Metronidazole, tablets 250 mg 40 pcs

Metronidazole refers to 5-nitroimidazole and has a broad spectrum of action against anaerobic microorganisms Peptostreptococcus species, Clostridium spp., Bacterioides spp., Fusobacterium spp., Veillonella spp., Prevotella (Prevotella bivia, Prevotella buccae, Prevotella disiens).

Indications

Active ingredient

Composition

Composition per tablet:

the active ingredient:

metronidazole – 250 mg;

excipients:

Potato starch – 45.0 mg,

povidone (polyvinylpyrrolidone low molecular weight medical) – 2.0 mg,

Stearic acid – 3.0 mg.

How to take, the dosage

Ingestion, during or after meals (or with milk), without chewing. In amebiasis Metronidazole is used for 7 days – 0.25-0.5 g 3 times a day (adults) and 30-40 mg/kg/day also in three doses (children).
In case of giardiasis the preparation is given for 5 days – adults 0.25-0.5 g 2-3 times per day (maximum 1.0 g/day), children of 1-3 years old – 0.25 g/day, children 6-10 years old – 0.375 g/day and children 11-15 years old – 0.50 g/day. The drug is taken 2-3 times a day.
In trichomoniasis in men (urethritis) and women (urethritis and vaginitis) metronidazole is indicated as a single dose of 2 g or as a course treatment during 10 days:
1 tablet (0.25 g) 2 times a day. To exclude possible reinfection it is necessary to conduct treatment of sexual partners at the same time. The course of treatment may be repeated in 4-6 weeks if necessary.
In case of non-specific vaginitis the preparation is used 0.5 g twice a day for seven days.
In the treatment of anaerobic infections Metronidazole is prescribed to adults at the rate of 1.0-1.5 g a day and to children at the rate of 20-30 mg/kg a day.
For eradication of Helicobacter pylori – 500 mg 3 times a day during 7 days (as a part of combined therapy).
For prevention of infectious complications – 750-1500 mg/day in 3 times 3-4 days before surgery or 1 g once a day during the first day after surgery. Some 1-2 days after the operation – 750 mg/day within 7 days.
In case of expressed renal dysfunction (creatinine clearance less than 10 ml/min) the daily dose should be reduced by half.

Interaction

In concomitant use with antacids containing aluminum hydroxide, with colestyramine absorption of metronidazole from the gastrointestinal tract is slightly reduced.

In concomitant use metronidazole potentiates the effect of indirect anticoagulants.

Simultaneous use with disulfiram may cause acute psychosis and impairment of consciousness.

An increase in plasma concentrations of carbamazepine and an increased risk of developing toxic effects when used concomitantly with metronidazole cannot be excluded.

Concomitant use with lansoprazole may cause glossitis, stomatitis and/or dark coloration of tongue; with lithium carbonate – possible increase of lithium concentration in blood plasma and development of intoxication symptoms; with prednisone – metronidazole excretion increases due to accelerated metabolism in liver under the influence of prednisone. There may be a decrease in the effectiveness of metronidazole.

Concomitant use with rifampicin increases clearance of metronidazole from the body; with phenytoin – there may be a slight increase in plasma concentrations of phenytoin; there has been described a case of development of toxic effect.

Concomitant use with phenobarbital significantly increases excretion of metronidazole from the body, apparently due to the acceleration of its metabolism in the liver under the influence of phenobarbital. The effectiveness of metronidazole may be reduced.

Concomitant use with fluorouracil increases toxic effects, but not the effectiveness of fluorouracil.

A case of acute dystonia after a single dose of chloroquine in a patient receiving metronidazole has been described.

Concomitant use with cimetidine may inhibit the metabolism of metronidazole in the liver, which may lead to delayed excretion and increased plasma concentrations.

Concomitant use of ethanol in patients receiving metronidazole may result in disulfiram-like reactions.

Special Instructions

Ethanol intake is contraindicated during treatment (development of disulfiram-like reaction is possible: spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face).

In combination with amoxicillin it is not recommended to use in patients under 18 years of age.

When prolonged therapy the blood count should be monitored. In case of leukopenia the possibility of continuing treatment depends on the risk of developing an infectious process.

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

It may immobilize treponemes and lead to a false positive Nelson’s test.

Darkens urine.

When treating trichomonas vaginitis in women and trichomonas urethritis in men, it is necessary to abstain from sexual activity. The simultaneous treatment of sexual partners is mandatory. The treatment does not stop during menstruation. After the therapy of trichomoniasis should be tested for three consecutive cycles before and after menstruation.

After treatment of giardiasis, if symptoms persist, three stool tests at intervals of several days should be performed after 3-4 weeks (some successfully treated patients may have lactose intolerance caused by the infestation for weeks or months, resembling the symptoms of giardiasis).

Breastfeeding should be stopped during treatment.

Contraindications

Hypersensitivity to any of the ingredients of the drug and imidazoles;

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

Pregnancy and lactation;

Blood diseases, leukopenia (including history of leukopenia).

blood diseases (including history);

children under 3 years of age (for this dosage form).

WARNING

Renal and/or hepatic failure.

Side effects

Allergic reactions: urticaria, skin rash.

Local reactions: burning sensation or irritation of the penis in the sexual partner, burning sensation or increased frequency of urination, vulvitis (itching, burning pain or hyperemia of the mucous membrane in the area of the external genitalia). After discontinuation of the drug, vaginal candidiasis may develop.

Systemic reactions: change of taste, including “metallic” taste, dizziness, headache, dry mouth, nausea, vomiting, decreased appetite, spastic abdominal pain, constipation or diarrhea, dark coloring of urine, leukopenia or leukocytosis are possible.

Overdose

Symptoms: nausea, vomiting, ataxia; when taken as a radiosensitizer – seizures, peripheral neuropathy.

Treatment: no specific antidote, symptomatic and supportive therapy.

Similarities