Active substanceNitrofurantoinNitrofurantoin
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  • Dosage form: & nbsppills
    Composition:

    One tablet contains:

    Active substance: nitrofurantoin monohydrate - 50 mg.

    Auxiliary substances: potato starch - 46.34 mg, silicon dioxide colloid - 2.88 mg, calcium stearate - 0.78 mg.

    Description:

    The tablets are yellow or yellow with a greenish tint of color, round, flat-cylindrical with a bevel.

    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 is restored by bacterial flavoproteins to reactive compounds that inactivate or damage proteins of bacterial ribosomes and other macromolecules.As a result, aerobic respiration and the processes of protein, cell wall, DNA and RNA synthesis are violated. The multiple mechanism of action explains the weak acquired resistance of microorganisms to nitrofurans. Effective against Gram-positive and Gram-negative bacteria (Staphylococcus spp., Streptococcus spp., Shigella dysenteriae, Shigella flexneri, Shigella boydii, Shigella sonnei, Escherichia coli, Proteus spp.).
    Pharmacokinetics:

    Absorption from the gastrointestinal tract of the gastrointestinal tract is good. Bioavailability - 50% (food increases bioavailability). The rate of absorption depends on the size of the crystals. Connection with plasma proteins - 60 %. Metabolised in the liver and muscle tissue.

    The half-life of T1 / 2 is 20-25 min. Penetrates through the placenta, the blood-brain barrier of GEB, into breast milk. It is excreted completely by the kidneys (30-50% - unchanged).

    Indications:Bacterial uncomplicated urinary tract infections, including cystitis, urethritis, infection prevention in urological operations or examinations (cystoscopy, catheterization of the urinary tract, etc.).
    Contraindications:Hypersensitivity to nitrofurantoin, derivatives of nitrofuran or other components of the drug, chronic renal failure of chronic renal failure, chronic heart failure CHF II-III century, liver cirrhosis, chronic hepatitis, glucose-6-phosphate dehydrogenase deficiency, acute porphyria, anuria, oliguria, pulmonary fibrosis, pregnancy, lactation, children under 6 years (for this dosage form).
    Carefully:

    Diabetes mellitus, anemia, electrolyte disorders, deficiency of B vitamins.

    Pregnancy and lactation:

    The use of the drug during pregnancy is contraindicated.

    Breastfeeding (at the time of treatment should stop breastfeeding).
    Dosing and Administration:

    Apply inside, with food, with plenty of water. Adult patients.

    Acute uncomplicated urinary tract infections - 50 mg 4 times a day for 7 days.

    Prevention of infections during urological surgeries and examinations - adults - 100 mg at night.

    Children older than 6 years (body weight - more than 25 kg).

    Acute uncomplicated urinary tract infections - 50 mg 4 times a day for 7 days.

    For children with a body weight of less than 25 kg, the use of a drug in the form of a suspension is recommended.

    Side effects:

    From the digestive system: nausea, vomiting, abdominal pain, diarrhea, hepatitis, cholestatic syndrome, pancreatitis, pseudomembranous colitis.

    From the nervous system: dizziness, headache, asthenia, nystagmus, drowsiness, peripheral neuropathy.

    From the respiratory system: interstitial changes in the lungs, bronchial obstructive syndrome, cough, shortness of breath, chest pain, eosinophilia, interstitial pneumonia or fibrosis.

    On the part of the hematopoiesis system: leukopenia, granulesocitopenia,agranulocytosis, thrombocytopenia, hemolytic anemia, megaloblastic anemia (these changes are reversible).

    Allergic reactions: hives, Quincke's edema, itchy skin, rash; anaphylactic shock.

    Dermatological reactions: exfoliative dermatitis, multiforme erythema.

    Other: medicinal fever, arthralgia, flu-like symptoms are possible, superinfection of the genito-urinary tract, more often caused by Pseudomonas aeruginosa.

    Overdose:

    Symptom: vomiting.

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

    Interaction:

    Antibacterial effect reduces nalidixic acid, absorption - antacids, containing magnesium trisilicate. Incompatible with fluoroquinolones.The agents that promote the excretion of uric acid (probenecid, sulfinpyrazone) can inhibit the secretion of the renal tubules, while the level of nitrofurantoin in the urine decreases (decreases the antibacterial effect) and rises in the blood (toxicity increases).

    Special instructions: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. The risk of peripheral neuropathy is increased in patients with anemia, diabetes, violation of electrolyte balance, insufficiency of B vitamins, expressed by renal insufficiency.
    The drug should be discontinued if there is evidence of hemolysis in patients with suspected glucose-6-phosphate dehydrogenase deficiency.
    Nitrofurantoin should not be used to treat diseases of the cortex of the kidneys, with purulent paranephric and prostatitis.
    Nitrofurantoin is not prescribed in combination with drugs that cause renal dysfunction.
    Careful monitoring of patients receiving long-term nitrofurantoin therapy is necessary to identify signs of hepatitis. Nitrofurantoin it is advisable to take with milk or food to reduce the risk of side effects from the digestive system. After taking the drug, urine can turn yellow or brown. In patients receiving nitrofurantoin, there may be false-positive reactions in determining glucose in the urine.
    Before using the drug, consult a doctor!
    Effect on the ability to drive transp. cf. and fur:

    Nitrofurantoin may cause side effects from the central nervous system, including headache, drowsiness, dizziness. Care should be taken for those who have the above symptoms, they are not recommended during the treatment to drive vehicles or mechanisms.

    Form release / dosage:

    Pills.

    For 10 tablets per contour non-jammed packaging or contour cell packaging.

    1, 2, 3 contour non-cellular or contour cell packs, together with the instructions for use, are placed in a bundle.

    It is allowed to pack out-of-round non-cellular packages in a group container with the appropriate number of instructions for use ("For hospitals").

    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 expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001980
    Date of registration:23.01.2013
    The owner of the registration certificate:Tyumen Chemical - Pharmaceutical Plant, OJSC Tyumen Chemical - Pharmaceutical Plant, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.01.2013
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