Furazibakt^® (Powder) Instructions for Use

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

D06BX (Other chemotherapeutic preparations for topical use)

Active Substance

Furazidin (BP British Pharmacopoeia)

Dosage Form

Furazibakt®

Powder for solution for topical and external use 100 mg/1 g: sachet 5, 10, 15, 20 and 30 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for topical and external use – a mixture of coarse and fine powder of a brownish-orange color; the solution of the powder is transparent from orange to reddish-orange.

Excipients : sodium chloride – 900 mg.

1 g – sachets (5) – cardboard packs.
1 g – sachets (10) – cardboard packs.
1 g – sachets (15) – cardboard packs.
1 g – sachets (20) – cardboard packs.
1 g – sachets (30) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial and antiprotozoal drug for external and topical use. Nitrofuran derivative

Pharmacotherapeutic Group

Antimicrobial agent, nitrofuran derivative

Pharmacological Action

Broad-spectrum antimicrobial agent, belongs to the group of nitrofurans. The mechanism of action is associated with the inhibition of nucleic acid synthesis. Under the influence of nitrofurans, the activity of the respiratory chain and the tricarboxylic acid cycle (Krebs cycle) is suppressed, as well as other biochemical processes of microorganisms are inhibited, which leads to the destruction of their cell wall or cytoplasmic membrane.

Active against gram-positive cocci Staphylococcus spp., Streptococcus spp.; gram-negative rods Escherichia coli, Salmonella spp., Shigella spp., Klebsiella spp.

Resistant to furazidin are Pseudomonas aeruginosa, Enterococcus spp., Acinetobacter spp., most strains of Proteus spp., Serratia spp.

Depending on the concentration, it has a bactericidal or bacteriostatic effect. For most bacteria, the bacteriostatic concentration is from 10 to 20 µg/ml. The bactericidal concentration is approximately 2 times higher.

Pharmacokinetics

After oral administration, Furazidin is absorbed from the small intestine by passive diffusion. The absorption of nitrofurans from the distal segment of the small intestine exceeds absorption from the proximal and medial segments by 2 and 4 times, respectively (should be taken into account when simultaneously treating urogenital infections and gastrointestinal diseases, in particular chronic enteritis). Nitrofurans are poorly absorbed from the large intestine.

C_max in blood plasma persists from 3 to 7 or 8 hours, Furazidin is detected in urine after 3-4 hours.

In the body, Furazidin is distributed evenly. The high content of the drug in the lymph is clinically important (delays the spread of infection through the lymphatic pathways). Its concentration in bile is several times higher than in serum, and in cerebrospinal fluid it is several times lower than in serum. The furazidin content in saliva is 30% of its concentration in serum. The concentration of furazidin in the blood and tissues is relatively low, which is associated with its rapid excretion, while the concentration in the urine is significantly higher than in the blood.

Metabolized to a small extent (<10%).

Excreted by the kidneys through glomerular filtration and tubular secretion (85%), partially undergoes reabsorption in the tubules. At low concentrations of furazidin in the urine, the processes of filtration and secretion predominate; at high concentrations, secretion decreases and reabsorption increases. Furazidin, being a weak acid, does not dissociate in acidic urine, undergoes intensive reabsorption, which can enhance the development of systemic side effects. With an alkaline reaction of urine, the excretion of furazidin is enhanced.

With a decrease in the excretory function of the kidneys, the intensity of metabolism increases.

Indications

For oral administration: urogenital infections (acute cystitis, urethritis, pyelonephritis); gynecological infections; skin and soft tissue infections; severe infected burns; for prophylactic purposes during urological operations (including cystoscopy, catheterization).

For external and topical use: infectious and inflammatory diseases of the oral cavity and pharynx, infected wounds.

ICD codes

Dosage Regimen

For oral administration, a single dose is 25-100 mg, depending on age and indications.

The frequency of application during the day depends on the indications for use.

The course of treatment is 7-10 days. If it is necessary to repeat the course of treatment, a break of 10-15 days should be taken.

Externally 2-3 times/day for washing wounds or moistening dressing material.

Topically 2-3 times/day in the form of mouth and throat rinses.

Adverse Reactions

From the blood and lymphatic system agranulocytosis, thrombocytopenia, aplastic anemia.

From the immune system skin itching, papular rashes, angioedema, urticaria, exfoliative dermatitis, multiforme erythema.

From the nervous system dizziness, headache, drowsiness, peripheral neuropathy.

From the organ of vision visual impairment.

From the cardiovascular system intracranial hypertension.

From the respiratory system acute or chronic reaction from the lungs, which manifests as acute shortness of breath, fever, chest pain, cough with or without sputum, eosinophilia (reversible after drug withdrawal). The appearance of skin rash, itching, urticaria, angioedema and myalgia has also been reported. A chronic reaction from the lungs may occur a long time after cessation of treatment and is characterized by a gradual increase in shortness of breath, increased respiratory rate, intermittent fever, eosinophilia, progressive cough and interstitial pneumonitis and/or pulmonary fibrosis.

From the digestive system nausea, vomiting, decreased appetite, diarrhea, pancreatitis.

From the liver and biliary tract cholestatic jaundice, hepatitis.

From the musculoskeletal system arthralgia.

General disorders frequency unknown – fever, weakness, reversible alopecia, dark yellow or brown discoloration of urine.

Contraindications

Hypersensitivity to furazidin and nitrofuran derivatives; severe chronic renal failure (GFR < 30 ml/min); polyneuropathy (including diabetic); porphyria; pregnancy, breastfeeding period; for oral administration in dosage forms containing 50 mg or 100 mg of furazidin – children and adolescents under 18 years of age; for oral administration at a dose of 25 mg – children under 3 years of age; for external and topical use – children under 4 years of age.

With caution

Glucose-6-phosphate dehydrogenase deficiency, mild to moderate renal impairment, hepatic impairment, anemia, deficiency of B vitamins and folic acid, lung diseases (especially in patients over 65 years of age), diabetes mellitus.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

Contraindicated in severe chronic renal failure.

Pediatric Use

Contraindicated for oral administration in dosage forms containing 50 mg or 100 mg of furazidin – children and adolescents under 18 years of age; for oral administration at a dose of 25 mg – children under 3 years of age; for external and topical use – children under 4 years of age.

Geriatric Use

Use with caution in lung diseases, especially in patients over 65 years of age.

Special Precautions

To reduce the likelihood of side effects, Furazidin should be taken with plenty of fluid.

If side effects occur, use should be discontinued (toxic phenomena more often occur in patients with reduced renal excretory function).

During treatment, the patient is recommended to refrain from drinking alcohol, as side effects may be enhanced.

Do not take a double dose to compensate for a missed dose.

Use with caution in glucose-6-phosphate dehydrogenase deficiency.

Drug Interactions

When furazidin is combined with ristomycin, chloramphenicol, sulfonamides, the risk of hematopoiesis suppression increases (should not be used simultaneously).

It is not recommended to use drugs that can acidify urine (including ascorbic acid, calcium chloride) simultaneously with nitrofurans.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.