Furagin tablets 50mg №10×3

Name Furagin tab 50mg No. 10×3 Main active ingredient Furazidin Release form Tablets Composition Active ingredient: furagin. Each tablet contains 50 mg furagin. Excipients: modified corn starch, lactose monohydrate, sugar, polysorbate 80 (tween-80), stearic acid. Dosage 50 mg Pharmacological properties Pharmacodynamics Furagin is an antibacterial agent with a bacteriostatic effect, effective against both gram-positive (Staphylococcus epidermidis, Staphylococcus aureus, Staphylococcus faecalis) and gram-negative (Enterobacteriaceae – Escherichia coli, Klebsiella spp, Salmonella, Shygella, Proteus, Enterobacter, etc.) bacteria . The drug acts on staphylococci and other pathogenic strains of microorganisms that are resistant to sulfonamides and antibiotics. The resistance of microorganisms to furagin develops slowly and does not reach a high degree. The minimum inhibitory concentration of the drug in the treatment of urinary tract infections ranges from 0.7 mg/l to 20 mg/l. Pseudomonas aeruginosa is resistant to the drug. Nitrofurans inhibit the enzyme systems of microorganisms, as well as other biochemical processes in the bacterial cell, causing the destruction of its cytoplasmic membrane and cell membrane. As a result of the action of nitrofurans, microorganisms release less toxins, which improves the general condition of the patient even before a pronounced suppression of microflora. Pharmacokinetics Absorption Furagin is well absorbed from the gastrointestinal tract. Absorption of the drug mainly occurs from the distal small intestine by passive diffusion. Absorption from the distal small intestine exceeds absorption from the proximal 4 and 2 times, respectively. This must be taken into account in the simultaneous treatment of urogenital infections and diseases of the gastrointestinal tract (chronic enteritis). Furagin binds to plasma proteins. After a single dose of 200 mg, the maximum concentration of the active substance is reached in the blood plasma after 30 minutes, remains at this level for 1 hour, then slowly decreases. Bacteriostatic concentration in blood plasma persists for 8-12 hours. Metabolism/elimination 10% of the administered dose is biotransformed in the liver and in the kidneys; if kidney function is impaired, most of the administered dose is biotransformed. The half-life is short (about 6.1 hours). Furagin is excreted by the kidneys, mainly by tubular secretion (85%). 8-13% of furagin enter the urine unchanged, where its concentration, on average, many times exceeds the minimum inhibitory concentration for most sensitive bacteria. The maximum concentration of furagin in the urine is 5.7 μg / ml. The action of furagin is more pronounced in an acidic environment (pH ≤5.5). Urine alkalinizers reduce the therapeutic effect of furagin (slow down reabsorption and accelerate the excretion of furagin in the urine). Indications for use Acute and chronic urinary tract infections: pyelonephritis, cystitis, urethritis, prostatitis. Postoperative urinary tract infections: postoperative pyelonephritis, cystitis, prostatitis. Contraindications Hypersensitivity to furagin, to derivatives of the nitrofuran group or to excipients of the drug; severe renal failure (glomerular filtration rate (GFR) less than 30 ml / min); polyneuropathy (including diabetic); insufficiency of glucose-6-phosphate dehydrogenase (risk of developing hemolysis); porphyria (diseases caused by impaired metabolism of hemoglobin breakdown products); pregnancy; lactation; children under 6 years of age (for this dosage form); The use of furagin is not recommended in cases of urosepsis and parenchymal infections of the kidneys. Use during pregnancy and lactation Pregnancy Use is contraindicated. There are no well-controlled clinical studies on the safety of the drug during pregnancy. Nitrofurans penetrate the placental barrier, but their concentration in the blood of the fetus is many times lower than in the blood of the mother. Breast-feeding period Nitrofurans are excreted in breast milk. The use of nitrofurans during lactation is contraindicated, since it is possible to develop hemolytic anemia in newborns. Influence on the ability to drive vehicles and maintain mechanisms The drug does not affect the ability to drive vehicles and maintain mechanisms. Dosage and administrationFuragin is taken orally after meals with plenty of water. Adults: 100-200 mg (2-4 tablets) 2-3 times a day. The course of treatment is 7-10 days and depends on the severity of the disease, the effectiveness of treatment, as well as the functional state of the kidneys. If necessary, the course of treatment is repeated after 10-15 days. The maximum daily dose is 600 mg. For the prevention of chronic diseases of the urinary tract – 50 mg per day. Children over 6 years of age: for acute infection, the dose is 5-8 mg / kg of body weight per day, dividing the daily dose into 3-4 single doses, for 7-8 days. If prolonged treatment is necessary, the dose is reduced to 1-2 mg mg/kg of body weight per day. Use the drug with caution in patients with impaired liver and / or kidney function, during therapy, liver and / or kidney function should be monitored (see also sections “Contraindications”, “Precautions” and “Overdose”). With caution, prescribe the drug to elderly patients (see also the section “Precautions”). If you forget to take your next dose of medicine, take it as soon as you remember, but skip it if it is almost time for your next dose. Never take a double dose of a medicine to make up for a missed dose. Side effect The frequency of side effects according to the classification system MedDRA (Medical Dictionary of Regulatory Terminology): Very often (≥1 / 10); often (≥1/100 to <1/10); infrequently (≥1/1000 to <1/100); rarely (≥1/10,000 to <1/1000); very rarely (<1/10,000); the frequency of manifestation is not known (cannot be determined from the available data). Blood and lymphatic system disorders: very rarely - hematopoietic disorders (agranulocytosis, thrombocytopenia, aplastic anemia). Nervous system disorders: infrequently - dizziness, drowsiness; rarely - peripheral neuropathy. On