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FURAZOLIDONE
Release form
Tablets
For children
Not applicable to children under 8 years of age
For pregnant women
Contraindicated
For nursing mothers
Contraindicated
For drivers
Contraindicated
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: furazolidone; 1 tablet contains furazolidone 0.05 g (50 mg); auxiliary substances: potato starch; lactose monohydrate; colloidal anhydrous silicon dioxide; calcium stearate.
Medicinal form
Tablets. The main physical and chemical properties: yellow or greenish-yellow tablets, with a flat surface and a chamfer.
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. Disrupts the process of cellular respiration of bacteria, suppresses the biosynthesis of nucleic acids. Depending on the concentration, it has a bacteriostatic or bactericidal effect. Active against gram-negative rods (Escherichia, Salmonella, Shigella, Proteus, Klebsiella, Citrobacter), gram-positive cocci (streptococci, staphylococci), protozoa (giardia, trichomonads). Among the causative agents of intestinal infections, the causative agents of dysentery, typhoid and paratyphoid are the most sensitive. It has a weak effect on the causative agents of purulent and anaerobic infections. Resistance to furazolidone develops slowly. Activates phagocytosis, does not suppress the immune system. Pharmacokinetics. When taken orally, it is quickly absorbed in the gastrointestinal tract and distributed to tissues, including the central nervous system. The therapeutic concentration in the blood is maintained for 4–6 hours. It does not form 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 with bile, reaching high concentrations in the intestinal lumen, which allows it to be used for intestinal infections. In case of renal insufficiency, the drug accumulates in the blood as a result of slowing down excretion.
Indication
Bacillary dysentery, paratyphoid, food poisoning, enterocolitis, giardiasis, trichomonad colpitis.
Contraindication
Terminal stage of chronic renal failure, impaired liver function, deficiency of glucose-6-phosphate dehydrogenase, increased sensitivity to any components of the medicinal product and nitrofurans.
Interaction with other medicinal products and other forms of interaction
With the simultaneous use of furazolidone with monoamine oxidase inhibitors, sympathomimetics, tricyclic antidepressants and food products containing tyramine, there is a risk of hypertensive crisis. When combined with chloramphenicol and ristomycin, the risk of suppression of hematopoiesis increases. With the simultaneous use of furazolidone with amitriptyline, the occurrence of toxic psychosis is possible. Aminoglycosides and tetracycline enhance the antimicrobial effect of furazolidone. Means that alkalinize urine (sodium hydrogen carbonate, sodium bicarbonate, acetazolamide) reduce the effect of furazolidone, increasing its excretion with urine; agents that acidify urine 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 termination.
Features of use
The risk of peripheral polyneuropathies increases with anemia, diabetes, electrolyte balance disorders, hypovitaminosis B. For the prevention of neuritis with long-term use, furazolidone can be combined with vitamins of group B. Furazolidone is a monoamine oxidase inhibitor, and when using it, it is necessary to take the same safety measures as when using other monoamine oxidase inhibitors. Due to the risk of increased blood pressure and the development of mental disorders, it is recommended to exclude from the diet products containing tyramine and other vasoconstricting amines (cheese, cream, coffee, chocolate, smoked meats). Medicines for the treatment of cough and cold should not be taken simultaneously with furazolidone. The medicine 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. Taking the drug during pregnancy is contraindicated. During the period of treatment with the drug, breastfeeding should be stopped. The ability to influence the speed of reaction when driving vehicles or other mechanisms. You should not use the drug while driving vehicles or working with potentially dangerous mechanisms, as a decrease in concentration, dizziness, and drowsiness may occur when using the drug.
Methods of application
For adults and children over 8 years of age, use orally after meals, drinking a large amount of liquid (100–200 ml). For bacillary dysentery, paratyphoid, 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 should be prescribed the drug at the rate of 6-7 mg/kg of body weight per day; divide the daily dose into 4 doses (if it is necessary to take a dose of less than 50 mg, prescribe other furazolidone drugs in the appropriate dosage form and dosage). The duration of the treatment course 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; for children aged 8 years and older, the drug should be prescribed at the rate of 6 mg/kg of body weight per day in 3–4 doses. The course of treatment is 5–7 days. In the treatment of trichomonad infections, adults should be prescribed 2 tablets (0.1 g) 3-4 times a day for 3-4 days. For colpitis, treatment should be combined. Take 2 tablets (0.1 g) of the drug 3-4 times a day for 3 days. At the same time, inject powder containing furazolidone with lactose into the vagina, suppositories with the drug into the rectum. The highest doses for adults: single – 4 tablets (0.2 g), daily – 16 tablets (0.8 g). Furazolidone is not recommended for longer than 7 days. Children. Furazolidone in this dosage form should not be used by children under 8 years of age.
Overdose
Symptoms: acute toxic hepatitis, hemolytic or megaloblastic anemia, leukopenia, polyneuritis. Treatment: withdrawal of the drug, gastric lavage, use of antihistamines, calcium chloride, activated carbon, B vitamins, saline laxatives, correction of water-salt balance: symptomatic therapy aimed at supporting vital functions. There is no specific antidote.
Side effects
From the gastrointestinal tract: abdominal pain, nausea, bitterness in the mouth, lack of appetite, vomiting, diarrhea, anorexia, cholestasis, hepatotoxicity. From the side of the central nervous system: headache, drowsiness, dizziness, peripheral neuropathy. From the side of the blood system: rarely - leukopenia, agranulocytosis, hemolysis in people with glucose-6-phosphate dehydrogenase deficiency. From the side of the immune system: allergic reactions, including skin itching, skin hyperemia, urticaria, rashes on the skin of the face, trunk and lower limbs, including maculopapular, angioedema. Others: hypoglycemia, orthostatic hypotension, dark yellow urine, fever, weakness, general malaise. From the side of the respiratory system: rarely - acute pulmonary reactions.
Expiration date
3 years
Storage conditions
Store in the original packaging at a temperature not higher than 25 ºС. Keep out of the reach of children.
Packaging
20 tablets in a blister; 1 or 5 or 10 blisters in a cardboard pack.
Leave category
By prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.