Metronidazole Nycomed - Instructions For Use, Tablets 500 Mg, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Metronidazole Nycomed

Metronidazole Nycomed: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Metronidazole Nycomed

ATX code: J01XD01

Active ingredient: metronidazole (metronidazole)

Manufacturer: Takeda Pharma A / S (Denmark), Nycomed Dania APS (Denmark), Nycomed Austria (Austria)

Description and photo update: 2018-21-11

Metronidazole Nycomed is a broad-spectrum antiprotozoal and antibacterial drug.

Release form and composition

Dosage forms:

• film-coated tablets: oval, white (in a dark glass bottle 20 pcs., in a cardboard box 1 bottle);
• solution for infusion: transparent, without turbidity and visible inclusions (in a glass bottle 100 ml, in a cardboard box 1 bottle).

Composition of 1 tablet Metronidazole Nycomed:

• active substance: metronidazole - 250 or 500 mg;
• auxiliary components (core): potato starch, microcrystalline cellulose, lactose monohydrate, gelatin, magnesium stearate;
• shell: methylhydroxypropyl cellulose (hypromellose), titanium dioxide, talc, propylene glycol.

Composition of 100 ml of Metronidazole Nycomed solution:

• active substance: metronidazole - 500 mg;
• auxiliary components: disodium phosphate dihydrate, citric acid monohydrate, sodium chloride, sterile water.

Pharmacological properties

Pharmacodynamics

Metronidazole - a derivative of 5-nitroimidazole, is an antiprotozoal and antimicrobial agent. By biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic bacteria and protozoa and further interaction of the reduced 5-nitro group with deoxyribonucleic acid (DNA) of microbial cells, the synthesis of nucleic acids of microorganisms is suppressed, which leads to their death.

Metronidazole is active against Gardnerella vaginalis, Entamoeba histolytica, Trichomonas vaginalis, Lamblia spp., Giardia intestinalis, gram-negative anaerobic rod-shaped bacteria Bacteroides spp. (including Bacteroides vulgatus, Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides distasonis, Bacteroides fragilis), Veillonella spp., Fusobacterium spp., Prevotella (P. disiens, P. buccae, P. bivo-positive bacteria), some gram-positive bacteria., Peptococcus spp., Clostridium niger, Eubacterium spp.). For these cultures of microorganisms, the inhibitory concentration is at least 0.125–6.25 μg / ml.

When metronidazole is combined with amoxicillin, activity is shown against Helicobacter pylori (amoxicillin prevents the development of resistance to metronidazole).

Aerobic bacteria and facultative anaerobic organisms are not sensitive to metronidazole. However, in the presence of a mixed flora (anaerobes and aerobes), Metronidazole Nycomed exhibits a synergistic effect with antibiotics that are effective against conventional aerobes.

Metronidazole increases the sensitivity of tumors to radiation, participates in the stimulation of reparative processes, and has a sensitizing effect on alcohol (due to a disulfiram-like reaction).

Pharmacokinetics

Metronidazole is highly absorbed. Its bioavailability is at least 80%. With good penetration, the substance reaches bactericidal concentrations in most tissues and body fluids, including the kidneys, liver, lungs, skin, brain, cerebrospinal fluid, bile, amniotic fluid, saliva, vaginal secretions, abscess cavities, breast milk, semen. Metronidazole has the ability to penetrate the placental and blood-brain barriers. The volume of distribution (V _d) in adults is approximately 0.55 l / kg, in newborns - 0.54-0.81 l / kg.

The maximum concentration (C _max) of metronidazole in blood plasma is 6–40 μg / ml, depending on the dose and route of administration of the drug. The time to reach it is 1–3 hours.

Plasma proteins bind 10–20% of the dose.

About 30-60% of the active substance is metabolized as a result of hydroxylation, oxidation and glucuronidation processes with the formation of the main metabolite - 2-oxymetronidazole, which also has antiprotozoal and antimicrobial effects.

The half-life of metronidazole (T _1/2) with normal liver function is on average 8 hours (from 6 to 12 hours), with alcoholic liver disease - 18 hours (from 10 to 29 hours), in newborns born at 28-30 weeks pregnancy - about 75 hours, respectively, at 32–35 weeks - 35 hours, at 36–40 weeks - 25 hours. The drug is excreted mainly by the kidneys - 60-80% (of which 20% is unchanged), and through the intestines - 6-15%.

Renal clearance is 10.2 ml / min. In patients with renal failure, after repeated administration of metronidazole, it can accumulate in the blood serum (for this reason, in patients with severe renal impairment, the frequency of administration of the drug must be adjusted downward).

During hemodialysis, metronidazole and its main metabolites are rapidly excreted from the blood, while T _1/2 decreases to 2.6 hours. With peritoneal dialysis, a small amount of the active substance is excreted.