the part of the organ of vision: rarely - visual impairment. Respiratory, thoracic and mediastinal disorders: rarely, acute and chronic pulmonary reactions. Acute pulmonary reaction develops rapidly. It is manifested by severe shortness of breath, fever, chest pain, cough with or without sputum, eosinophilia (an increase in the number of eosinophilic granulocytes in the blood). There is evidence of skin rashes, itching, urticaria, myalgia (muscle pain), angioedema (swelling of the face, neck, tissues of the oral cavity and larynx) simultaneously with an acute pulmonary reaction. An acute pulmonary reaction is based on a hypersensitivity reaction, which can develop over several hours, less often within minutes. An acute pulmonary reaction is reversible and disappears upon discontinuation of the drug. A chronic pulmonary reaction may develop after a long period of time after stopping treatment with nitrofurans (including furagin). Characterized by a gradual increase in dyspnea, rapid breathing, unstable fever, eosinophilia, progressive cough, and interstitial pneumonitis and/or pulmonary fibrosis. Gastrointestinal disorders: infrequently - loss of appetite, nausea; rarely - vomiting, diarrhea; very rarely - pancreatitis (inflammation of the pancreas). Skin and subcutaneous tissue disorders: rarely - papular rash, itching, transient hair loss; very rarely - angioedema, urticaria, exfoliative dermatitis, Erythema multiforme. Musculoskeletal and connective tissue disorders: very rarely - arthralgia (joint pain). Vascular disorders: very rarely - mild intracranial hypertension. General disorders: rarely - weakness, fever. Liver and biliary tract disorders: very rarely - cholestatic jaundice, hepatitis. Furagin stains urine brown. Side effects are reduced if the drug is taken after meals with plenty of liquid. If side effects occur during the administration of the medicinal product, especially those not indicated in the instructions for use, it is necessary to inform the attending physician about this. Overdose Nitrofurans are low toxic. Usually, toxic effects are possible in patients with impaired renal function. Symptoms: headache, dizziness, depression, peripheral polyneuritis, allergic reactions (urticaria, angioedema, bronchospasm), nausea, vomiting, hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency), megaloblastic anemia, very rarely - liver dysfunction. Treatment: gastric lavage, intravenous infusion solution (administration of a large amount of liquid). Carry out symptomatic and supportive therapy. In severe cases, hemodialysis is performed. There is no specific antidote. Interaction with other drugs Means that alkalinize urine reduce the therapeutic effect of furagin (accelerate the excretion of furagin in the urine). Medicines that acidify urine (acids, including ascorbic acid, as well as calcium chloride), increase the concentration of furagin in the urine (its excretion with urine slows down), the therapeutic effect increases, but the risk of developing toxic phenomena may also increase. Furagin is not recommended to be taken simultaneously with chloramphenicol, ristomycin and sulfonamides, as the risk of hematopoiesis suppression increases. Nitrofurans in vitro exhibit antagonism to quinolones (nalidixic acid, oxolinic acid, norfloxacin), but the clinical significance of this interaction in vivo has not been studied, so the simultaneous use of these drugs should be avoided. Probenecid and sulfinpyrazone (uricosuric agents) reduce the excretion of furagin, thus increasing the risk of unwanted side effects and toxic effects. Antacids containing magnesium trisilicate reduce the absorption of furagin. In renal failure, it is not recommended to take furagin simultaneously with aminoglycosides. Do not drink alcohol during treatment, as undesirable side effects may occur (palpitations, pain in the heart area, headache, nausea, vomiting, convulsions, lowering blood pressure, feeling hot and afraid). Precautions Caution should be observed in patients with impaired renal function (with GFR less than 30 ml / min, contraindicated), anemia, deficiency of B vitamins and folic acid, lung diseases. Prolonged use of furagin can cause the development of peripheral neuropathy. With caution, prescribe the drug to patients with diabetes mellitus, since taking the drug can contribute to the development of polyneuropathy. In the course of experimental studies and clinical observations of patients, it was found that nitrofurans adversely affect the function of the testicles, which manifests itself in the form of a decrease in the amount of sperm and ejaculate, a decrease in sperm motility and a pathological change in their morphology. In the case of long-term use of furagin, it is necessary to periodically monitor the number of leukocytes in the blood, indicators of liver and kidney function, as well as lung function, especially in elderly patients (over 65 years of age). In rare cases, the development of pseudomembranous colitis is possible, the cause of which is the suppression of the natural microflora of the rectum and the reproduction of Clostridium difficile. With a mild form of pseudomembranous colitis, it is enough to stop taking the drug. When conducting appropriate therapy, do not take drugs that slow down intestinal motility. Taking the drug with food reduces the risk of developing colitis, without significantly affecting the absorption of the drug. Laboratory studies of patients taking furagin may give a false-positive reaction for the presence of glucose in the urine if the copper reduction method is used to determine it. Furagin does not affect the results of the determination of glucose in the urine, performed by the enzymatic method. Lactose. Each tablet of the medicinal product contains 18.8 mg of lactose monohydrate. This medicine is not recommended for patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Sucrose. Each tablet contains 10 mg of sucrose. This medicine is undesirable for patients with rare congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. Storage conditions Storage conditions: protected from moisture and light №10х3