Composition
Per tablet:
Active ingredient: Â Nitrofurantoin (furadonin) – 100.0 mg.
Excipients: potato starch-92.3 mg, colloidal anhydrous silicon dioxide-4.0 mg, stearic acid-2.0 mg, polysorbate (twin-80) – 1.7 mg
Pharmacological action
Pharmacotherapy group
Antimicrobial agent – nitrofuran
ATX code
J01XE01
Pharmacodynamics :
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-bactericidal.
It is 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 mycoplasma.
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.
Binding to plasma proteins is 60%. Penetrates the placenta the blood-brain barrier is excreted in breast milk. Effective therapeutic concentration of the drug is achieved in the urinary tract and not in the blood and tissues.
It is metabolized in the liver and muscle tissue.
The elimination half-life (T 1/2) is 20-25 minutes. It is completely excreted by the kidneys (30-50% – unchanged).
In patients with impaired renal function, the concentration of nitrofurantoin in blood plasma and T 1/2 increases.
If creatinine clearance (CC) is less than 60 ml/min, the therapeutic concentration of nitrofurantoin in the urine is not reached, accumulation of the Active ingredient and an increased risk of toxicity may occur.
Nitrofurantoin is more active in acidic urine. If the pH of urine is higher than 8, the drug loses its bactericidal activity.
Indications
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 urological operations or examinations (cystoscopy urinary tract catheterization, etc. ).
Use during pregnancy and lactation
The drug is contraindicated during pregnancy.
If it is necessary to use the drug during lactation, breastfeeding should be discontinued.
Contraindications
– Hypersensitivity to nitrofurantoin derivative of nitrofuran or other components of the drug;
– chronic renal failure (KK <60 ml/min), anuria oliguria;
– chronic heart failure II-III degree;
– deficiency of glucose-6-phosphate dehydrogenase;
– cirrhosis of liver chronic hepatitis;
pulmonary fibrosis;
acute porphyria;
– neuritis or neuropathy;
– pregnancy;
– the period of breastfeeding;
– children’s age up to 12 years (for this dosage form).
With caution:
Diabetes mellitus anemia electrolyte imbalance B vitamin deficiency liver failure lung diseases a tendency to develop peripheral neuropathies (itching of the hands and feet numbness).
Side effects
the incidence of adverse reactions observed when taking nitrofurantoin in the following gradation: very often (> 1/10), often (> 1/100 < 1/10) uncommon (> 1/1000 < 1/100) rare (> 1/10 000 < 1/1000) very rare (< 1/10 000) and the frequency unknown (cannot be estimated on the basis of available data).
Infectious and parasitic diseases:
frequency unknown-pseudomembranous colitis superinfection of the genitourinary tract more often caused by Pseudomonas aeruginosa or Candida spp.
Disorders of 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) with an increase in two or more parameters in the blood serum-antinuclear antibodies, antibodies to smooth muscle 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.
Nervous system disorders:
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.
Respiratory, thoracic and mediastinal disorders:
very rare: acute and chronic hypersensitivity reactions 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 infiltrate or compaction and pleural effusion may appear within a few hours or days of starting therapy; after discontinuation of the drug, they usually resolve. Subacute or acute pulmonary symptoms, including pulmonary fibrosis, may develop unnoticed in patients with prolonged therapy; fibrosis may be irreversible, especially if therapy was continued after the onset of symptoms (see the section “Contraindications”).
Disorders of the gastrointestinal tract:
often – nausea vomiting lack of appetite;
rarely-diarrhea abdominal pain pancreatitis inflammation of the salivary glands.
Liver and / or biliary tract disorders:
rarely – hepatitis cholestatic jaundice (dose-independent and disappear after discontinuation of the drug).
Skin and subcutaneous tissue disorders:
often-allergic reactions (skin rashes, urticaria, pruritus);
very rarely – exfoliative dermatitis, erythema multiforme.
Genital and breast disorders:
very rarely-passing violation of spermatogenesis.
Other services:
rarely-joint pain reversible hair loss.
Interaction
Antacids and adsorbents reduce the absorption of nitrofurantoin.
The simultaneous use of nitrofurantoin and quinolone preparations (nalidixic acid fluoroquinolones) leads to a decrease in the antibacterial effect of the latter.
Drugs that promote the elimination of uric acid (probenecid and sulfinpyrazone) can block the secretion of 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 decreases in an alkaline environment, so it is not recommended to combine nitrofurantoin with drugs that increase the pH of urine (Sodium hydrocarbonate).
How to take, course of use and dosage
The drug is taken orally with meals. wash it down with plenty of liquid.
Adults and children over 12 years of age:
For acute uncomplicated urinary tract infections-100 mg (1 tablet) 2 times a day. The course of treatment is 7 days.
The symptoms of the disease may disappear before the infection is cured, and if you stop using the medication, the disease may worsen again.
For severe complicated recurrent infections – 100 mg (1 tablet) 3-4 times a day for 7 days. If nausea occurs, reduce the dose or stop taking it.
Prevention of urinary tract infections, including uncomplicated chronic diseases and urological operations or examinations (cystoscopy, urinary tract catheterization, etc. ) – 100 mg (1 tablet) per night.
Children under 12 years of age: the use of the drug is not recommended due to the large dose of the Active ingredient in one tablet.
Overdose
Symptoms: nausea vomiting headache dizziness.
Treatment: taking large amounts of fluids leads to increased excretion of nitrofurantoin in the urine. Dialysis is effective.
Special instructions
The frequency of side effects from the gastrointestinal tract decreases when taking the drug with food and a large amount of liquid.
Caution should be observed in cases of anemia diabetes mellitus electrolyte imbalance B vitamins and folic acid deficiency 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 at the first sign of peripheral neuropathy (paresthesia). since the development of this complication can be life-threatening.
When the first hypersensitivity reactions occur, hepatitis develops, 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
The drug should be discontinued if there are signs of hemolysis in patients with suspected glucose-6-phosphate dehydrogenase deficiency.
Nitrofurantoin can turn your urine dark yellow or brown.
Nitrofurantoin should not be used to treat diseases of the cortical substance of the kidneys purulent paranephritis prostatitis.
Do not take the drug for the treatment of pyelonephritis, which is accompanied by inflammation of the parenchymal tissue or perirenal inflammation.
Nitrofurantoin should not be used in combination with drugs that cause impaired renal function.
Treatment with nitrofurantoin can lead to the appearance of resistant microorganisms.
Patients receiving nitrofurantoin may experience false positive reactions when determining glucose in the urine.
Do not consume alcoholic beverages during treatment.
Influence on the ability to drive vehicles and mechanisms:
During treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions due to side effects from the nervous system.
Storage conditions
At a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf
life is 3 years.
Do not use after the expiration date indicated on the package.
Active ingredient
Nitrofurantoin
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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