reach of children, in a dry, dark place at a temperature of 0 to 30°C. Do not freeze. Shelf life - 2 years.

Treatment of gynecological diseases caused by pathogenic microorganisms is always accompanied by the use of antibiotics. A common drug is the antibiotic Metronidazole - the instructions for use indicate that it is prescribed for the treatment of candidiasis, trichomoniasis, infectious diseases of the intestines and abdominal cavity, gastritis and ulcers caused by the pathogenic bacterium Helicobacter pylori. Doctors prescribe it in combination with medications that restore microflora, because the antibiotic destroys not only pathogenic, but also necessary microorganisms.

What is Metronidazole

Drug therapy includes the use of antibiotics. Clinical and pharmacological group of Metronidazole - instructions for use indicate that it is an antiprotozoal drug and has an antibacterial and antiviral effect. It acts against many known bacteria and is used in gynecology, dermatology, gastroenterology and oncology for the treatment and prevention of pathologies caused by pathogenic microorganisms. The medicine is a derivative of 5-nitroimidazole.

Composition and release form

The table below shows the components of the medicine in accordance with the release form:

Release form	Component name	Quantity
In tablet form	Metronidazole
	Hydroxypropyl methyl cellulose
	Microcrystalline cellulose
	Croscarmellose sodium
	Metronidazole
	Polyethylene glycol 400, 1500	0.125 / 0.25 / 0.5 mg
	Metronidazole
In the form of a solution for droppers	Sodium dihydrogen phosphate
	Sodium chloride
	Lemon acid
	Purified water
	Metronidazole
	Vaseline oil
	Propanediol
	Emulsion wax
	Sterile water
	Propanetriol
	Sodium salt
	Metronidazole
Vaginal gel

Release form

For different purposes of use, the drug is available in 4 forms:

• flat-cylindrical tablets of green or yellow hue;
• cream for external use;
• suppositories for intravaginal use;
• solution for injection (droppers) in ampoules 0.5%.

The above forms have different compositions and are recommended for use in different pathological situations. Tablets, cream, suppositories and Metronidazole solution have an antimicrobial effect. The solution in ampoules and tablets are often used in gastroenterology, suppositories in gynecology, and ointment for the treatment of dermatological pathologies.

Pharmacodynamics and pharmacokinetics

The components of the drug interact with the DNA cells of microorganisms, inhibit the synthesis of nucleic acids and the metabolism of the substance - this leads to the death of pathogenic bacteria. The drug is active against strains of bacteria such as gram-positive anaerobic infections. Metronidazole - instructions for use indicate that it is not effective against aerobic microorganisms, mixed flora of anaerobic bacteria and aerobes. Increases the sensitivity of tumors to radiation therapy if tumor resistance is explained by cell hypoxia.

Pharmacokinetics: has a high level of absorption and penetrating ability. After entering the body it reaches a bactericidal concentration. Absorbed into the lungs, skin, kidneys, liver, brain, saliva, seminal fluid, bile, vaginal secretions, placental barrier, breast milk and amniotic fluid. Many oncologists also recommend taking Metronidazole - the instructions for use indicate that it increases the sensitivity of tumor cells to radiation exposure. The drug in the form of tablets and suppositories is partially absorbed, 80%.

Indications for use

The drug has a wide spectrum of action and is recommended for the treatment of the following pathologies:

• trichomoniasis;
• acute and chronic amoebiasis;
• abscess of the lungs, liver;
• skin infections;
• pathologies that were provoked by anaerobic microorganisms;
• abscess of the ovaries and fallopian tubes after intervention;
• infectious complications;
• pseudomembranous colitis;
• dysentery;
• sepsis;
• urethritis;
• pneumonia;
• alcoholism treatment;
• bone infections;
• meningitis;
• brain abscess;
• endocarditis.

