Active substanceNitrofurantoinNitrofurantoin
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  • Dosage form: & nbsppills
    Composition:

    Composition per one tablet:

    active substance: nitrofurantoin monohydrate 100.0 mg;

    Excipients: potato starch 92.2 mg, silicon dioxide colloid 6.2 mg, calcium stearate 1.6 mg.
    Description:Round flat cylindrical with a bevel of a yellow or greenish-yellow tablet.
    Pharmacotherapeutic group:antimicrobial agent-nitrofuran
    ATX: & nbsp

    J.01.X.E.01   Nitrofurantoin

    Pharmacodynamics:Antimicrobial agent from the group of nitrofurans, primarily for the treatment of urinary tract infections. It disrupts synthesis, proteins in bacteria and the permeability of the cytoplasmic membrane. In small doses nitrofurantoin has bacteriostatic action, in large - bactericidal. The drug reaches its effective therapeutic concentration in the urinary tract, and not in the blood and tissues.Effective against Gram-positive and Gram-negative bacteria (Staphylococcus spp., Streptococcus spp., Shigella dysenteria, Shigella flexneri, Shigella boydii, Shigella sonnei, Escherichia coli, Proteus spp., Salmonella spp., Bacteroides spp.). Resistance to the drug show: Pseudomonas aeruginosa, Pseudomonas cepacia, Providencia spp., Acinetobacter spp. Nitrofurantoin is not used for urinary infections caused by gonococci, chlamydia and mycoplasmas.
    Pharmacokinetics:

    It is well absorbed in the gastrointestinal tract. Bioavailability

    - 50% (food increases bioavailability). The rate of absorption depends on the size of the crystals (the microcrystalline form is characterized by rapid solubility and absorption rate, short reach time Cmah in the urine). Connection with plasma proteins - 60%. The drug does not reach an effective therapeutic concentration in the blood and tissues of the body. Metabolised in the liver and muscle tissue. The half-life is 25-30 minutes. It is excreted completely by the kidneys (30-50% - unchanged).

    In patients with impaired renal function, the concentration nitrofurantoin in plasma and the half-life increase. If the creatinine clearance 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. In this case, the drug is not recommended.

    Nitrofurantoin displays a bolActivity in acid urine. If the urine pH is higher than 8, the drug loses its bactericidal activity.

    Penetrates through the placenta, blood-brain barrier, excreted in breast milk.

    Indications:Bacterial infections of the urinary tract: acute uncomplicated infections, severe complicated recurrent infections, prevention of urinary tract infections, t.ch. with uncomplicated chronic diseases and with urological operations or examination (cystoscopy, urinary tract catheterization, etc.).
    Contraindications:

    - hypersensitivity to nitrofurantoin, nitrofuran derivative

    or excipients of the drug

    - anuria

    - oliguria

    - chronic renal failure (creatinine clearance less than 60 ml / min)

    - deficitst glucose-6-phosphate dehydrogenase

    - porphyria

    - neuritis or polyneuropathy

    - pulmonary fibrosis

    - chronic heart failure II-III stage

    - cirrusliver, chronic hepatitis

    - pregnantlyand the period of breastfeeding

    - children under 12 years of age (dFor this dosage form)

    Pregnancy and lactation:

    The drug is contraindicated in pregnancy and during breastfeeding, because nitrofurantoin penetrates the placental barrier and is found in the parent milk.

    Dosing and Administration:

    Inside, squeezed a lot of liquid.

    Acute uncomplicated infection: adults - 100 mg 2 times a day for 7 days.

    Children over 12 years old it is possible to apply doses to ladies of adults.

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

    Severe chronic relapsing infection: Adults -100 mg 3-4 times a day for 7 days. When nausea occurs, lower the dose or stop taking it.

    Prevention of urinary tract infections, incl. with uncomplicated chronic diseases and with urological operations or examination (cystoscopy, urinary tract catheterization, etc.): Adults -100 mg per night;

    Children. DFor children under 12 years of age, the use of tablets of Furadonin 100 mg is not recommended because of the large dose of active ingredient in one tablet.

    Side effects:

    Classification of adverse reactions according to the frequency of development: very often ( 1/10); often (1/100 up to <1/10); infrequently ( 1/1000 to <1/100); rarely (1/10 000 to <1/1000); very rarely (<1/10000); * - not known (can not be determined from available data).

    Disorders from the gastrointestinal tract: often - nausea, vomiting, absence appetite, the frequency and severity of which depends on the dose. Rarely - diarrhea, pancreatitis; pain in a stomach*. The frequency of side effects decreases with taking the drug with food and a lot of liquid.

