Instructions for Urofuragin tablets 50 mg blister No. 30
Composition
active ingredient: furazidin (furagin);
1 tablet contains 50 mg of furagin;
excipients: corn starch, sucrose, colloidal anhydrous silicon dioxide, stearic acid.
Dosage form
Pills.
Main physicochemical properties: tablets, not coated, flat on both sides, yellow-orange in color, with a dividing line on one side, with a bevel.
Pharmacotherapeutic group
Antimicrobial agents for systemic use. Nitrofuran derivatives.
ATX code J01X E03
Pharmacological properties
Pharmacodynamics
Furagin, or furazidin, is a nitrofuran derivative. The drugs of this group have a bacteriostatic effect on a wide range of microorganisms, including gram-positive bacteria (Staphylococcus epidermidis, Staphylococcus aureus, Staphylococcus faecalis) and many gram-negative strains (Enterobacteriaceae: Salmonella, Shigella, Proteus, Klebsiella, Escherichia, Enterobacter). Nitrofuran derivatives have an antiprotozoal effect and only slightly affect fungi. They do not affect Pseudomonas aeruginosa and most strains of Proteus vulgaris.
The strongest effect of furagin is manifested in an acidic environment (pH 5.5), an alkaline environment weakens its effect. The strong bacteriostatic effect of furagin is associated with the presence of an aromatic substituent from the nitro group.
Nitrofuran derivatives are reduced to active derivatives by bacterial flavoproteins. These derivatives then transform ribosomal proteins and other compounds necessary for the synthesis of cellular proteins, nucleic acids (DNA and RNA) and in the processes of cellular respiration. No cross-resistance to nitrofuran derivatives in combination with antibiotics and sulfonamides was observed.
Pharmacokinetics
After oral administration, furagin is very rapidly absorbed and reaches a maximum concentration in the blood serum within about 0.5 hours. The serum concentration curve indicates an open, single-compartment distribution model of the drug. These concentrations are insignificant from a therapeutic point of view and are about 4.2 μM/ml.
Excretion in individuals taking furagin, determined in a study of its relative bioavailability, averaged about 6.25 mg/ml. Available published data suggest that taking nitrofuran derivatives with food, especially high in protein, increases bioavailability by 40–50% and increases urinary excretion, i.e. increases the concentration of the drug in the urine, which increases its effectiveness.
Indication
Lower urinary tract infections.
Contraindication
Hypersensitivity to nitrofuran derivatives or to any of the excipients.
Pregnancy and breastfeeding.
Renal insufficiency (creatinine clearance below 60 ml/min or elevated serum creatinine concentration). Contraindicated in patients on hemodialysis or peritoneal hemodialysis.
Polyneuropathy (including diabetic).
Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis).
Porphyria. Severe liver failure.
Interaction with other medicinal products and other types of interactions
Furagin is an antagonist of nalidixic acid, which weakens its bacteriological effect. Antibiotics (aminoglycosides and tetracycline), taken in combination with furagin, enhance its antibacterial effect. Chloramphenicol and ristomycin increase the hemotoxic effect of furagin.
Uricosuric drugs, such as probenecid (in high doses) and sulfinpyrazone, reduce the tubular excretion of nitrofuran derivatives and can cause accumulation of furagin in the body, increasing its toxicity and reducing its concentration in the urine below the minimum bacteriostatic level, which leads to a weakening of therapeutic efficacy.
With simultaneous use of alkaline drugs containing magnesium trisilicate, the absorption of furagin is reduced.
Atropine slows down the absorption of nitrofuran derivatives, but the total amount of absorbed substance does not change. Simultaneous administration of B vitamins increases the absorption of nitrofuran derivatives.
During the period of use of nitrofuran derivatives, false positive results of tests determining the amount of glucose in urine using Benedict's and Fehling's solutions were observed. The use of enzymatic methods for determining glucose in urine gave correct results.
Application features
Particular caution should be exercised in patients with impaired renal or hepatic function, neurological disorders, anemia, electrolyte disturbances, B vitamin and folic acid deficiency, and lung diseases.
The drug should be taken with caution by patients with diabetes mellitus, since furagin can cause the development of polyneuropathy. In patients taking nitrofuran derivatives, the development of peripheral neuropathy was observed, which in severe cases can be irreversible and threaten the patient's life. Therefore, at the first symptoms of neuropathy (paresthesia), taking Urofuragin should be discontinued.
