FURAGIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FURAGIN (FURAGIN)

Composition:

Active substance: furagin;

1 tablet contains 50 mg of furagin;

Excipients: lactose monohydrate; sucrose; modified corn starch; stearic acid; polysorbate.

Pharmaceutical form. Tablets.

Main physicochemical properties: flat cylindrical tablets with a score line, yellow to yellow with an orange hue.

Pharmacotherapeutic group.

Antibacterial agents for systemic use. Nitrofuran derivatives. Furazidin.

ATC code J01X E03.

Pharmacological Properties

Pharmacodynamics

Furagin is a nitrofuran antibacterial agent with bacteriostatic activity. It is effective against Gram-positive (Staphylococcus epidermidis, Staphylococcus aureus, Staphylococcus faecalis) and Gram-negative bacteria (Enterobacteriaceae, Klebsiella spp., Escherichia coli). The high bacteriostatic activity of furagin 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, leading to disruption of the cytoplasmic membrane and cell wall of the bacterium.

Pharmacokinetics

Absorption. Furagin is well absorbed from the gastrointestinal tract. Absorption occurs mainly in the distal segment of the small intestine via passive diffusion (absorption is several times higher than in the proximal segment). After a single 200 mg dose, maximum plasma concentration is reached within 30 minutes, remains at this level for 1 hour, and then gradually declines. Bacteriostatic concentrations of furagin in plasma 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). Furagin is excreted primarily by the kidneys via tubular secretion (85%). About 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.

Furagin penetrates well across 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 impaired 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 or peritoneal dialysis.

Contraindicated in children (under 18 years of age).

Do not use during pregnancy and breastfeeding.

Furagin is not recommended in urosepsis and parenchymal kidney infection.

Interaction with other medicinal products and other types of interactions.

Agents that alkalinize urine reduce the therapeutic effect of Furagin (accelerate elimination of Furagin with urine).

Agents that acidify urine (acids, including ascorbic acid, as well as calcium chloride) increase the concentration of Furagin in urine (its excretion with urine is slowed), thus enhancing the therapeutic effect of the drug, but at the same time 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 elimination of furagin, increasing the risk of adverse reactions and toxicity.

Simultaneous use of Furagin and antacids (containing magnesium trisilicate) reduces absorption of Furagin.

In renal impairment, concomitant use of Furagin with aminoglycosides is not recommended.

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

Alcohol consumption is prohibited during treatment, as alcohol may intensify adverse effects (palpitations, chest pain, headache, nausea, vomiting, seizures, hypotension, 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.

Peripheral neuropathy (pain, sensory disturbances in the area supplied by the corresponding nerve) may develop during prolonged use of Furagin. If symptoms of neuropathy occur, the drug should be discontinued.

Furagin may cause polyneuropathy in patients with diabetes mellitus.

The use of Furagin 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 a decrease in sperm and ejaculate volume, reduced sperm motility, and pathological changes in sperm morphology.

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

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, discontinuation of the drug is sufficient. When administering appropriate therapy, avoid drugs that slow intestinal peristalsis. Taking Furagin with food reduces the risk of colitis development, without significantly affecting drug absorption.

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

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

The drug contains sugar, which should be taken into account when treating patients with diabetes mellitus.

If you have known intolerance to certain sugars, consult your doctor before taking this medication.

To prevent neuritis, concomitant administration of antihistamines and vitamin B complex (nicotinamide, thiamine) is advisable.

Use during pregnancy or breastfeeding.

Furagin is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The drug usually does not affect reaction speed when driving or operating machinery. However, individuals who experience dizziness, drowsiness, or other central nervous system side effects during treatment should exercise caution.

Administration and Dosage

Furagin should be taken orally, immediately after meals, with a large amount of water.

Adults: 100−200 mg (2−4 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, it should be taken as soon as the patient remembers.

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

Children

The drug should not be used in children.

Overdose

Toxic effects usually occur 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 – liver function disorders.

Treatment: discontinue the drug, increase 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

Furagin, 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; unknown (cannot be estimated from available data).

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

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

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 abruptly. 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 angioneurotic edema (facial, neck, oral cavity and laryngeal tissue swelling) have been reported simultaneously with acute pulmonary reaction. Acute pulmonary reaction is based on 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 cessation of nitrofuran therapy (including Furagin). Typical features include progressive dyspnea, tachypnea, unstable fever, eosinophilia, progressive cough, and 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 darken the urine, turning it deep yellow or brown.

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

If adverse reactions not listed in this medicinal product’s instructions occur during treatment, the physician must be informed immediately.

Shelf life.

5 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

10 tablets in a blister. 3 blisters in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

JSC "Olfa" / Olpha AS.

Manufacturer's address and place of business.

Rupnicu iela 5, Olaine, Olaines novads, LV-2114, Latvia.