How to take Metronidazole

The dosage of each form of the drug is prescribed by the doctor individually depending on the diagnosis, age of the patient and individual characteristics. Children from 2 to 12 years old are prescribed 45-50 mg per 1 kg of body weight 3 times a day for 10 days. For the treatment of giardiasis - 500 mg 2 times a day for a maximum of 7 days. Children under 1 year of age: 125 mg per day 2 times a day for 5 days. Patients over 12 years of age and adults should take 250-500 mg 3 times a day for no more than 7-10 days. For the prevention of infectious diseases, for children and adults, a single dose should consist of 4 tablets.

Candles

For the treatment of gynecological infections, the drug Metronidazole - the instructions for use indicate that it is prescribed in the form of vaginal tablets. When absorbed into the mucous membrane, the active components disrupt the DNA structure of pathogenic cells. Suppositories are active against Trichomonas, obligate microbes and others, but will not be able to eliminate aerobic bacteria. Vaginal suppositories are inserted vaginally, 1 piece at night. The course of treatment is 10 days, if necessary it should be repeated after waiting an interval of 5-6 weeks.

Contraindications for use are pregnancy and breastfeeding. Vaginal suppositories should be inserted deep into the vagina after the washing procedure. If irritation, burning and other symptoms occur, you should consult a doctor and stop using the drug. 7-8 hours after administration, the suppository dissolves and can leak out; to avoid leakage, it is recommended to use sanitary pads.

Metronidazole intravenously

This form of the drug is prescribed for the treatment of acute infectious bacterial diseases of the abdominal cavity, bones, joints, central nervous system, intestines, liver and kidneys. It is administered intravenously by infusion, for adults the first dose is 0.5-1 g, subsequent doses are 500 mg every 8 hours. The daily dose should not exceed 1 g. Use with caution during the 1st and 2nd trimester of pregnancy and lactation.

Gel

Actively used in dermatology for the treatment of acne, it is active against Demodex mites, which live in hair follicles and sebaceous glands. Metronidazole Nycomed gel should be applied in a thin layer to the affected, previously cleansed area of ​​the skin twice a day - in the morning and at night. The duration of treatment is from 1 to 5 months. When applying, avoid mucous membranes and areas near the eyes. Effective against acne, eczema, dermatitis, oily seborrhea, bedsores, anal fissures, trophic ulcers of the extremities.

Metronidazole tablets

The drug is taken orally after meals and can be washed down with water or milk. The tablets have a greenish or yellowish tint and a flat-cylindrical shape. Adults: 1-1.5 g per day for 1 week. The duration of the course of therapy is 5 days. When treating Trichomonas vaginitis, it is necessary to treat both partners simultaneously. Doctors often prescribe this form of release to treat many infectious diseases. The tablets are well tolerated by patients, side effects are rare.

special instructions

During treatment with Metronidazole, you should not take ethanol - this can cause nausea, abdominal pain, vomiting and headache. The components of the medication contribute to the darkening of urine. During therapy for vaginitis and gynecological bacterial infections, you should refrain from sexual activity for the period of treatment, but continue it during the menstrual cycle. If any side effects occur, such as ataxia, headache, dizziness, you should stop taking the drug and consult your doctor.

Metronidazole for children

This drug is prescribed orally to patients from birth to 18 years of age in varying dosages depending on the diagnosis and exact age. For giardiasis, children from 2 to 5 years old - 250 mg per day, up to 1 year - 125 mg, from 5 to 8 years - 370 mg, from 8 to 18 - 500 mg per day. For giardiasis, the daily dose is 45 mg, which should be divided into 15 mg divided into 3 doses over 5 days. For liver abscess, the recommended dose for a child from 1 to 3 years old is 0.5 g per day, from 3 to 7 years old - 1 g, from 7 to 10 years old - 1.25 g. For ulcerative stomatitis, the drug is not prescribed to children.

Drug interactions

There are several groups of drugs with which this medicine is not recommended to be combined:

• disulfiram – simultaneous use contributes to the development of adverse neurological disorders;
• cimetidine – increases the concentration of metronidazole in the blood, increases the risk of side effects;
• phenytoin, phenobarbital reduce its concentration in the blood plasma;
• lithium preparations – provoke neurological symptoms due to intoxication;
• sulfonamides enhance the antimicrobial effect, indirect anticoagulants, have a positive effect when taken simultaneously.