With prolonged use of the drug, monitoring of blood morphology (leukocytosis) and biochemical parameters of kidney and liver function is necessary.
Avoid drinking alcohol while taking furazidine.
The medicinal product contains sucrose. Use is contraindicated in patients with rare hereditary disorders associated with fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency.
Use during pregnancy or breastfeeding
Given the lack of clinical data on the possible teratogenic effects of furagin, the drug is contraindicated during pregnancy and childbirth due to the risk of hemolytic anemia in the newborn.
Breast-feeding
Since furazidine passes into breast milk, the drug should not be used during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no data on the effect of furagin on the ability to drive and use machines. However, some patients may experience side effects that may affect the speed of psychomotor reactions (see section "Adverse reactions. Nervous system disorders").
Method of administration and doses
Adults
100 mg (2 tablets) 3 times a day.
Method of application.
The drug Urofuragin is taken orally during meals rich in proteins, which increase the bioavailability of nitrofuran derivatives.
The drug is taken for 5 to 10 days. If necessary, the course of treatment can be repeated after 10–15 days.
Children
The medicine should not be used in children.
Overdose
Since the drug is excreted from the body by the kidneys, patients with impaired renal function are at increased risk of overdose. In case of overdose, the following symptoms are possible: headache, dizziness, allergic reactions, nausea, vomiting, anemia, ataxia, tremor, neurotoxic symptoms.
In case of overdose, gastric lavage and intravenous infusion of the solution are recommended. Blood morphology, laboratory tests of liver function and monitoring of lung function are indicated. In severe cases, hemodialysis should be performed.
For the prevention of neuritis - B vitamins.
Adverse reactions
The most common adverse reactions were nausea (8%), headache (6%), and excessive flatulence (1.5%). Other symptoms were observed in less than 1% of patients. Adverse reactions classified by organ system are listed below.
Blood and lymphatic system disorders
Cyanosis due to methemoglobinemia. In individuals with glucose-6-phosphate dehydrogenase deficiency, the use of furagin may lead to the formation of megaloblastic or hemolytic anemia.
From the nervous system
Dizziness, drowsiness, visual impairment, peripheral neuropathy, including acute or irreversible (its formation is facilitated, in particular, by renal failure, anemia, diabetes mellitus, electrolyte disturbances, vitamin B deficiency).
Respiratory, thoracic and mediastinal disorders
Acute, subacute and chronic hypersensitivity reactions to nitrofuran derivatives. Chronic reactions have been observed in patients taking furagin for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and disseminated interstitial pneumonia) are especially possible in elderly patients. Acute hypersensitivity reactions from the respiratory system: fever, chills, cough, chest pain, shortness of breath, pleural effusion, changes in the radiological picture of the lungs and eosinophilia. Most often, these side effects quickly disappeared after discontinuation of the drug.
In the case of chronic reactions, the exacerbation of symptoms and their reversibility after discontinuation of the drug depend on the continuation of the course of treatment after the appearance of the first undesirable symptoms.
From the digestive system
Constipation, diarrhea, dyspeptic phenomena, abdominal pain, vomiting, sialadenitis, pancreatitis, pseudomembranous colitis.
Skin and subcutaneous tissue disorders
Alopecia, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome.
General violations
Fever, malaise, malaise, infections caused by microorganisms resistant to nitrofuran derivatives, most often Pseudomonas bacilli or Candida fungi.
On the part of the immune system
Itching, urticaria, anaphylaxis, angioedema, rash.
Liver and biliary tract
Symptoms of drug-induced hepatitis, cholestatic jaundice, necrosis of the liver parenchyma.
Clinical studies have shown that nitrofuran derivatives negatively affect testicular function, can reduce sperm motility, reduce sperm secretion, and also lead to pathological changes in sperm morphology.
In addition, it has been reported that patients taking furazidine experience musculoskeletal and connective tissue disorders with an unknown frequency: muscle cramps, muscle pain.
Expiration date
4 years.
Storage conditions
Store in a dry place in the original packaging.
Packaging
30 tablets in a PVC and aluminum foil blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Adamed Pharma JSC, Poland.
Location
St. Marsh. J. Pilsudskiego 5, 95-200, Pabianice, Poland.
