Nifuratel (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmaceutical Technologies Center LLC (Russia)

Manufactured By

Mega Pharm, CJS (Russia)

Or

Pharmproekt, JSC (Russia)

ATC Code

G01AX05 (Nifuratel)

Active Substance

Nifuratel (Rec.INN registered by WHO)

Dosage Form

Nifuratel

Tablets, coated, 200 mg: 20, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets, coated white, round, biconvex.

Excipients: corn starch, rice starch, macrogol 6000, talc, magnesium stearate, gelatin, acacia gum.

Coating composition: sucrose, magnesium carbonate, titanium dioxide, wax.

10 pcs. – blister packs (2) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug, a derivative of nitrofuran

Pharmacotherapeutic Group

Antimicrobial and antiprotozoal agent – nitrofuran

Pharmacological Action

Antimicrobial drug, a derivative of nitrofuran. It has antiprotozoal, antibacterial, and antifungal action. It has low toxicity.

Highly active against Gram-positive and Gram-negative microorganisms (at MIC 12.5-25 mcg/ml it suppresses from 44.3% to 93.2% of cultures).

Active against Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Shigella flexneri, Shigella sonnei, Salmonella typhi, Salmonella typhimurium, Salmonella enterica, Klebsiella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Morganella spp., Rettgerella spp., Pragia fontium, Budvicia aquatica, Rachnella aquatilis, Acinetobacter spp., other atypical enterobacteria, as well as protozoa (including against the causative agents of intestinal amoebiasis and giardiasis), fungi of the genus Candida, Trichomonas vaginalis; less active against Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa. Suppresses the activity of Lactobacillus acidophilus.

It is the drug of choice for the therapy of salmonellosis, shigellosis, and other intestinal bacterial infections.

Especially effective against Helicobacter pylori strains resistant to metronidazole.

Pharmacokinetics

After administration, it is rapidly absorbed from the gastrointestinal tract. Penetrates the blood-brain barrier and the placental barrier, excreted in breast milk. Biotransformed in the liver and in muscle tissue. Completely excreted in the urine (30-50% unchanged).

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to nifuratel: vulvovaginal infections; urinary tract infections; intestinal amoebiasis; giardiasis; chronic inflammatory diseases of the upper gastrointestinal tract associated with Helicobacter pylori.

ICD codes

Dosage Regimen

Administer orally. The dosage is determined by the indication, patient age, and body weight.

For adults, the typical single dose is 200 mg to 400 mg.

For children, calculate the single dose based on 10 mg/kg to 30 mg/kg of body weight.

For vulvovaginal candidiasis and trichomoniasis, take 200 mg three times daily for 7 to 10 days.

For urinary tract infections (cystitis, urethritis, pyelonephritis), take 400 mg two to three times daily for 7 to 14 days.

For intestinal amoebiasis, take 400 mg two to three times daily for 10 days.

For giardiasis, take 400 mg two to three times daily for 7 to 10 days.

For Helicobacter pylori eradication, use 400 mg twice daily as part of a combination therapy regimen for 10 to 14 days.

Adjust the frequency of administration and treatment duration based on clinical response and severity of infection.

Take tablets with a sufficient amount of water, preferably during or after a meal.

Adverse Reactions

From the digestive system: nausea, vomiting, bitter taste in the mouth, diarrhea, heartburn, stomach pain.

Allergic reactions: skin rash, itching.

Contraindications

Hypersensitivity to nifuratel.

Use in Pregnancy and Lactation

Use during pregnancy is possible only for strict indications, when the intended benefit to the mother outweighs the potential risk to the fetus, because Nifuratel penetrates the placental barrier.

If it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be decided, because Nifuratel is excreted in breast milk.

Special Precautions

When treating vaginal infections, local therapy is carried out simultaneously with the oral administration of nifuratel.

During treatment, sexual intercourse should be avoided.

Drug Interactions

Nifuratel enhances the antifungal effect of nystatin.

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.