Side effects

The drug has a number of side effects on many body systems. Digestive problems may include vomiting, nausea, dry mouth, glossitis, and pancreatitis. The nervous system may respond with headache, insomnia, peripheral neuropathy, hallucinations, confusion, irritability, excitability, impaired coordination of movements, ataxia, and depression.

In addition to these symptoms, urticaria, itching, and hyperemia may be observed on the skin. From the genitourinary system there may be cystitis, candidiasis, urinary incontinence, staining of urine. All of the above signs refer to symptoms of intoxication; if they occur, you should urgently stop treatment, then rinse your stomach or skin and consult a doctor. Symptoms of giardiasis may appear with successful treatment of the pathology; they need to be rechecked every 3-4 days 3 times.

Contraindications

Before using this medication, you should consult your doctor who can determine the presence of contraindications. The use of Metronidazole Nycomed may be prohibited if the following symptoms are present:

• 1st trimester of pregnancy, with caution in the 2nd and 3rd trimester;
• individual intolerance:
• leukopenia;
• breastfeeding period;
• organic type CNS lesions;
• liver failure;
• renal failure;
• epilepsy.

Terms of sale and storage

The medicine can be purchased in pharmacy chains only with a prescription. Information about storing Metronidazole - the instructions for use indicate that it should be stored only in dry rooms, isolated from light and direct sunlight, the storage temperature should not exceed 25 degrees. The shelf life of the drug is 2 years from the date of manufacture.

Metronidazole analogs

There are a large number of alternative drugs on the market. Some of them:

Metronidazole price

The table below shows the price range for different forms of release of the antibacterial drug in Moscow and the Moscow region. You can buy it in pharmacies or online through an online store. When purchasing a medicine online, be sure to check the date of manufacture and the integrity of the packaging.

Video

international and chemical names: metronidazole; 1 -(β-hydroxyethyl)-2-methyl-5-nitroimidazole;

Basic physical and chemical properties

the solution is clear, colorless or pale yellow;

Compound

100 ml of solution contains metronidazole 500 mg;

Excipients: sodium chloride, water for injection.

Release form

Solution for infusion.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Imidazole derivatives. ATC code J01X D01.

Pharmacological properties

Pharmacodynamics Metronidazole is an antibacterial and antiprotozoal agent from the group of nitroimidazole derivatives. The mechanism of action of the drug is due to a violation of the DNA structure of sensitive microorganisms. Active against the protozoa Trichomonas vaginalis, Giardia lamblia, Entamoeba histolutica, Balantidum coli, some strains of Blastocystis hominis

The antibacterial spectrum of metronidazole, which is determined in vitro includes clinically significant anaerobic gram-negative, anaerobic gram-positive and aerobic gram-negative bacteria, namely:

sensitive (anaerobic gram-negative bacteria) - Bacteroides spp. (including Bacteroides fragilis, Bacteroides vulgatus, Bacteroides caccae, Bacteroides uniformis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides melaninigenicus), Fusobacterium spp., Prevotella spp. (including Prevotella bivia, Prevotella buccae, Prevotella disiens), Campylobacter spp.;

sensitive (anaerobic gram-positive bacteria) - Peptococcus spp., Peptostreptococcus spp., Entamoeba hystolytica, Veillonella spp., Clostridium spp. (including Clostridium difficile), Eubacterium spp.;

sensitive (aerobic gram-negative bacteria) - Helicobacter spp. (including Helicobacter pylori), Gardnerella vaginalis;

persistent - Acidophilus, Chlamydia, Clostridium welchii, Escherichia coli, Streptococcus, Propinibacterium acnes

In the presence of mixed microflora (anaerobes and aerobes), the drug acts synergistically with antibiotics active against aerobic pathogens.

