Active substanceNitrofurantoinNitrofurantoin
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  • Dosage form: & nbsppills
    Composition:

    One tablet contains

    Active substance: nitrofurantoin (furadonin) - 100 mg.

    Excipients: potato starch - 92.30 mg, silicon dioxide colloidal anhydrous - 4.00 mg, stearic acid - 2.00 mg, polysorbate-80 (tween 80) - 1.70 mg.

    Description:Round flat-cylindrical tablets of yellow or yellow with a greenish tint of color with a bevel; light marbles are allowed on the surface.
    Pharmacotherapeutic group:Antimicrobial agent - nitrofuran
    ATX: & nbsp

    J.01.X.E.01   Nitrofurantoin

    Pharmacodynamics:

    Antimicrobial agent from the group of nitrofurans, intended primarily for the treatment of urinary tract infections. Nitrofurantoin violates the synthesis of proteins in bacteria and the permeability of the cell membrane.In small doses has a bacteriostatic effect, in large - 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 infections of the urinary tract caused by gonococci, chlamydia, mycoplasmas.

    Pharmacokinetics:

    Nitrofurantoin is well absorbed in the gastrointestinal tract. Bioavailability - 50% (food increases bioavailability). The rate of absorption depends on the size of the crystals.

    Connection with blood plasma proteins - 60%. Penetrates through the placenta, blood-brain barrier, excreted in breast milk. The drug reaches its effective therapeutic concentration in the urinary tract, and not in the blood and tissues.

    Metabolised in the liver and muscle tissue.

    The half-life (T1 / 2) is 20-25 min. It is excreted completely by the kidneys (30-50% - unchanged).

    In patients with impaired renal function, the concentration of nitrofurantoin in the blood plasma and T1 / 2 increases. If creatinine clearance (CK) is less than 60 ml / min, the therapeutic concentration of nitrofurantoin in urine is not achieved, it is possible to accumulate the active substance and an increased risk of toxicity.

    Nitrofurantoin shows great activity in acid urine. If the pH of the urine is higher than 8, then the drug loses its bactericidal activity.

    Indications:Bacterial infections of the urinary tract caused by microorganisms sensitive to nitrofuranthine: acute uncomplicated infections, severe complicated recurrent infections, prevention of urinary tract infections, including in uncomplicated chronic diseases and with urological surgeries or examination (cystoscopy, catheterization of the urinary tract, etc.).
    Contraindications:

    - Hypersensitivity to nitrofurantoin, derivatives of nitrofuran or other components of the drug;

    - chronic renal failure (QC ≥60 ml / min), oliguria, anuria;

    - chronic heart failure of II - III degree;

    - deficiency of glucose-6-phosphate dehydrogenase;

    - cirrhosis of the liver, chronic hepatitis;

    - pulmonary fibrosis;

    - acute porphyria;

    - neuritis or polyneuropathy;

    - Pregnancy;

    - the period of breastfeeding;

    - Children under 12 years of age (for this dosage form).

    Carefully:

    With diabetes, anemia, electrolyte imbalance, deficiency of B vitamins,insufficiency of liver function, lung diseases, propensity to develop peripheral neuropathies (itching of hands, feet, numbness).

    Pregnancy and lactation:

    The drug during pregnancy is contraindicated.

    If you need to use the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    The drug is taken orally, with food, with plenty of liquid.

    Adults and children over 12 years of age:

    In acute uncomplicated urinary tract infections - 100 mg (1 tablet) 2 times a day. The course of treatment is 7 days.

    Symptoms of the disease may disappear before the cure for infection comes, and when the drug is discontinued the disease may become aggravated again.

    In severe complicated recurrent infections - 100 mg (1 tablet) 3-4 times a day for 7 days. When nausea occurs, lower the dose or stop taking it.

    Prevention of urinary tract infections, including uncomplicated chronic diseases and urological operations or examination (cytoscopy, urinary tract catheterization, etc.) - 100 mg (1 tablet) at night.

    Children under 12 years of age: The use of the drug is not recommended because of the large dose of active ingredient in one tablet.

    Side effects:

    The incidence of adverse reactions observed with nitrofurantoin is given in the following gradation: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 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:

    frequency unknown - pseudomembranous colitis, superinfection of the genito-urinary tract, often caused by Pseudomonas aeruginosa or Candida spp.

