Furadonin, tablets 100 mg 20 pcs

Pharmacotherapeutic group

An antimicrobial agent – nitrofuran

ATX code

J01XE01

Pharmacodynamics:

An antimicrobial 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 bacteriostatic action and in large doses it has bactericidal action.

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 is 50% (food increases bioavailability). Absorption rate depends on the size of the crystals.

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

The drug is metabolized in the liver and muscle tissue.

The elimination half-life (T1/2) is 20-25 minutes. It is completely eliminated by the kidneys (30-50% – unchanged).

In patients with impaired renal function the plasma concentrations of nitrofurantoin and T1/2 are increased.

If creatinine clearance (CK) is less than 60 ml/min therapeutic urinary concentration of nitrofurantoin is not achieved there may be cumulation of the active substance and increased risk of toxicity.

Nitrofurantoin shows greater activity in acidic urine. If the pH of the urine is higher than 8, the drug loses its bactericidal activity.

Indications

Active ingredient

Composition

Per tablet:

Active ingredient: Nitrofurantoin (furadonin) – 100.0 mg.

Excipients: potato starch – 92.3 mg, colloidal anhydrous silica – 4.0 mg, stearic acid – 2.0 mg, polysorbate (tween-80) – 1.7 mg.

How to take, the dosage

The drug is taken orally with meals with plenty of fluids.

Adults and children over 12 years:

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

The symptoms may disappear before the infection is cured, and the disease may get worse again if the medicine is stopped.

In severe complicated recurrent infections, 100 mg (1 tablet) 3-4 times a day for 7 days. If nausea occurs, the dose should be reduced or discontinued.

Prophylaxis of urinary tract infections, including in uncomplicated chronic diseases and during urological operations or examination (cystoscopy, urinary tract catheterization, etc.) – 100 mg (1 tablet) at night.

In children under 12 years of age: It is not recommended because of the high dose of active substance in one tablet.

Interaction

Antacids and adsorbents reduce absorption of nitrofurantoin.

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

The uric acid promoters (probenecid and sulfinpyrazone) can block renal tubular secretion and so reduce nitrofurantoin concentrations in the urine (decreased antibacterial effect) and increase concentrations in the blood (increased toxicity).

The antibacterial activity of nitrofurantoin is reduced in an alkaline environment so it is not recommended to combine nitrofurantoin with drugs that increase urine pH (sodium hydrogen carbonate).

Special Instructions

The incidence of gastrointestinal side effects is reduced when the drug is taken with food and plenty of fluids.

Cautions should be taken if there is anemia, diabetes, electrolyte imbalance, vitamin B group and folic acid deficiency, liver disease, and if there is a tendency to develop peripheral neuropathies (itching of the hands or feet with numbness).

The drug should be discontinued at the first signs of peripheral neuropathy (paresthesias) because this complication can be life-threatening.

In case of the first hypersensitivity reactions of hepatitis or blood disorders, the drug should be stopped and appropriate measures taken.

Long-term treatment should monitor lung function, especially in elderly patients who may have decreased lung function (see section on side effects).

Long-term treatment should monitor liver function (see “Contraindications” and “Side effects”).

If the CK < 60 ml/min urinary therapeutic concentration of nitrofurantoin is not achieved, there may be cumulation of the active substance and an increased risk of toxicity (see section “Contraindications”).

The drug should be discontinued if there are signs of hemolysis in patients with suspected glucose-6-phosphate dehydrogenase deficiency.

Nitrofurantoin may stain urine dark yellow or brown.

Nitrofurantoin should not be used to treat cortical kidney disease purulent paranephritis prostatitis.

Nitrofurantoin should not be used to treat pyelonephritis which is accompanied by parenchymal inflammation or perirenal inflammation.

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

The treatment with nitrofurantoin may lead to the emergence of resistant microorganisms.

Patients receiving nitrofurantoin may experience false positive reactions when determining glucose in the urine.

Do not drink alcoholic beverages during treatment.

We should be careful during treatment to drive vehicles and engage in other potentially dangerous activities that require increased concentration and quick psychomotor reactions due to the side effects on the nervous system.

Contraindications

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

– Chronic renal failure (CK <60 ml/min) oliguria anuria;

– chronic heart failure degree II-III;

– glucose-6-phosphate dehydrogenase deficiency;

– cirrhosis of the liver chronic hepatitis;

– pulmonary fibrosis;

– acute porphyria;

– neuritis or polyneuropathy;

– pregnancy;

– period of breastfeeding;

– childhood under 12 years (for this dosage form).

In diabetes, anemia, electrolyte imbalance, vitamin B deficiency, liver failure, lung disease, a tendency to develop peripheral neuropathies (itching of the hands and feet numbness).

Side effects

The incidence of adverse reactions noted with nitrofurantoin is as follows: Very common (> 1/10) common (> 1/100 < 1/10) infrequent (> 1/1000 < 1/100) rare (> 1/10 000 < 1/1000) very rare (< 1/10 000) and frequency unknown (cannot be estimated from available data).

Infectious and parasitic diseases:

frequency unknown – pseudomembranous colitis superinfection of the urogenital 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.

Disorders of the immune system:

very rarely – lupus-like syndrome (rash eosinophilia fever arthralgia) with an increase in two or more parameters in the serum – antinuclear antibodies antibodies to smooth muscle or to the basal membrane of the glomerules and Coombs reaction. In some cases – angioedema anaphylaxis autoimmune reactions associated with chronic changes in the lungs or liver.

Disorders of the nervous system:

often – headache;

rarely – increased intracranial pressure;

frequency unknown – dizziness asthenia nystagmus somnolence; peripheral polyneuropathy (including optic neuritis) the first symptoms of which are numbness and burning sensation in the legs muscle weakness.

Disorders of the respiratory system of the thorax and mediastinum:

very rare: acute and chronic pulmonary hypersensitivity reactions characterized by fever eosinophilia cough chest pain dyspnea (“nitrofurantoin pneumonia”) interstitial changes in the lungs bronchoobstructive syndrome pleurisy. Pulmonary infiltrates or thickening and pleural effusions may appear within hours or days of starting therapy; they usually resolve after stopping the drug. 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 contraindications).

Gastrointestinal disorders:

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-dependent and resolves after discontinuation of the drug).

Skin and subcutaneous tissue disorders:

often – allergic reactions (skin rashes urticaria pruritus);

very rarely – exfoliative dermatitis erythema multiforme.

Gender and mammary gland disorders:

very rare – transient impairment of spermatogenesis.

Other:

rarely – pain in the joints reversible hair loss.

Overdose

Symptoms: nausea vomiting headache dizziness.

Treatment: ingestion of large amounts of fluid leads to increased excretion of nitrofurantoin in the urine. Dialysis is effective.

Pregnancy use

The drug is contraindicated during pregnancy.

Breast-feeding should be stopped if the drug has to be used during lactation.

Similarities