Pharmacokinetics Plasma concentrations of metronidazole are proportional to the administered dose. The pharmacokinetics of metronidazole are linear with respect to dose and peak plasma concentration after an eight-year intravenous infusion of 100 to 4,000 mg metronidazole in healthy volunteers.

With infusion administration, high concentrations of metronidazole are achieved in all tissues of the body. The half-life of metronidazole is 8 hours, which ensures that the concentration remains at a bactericidal level for at least 8 hours.

Distribution. After intravenous administration, metronidazole easily penetrates into tissues, the volume of distribution is 70 - 95% of body weight. Reaches bactericidal concentrations in most tissues and fluids of the human body, including the brain, cerebrospinal fluid, abscess cavities,

saliva, bile, sexual secretions, amniotic fluid and breast milk. To a small extent (about 20%) binds to blood plasma proteins. Biotransformed in the liver by oxidation and conjugation with glucuronic acid.

Metabolism. It is excreted by the kidneys (60 - 80% of the dose) and feces (6 - 15% of the dose), with about 20% unchanged.

Conclusion. Renal clearance is 10 ml/min/1.73 sq. m (glomerular filtration rate). In patients with impaired renal function, accumulation of metronidazole in the blood serum is observed after repeated administration.

In patients receiving intravenous metronidazole, 15 mg/kg was used as a loading dose over 6 hours. To compensate for the decrease in renal activity, each six-hour dose was reduced in direct proportion to 7.5 mg/kg and reached the highest steady state plasma concentration of metronidazole, which averaged

Indications for use

Treatment of severe life-threatening infections caused by metronidazole-sensitive microorganisms:

• abdominal infections (including peritonitis, abdominal abscesses and

• infections of the skin, soft tissues;
• gynecological infections (including endometritis; endomyometritis; tubo-ovarian abscess; postoperative vaginal complications in the form of various inflammatory reactions -

cervicitis, endometritis);

• bacterial sepsis;
• infections of bones and joints (including septicemia, gas gangrene, osteomyelitis);
• infections of the central nervous system (including meningitis, brain abscess);
• respiratory tract infections (including destructive pneumonia, empyema,

lung abscess);

• infective endocarditis;
• protozoal infections (intestinal amebiasis and amoebic liver abscess)

The drug is also used to prevent postoperative complications caused by anaerobic bacteria. Metronidazole is effective against bacterial infections resistant to clindamycin, penicillin and chloramphenicol.

Method of administration and dose. The drug is administered intravenously at a rate that should not exceed 5 ml/min. Typically, 100 ml of the drug is administered over 30-60 minutes.

Adults and children over 12 years old: The initial dose is 15 mg/kg body weight (for a person weighing 70 kg, maximum 1000 mg), maintenance dose - 7.5 mg/kg (maximum 500 mg) every 6 to 8 hours. The daily dose should not exceed 4000 mg. The course of treatment is 7-10 days, for severe infections - 2-3 weeks.

If the clinical situation improves, you should switch to the use of oral metronidazole (200 - 400 mg 3 times a day).

Elderly patients- 7.5 mg/kg body weight (maximum 500 mg) every 8 to 12 hours. In elderly people, the pharmacokinetics of metronidazole may change, so the level of metronidazole in the blood serum should be monitored.

Children under 12 years of age: The initial dose is 7.5 mg/kg body weight every 8 hours for 3 days, then the drug is administered in the same dose every 12 hours. The daily dose should not exceed 30 mg/kg body weight.

In patients with renal failure(creatinine clearance less than 50 ml/min) doses should be reduced (see table below).

In patients with impaired liver function after repeated administration, accumulation of metronidazole and its derivatives in plasma is possible, so the frequency of administration should be reduced - the daily dose is 1000 mg, divided into 2 administrations.

To prevent postoperative complications caused by anaerobic bacteria, adults and children over 12 years old are administered 500 mg on the eve of surgery, and on the day of surgery (no later than 1 hour before it begins) and in the next 1-2 days - 500 mg 3 times a day with an interval 8 hours (in the future, oral forms of metronidazole are prescribed). The course of prophylactic use usually lasts 7 days.

