Furazolidon Reneval (Tablets) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

J01XE (Nitrofuran derivatives)

Active Substance

Furazolidone (Rec.INN WHO registered)

Dosage Form

Furazolidone Reneval

Tablets 50 mg: 10, 14, 20, or 28 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, flat-cylindrical, yellow or greenish-yellow in color with a bevel.

Excipients: potato starch, lactose monohydrate, sucrose (sugar), crospovidone, povidone K30, calcium stearate, polysorbate 80 (tween 80).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug, a derivative of nitrofuran. Urinary antiseptic

Pharmacotherapeutic Group

Systemic antibacterial agents; other antibacterial agents; nitrofuran derivatives

Pharmacological Action

Antimicrobial and antiprotozoal agent, a derivative of nitrofurans. 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 pathogens of purulent and anaerobic infections. Microbial resistance develops 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, concentrations in the cerebrospinal fluid 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

Administer orally. The dosage regimen is set individually based on the indication, severity of infection, and patient age.

For adults, prescribe 100-150 mg (2-3 tablets of 50 mg) four times daily. The maximum single dose is 200 mg (4 tablets). The maximum daily dose is 800 mg (16 tablets).

The standard course of treatment is 5 to 10 days. Do not exceed the recommended duration of therapy without medical supervision.

For acute bacterial diarrhea, continue treatment for 5-7 days. For paratyphoid fever and giardiasis, a 7-10 day course is typical.

For pediatric patients, calculate the dose based on body weight: 10 mg/kg/day in 3-4 divided doses. The maximum daily dose for children is 400 mg (8 tablets).

Take tablets with a full glass of water to ensure proper absorption. Administer after meals to minimize potential gastrointestinal adverse reactions.

If no clinical improvement is observed within 3-5 days, re-evaluate the diagnosis and treatment strategy. Monitor for signs of peripheral neuropathy with prolonged use.

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; children’s age – depending on the dosage form.

With caution

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

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

Use with caution in liver diseases.

Use in Renal Impairment

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

Pediatric Use

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

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 imbalances, 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.

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

Furazolidone increases the suppression 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 30°C (86°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.