Furamag^® (Capsules) Instructions for Use

Marketing Authorization Holder

Onlinepharm, JSC (Latvia)

ATC Code

J01XE03 (Furazidin)

Active Substance

Furazidin (BP British Pharmacopoeia)

Dosage Form

Furamag®

Capsules 50 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 3, yellow in color; the capsule contents are a powder ranging from orange-brown to reddish-brown, with the possible presence of white, orange, and orange-brown particles.

Excipients: magnesium hydroxycarbonate – 50 mg, talc – 3 mg, corn starch – 2.5 mg, sodium stearyl fumarate – 0.5 mg.

Composition of hard gelatin capsule No. 3: titanium dioxide (E171) – 1.32%, quinoline yellow dye (E104) – 1.2%, gelatin – 97.48%.

10 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug, a derivative of nitrofuran

Pharmacotherapeutic Group

Antimicrobial agent – nitrofuran

Pharmacological Action

Broad-spectrum antimicrobial agent belonging to the group of nitrofurans.

Resistance to furazidin develops slowly and does not reach a high degree.

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

Resistant to the drug: Pseudomonas aeruginosa, Enterococcus spp., Acinetobacter spp., most strains of Proteus spp., Serratia spp.

The mechanism of action is associated with the inhibition of nucleic acid synthesis.

Depending on the concentration, it exerts a bactericidal or bacteriostatic effect.

Against Staphylococcus spp., Escherichia coli, Aerobacter aerogenes, Bacterium citrovorum, Proteus mirabilis, Proteus morganii, Furazidin is more active compared to other nitrofurans.

Furazidin exhibits higher activity against Enterococcus faecalis, Staphylococcus spp. compared to other groups of antibacterial drugs.

For most bacteria, the bacteriostatic concentration ranges from 1:100,000 to 1:200,000. The bactericidal concentration is approximately 2 times higher.

Under the influence of nitrofurans, microorganisms experience suppression of the respiratory chain and the tricarboxylic acid cycle (Krebs cycle), as well as inhibition of other biochemical processes of microorganisms, resulting in the destruction of their cell wall or cytoplasmic membrane.

As a result of the action of nitrofurans, microorganisms release fewer toxins, which is why an improvement in the patient’s general condition is possible even before significant suppression of microbial growth. Unlike many other antimicrobial agents, nitrofurans do not suppress the immune system but, on the contrary, activate it: they increase the complement titer and the ability of leukocytes to phagocytize microorganisms. Nitrofurans in therapeutic doses stimulate leukopoiesis.

Pharmacokinetics

Absorption

After oral administration, Furazidin is absorbed in the small intestine by passive diffusion. The absorption of nitrofurans from the distal segment of the small intestine is 2 and 4 times higher than from the proximal and medial segments, 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 for 3 to 7 or 8 hours; Furazidin is detected in urine after 3-4 hours.

Distribution

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

Metabolism

It undergoes minor biotransformation (<10%).

Excretion

Unlike nitrofurantoin (Furadonin), after taking furazidin, the urine pH does not change. Four hours after taking the drug, the concentration of furazidin in the urine significantly exceeds the concentration that occurs after taking the same dose of furagin.

It is excreted by the kidneys through glomerular filtration and tubular secretion (85%), partially undergoing 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 may enhance the development of systemic side effects. With an alkaline urine reaction, the excretion of furazidin is enhanced.

Pharmacokinetics in special clinical cases

With reduced renal excretory function, the intensity of metabolism increases.

Indications

Infections caused by microorganisms sensitive to furazidin:

• Urogenital infections (acute cystitis, urethritis, pyelonephritis);
• Gynecological infections;
• Skin and soft tissue infections;
• Severe infected burns;
• For prophylactic purposes in urological operations (including cystoscopy, catheterization).

ICD codes

Dosage Regimen

Take orally after meals with plenty of fluid.

Adults – 50-100 mg 3 times/day.

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.

For prophylaxis of infection during urological operations, cystoscopy, catheterization, etc. –adults 50 mg.

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

Adverse Reactions

From the digestive system rarely – nausea, vomiting, loss of appetite, impaired liver function.

From the nervous system rarely – headache, dizziness, polyneuritis.

Allergic reactions rarely – skin rash (including papular eruptions).

Contraindications

• Hypersensitivity to furazidin and nitrofuran derivatives;
• Severe chronic renal failure (GFR < 30 ml/min);
• Polyneuropathy (including diabetic);
• Porphyria;
• Pregnancy;
• Breastfeeding period;
• Children and adolescents under 18 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

Contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in hepatic impairment.

Use in Renal Impairment

Contraindicated in severe chronic renal failure (GFR < 30 ml/min).

Use with caution in mild to moderate renal impairment.

Toxic phenomena resulting from the use of furazidin are more common in patients with reduced renal excretory function (the intensity of furazidin metabolism increases).

Pediatric Use

Contraindicated in children and adolescents under 18 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, this medication should be taken with plenty of fluid.

If side effects occur, the use of this medication should be discontinued (toxic phenomena are more common in patients with reduced renal excretory function).

During treatment, the patient is advised to refrain from consuming alcoholic beverages, as side effects may be enhanced.

Effect on ability to drive vehicles and operate machinery

No effect on the ability to drive vehicles and operate machinery has been noted.

Drug Interactions

Furazidin should not be used simultaneously with ristomycin, chloramphenicol, sulfonamides (increased risk of hematopoiesis suppression).

It is not recommended to prescribe 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

Rx Only

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.