Children under 12 years of age are administered 7.5 mg/kg body weight for prophylactic purposes.

Side effect

In general, intravenous metronidazole does not cause many side effects.

From the digestive tract: nausea, vomiting, dyspeptic disorders, metallic taste in the mouth.

From the hematopoietic organs: leukopenia, neutropenia.

Allergic reactions: erythematous rash, itching.

From the nervous system: dizziness, fainting, ataxia, headache, confusion, convulsions, peripheral neutropathy, which manifests itself in the form of paresthesia of the extremities.

Local reactions: thrombophlebitis.

Other: fever, change in urine color (caused by metronidazole metabolites).

Contraindications

Hypersensitivity to metronidazole or other nitroimidazole derivatives. I trimester of pregnancy, period of breastfeeding.

Overdose

Possible increased adverse reactions. There is no specific antidote. Treatment is symptomatic.

Features of application

The drug should be used with caution in patients with central nervous system diseases, severe liver and kidney diseases. The dose of the drug in such cases should be reduced accordingly.

With long-term use, it is necessary to monitor the composition of peripheral blood. During treatment with metronidazole, concomitant candidiasis (established or not yet diagnosed) may worsen, which requires the use of fungicidal drugs.

In elderly people, the pharmacokinetics of metronidazole may change, so the level of metronidazole in the blood serum should be monitored.

During treatment with the drug, you should not drink alcohol.

When administered intravenously, the infusion solution should not be mixed with other drugs.

Pregnancy and breastfeeding. The safety of metronidazole in women during pregnancy has not been sufficiently studied. In the second and third trimesters of pregnancy, the drug can be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus. During the period of use of the drug, breastfeeding should be stopped.

Impact on the ability to drive a car or operate complex machinery. The drug may cause side effects from the nervous system (dizziness, drowsiness, etc.), so you should refrain from driving vehicles and performing work that requires increased attention and reaction speed.

Interaction with other drugs

Metronidazole potentiates the effect of indirect anticoagulants (warfarin), increases the toxicity of lithium (increases the concentration in the blood). The drug may enhance the toxic effects of disulfiram (disorientation, acute psychosis), so treatment with metronidazole can only be started 2 weeks after discontinuation of disulfiram. Inducers of microsomal liver enzymes (phenobarbital, phenytoin) accelerate the metabolism of metronidazole, which leads to a decrease in its concentration in the blood serum; microsomal enzyme inhibitors (cimetidine) may increase the concentration of metronidazole in the blood.

Conditions and shelf life

Store at a temperature not exceeding 30 0 C in a place protected from light and out of reach of children. Do not freeze.

Shelf life - 3 years.

Vacation conditions

On prescription.

Package

100 ml of metronidazole infusion solution 0.5% in a disposable sterile polyethylene bottle, placed in a polypropylene bag, in a cardboard box.

Warning.

When administered intravenously, observe asepsis regarding infusion equipment and metronidazole. Do not use if container leaks or solution is contaminated. Do not use a solution containing mechanical impurities.

Manufacturer

Orchid Healthcare, (a division of Orchid Chemicals and Pharmaceuticals Limited),

Address

C P - 918, Phase III, Industrial Area, Bhiwadi - 301019, Rayasthan, India.

Metronidazole is a drug with antibacterial and antiprotozoal properties. The infusion form is available in 100 ml bottles containing 500 mg of Metronidazole.

Action of the medicine

The mechanism of action of Metronidazole is explained by changes in the DNA structure of pathogenic microorganisms susceptible to it. Which leads to their death. These are representatives of the protozoa: Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia, Balantidium coli; anaerobic gram-negative rods (Bacteroides spp., Fusobacterium spp.); gram-positive (Clostridium spp., Eubacterium spp.); gram-positive cocci (Peptococcus spp., Peptostreptococcus spp.); as well as Gardnerella vaginalis and Helicobacter pylori.

