Instructions Furazolidone tablets 0.05 g blister No. 20
Composition
active ingredient: furazolidone;
1 tablet contains furazolidone 0.05 g (50 mg);
Excipients: potato starch; lactose monohydrate; colloidal anhydrous silicon dioxide; calcium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets of yellow or greenish-yellow color, with a flat surface and a bevel.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents. Furazolidone. ATX code G01A X06.
Pharmacological properties
Pharmacodynamics.
Furazolidone is an antimicrobial and antiprotozoal agent, a derivative of nitrofuran. It disrupts the process of cellular respiration of bacteria, inhibits the biosynthesis of nucleic acids. Depending on the concentration, it exhibits a bacteriostatic or bactericidal effect. Active against gram-negative bacilli (Escherichia, Salmonella, Shigella, Proteus, Klebsiella, Citrobacter), gram-positive cocci (streptococci, staphylococci), protozoa (giardia, trichomonads). Among the pathogens of intestinal infections, the most sensitive are pathogens of dysentery, typhoid fever and paratyphoid fever. It has a weak effect on pathogens of purulent and anaerobic infections. Resistance to furazolidone develops slowly. Activates phagocytosis, does not suppress the immune system.
Pharmacokinetics.
When taken orally, it is rapidly absorbed in the gastrointestinal tract and distributed into tissues, including the central nervous system. Therapeutic blood concentrations are maintained for 4-6 hours. It does not create high concentrations in the blood and tissues (including the kidneys), as it is largely rapidly metabolized in the liver, turning into an amino derivative. The main route of elimination is renal excretion (65%). It is partially excreted in the bile, reaching high concentrations in the intestinal lumen, which allows it to be used for intestinal infections. In renal failure, the drug accumulates in the blood due to a slowdown in excretion.
Indication
Bacillary dysentery, paratyphoid, food poisoning, enterocolitis, giardiasis, trichomonas colpitis.
Contraindication
End-stage chronic renal failure, liver dysfunction, glucose-6-phosphate dehydrogenase deficiency, hypersensitivity to any components of the drug and nitrofurans.
Interaction with other medicinal products and other types of interactions
With simultaneous use of furazolidone with monoamine oxidase inhibitors, sympathomimetics, tricyclic antidepressants and food products containing tyramine, there is a risk of developing hypertensive crisis. When combined with chloramphenicol and ristomycin, the risk of hematopoiesis inhibition increases.
With simultaneous use of furazolidone with amitriptyline, toxic psychosis may occur.
Aminoglycosides and tetracycline enhance the antimicrobial effect of furazolidone.
Urine alkalizing agents (sodium bicarbonate, sodium bicarbonate, acetazolamide) reduce the effect of furazolidone, increasing its excretion in the urine; urine acidifying agents increase the effect of the drug.
Sensitizes the body to alcohol. Due to the risk of disulfiram-like reactions, alcohol should not be consumed during furazolidone therapy and for 4 days after its discontinuation.
Application features
The risk of peripheral polyneuropathies increases with anemia, diabetes mellitus, electrolyte imbalance, and vitamin B deficiency.
To prevent neuritis with long-term use, furazolidone can be combined with B vitamins.
Furazolidone is a monoamine oxidase inhibitor and when using it, the same precautions as when using other monoamine oxidase inhibitors should be observed.
Due to the risk of increased blood pressure and the development of mental disorders, it is recommended to exclude from the diet foods containing tyramine and other vasoconstrictor amines (cheese, cream, coffee, chocolate, smoked meats).
Cough and cold medicines should not be taken simultaneously with furazolidone. The drug contains lactose, so it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy. Breastfeeding should be discontinued during treatment with the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug should not be used while driving or operating potentially dangerous machinery, as the drug may cause decreased concentration, dizziness, and drowsiness.
Method of administration and doses
In bacillary dysentery, paratyphoid fever, food poisoning, adults are prescribed 2 tablets (0.1 g) 4 times a day for 5-7 days or in cycles of 3-6 days with an interval of 3-4 days. Children over 8 years of age are prescribed the drug at the rate of 6-7 mg/kg of body weight per day; the daily dose is divided into 4 doses (if it is necessary to take a dose of less than 50 mg, other furazolidone preparations in the appropriate dosage form and dosage are prescribed). The duration of the course of treatment is 5-7 days, depending on the severity of the disease, effectiveness and sensitivity to therapy.
For giardiasis, adults are prescribed 2 tablets (0.1 g) 4 times a day; children over 8 years of age are prescribed the drug at the rate of 6 mg/kg of body weight per day in 3-4 doses. The course of treatment is 5-7 days.
When treating trichomonas infections, adults should be prescribed 2 tablets (0.1 g) 3-4 times a day for 3-4 days.
In case of colpitis, the treatment should be combined. Take 2 tablets (0.1 g) of the drug orally 3-4 times a day for 3 days. At the same time, introduce powder containing furazolidone with lactose into the vagina, and suppositories with the drug into the rectum.
Higher doses for adults: single dose – 4 tablets (0.2 g), daily dose – 16 tablets (0.8 g). Furazolidone is not recommended for longer than 7 days.
Children
Furazolidone in this dosage form should not be used in children under 8 years of age.
Overdose
Symptoms: acute toxic hepatitis, hemolytic or megaloblastic anemia, leukopenia, polyneuritis.
Treatment: drug withdrawal, gastric lavage, antihistamines, calcium chloride, activated charcoal, B vitamins, saline laxatives, correction of water-salt balance: symptomatic therapy aimed at supporting vital functions. There is no specific antidote.
Adverse reactions
Gastrointestinal: abdominal pain, nausea, bitter taste in the mouth, loss of appetite, vomiting, diarrhea, anorexia, cholestasis, hepatotoxicity.
From the side of the central nervous system: headache, drowsiness, dizziness, peripheral neuropathies.
From the blood system: rarely - leukopenia, agranulocytosis, hemolysis in individuals with glucose-6-phosphate dehydrogenase deficiency.
On the part of the immune system: allergic reactions, including skin itching, skin hyperemia, urticaria, rashes on the skin of the face, trunk and lower extremities, including maculopapular, angioedema.
Others: hypoglycemia, orthostatic hypotension, dark yellow urine, fever, weakness, general malaise.
On the part of the respiratory system: rarely - acute pulmonary reactions.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
20 tablets in a blister; 1 or 5 or 10 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
PJSC "Monpharm".
Location of the manufacturer and its business address
Ukraine, 19100, Cherkasy region, Monastyryshche, Zavodska st., 8.