Indications for use

According to the instructions, Metronidazole Nycomed is indicated for the prevention and treatment of the following infectious diseases caused by microorganisms sensitive to metronidazole:

• extraintestinal amebiasis (including amoebic liver abscess), intestinal amoebic dysentery, giardiasis, trichomoniasis, trichomonas urethritis, trichomonas vaginitis, balantidiasis, giardiasis, cutaneous leishmaniasis and other protozoal infections:
• infections of the abdominal cavity, central nervous system, bones and joints, pelvic organs, soft tissues and skin, sepsis;
• pseudomembranous enterocolitis (associated with antibiotic therapy);
• duodenal ulcer or gastritis of the stomach associated with Helicobacter pylori infection (as part of complex therapy with amoxicillin);
• granulomatous enteritis.

Metronidazole Nycomed is used in radiation therapy of patients with tumors as a radiosensitizing drug in cases where the resistance of the neoplasm is due to tissue hypoxia in tumor cells.

The drug is also used in surgical operations to prevent anaerobic infections.

Contraindications

Absolute:

• leukopenia (including a history);
• epilepsy;
• liver dysfunction (in the case of high doses);
• organic lesions of the central nervous system;
• I trimester of pregnancy;
• lactation period;
• hemodialysis;
• children under 3 years old;
• increased individual sensitivity to any component of the drug.

Relative contraindications (diseases / conditions requiring caution when using Metronidazole Nycomed):

• diseases of the blood and central nervous system. If the recommended duration of treatment is exceeded, it is necessary to carry out systematic monitoring of the blood picture (especially the indicator of the level of leukocytes) and periodic assessment of the neurological status in order to avoid the occurrence of adverse reactions from the central and peripheral nervous system (dizziness, ataxia, paresthesia, epileptic seizures);
• impaired renal function;
• liver failure and severe liver disease. A dose reduction of metronidazole is required, especially in patients with hepatic encephalopathy, since the drug can cause an increase in its symptoms;
• simultaneous use with lithium preparations. During joint therapy and 2-3 weeks after discontinuation of metronidazole, careful monitoring of the level of lithium, creatinine and electrolytes in serum is necessary;
• congenital galactose intolerance, Lapp lactase deficiency, impaired absorption of glucose-galactose - when using Metronidazole Nycomed in the form of tablets;
• II and III trimesters of pregnancy.

Instructions for the use of Metronidazole Nycomed: method and dosage

Film-coated tablets

Metronidazole Nycomed tablets are taken orally without chewing, during or after meals. They can also be drunk between meals, but in this case, the tablets must be taken with milk.

Recommended dosage regimens according to indications:

• infections caused by anaerobic microorganisms: adults - 1 tablet Metronidazole Nycomed 500 mg 3 times a day, children over 3 years old - at the rate of 30-50 mg / kg body weight per day in 3 divided doses;
• acute amoebic dysentery, amoebic liver abscess: adults - 4 tablets (2000 mg) once a day for 3 days or 1-2 tablets (500-1000 mg) 3 times a day for 5 to 10 days, children from 3 years - 30-50 mg / kg per day in 3 divided doses for 5 days;
• asymptomatic amebiasis: adults - 1 tablet 500 mg 3 times a day, children over 3 years old - 25–40 mg / kg per day in 2–4 doses for 5 to 10 days;
• giardiasis: adults - 4 tablets (2000 mg) 1 time per day for 2-3 days or 1 tablet Metronidazole Nycomed 500 mg 2 times a day for 5 to 7 days, children from 3 years old - 25-40 mg / kg per day in 2-4 doses for 7 days;
• trichomoniasis: adults - 1 tablet 500 mg 2 times a day for 6 days or 4 tablets (2000 mg) once;
• ulcerative gingivitis: adults - 1 tablet 500 mg 3 times a day for 3 days;
• nonspecific vaginitis: adults: 4 tablets (2000 mg) on the first and third days or 1 tablet 500 mg 2 times a day for 7 days;
• Crohn's disease: adults - 1 tablet of 500 mg 2 times a day, children over 3 years old - 15 mg / kg per day in 2 divided doses;
• prevention of anaerobic infections during surgical operations: adults - 2 tablets (1000 mg) once, children from 3 years old - at the rate of 25 mg / kg of body weight;
• postoperative therapy: adults - 1 tablet 500 mg 3 times a day, children over 3 years old - 30-50 mg / kg daily in 3 divided doses.

In patients with severely impaired liver function due to the risk of accumulation of metronidazole and its metabolites, it is recommended to reduce the daily dose by three times and take the drug once a day.

In renal failure, as well as in elderly and older patients, a dose reduction of Metronidazole Nycomed is not required.

Solution for infusion

Parenteral administration of the drug is used only in acute and severe infectious lesions or in cases where oral administration is impossible.