Solution for infusion is transparent, slightly yellow with a greenish tint.

Metronidazole has a high degree of bioavailability. It easily penetrates various tissues and structures of the body: bones, skin, liver, bile, saliva, pleural fluid.

It has been proven to easily penetrate the blood-brain barrier, the placenta, and is found in breast milk.

The drug is metabolized by liver cells. It is excreted from the human body by the kidneys and bile.

Indications

The instructions for use recommend the use of this medication intravenously in a hospital setting if the disease is severe. A dropper with Metronidazole is also prescribed if for some reason it is not possible to take the tablets orally.

Main indications:

• septic complications;
• peritonitis;
• abscesses in the abdominal cavity, lungs, bones, skin;
• gynecological infectious pathologies;
• brain infections;
• trichomoniasis;
• prevention of postoperative infections after surgical interventions in the abdominal cavity, during gynecological operations.

Features of application

The instructions for Metronidazole prohibit mixing it with other medications in one bottle.
The rate at which the drug is injected into a vein should not be more than 5 ml per minute. Given the half-life, the drug should be repeated after 8 hours.

For children under 12 years of age, unless there are other medical recommendations, the instructions indicate the dosage based on the child’s weight: 7.5 mg/kg. It is administered three times a day.
For adults, it is recommended to administer 500 mg also three times a day. In some cases, on the recommendation of a specialist, the dosage may be increased. Up to 4 g of Metronidazole can be administered per day.

Since, most often, it is the patient’s serious condition that is an indication for intravenous use of the drug, the dosage and duration of treatment are often individual for each patient. If the patient's condition improves, it may be recommended to switch to oral (tablet) forms of the drug.

Metronidazole is relevant for the prevention of postoperative infection. For adult patients and children under 12 years of age, it is prescribed by infusion of 1-2 bottles (500 mg) before surgery. After surgery, a bottle three times a day. Then the patient is recommended to switch to taking tablets if there is a need to continue antibiotic therapy. The dosage and duration of treatment with Metronidazole depend on the type of operation, changes in its course, and the general condition of the patient.

Metronidazole is an antibacterial agent for systemic use.

If there is severe insufficiency of liver and kidney function (creatinine clearance below 30 ml/min), then the instructions recommend not exceeding a daily dose of 1000 mg in two doses.

Metronidazole is recommended for use as a radiosensitizing agent. The drug is administered half an hour, an hour before irradiation. The dose is calculated based on the patient’s weight: 160 mg/kg body weight, but not more than 1000 mg per administration. Take Metronidazole for a week or two. For the entire course, its amount should not exceed 60,000 mg. Further radiation therapy is carried out without Metronidazole.

For oncological lesions of the skin, cervix and uterine body, use the drug 2 hours before the irradiation procedure. Use the solution topically, applying tampons soaked in Metronidazole. If the tumor formation is cleared of necrosis, then Metronidazole applications are carried out for a couple of weeks. If the regression is weak, then applications are made throughout the entire course of radiation treatment.

In case of mixed infection, it is allowed to use Metronidazole and other antibacterial drugs without directly mixing them in one bottle.

It is necessary, during long-term treatment, to periodically monitor blood tests, taking into account the risk of a decrease in the volume of leukocytes. The question of stopping the drug is decided by the attending physician, and depends on the severity of the infectious process.

When treating trichomoniasis, it is necessary to treat both partners and abstain from sexual relations during therapy.

For mixed infections, metronidazole infusion solution can be used in combination with parenteral agents

If adverse neurological reactions occur, Metronidazole therapy is discontinued. Considering the possible effect on the nervous system and reaction speed, it is not recommended to drive during Metronidazole therapy.

Interaction with other drugs

Disulfiram: the likelihood of adverse neurological effects increases. The break between taking Disulfiram and Metronidazole should be at least 2 weeks.

