Furazolidone (Tablets) Instructions for Use

ATC Code

J01XE (Nitrofuran derivatives)

Active Substance

Furazolidone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibacterial drug, a derivative of nitrofuran

Pharmacotherapeutic Group

Systemic antibacterial agents; other antibacterial agents; nitrofuran derivatives

Pharmacological Action

Antimicrobial and antiprotozoal agent, a derivative of nitrofurans. It is active against Trichomonas spp., Giardia lamblia, Shigella dysenteria, Shigella flexneri, Shigella boydii, Shigella sonnei, Salmonella typhi, Salmonella paratyphi, Staphylococcus spp. It has a weak effect on the causative agents of purulent and anaerobic infections. Microorganisms develop resistance slowly.

Nitrofurans disrupt the cellular respiration processes of microorganisms, suppress the Krebs cycle, and also inhibit the biosynthesis of nucleic acids of microorganisms, resulting in the destruction of their cell wall or cytoplasmic membrane. As a result of the action of nitrofurans, microorganisms release fewer toxins, which is why an improvement in the patient’s general condition is possible even before a pronounced suppression of microflora growth. It blocks MAO.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract. Against the background of meningitis inflammation, concentrations in the cerebrospinal fluid are created that are equal to those in plasma. It is rapidly and intensively metabolized mainly in the liver with the formation of a pharmacologically inactive metabolite (amino derivative). It is excreted mainly by the kidneys (65%). Partially excreted with bile, reaching high concentrations in the intestinal lumen.

Indications

Dysentery, paratyphoid fever, giardiasis, acute bacterial and protozoal diarrhea.

ICD codes

Dosage Regimen

Tablets

Furazolidone is prescribed orally.

For the treatment of paratyphoid fever, dysentery, food toxic infections, adults take 0.1-0.15 g after meals 4 times/day for 5-10 days (the duration of administration depends on the nature and severity of the pathological process). In the same doses, Furazolidone can be taken in cycles of 3-6 days (intervals of 3-4 days).

Doses for children – 10 mg/kg of body weight per day (the daily dose is divided into 3-4 doses).

It is not recommended to prescribe Furazolidone for more than 10 days.

For the treatment of giardiasis, adults take 0.1 g of furazolidone 4 times a day, children – at a dose of 10 mg/kg of body weight per day (the daily dose is divided into 3-4 doses).

Maximum daily doses for adults for oral administration: single – 0.2 g, daily – 0.8 g.

Adverse Reactions

From the hematopoietic system: leukopenia, agranulocytosis, hemolysis in persons with glucose-6-phosphate dehydrogenase deficiency.

From the immune system: decreased blood pressure, urticaria, fever, arthralgia, measles-like rash, skin itching, rash, including maculopapular rash.

From the nervous system: headache, dizziness, peripheral neuropathy.

From the cardiovascular system: orthostatic hypotension, decreased blood pressure.

From the digestive system: abdominal pain, nausea, vomiting, diarrhea, anorexia, colitis, proctitis, anal itching, staphylococcal enteritis.

From the liver and biliary tract: impaired liver function, cholestasis.

From the urinary system: impaired renal function.

Other: hypoglycemia, dark yellow coloration of urine, weakness, malaise, disulfiram-like reaction.

Contraindications

Hypersensitivity to furazolidone and other nitrofuran derivatives; terminal stage of chronic renal failure, glucose-6-phosphate dehydrogenase deficiency; pregnancy, breastfeeding period; childhood – depending on the dosage form.

With caution

Chronic renal failure, liver and nervous system diseases, old age

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated. If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Use with caution in liver diseases.

Use in Renal Impairment

Contraindicated for use in the terminal stage of chronic renal failure. Use with caution in chronic renal failure.

Pediatric Use

It can be used in children of appropriate age categories strictly according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the furazolidone drug instructions regarding contraindications for use in children of different ages for specific furazolidone dosage forms.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Furazolidone is an MAO inhibitor and appropriate precautions should be observed during its use, including excluding foods containing tyramine (cheese, cream, beans, pickled herring, strong coffee) from the diet.

The risk of peripheral polyneuropathy is increased in anemia, diabetes mellitus, electrolyte imbalance, and B vitamin deficiency.

With prolonged use of furazolidone, B vitamins are prescribed simultaneously to prevent the development of neuritis.

In the presence of pre-existing liver pathology, the risk of hepatotoxic effects of furazolidone increases.

Due to the risk of disulfiram-like reactions, it is not recommended to consume ethanol during furazolidone therapy and for 4 days after its discontinuation.

Effect on the ability to drive vehicles and mechanisms

During treatment, patients should avoid driving vehicles and other activities requiring high concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use of furazolidone with MAO inhibitors, sympathomimetics, tricyclic antidepressants and food products containing tyramine, there is a risk of a sharp increase in blood pressure.

Agents that alkalize urine reduce the effect of furazolidone, while those that acidify it increase it.

Furazolidone increases the inhibition of hematopoiesis against the background of chloramphenicol and ristomycin.

Simultaneous administration of aminoglycosides and tetracyclines enhances antimicrobial properties.

The use of furazolidone in combination with ethanol can lead to the development of disulfiram-like reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.