    Violations from the blood and lymphatic system:

    rarely - megaloblastic anemia, leukopenia, granulocytopenia or agranulocytosis, thrombocytopenia, hemolytic anemia in patients with deficiency of glucose-6-phosphate dehydrogenase.

    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 basal membrane of the glomeruli and the Coombs reaction. In some cases - angioedema, anaphylaxis, autoimmune reactions,associated with chronic changes in the lungs or liver.

    Impaired 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 numbness and burning sensation in the legs, muscle weakness.

    Disturbances from the respiratory system, chest and mediastinal organs:

    very rarely: 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 obstruction syndrome, pleurisy. Pulmonary infiltrate or compression and pleural effusion may occur within a few hours or days from the start of therapy; After stopping 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 continues after the onset of symptoms (see.section "Contraindications").

    Disorders from the gastrointestinal tract:

    often - nausea, vomiting, lack of appetite;

    rarely - diarrhea, abdominal pain, pancreatitis, inflammation of the salivary glands.

    Disorders from the liver and / or bile ducts:

    rarely - hepatitis, cholestatic jaundice (dozonezavisimy and pass after withdrawal of the drug).

    Disturbances from the skin and subcutaneous tissues:

    often - allergic reactions (skin rashes, hives, itching);

    very rarely - exfoliative dermatitis, erythema multiforme.

    Violations of the genitals and breast:

    very rarely - a passing violation of spermatogenesis.

    Other:

    rarely - pain in the joints, reversible hair loss.

    Overdose:

    Symptoms: nausea, vomiting, headache, dizziness.

    Treatment: taking large amounts of fluid leads to an increase in excretion of nitrofurantoin in the urine. Effective dialysis.

    Interaction:

    Antacids and adsorbents reduce the absorption of nitrofurantoin.

    The simultaneous use of nitrofurantoin and preparations of the quinolone group (nalidixic acid, fluoroquinolones) leads to a decrease in the antibacterial action of the latter.

    The agents 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).

    Antibacterial effect of nitrofurantoin decreases in alkaline environment, therefore, it is not recommended to combine nitrofurantoin with drugs that raise the pH of urine (sodium hydrogen carbonate).

    Special instructions:

    The frequency of side effects from the gastrointestinal tract decreases when taking the drug with food and plenty of fluid.

    Caution should be observed in anemia, diabetes, electrolyte imbalance, deficiency of B vitamins and folic acid, lung diseases, liver failure, and peripheral neuropathy (itchy hands or feet, numbness).

    The drug should be discontinued with the first signs of peripheral neuropathy (the emergence of paresthesias), since the development of this complication can be life threatening.

    When the first reactions of hypersensitivity of the lungs appear, the development of hepatitis, and violations by the blood, the drug should be stopped and appropriate measures taken.

    With prolonged treatment, lung function should be monitored, especially for elderly patients who may have impaired lung function (see section "Side effect").

    For prolonged treatment, liver function should be monitored (see "Contraindications" and "Side effects" sections).

    If the SC is less than 60 ml / min, the therapeutic concentration of nitrofurantoin in the urine is not achieved, it is possible to accumulate the active substance and an increased risk of toxicity (see the section "Contraindications").

    The drug should be discontinued if there is evidence of hemolysis 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 cortex of kidneys, purulent paranephritis, prostatitis.

    Do not take the drug to treat pyelonephritis, which is accompanied by inflammation of the parenchymal tissue or perirenal inflammation.

    Nitrofurantoin should not be used in combination with drugs that cause kidney dysfunction.

    Treatment with nitrofurantoin can lead to the emergence of resistant microorganisms.

    In patients receiving nitrofurantoin, there may be false-positive reactions in determining glucose in the urine.

    During treatment, you should not drink alcoholic beverages.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions, due to side effects from the nervous system.

    Form release / dosage:

    Tablets of 100 mg.

    Packaging:

    10 tablets per contour non-jawed packaging made of packaging material combined on a paper basis.

    For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 20 tablets in a glass jar for storing medicines.

    1, 2, 3, 4 or 5 contour cell packs of 10 tablets or 1 can of 20 tablets,together with instructions for medical use, put in a pack of cardboard.

    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004292
    Date of registration:15.05.2017
    Expiration Date:15.05.2022
    The owner of the registration certificate:AVEKSIMA, JSC AVEKSIMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp15.06.2017
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