1. Cimetidine: the risk of side effects increases.
2. Group of sulfonamides: antimicrobial effect increases.
3. Phenobarbital: activate the breakdown of Metronidazole by the liver. As a result, plasma concentrations of Metronidazole decrease.
4. Prednisolone: ​​Reduces the effectiveness of the medication.
5. Indirect anticoagulants: their effect is enhanced.
6. Lithium: Metronidazole increases its concentration in the blood. As a result, lithium intoxication is possible.
7. Fluorouracil: increased toxic effects.
8. Non-depolarizing muscle relaxants: the muscle relaxant effect is enhanced.

Side effect

Metronidazole is characterized by rare side effects, provided that the doses and recommendations for use are followed.

From the gastrointestinal tract: dyspeptic symptoms (nausea, vomiting, diarrhea), metallic taste in the mouth.

Nervous system: convulsions, paresthesia in the extremities, dizziness, disturbance of orientation and reaction speed, nervousness, sleep disturbance, headache, fainting, sensation of noise and ringing in the ears, decreased hearing acuity.

Hypersensitivity reactions: skin redness, rash, itching.

Hematopoietic organs: decreased number of leukocytes, platelets, bone marrow aplasia.

Candidiasis of different localization.

Contraindications

Metronidazole is not prescribed for:

• hypersensitivity to nitroimidazoles;
• pregnancy 1st semester;
• during lactation.

Storage

The drug is well preserved in a place protected from light. The temperature should not be more than 25 °C. Shelf life 3 years.

Metronidazole is a medicinal solution that is used to kill helminths and bacteria of various kinds. It is worth noting that the drug is very effective in fighting different types of helminths, which is why this particular solution is used to treat patients in a hospital. In the process of introducing Metronidazole in a dropper into a person’s blood, the main component penetrates cells and tissues, and then begins to gradually destroy helminths. It is worth considering that each type of disease requires a certain dosage; the result of treatment will depend on the correctly selected dose.

For what diseases is Metronidazole used:

• for viral diseases;
• used to destroy bacterial infections;
• destroys gram-positive microorganisms.

Important! This drug can be used in conjunction with Amoxicillin, in which case the effectiveness of treatment increases, which makes it possible to eliminate Helicobacter pylori.

Indications for use

The instructions for using Metronidazole in solution indicate that this drug can be used not only by adults, but also by young children, which is why the solution is often used in pediatrics. This product is quite affordable and at the same time has a minimal toxicity index. Partial elimination of the drug from the body occurs six hours after the last dose. If treatment is carried out in childhood, the medication can be eliminated from the body from one day to thirty hours.

This medicine contains an antibiotic, as well as other excipients. Thanks to its special composition, the medicine easily penetrates into the cells of human organs, and distribution occurs evenly. Most of Metronidazole is excreted by the kidneys, while the remainder is excreted in the feces.

Diseases for which the solution is prescribed:

• systemic infections that have worsened due to the development of anaerobic microorganisms;
• giardiasis of any stage;
• trichomonas urethritis;
• intestinal and extraintestinal amebiasis;
• trichomonas vaginitis;
• cutaneous form of leishmaniasis.

Instructions for use by adults

If Metronidazole is prescribed to a child twelve years of age or older, then half to one gram of an antibacterial agent can be administered intravenously, and the administration process will last from half an hour to sixty minutes. After this, the patient is prescribed 500 mg of the active substance, which must be administered intravenously every eight hours. It is very important to correctly calculate the rate of administration; it should not be more than five milligrams per minute. Treatment with this method lasts for one week; if after the course the patient feels better, the doctor can transfer the patient to maintenance therapy.

How is the medicine used for children under 12 years of age?

If the patient is under 12 years old, then the treatment regimen will be the same, but the dosage calculation will be slightly different; the attending physician will have to calculate the dosage depending on the exact body weight of the child, as well as his age group. As indicated in the instructions, the doctor should use 7.5 mg of the drug per kilogram of the child’s weight. Metronidazole drips are given for seven or eight days. After this, the doctor may prescribe intramuscular administration of the drug if the treatment has shown good results.