Metronidazole Nycomed solution is administered intravenously as a drop infusion with glucose solution or isotonic sodium chloride solution for 20-30 minutes.

For adults and children over 12 years of age, intravenous administration of 100 ml of infusion solution (500 mg) 3 times a day is recommended. You can start the introduction with 200 ml (1000 mg).

Children from 3 to 12 years old Metronidazole Nycomed is administered at the rate of 20 mg / kg of body weight per day in 3 divided doses.

Side effects

Possible side reactions from systems and organs:

• gastrointestinal tract: nausea, vomiting, epigastric pain, glossitis, diarrhea, stomatitis, loss of appetite, metallic taste in the mouth, anorexia, constipation, dryness of the oral mucosa, pancreatitis (reversible forms), coated tongue / discoloration of the tongue (due to the growth of fungal microflora);
• immune system: angioedema, anaphylactic shock;
• nervous system: headache, dizziness, convulsions, peripheral sensory neuropathy, aseptic meningitis. Reversible cases of the development of encephalopathy and subacute cerebellar syndrome (ataxia, impaired coordination and synergism of movements, dysarthria, tremor, nystagmus, gait disturbance), which passed after the discontinuation of Metronidazole Nycomed, were recorded;
• psyche: psychotic disorders (including hallucinations, confusion), irritability, insomnia, hyperexcitability, depression;
• organ of vision: transient visual disorders (including myopia, diplopia, decreased visual acuity, blurred contours of objects, impaired color perception), optic neuritis / neuropathy;
• blood and lymphatic system: leukopenia, agranulocytosis, thrombocytopenia, neutropenia;
• liver and biliary tract: increased activity of liver enzymes [ALT (alanine aminotransferase), AST (aspartate aminotransferase), alkaline phosphatase (alkaline phosphatase)], development of cholestatic or mixed hepatitis, hepatocellular liver damage, sometimes accompanied by jaundice. When combined therapy of metronidazole with other antibiotics, cases of liver dysfunction have been recorded, requiring liver transplantation;
• skin and subcutaneous tissues: itching, rash, urticaria, flushing of the skin, pustular skin rash, malignant exudative erythema, toxic epidermal necrolysis;
• kidneys and urinary tract: urine staining reddish-brownish (due to the presence of a water-soluble metabolite of metronidazole in the urine), urinary incontinence, polyuria, dysuria, cystitis, candidiasis;
• other reactions: weakness, nasal congestion, fever, arthralgia;
• laboratory studies: flattening of the T wave on the electrocardiogram, changes in blood test parameters, such as the activity of AST, ALT, LDH (lactate dehydrogenase), hexokinase, triglyceride levels (the values of these parameters can be reduced to zero).

Overdose

In case of an overdose of Metronidazole Nycomed, symptoms such as nausea, vomiting, dizziness, headache, metallic taste in the mouth, and aversion to food may occur. In rare cases, drowsiness, insomnia, depression of the central nervous system, staining of urine in a dark color, oliguria are possible. Ototoxic effects and epileptic seizures are extremely rare.

Since the specific antidote of metronidazole is unknown, symptomatic and supportive therapy is recommended in case of an overdose. The hemodialysis procedure is effective to remove the drug from the blood, but it is rarely necessary.

special instructions

During the period of treatment with Metronidazole Nycomed and within 3 days after its cancellation, it is forbidden to consume alcohol, including alcohol-containing drugs (both in oral and parenteral form), since metronidazole in this case can cause a disulfiram-like reaction.

In the case of long-term therapy, it is necessary to systematically conduct a clinical blood test.

During treatment with metronidazole for Trichomonas urethritis in men and Trichomonas vaginitis in women, it is recommended to abstain from sexual activity. Mandatory simultaneous therapy of sexual partners is required. After a course of treatment for trichomoniasis for three cycles before and after menstruation, control tests should be performed.

The use of metronidazole in combination with amoxicillin is not recommended in patients under 18 years of age.

If symptoms persist after giardiasis therapy with Metronidazole Nycomed, after 3-4 weeks, three stool tests should be performed with an interval of several days, since in some cases, successfully treated patients may persist for several weeks or months due to the invasion of lactose intolerance, similar to the symptoms of giardiasis.

If dizziness, ataxia and any other deterioration in the patient's neurological status appear, therapy should be discontinued.

In the case of leukopenia, when deciding on the possible continuation of drug treatment, the degree of risk of developing an infectious process should be taken into account.

When using metronidazole, urine may turn dark.

Metronidazole Nycomed can cause immobilization of treponemas and lead to a false positive TPI test (Nelson's test).

