One tablet contains the active substance: nitrofurantoin (furadonin) - 100 mg. Excipients: potato starch - 92.30 mg, anhydrous colloidal silicon dioxide - 4.00 mg, stearic acid - 2.00 mg, polysorbate-80 (tween-80) - 1.70 mg.
An antimicrobial agent from the group of nitrofurans, intended primarily for the treatment of urinary tract infections. Nitrofurantoin disrupts protein synthesis in bacteria and cell membrane permeability. In small doses it has a bacteriostatic effect, in large doses it is bactericidal. Effective against gram-positive and gram-negative bacteria (Staphylococcus spp., Streptococcus spp., Shigella dysenteria, Shigella flexneri, Shigella boydii, Shigella sonnei, Escherichia coli., Proteus spp.). Resistant to nitrofurantoin: Pseudomonas aeruginosa, Pseudomonas cepacia, Providencia spp., Acinetobacter spp. Nitrofurantoin is not used for urinary tract infections caused by gonococci, chlamydia, mycoplasmas.
Nitrofurantoin is well absorbed in the gastrointestinal tract. Bioavailability - 50% (food increases bioavailability). The absorption rate depends on the size of the crystals. Communication with blood plasma proteins - 60%. Penetrates through the placenta, the blood-brain barrier, excreted in breast milk. The drug reaches an effective therapeutic concentration in the urinary tract, and not in the blood and tissues. Metabolized in the liver and muscle tissue. The half-life (T1 / 2) is 20-25 minutes. It is excreted completely by the kidneys (30-50% - unchanged). In patients with impaired renal function, the concentration of nitrofurantoin in blood plasma and T1 / 2 increase. If creatinine clearance (CC) is less than 60 ml / min, a therapeutic concentration of nitrofurantoin in the urine is not achieved, the accumulation of the active substance and an increased risk of toxicity are possible. Nitrofurantoin is more active in acid urine. If the urine pH is above 8, then the drug loses bactericidal activity.
The frequency of adverse reactions observed with nitrofurantoin is given in the following gradation: very often (greater than or equal to 1/10), often (greater than or equal to 1/100, <1/10), infrequently (greater than or equal to 1/1000, <1/100), rarely (greater than or equal to 1/10 000, <1/1000), very rarely (<1/10 000) and the frequency is unknown (it is impossible to estimate based on available data). Infectious and parasitic diseases: the frequency is unknown - pseudomembranous colitis, urogenital tract superinfection, often caused by Pseudomonas aeruginosa or Candida spp. Disorders from the blood and lymphatic system: rarely - megaloblastic anemia, leukopenia, granulocytopenia or agranulocytosis, thrombocytopenia, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency. Immune system disorders: very rarely - lupus-like syndrome (rash, eosinophilia, fever, arthralgia), while in the blood serum there is an increase in two or more parameters - antinuclear antibodies, antibodies to smooth muscles or to the glomerular basement membrane and the Coombs reaction. In some cases, angioedema, anaphylaxis, autoimmune reactions associated with chronic changes in the lungs or liver. Disorders from the nervous system: often - headache; rarely - increased intracranial pressure; frequency unknown - dizziness, asthenia, nystagmus, drowsiness; peripheral polyneuropathy (including optic neuritis), the first symptoms of which are a feeling of numbness and burning in the legs, muscle weakness. Disorders of the respiratory system, chest and mediastinal organs: very rare: acute and chronic reactions of hypersensitivity of the lungs, characterized by fever, eosinophilia, cough, chest pain, shortness of breath ("nitrofurantoin pneumonia"), interstitial changes in the lungs, bronchial obstructive syndrome pleurisy. Pulmonary infiltration or compaction and pleural effusion may appear within a few hours or days from the start of therapy; after discontinuation of the drug, they usually resolve. Subacute or acute pulmonary symptoms, including pulmonary fibrosis, can develop imperceptibly in patients with prolonged therapy; fibrosis may be irreversible, especially if therapy was continued after the onset of symptoms (see section "Contraindications"). Violations of the gastrointestinal tract: often - nausea, vomiting, lack of appetite; rarely - diarrhea, abdominal pain, pancreatitis, inflammation of the salivary glands. Violations of the liver and / or biliary tract: rarely - hepatitis, cholestatic jaundice (dose-independent and disappear after discontinuation of the drug). Disorders from the skin and subcutaneous tissues: often - allergic reactions (skin rashes, urticaria, itching); very rarely - exfoliative dermatitis, erythema polyforma. Disorders from the genitals and mammary gland: very rarely - a passing violation of spermatogenesis. Other: rarely - joint pain, reversible hair loss.