Contraindications for use

It is not permitted to use the medicine in ampoules or solution for intravenous administration in all cases. There is a whole list of contraindications for which the use of the medicine is strictly prohibited.

Main contraindications:

• The medicine cannot be used in the first trimester of pregnancy; in the second and third periods, the doctor may prescribe the use of the medicine, but a dosage adjustment must be used;
• period of feeding the baby with breast milk;
• various lesions of the patient’s central nervous system;
• multiple sclerosis and epileptic seizures;
• child's age up to two years;
• disorders of the kidneys;
• allergic reactions to the main component or auxiliary additives;
• acute liver failure;
  fatty hepatosis and hepatitis, as well as cirrhosis;
• leukopenia.

Helpful information! This drug may not combine well with certain types of medications. During the treatment period, the doctor should stop taking any anticoagulants, Phenytoin, as well as Cimetidine and Phenobarbital. In addition, reviews from doctors indicate that the medicine does not interact well with alcoholic beverages and alcohol-based sedatives.

Side effects from treatment with Metronidazole

There is a whole list of symptoms that may appear immediately after using this drug. It should be clarified that most of them manifest themselves when the solution is taken for too long, or when the drug is overdosed.

Side effects:

• neutropenia;
• stool disorders, expressed in diarrhea or constipation;
• leukopenia;
• colic in the intestines;
• metallic taste in the mouth;
• attacks of nausea and heartburn;
• dry mucous membranes;
• stomatitis;
• pancreatitis and glossitis develop;
• disorientation may occur;
• a violation of coordination appears;
• dizziness and confusion may occur;
• migraines and increased excitability often occur;
• weakness and insomnia are often observed;
• ataxia may appear;
• hallucinations occur;
• Allergic reactions are common;
• fever and nasal congestion appear;
• urine turns dark;
• women develop candidiasis;
• Cystitis or polyuria may occur.

Important! The list of side effects is very long, it is for this reason that the dosage of this medicinal solution should not be exceeded. Only the attending physician can prescribe treatment.

If the patient has a mixed infection, the doctor may prescribe not only the use of this drug, but also additional antibacterial medications. But it is very important to remember that mixing two medications in one bottle is strictly prohibited. The product can be administered as an injection or as a drip using a dropper. The instructions in the instructions indicate that the solution is not recommended for use under 18 years of age if it is mixed with Amoxicillin.

It is worth noting that injections and droppers with such a substance are not combined with the use of ethanol, as this can be very dangerous. As a result, a disulfiram-like reaction begins to develop, which is expressed by painful sensations in the head, severe attacks of nausea and repeated vomiting. Redness of some areas of the skin may be observed, as blood begins to actively flow to them.

With sufficiently long-term treatment, the doctor must constantly monitor the patient’s blood composition, monitoring should be carried out every week. The thing is that the use of Metronidazole leads to the fact that the volume of leukocytes in the blood is greatly reduced. Termination of treatment is possible only if the infection begins to gradually decrease and the patient’s condition returns to normal. Only the attending physician can complete the course of treatment, and only if all the patient’s indications are normal. When a patient has trichomoniasis, both partners should undergo the treatment process.

Important! If treatment is carried out on only one infected person, infection may occur again.

How does Metronidazole interact with other medications?

If the solution is used for treatment together with Disulfiram, it may worsen side effects that are associated with the patient’s nervous system. In order not to harm your health, these two drugs should be used separately, and you must wait at least two weeks between their doses.

Cimetidine, together with Metronidazole, can lead to the development of a large number of side effects, which will have a very negative impact on the patient’s health. If we talk about drugs from the sulfonamide group, then this combination will help enhance the effect on microbes, thereby helping to speed up the healing process. The use of Phenobarbital leads to the fact that Metronidazole, entering the liver, is quickly broken down, because of this the concentration of the drug in the blood decreases. This significantly reduces the effect of the drug. Also, the effectiveness of the solution will be greatly reduced if the medication is used in conjunction with Prednisolone.