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Composition:


active substance: 1 tablet contains furazidine, in terms of 100% substance 50 mg; excipients: cellactose-80 (a mixture of lactose monohydrate and microcrystalline cellulose in a ratio of 3:1), potato starch, magnesium stearate, polysorbate-80.


Dosage form. Pills.


Basic physical and chemical properties: tablets are round in shape, with a biconvex surface, from yellow to yellow with an orange tint, slightly uneven surface color, the presence of inclusions of a more intense color is allowed.


Pharmacotherapeutic group. Antimicrobial agents for systemic use. Nitrofuran derivatives. Furazidine. ATX code J01X E03.


Pharmacological properties.


Pharmacodynamics.


Furagin is a nitrofuran antibacterial agent with a bacteriostatic effect. It is effective against Gram-positive (Staphylococcus epidermidis, Staphylococcus aureus, Staphylococcus faecalis) and Gram-negative (Enterobacteriaceae, Klebsiella spp, Escherichia coli) bacteria. The high bacteriostatic activity of furazidine is associated with the presence of an aromatic Nitro group. Furazidine resistance develops slowly. Furazidine inhibits the enzyme systems of microorganisms, as well as other biochemical processes in the bacterial cell, which, in turn, causes disruption of the cytoplasmic membrane and the bacterial cell wall.


Pharmacokinetics.


Absorption. Furazidine is well absorbed from the digestive tract. Absorption of the drug mainly takes place from the distal part of the small intestine by passive diffusion (exceeds absorption from the proximal part by several times). After a single dose of 200 mg, the maximum concentration of furazidine is reached in the blood plasma after 30 minutes, remains at this level for 1 hour, then slowly decreases. The bacteriostatic concentration of furazidine in blood plasma persists for 8-12 hours. Furazidine binds to plasma proteins.


Metabolism/elimination. 10% of the dose taken is transformed in the liver and kidneys. When renal function is impaired, most of the dose is biotransformed. The elimination Half-Life of furazidine is short (about 1 hour). Furazidine is excreted by the kidneys, mainly by tubular secretion (85 %). 8-13% of furazidine enters the urine unchanged, where its concentration is on average many times higher than the minimum concentration for most sensitive bacteria. The maximum concentration of furazidine in the urine is 5.7 mcg/ml.


Furazidine penetrates well through the placental barrier.


Clinical characteristics.


Indications.


Acute and chronic urinary tract infections: pyelonephritis, cystitis, urethritis, prostatitis, postoperative infections of the genitourinary system.


Contraindications.


- Hypersensitivity to furagin, to derivatives of the nitrofuran group or to excipients of the drug.


- Severe renal failure (creatinine clearance less than 30 mL/min).


- Severe liver failure.


- Polyneuropathy (including diabetic).


-Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis).


- Porphyria (diseases caused by a violation of the metabolism of hemoglobin breakdown products).


- Rare congenital galactose intolerance, glucose-galactose malabsorption.


- Sucrose/isomaltase/lactase deficiency, lactose intolerance.


- Patients undergoing hemodialysis or peritoneal hemodialysis.


Interactions with other drugs and other types of interactions.


Drugs that alkalize the urine reduce the therapeutic effect of Furagin (accelerate the excretion of furazidine in the urine).


Drugs that acidify the urine (acids, including ascorbic acid, as well as calcium chloride) increase the concentration of furazidine in the urine (its excretion in the urine slows down) and thus increases the therapeutic effect of the drug, but at the same time increases the risk of increased toxicity.


Use simultaneously with levomycetin, ristomycin and sulfonamides increases the suppression of hematopoiesis.


Due to the antagonism of Furagin with quinolones (nalidixic acid, oxolinic acid, norfloxacin), the simultaneous use of these drugs should be avoided.


The use of probenecid and sulfinpyrazone reduces the elimination of furazidine, which increases the risk of undesirable side effects and toxicity.


Concomitant use of Furagin and antacids (which contain magnesium trisilicate) reduces the absorption of furazidine.


In case of renal failure, it is not recommended to use Furagin simultaneously with aminoglycosides. The antibacterial effect of Furagin is significantly enhanced when used simultaneously with antibiotics (penicillins and cephalosporins), it is well combined with tetracycline and erythromycin.


During treatment, you should not drink alcohol, as alcohol can increase the severity of side effects (increased heartbeat, heart pain, headache, nausea, vomiting, convulsions, low blood pressure, fever, anxiety).


Application features.


The drug should be used with caution in such cases:


- impaired renal function (use is contraindicated in severe renal failure);


- anemia;


- deficiency of B vitamins and folic acid;


- lung diseases;


- with prolonged use of Furagin, peripheral neuropathy may develop (pain, impaired sensitivity in the area of the corresponding nerve). If symptoms of neuropathy develop the drug should be discontinued;


- in diabetes mellitus, the drug can cause polyneuropathy.


