Urofuragin max

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT UrofuraginMax

Composition:

Active substance: furagin;

1 tablet contains 100 mg of furagin;

Excipients: lactose monohydrate, microcrystalline cellulose silica (consisting of microcrystalline cellulose (98%) and colloidal anhydrous silicon dioxide (2%)), magnesium stearate, colloidal anhydrous silicon dioxide, sodium starch glycolate (type A).

Pharmaceutical form. Tablets.

Main physicochemical properties: yellow or yellow-orange colored tablets, round, biconvex, with a score line on one side, diameter – 10 mm.

Pharmacotherapeutic group.

Antimicrobial agents for systemic use. Nitrofuran derivatives. Furazidin.

ATC code J01X E03.

Pharmacological properties.

Pharmacodynamics.

Urofuragin Max is a nitrofuran antibacterial agent with bacteriostatic activity. It is effective against gram-positive (Staphylococcus epidermidis, Staphylococcus aureus, Staphylococcus faecalis) and gram-negative (Enterobacteriaceae, Klebsiella spp., Escherichia coli) bacteria. The high bacteriostatic activity of the drug is associated with the presence of an aromatic nitro group. Resistance to furagin develops slowly. Furagin inhibits microbial enzyme systems and other biochemical processes within the bacterial cell, thereby disrupting the cytoplasmic membrane and the bacterial cell wall.

Pharmacokinetics.

Absorption. Furagin is well absorbed from the gastrointestinal tract. Drug absorption occurs mainly from the distal segment of the small intestine via passive diffusion (absorption is several times higher than from the proximal segment). After a single 200 mg dose, maximum plasma concentration of furagin is reached within 30 minutes, remains at this level for 1 hour, and then gradually declines. Bacteriostatic plasma concentrations of furagin are maintained for 8–12 hours. Furagin binds to plasma proteins.

Metabolism/Elimination. Approximately 10% of the administered dose is biotransformed in the liver and kidneys. In case of impaired renal function, a larger portion of the administered dose undergoes biotransformation.

The elimination half-life of furagin is short (approximately 1 hour). The drug is excreted primarily by the kidneys via tubular secretion (85%). 8–13% of furagin is excreted unchanged in urine, where its concentration is many times higher than the minimum inhibitory concentration for most susceptible bacteria. The maximum concentration of furagin in urine is 5.7 µg/mL.

The drug readily crosses the placental barrier.

Clinical characteristics.

Indications.

Acute and chronic urinary tract infections: pyelonephritis, cystitis, urethritis; prostatitis; postoperative infections of the urogenital system.

Contraindications.

Hypersensitivity to furagin, to derivatives of the nitrofuran group, or to excipients of the medicinal product;

• severe renal impairment (creatinine clearance less than 30 mL/min);

− severe hepatic impairment;

• polyneuropathy (including diabetic);
• glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis);
• porphyria (diseases caused by disorders in the metabolism of hemoglobin breakdown products);
• rare congenital galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
• deficiency of sucrase/isomaltase/lactase, fructose/lactose intolerance.

Contraindicated in patients undergoing hemodialysis, including peritoneal dialysis.

Contraindicated in children (under 18 years of age).

Should not be used during pregnancy and breastfeeding.

The medicinal product Urofuragin Max is not recommended for urosepsis and kidney parenchyma infections.

Interaction with other medicinal products and other types of interactions.

Medicinal products that alkalinize urine reduce the therapeutic effect of Urofuragin Max (accelerate its excretion in urine).

Medicinal products that acidify urine (acids, including ascorbic acid, as well as calcium chloride) increase the concentration of Urofuragin Max in urine (its excretion in urine is slowed), thus enhancing the therapeutic effect of the drug, but simultaneously increasing the risk of increased toxicity.

Concomitant use with chloramphenicol, ristomycin, and sulfonamides enhances suppression of hematopoiesis.

Due to antagonism of action between furagin and quinolones (nalidixic acid, oxolinic acid, norfloxacin), simultaneous use of these drugs should be avoided.

Concomitant use of probenecid and sulfinpyrazone reduces excretion of furagin, increasing the risk of adverse reactions and toxicity.

Simultaneous administration of furagin and antacids (containing magnesium trisilicate) reduces absorption of furagin.

In renal impairment, concomitant use of the medicinal product Urofuragin Max with aminoglycosides is not recommended.

Antibacterial action of furagin is significantly enhanced when used concomitantly with antibiotics (penicillins and cephalosporins), and it combines well with tetracycline and erythromycin.

Alcohol consumption is prohibited during treatment, as alcohol may intensify adverse effects (increased heart rate, chest pain, headache, nausea, vomiting, seizures, decreased arterial pressure, fever, anxiety).

Special precautions for use.

The drug should be used with caution in the following cases:

• anemia;
• vitamin B group and folic acid deficiency;
• lung diseases.

During prolonged use of the medicinal product Urofuragin Max, peripheral neuropathy (pain, sensory disturbances in the area of the affected nerve) may develop. If symptoms of neuropathy occur, the drug should be discontinued.

In patients with diabetes mellitus, the medicinal product may cause polyneuropathy.

The use of Urofuragin Max is not recommended in cases of urosepsis and parenchymal kidney infection.

Experimental studies and clinical observations in patients have shown that nitrofurans adversely affect testicular function, manifested by decreased sperm count and ejaculate volume, reduced sperm motility, and pathological changes in sperm morphology.