Influence on the ability to drive vehicles and complex mechanisms

Since during treatment with Metronidazole Nycomed, side effects such as dizziness, visual impairment, psychotic reactions are possible, you should refrain from driving and all types of activities that require a quick motor / mental reaction and increased attention.

Application during pregnancy and lactation

Metronidazole crosses the placental barrier. In the first trimester of pregnancy, the use of Metronidazole Nycomed is contraindicated, in the second and third trimesters, the drug should be used with caution, only with the permission of the doctor and after a careful assessment of the benefit / risk ratio.

Due to the fact that metronidazole is able to be excreted into breast milk, if it is necessary to use it in women during lactation, it is necessary to decide on the termination of breastfeeding.

Pediatric use

Metronidazole Nycomed is contraindicated for use in children under 3 years of age.

With impaired renal function

Patients with renal insufficiency should be prescribed the drug with caution.

For violations of liver function

Metronidazole Nycomed is contraindicated in patients with impaired liver function if it is necessary to use it in high doses.

In cases of insufficient functioning of the liver and severe hepatic diseases, a decrease in the dose of the drug is required, especially in hepatic encephalopathy.

Use in the elderly

There is no need to adjust the dose of Metronidazole Nycomed for elderly and older patients.

Drug interactions

The use of metronidazole at the same time as some drugs can lead to the development of the following effects:

• alcohol, including alcohol-containing drugs: the development of a disulfiram-like reaction (vomiting, skin redness, fever, tachycardia and rapid breathing) due to the suppression of acetaldehyde metabolism by metronidazole;
• amiodarone: an increased risk of a cardiotoxic effect (prolongation of the QT interval, bidirectional fusiform ventricular tachycardia, cardiac arrest) due to weakening of amiodarone metabolism;
• busulfan: an increase in its concentration in blood plasma and, as a consequence, an increase in its toxicity;
• disulfiram: development of various neurological disorders. The interval between application should be at least 2 weeks;
• ergot alkaloids (for example, ergotamine): an increase in the likelihood of developing ergotism (nausea, vomiting, vasospastic ischemia) due to the suppression of cytochrome P450 3A4 activity by metronidazole and a slowdown in the metabolism of ergot alkaloids;
• warfarin: an increase in its effects and an increase in the risk of bleeding as a result of inhibition of warfarin metabolism by metronidazole. With simultaneous use, it is necessary to control the prothrombin time (at short intervals) and adjust the dose of warfarin;
• carbamazepine: an increase in its concentration in the blood serum and an increase in the toxicity of carbamazepine as a result of a slowdown in its metabolism under the influence of metronidazole;
• lithium preparations: an increase in the content of lithium in the blood plasma and the risk of its toxic effects (severe thirst, weakness, tremor, confusion) due to a decrease in renal lithium clearance;
• vecuronium: enhancing its action;
• tacrolimus: an increase in its concentration in blood plasma and an increase in the risk of developing toxic effects of tacrolimus (hypercalcemia, hyperglycemia, nephrotoxicity) due to the suppression of its metabolism and excretion by metronidazole;
• phenytoin: an increase in the likelihood of the toxic effects of phenytoin and a decrease in the plasma concentration of metronidazole due to inhibition of phenytoin metabolism or increased microsomal metabolism of metronidazole;
• phenobarbital: a decrease in the content of metronidazole in the blood plasma as a result of the acceleration of its metabolism in the liver;
• fluorouracil: an increase in its serum concentration and, as a consequence, an increase in toxic effects (vomiting, stomatitis, anemia, granulocytopenia, thrombocytopenia) due to a decrease in fluorouracil clearance;
• cholestyramine: weakening of the action of metronidazole due to a decrease in its absorption;
• cyclosporine: an increase in its content in the blood under the influence of metronidazole. When used together, frequent monitoring of the serum concentration of cyclosporine and creatinine should be carried out;
• cimetidine: an increase in the concentration of metronidazole in the blood serum and an increase in the likelihood of developing adverse reactions;
• indirect anticoagulants: an increase in their action, which can lead to an increase in prothrombin time;
• non-depolarizing muscle relaxants (vecuronium bromide): not recommended to be combined with metronidazole;
• sulfonamides: enhancement of the antimicrobial action of metronidazole.

Analogs

Analogs of Metronidazole Nycomed are: Klion, Metrogyl, Metron, Metronidazole, Metronidazole-AKOS, Metronidazole-Teva, Metronidal, Trichopol, Efloran and others.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Metronidazole Nycomed

There are few reviews of Metronidazole Nycomed, mostly they write about similar drugs containing metronidazole. Having a fairly high efficiency in the treatment of various infectious diseases, these drugs cause a lot of concern in patients taking them due to serious side effects and frequent reactions of incompatibility with other drugs.

Price for Metronidazole Nycomed in pharmacies

The price of Metronidazole Nycomed for a pack of 20 tablets averages 65 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!