The use of furazidine is not recommended for urosepsis and kidney parenchyma infection.


Experimental studies and clinical observation of patients indicate that Nitrofurans ( including Furagin) adversely affect testicular function, which is manifested in the form of a decrease in the amount of sperm and ejaculate, a decrease in the motility of spermatazoids and pathological changes in their morphology. 


When using furazidine, diarrhea may occur caused by suppression of the normal microflora of the large intestine by the drug.


In rare cases, pseudomembranous colitis may develop, which is caused by inhibition of the natural microflora of the rectum and 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 medications that slow down intestinal motility. Taking the drug with a meal reduces the risk of colitis, without significantly affecting the absorption of furazidine.


Laboratory testing of patients who have used Furagin may give a false positive reaction to the presence of glucose in the urine, if the copper reduction method is used to determine. Furazidine does not affect the results of determination of glucose in urine performed by the enzyme method.


In the case of long-term therapy, a blood test (white blood cell count), liver and kidney function indicators, and lung function should be monitored, especially in patients over 65 years of age.


To prevent the occurrence of neuritis, it is advisable to take antihistamines and B vitamins (nicotinamide, thiamine) at the same time.


If you are found to be intolerant to certain sugars, consult your doctor before taking this medicine.


Use during pregnancy or lactation.


Contraindicated use during pregnancy or lactation.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


Usually, the drug does not affect the reaction rate when driving vehicles or other mechanisms, but people who experience dizziness, drowsiness or other side effects from the central nervous system during treatment should exercise caution.


Dosage and administration.


The drug should be taken orally, immediately 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, depending on the severity of the disease, the effectiveness of treatment, as well as on the functional state of the kidneys. If necessary, repeat the course of treatment in 10-15 days.


The maximum daily dose is 600 mg.


If you miss taking the drug, the next dose should be taken as soon as the patient remembers. Do not take a double dose of the drug to replace the missed dose.


Children. The drug should not be used in children.


Overdose.


Usually, toxic manifestations are possible in patients with impaired renal function.


Symptoms: headache, dizziness, depression, peripheral polyneuritis, allergic reactions (urticaria, angioedema, bronchospasms), nausea, vomiting, hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency), megaloblastic anemia, rarely − impaired liver function.


Treatment: withdrawal of the drug, the use of large amounts of fluids, the use of enterosorbents, antihistamines, B vitamins (thiamine bromide). Therapy is symptomatic. In severe cases – hemodialysis. There is no specific antidote.

Adverse reactions.


Classification of frequency of adverse reactions: very common (≥1/10); often (≥1/100 to rare (≥1/10000 to very rare (


From the blood system: very rarely - hematopoietic disorders (agranulocytosis, thrombocytopenia, aplastic anemia).


Immune system disorders: hypersensitivity reactions, including pruritus, rash, urticaria, angioedema.


From the nervous system: infrequently – dizziness, drowsiness; rarely – peripheral neuropathy; very rarely – headache, mild intracranial hypertension, neuritis, polyneuritis.


From the side of the visual organs: infrequently – visual impairment.


From the respiratory system: rarely – acute and chronic pulmonary reactions. Acute pulmonary reaction develops rapidly and is manifested by severe shortness of breath, fever, chest pain, cough with/without sputum, eosinophilia (an increase in the number of Eosinophilic granulocytes in the blood). Simultaneous appearance of skin rashes, itching, urticaria, myalgia (muscle pain), angioedema (swelling of the face, neck, oral and laryngeal tissues) is possible with an acute pulmonary reaction. An acute pulmonary reaction is based on a hypersensitivity reaction that can develop within a few hours, less often within minutes. An acute pulmonary reaction is reversible and disappears when the drug is discontinued. A chronic pulmonary reaction may develop long after discontinuation of treatment with Nitrofurans (including furazidine). It is characterized by a gradual increase in shortness of breath, rapid breathing, unstable fever, eosinophilia, progressive cough and interstitial pneumonitis and/or pulmonary fibrosis.


From the digestive tract: infrequently – decreased appetite, flatulence, nausea; isolated – vomiting, diarrhea; rare – pancreatitis.


From the skin and subcutaneous tissue: rarely – papular rash, pruritus; very rarely – angioedema, urticaria, dermatitis, erythema multiforme.


Musculoskeletal disorders: very rarely – arthralgia (joint pain).


General disorders: rarely-weakness, fever, temporary hair loss.


From the hepatobiliary system: very rarely – cholestatic jaundice, hepatitis, impaired liver function.


Furagin turns the urine dark yellow or brown.


To reduce side effects, it is recommended to take B vitamins, antihistamines and consume large amounts of fluids. In case of severe adverse reactions, the dose should be reduced or the drug should be discontinued.


If adverse reactions occur while taking the drug that are not specified in the instructions for medical use, you should inform your doctor about this.

Tags: Furazidine