    Infectious and parasitic diseases: pseudomembranous colitis

    Impaired nervous system: often a headache. Dizziness *, asthenia *, nystagmus *, drowsiness *. Rarely - increased intracranial pressure. In some cases: in patients with insufficient liver function, anemia, diabetes mellitus, electrolyte imbalance, deficiency of B vitamins, serious peripheral polyneuropathies are possible, the first symptoms of which are numbness and burning sensation in the legs, muscle weakness. With these symptoms, the drug should be discontinued.

    Disturbances from the respiratory system, chest and mediastinal organs: acute and chronic reactions of hypersensitivity of the lungs, characterized by fever, eosinophilia, cough, chest pain, dyspnea. Interstitial changes in the lungs, bronchoobstructive syndrome. 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 fibrosis of the lungs, can develop imperceptibly in patients with prolonged therapy; Fibrosis may be irreversible, especially if therapy continues after the onset of symptoms. When the first reactions of hypersensitivity of the lungs appear, the drug should be discontinued.

    Disorders from the liver and / or bile ducts: rarely hepatitis,Cholestatic jaundice (dozonezavisimy and pass after drug withdrawal).

    Disorders from the rut and subcutaneous tissues: often allergic reactions - dermal rashes, hives, itching; in some cases - inflammation of the salivary glands, exfoliative dermatitis, polymorphic erythema.

    Violations of 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: in some cases - angioedema, anaphylaxis. In some cases - autoimmune reactions, mainly associated with chronic changes in the lungs or liver. The symptoms of this syndrome volchanochnopodobnogo - rash, eosinophilia, fever, arthralgia, eosinophilia short term, while in the blood serum, an increase of at least two parameters - antinuclear antibodies, antibodies to smooth muscle or to the glomerular basement membrane, and Coombs' test.

    Violations from the genitals and breast: in very rare cases - passing violation of spermatogenesis.

    Others: rarely - pain in the joints, reversible hair loss.

    If you notice any side effects not listed in this manual, or any of these side effects is expressed particularly strongly, should consult with your doctor about whether to continue using the drug.

    Overdose:

    Symptoms: nausea, vomiting, headaches, dizziness.

    Treatment: reception of a large amount of fluid leads to an increase in excretion of the drug with urine. Effective dialysis.
    Interaction:Antacids and adsorbents reduce the absorption of nitrofurantoin.

    Antifungal agents (probenecid and sulfinpyrazone) reduce efficacy and increase the risk of nitrofurantoin toxicity.

    In vitro nitrofurantoin weakens the antibacterial action of drugs of the quinolone group (nalidixic acid, fluoroquinolones). The simultaneous use of these drugs should be avoided.

    The antibacterial effect of nitrofurantoin decreases in an alkaline environment, so recommend combining nitrofurantoin with drugs that raise the pH of urine (sodium hydrogen carbonate).

    Special instructions:

    Caution should be observed in anemia, diabetes, electrolyte imbalance, deficiency of B vitamins and folic acid, lung diseases, insufficiency liver, as well as with the propensity to develop peripheral neuropathies (itching of the hands or feet, numbness).

    With prolonged therapy, it is necessary to monitor lung function, especially in elderly patients who may have impaired lung function.

    With prolonged therapy, liver function should be monitored. There are isolated cases of cholestatic jaundice and chronic hepatitis.

    In patients with impaired renal function, the concentration of nitrofurantoin in the plasma and the half-life increase. If creatinine clearance is less than 60 ml / min, the therapeutic concentration of nitrofurantoin in urine is not achieved, cumulation is possible active substance and an increased risk of toxicity. In this case, the drug is not recommended.

    Furadonin can stain urine in a dark yellow or brown color.

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

    Treatment with furadonin can lead to the emergence of resistant microorganisms.
    During treatment, you should not drink alcoholic beverages.
    Effect on the ability to drive transp. cf. and fur:

    Furadonin is not affected on the ability to drive a vehicle, But people with dizziness, headache or other side effects from the central nervous system should be careful.

    Form release / dosage:

    Tablets of 100 mg.

    For 10 tablets in a contour mesh package, from a polyvinylchloride film of white color and aluminum foil.

    2 contour squares, together with instructions for use, are placed in a pack of cardboard.
    Storage conditions:

    List B. In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.
    Shelf life:5 years. Do not use the product after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N016135 / 01
    Date of registration:24.11.2009
    The owner of the registration certificate:Olainfarm, AOOlainfarm, AO Latvia
    Manufacturer: & nbsp
    Representation: & nbspOLAINFARM JSC OLAINFARM JSC Latvia
    Information update date: & nbsp10.03.2015
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