Diarrhea due to suppression of normal colonic microflora may occur during furagin use.

In rare cases, pseudomembranous colitis may develop, caused by suppression of the natural rectal microflora and overgrowth of Clostridium difficile. In mild cases of pseudomembranous colitis, the drug should be discontinued. During appropriate therapy, avoid using drugs that slow intestinal peristalsis. Taking furagin with food reduces the risk of colitis, without significantly affecting drug absorption.

Laboratory testing in patients taking Urofuragin Max may yield false-positive results for glucose in urine when using the copper reduction method. Furagin does not affect the results of glucose testing in urine by the enzymatic method.

In case of prolonged therapy, regular blood tests (leukocyte count), monitoring of liver and kidney function, and lung function assessment should be performed, especially in patients aged 65 years and older.

Urofuragin Max contains lactose monohydrate.

If intolerance to certain sugars is established, consult a physician before taking this medicinal product.

To prevent neuritis, it is advisable to take antihistamines and vitamin B complex (nicotinamide, thiamine) concomitantly.

Urofuragin Max contains sodium. The medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is practically sodium-free.

Use during pregnancy or breastfeeding.

The medicinal product Urofuragin Max is contraindicated during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Generally, the medicinal product does not affect reaction speed while driving or operating machinery. However, patients who experience dizziness, drowsiness, or other central nervous system adverse reactions during treatment should exercise caution.

Dosage and Administration

The medicinal product Urofuragin Max should be taken orally, immediately after meals, with a large amount of water.

Adults: 100−200 mg (1−2 tablets) 2−3 times daily. The treatment course lasts 7−10 days, depending on the severity of the disease, treatment efficacy, and renal function. If necessary, the treatment course may be repeated after 10−15 days.

Maximum daily dose – 600 mg.

If a dose is missed, the next dose should be taken as soon as the patient remembers.

Do not take a double dose to make up for a missed dose.

Children.

The medicinal product must not be used in children.

Overdose.

Toxic effects are usually possible in patients with impaired renal function.

Symptoms: headache, dizziness, depression, peripheral polyneuritis, allergic reactions (urticaria, angioneurotic edema, bronchospasm), nausea, vomiting, hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency), megaloblastic anemia, rarely – impaired liver function.

Treatment: discontinue the drug, increased fluid intake, use of enterosorbents, antihistamines, and B-group vitamins (thiamine bromide). Symptomatic therapy. In severe cases – hemodialysis.

There is no specific antidote.

Side effects

Urofuragin Max, like other medicinal products, may cause adverse reactions, which do not occur in all patients.

Frequency of adverse reactions according to MedDRA classification: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000), including isolated cases; frequency not known (cannot be estimated from the available data).

Blood and lymphatic system disorders: very rare – blood dyscrasias (agranulocytosis, thrombocytopenia, aplastic anemia).

Immune system disorders: hypersensitivity reactions, including pruritus, rash, urticaria, angioedema.

Nervous system disorders: uncommon – dizziness, somnolence; rare – peripheral neuropathy.

Eye disorders: rare – visual disturbances.

Respiratory, thoracic and mediastinal disorders: rare – acute and chronic pulmonary reactions.

Acute pulmonary reaction develops rapidly. It is characterized by severe dyspnea, fever, chest pain, cough with or without sputum, and eosinophilia (increased number of eosinophilic granulocytes in blood). Skin rash, pruritus, urticaria, myalgia (muscle pain), and angioedema (swelling of the face, neck, tissues of the oral cavity and larynx) have been reported simultaneously with acute pulmonary reaction. Acute pulmonary reaction is based on a hypersensitivity reaction, which may develop within several hours, rarely within minutes. Acute pulmonary reaction resolves upon discontinuation of the drug. Chronic pulmonary reaction may develop after a prolonged period following discontinuation of nitrofurans (including furagin). Typical features include progressive dyspnea, tachypnea, unstable fever, eosinophilia, progressive cough, interstitial pneumonitis and/or pulmonary fibrosis.

Gastrointestinal disorders: uncommon – decreased appetite, nausea; rare – vomiting, diarrhea; very rare – pancreatitis.

Skin and subcutaneous tissue disorders: rare – papular rash, pruritus; very rare – angioedema, urticaria, exfoliative dermatitis, erythema multiforme.

Musculoskeletal and connective tissue disorders: very rare – arthralgia (joint pain).

Hepatobiliary disorders: very rare – cholestatic jaundice, hepatitis.

General disorders: rare – weakness, increased body temperature, temporary hair loss.

Furagin may discolor urine to dark yellow or brown.

To reduce adverse effects, it is recommended to take vitamin B complex, antihistamines, and consume large amounts of fluids. In case of pronounced adverse effects, the dose should be reduced or the drug discontinued.

If adverse reactions occur during treatment that are not listed in the instructions for medical use, a physician should be informed.

Reporting of suspected adverse reactions after drug registration is important. It allows monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, or their legal representatives should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging to protect from light.

No special storage conditions required.

Keep out of reach of children.

Packaging.

15 tablets in a blister. 1 blister per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Sp. z o.o. "Adamed Pharma", Poland.

Manufacturer's address and location of its business activity.

ul. Marszałka J. Piłsudskiego 5, 95-200 Pabianice, Poland.