5-NOK^® (Tablets) Instructions for Use

ATC Code

J01XX07 (Nitroxoline)

Active Substance

Nitroxoline (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibacterial drug, a derivative of 8-hydroxyquinoline. Urinary antiseptic

Pharmacotherapeutic Group

Antimicrobial agent, oxyquinoline

Pharmacological Action

Antimicrobial agent, a derivative of 8-hydroxyquinoline. The mechanism of action is associated with selective inhibition of bacterial DNA synthesis.

Nitroxoline is active against gram-positive bacteria: Staphylococcus spp. (including Staphylococcus aureus), Streptococcus spp. (including β-hemolytic streptococci, Streptococcus pneumoniae, Enterococcus faecalis), Corynebacterium diphtheriae, Bacillus subtilis; gram-negative bacteria: Neisseria gonorrhoeae, Escherichia coli, Proteus spp., Klebsiella spp., Salmonella spp., Shigella spp., Enterobacter spp.

Nitroxoline is also active against Mycobacterium tuberculosis, Trichomonas vaginalis, and some types of fungi (Candida spp., dermatophytes, molds, some causative agents of deep mycoses).

Pharmacokinetics

After oral administration, it is highly absorbed from the gastrointestinal tract.

It is excreted by the kidneys unchanged. High concentrations of nitroxoline are determined in the urine.

Indications

Infectious and inflammatory diseases primarily of the urinary tract (including pyelonephritis, cystitis, urethritis, epididymitis, infected adenoma or carcinoma of the prostate gland), caused by microorganisms sensitive to nitroxoline. Prevention of infectious complications during diagnostic and therapeutic procedures (catheterization, cystoscopy) in the postoperative period during surgical interventions on the kidneys and urinary tract.

ICD codes

Dosage Regimen

Tablets

For adults, the dose is 600-800 mg/day. The frequency of administration is 3-4 times/day with an interval of 6-8 hours. The course of treatment is 10-14 days.

The maximum daily dose is 1-1.2 g.

For children, the dose is 10-30 mg/kg/day in 3-4 doses.

For chronic recurrent processes, the course of treatment is several months.

Adverse Reactions

From the digestive system: nausea, vomiting, loss of appetite; in isolated cases – impaired liver function.

Allergic reactions: skin rash, itching.

From the CNS and peripheral nervous system: in isolated cases – ataxia, headache, paresthesia, polyneuropathy; with long-term use, one case of optic neuritis has been described.

From the cardiovascular system: in isolated cases – tachycardia.

Contraindications

Impaired renal function accompanied by oligo- or anuria, severe liver disease, glucose-6-phosphate dehydrogenase deficiency, cataract, neuritis, pregnancy, lactation, hypersensitivity to quinoline drugs.

Use in Pregnancy and Lactation

Nitroxoline is contraindicated for use during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe liver diseases.

Use in Renal Impairment

Contraindicated in impaired renal function accompanied by oligo- or anuria.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

During the use of nitroxoline, urine turns saffron-yellow.

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.