The frequency of side effects from the gastrointestinal tract decreases when taking the drug with food and plenty of fluids. Caution should be observed in case of anemia, diabetes mellitus, electrolyte imbalance, deficiency of B vitamins and folic acid, lung diseases, liver failure, as well as a tendency to develop peripheral neuropathies (itching of the hands or feet, numbness). The drug should be discontinued in the presence of the first signs of peripheral neuropathy (the occurrence of paresthesias), since the development of this complication can be life-threatening. When the first reactions of increased sensitivity of the lungs, the development of hepatitis, and blood disorders occur, the drug should be discontinued and appropriate measures taken. With prolonged treatment, lung function should be monitored, especially in elderly patients who may have impaired lung function (see section “Side effects”). With prolonged treatment, liver function should be monitored (see sections "Contraindications" and "Side effects"). If the CC is less than 60 ml / min, the therapeutic concentration of nitrofurantoin in the urine is not achieved, cumulation of the active substance and an increased risk of toxicity are possible (see section "Contraindications"). The drug should be discontinued if signs of hemolysis appear in patients with suspected glucose-6-phosphate dehydrogenase deficiency. Nitrofurantoin can stain urine in a dark yellow or brown color. Nitrofurantoin should not be used to treat diseases of the cortical substance of the kidneys, purulent paranephritis, prostatitis. You should not take a drug for the treatment of pyelonephritis, which is accompanied by inflammation of the parenchymal tissue or perineal inflammation. Nitrofurantoin should not be used in combination with drugs that cause impaired renal function. Treatment with nitrofurantoin can lead to the emergence of resistant microorganisms. In patients receiving nitrofurantoin, false-positive reactions may occur when determining glucose in the urine. During treatment, you can not drink alcoholic beverages. Effect of the drug on the ability to drive vehicles and mechanisms: During treatment, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions, due to side effects from the nervous system.
Bacterial urinary tract infections caused by nitrofurantoin-sensitive microorganisms: acute uncomplicated infections, severe complicated recurrent infections, prevention of urinary tract infections, including uncomplicated chronic diseases and urologic surgery or examination (cystoscopy, urinary catheterization, etc. )
- Hypersensitivity to nitrofurantoin, nitrofuran derivatives or other components of the drug; - chronic renal failure (CC? 60 ml / min), oliguria, anuria; - chronic heart failure II - III degree; - deficiency of glucose-6-phosphate dehydrogenase; - liver cirrhosis, chronic hepatitis; - pulmonary fibrosis; - acute porphyria; - neuritis or polyneuropathy; - pregnancy; - period of breastfeeding; - children's age up to 12 years (for this dosage form). Carefully: In diabetes mellitus, anemia, electrolyte imbalance, deficiency of B vitamins, liver failure, lung diseases, a tendency to develop peripheral neuropathies (itching of the hands, feet, numbness). Pregnancy and lactation: The drug is contraindicated during pregnancy. If it is necessary to use the drug during lactation, breastfeeding must be stopped.
Antacids and adsorbents reduce the absorption of nitrofurantoin. The simultaneous use of nitrofurantoin and drugs of the quinolone group (nalidixic acid, fluoroquinolones) leads to a decrease in the antibacterial effect of the latter. Means that promote the excretion of uric acid (probenecid and sulfinpyrazone) can block the secretion of the renal tubules, while the concentration of nitrofurantoin in the urine decreases (the antibacterial effect decreases) and the concentration in the blood increases (toxicity increases). The antibacterial effect of nitrofurantoin is reduced in an alkaline environment, so it is not recommended to combine nitrofurantoin with drugs that increase the pH of urine (sodium hydrogen carbonate).
|Pills in 1 package||20|
|Expiration Date (in months)||36|
|Country of origin||Russia|