Nitroxoline (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
Systemic antibacterial agents; other antibacterial agents
Pharmacological Action
An antimicrobial agent, a derivative of 8-hydroxyquinoline. The mechanism of action is associated with the 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, 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 predominantly 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 manipulations (catheterization, cystoscopy) in the postoperative period during surgical interventions on the kidneys and urinary tract.
ICD codes
| ICD-10 code | Indication |
| N10 | Acute tubulointerstitial nephritis (acute pyelonephritis) |
| N11 | Chronic tubulointerstitial nephritis (chronic pyelonephritis) |
| N30 | Cystitis |
| N34 | Urethritis and urethral syndrome |
| N41 | Inflammatory diseases of prostate |
| N45 | Orchitis and epididymitis |
| Z29.2 | Other prophylactic chemotherapy (administration of antibiotics for prophylactic purposes) |
| ICD-11 code | Indication |
| GA91.Z | Inflammatory and other diseases of prostate, unspecified |
| GB02.Z | Orchitis or epididymitis, unspecified |
| GB50 | Acute tubulo-interstitial nephritis |
| GB51 | Acute pyelonephritis |
| GB55.Z | Chronic tubulo-interstitial nephritis, unspecified |
| GB5Z | Renal tubulo-interstitial diseases, unspecified |
| GC00.Z | Cystitis, unspecified |
| GC02.Z | Urethritis and urethral syndrome, unspecified |
| QC05.Y | Other specified prophylactic measures |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and 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, a 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 diseases, 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 the lactation (breastfeeding) period.
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, the 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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Coated tablets, 50 mg: 50 pcs.
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
Irbit Chemical Pharmaceutical Plant, JSC (Russia)
Or
Avexima Siberia LLC (Russia)
Dosage Form
 |
Nitroxoline | Coated tablets, 50 mg: 50 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets light orange or orange in color, round, biconvex; the cross-section shows three layers: the inner layer is from yellow to grayish-yellow, a slightly greenish tint is allowed; the middle layer is white and the outer layer is from light orange to orange.
| 1 tab. | |
| Nitroxoline | 50 mg |
Excipients: lactose monohydrate – 18.8 mg, potato starch – 26 mg, colloidal silicon dioxide – 0.6 mg, talc – 2.8 mg, calcium stearate – 0.9 mg, polysorbate 80 (tween 80) – 0.9 mg.
Shell composition: sucrose – 83.13 mg, magnesium hydroxycarbonate – 10.77 mg, povidone K17 – 1.66 mg, colloidal silicon dioxide – 0.81 mg, talc – 0.3 mg, titanium dioxide – 2.82 mg, tropaeolin O dye – 0.18 mg, azorubine dye (acid red 2C for pharmaceutical purposes) – 0.03 mg, beeswax – 0.3 mg.
10 pcs. – contour cell packs (5) – cardboard packs.
50 pcs. – dark glass jars (1) – cardboard packs.
Coated tablets, 50 mg: 50 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Nitroxoline | Coated tablets, 50 mg: 50 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Nitroxoline | 50 mg |
50 pcs. – dark glass jars (1) – cardboard packs.
Coated tablets 50 mg: 10, 20, 30, 40 or 50 pcs.
Marketing Authorization Holder
Tatkhimpharmpreparaty, JSC (Russia)
Dosage Form
|
Nitroxoline | Coated tablets 50 mg: 10, 20, 30, 40 or 50 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets from orange to brownish-orange in color, round, biconvex; the cross-section shows three layers; marbling of the tablet surface is allowed.
| 1 tab. | |
| Nitroxoline | 50 mg |
Excipients: lactose monohydrate, potato starch, colloidal silicon dioxide (aerosil), talc, calcium stearate.
Shell composition: sucrose, basic magnesium carbonate, colloidal silicon dioxide (aerosil), titanium dioxide, povidone K-17 (low molecular weight polyvinylpyrrolidone), beeswax, orange yellow dye (sunset yellow, orange-yellow S) E110, talc.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
Coated tablets 50 mg: 10, 25, 30, 40, 50 or 100 pcs.
Marketing Authorization Holder
Uralbiopharm, JSC (Russia)
Dosage Form
|
Nitroxoline-UBF | Coated tablets 50 mg: 10, 25, 30, 40, 50 or 100 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Nitroxoline | 50 mg |
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – contour cell packs.
10 pcs. – contour cell packs (paper with polymer coating/PVC).
10 pcs. – contour cell packs (5) (paper with polymer coating/PVC) – cardboard packs.
25 pcs. – polymer jars.
30 pcs. – polymer jars.
40 pcs. – polymer jars.
50 pcs. – polymer jars.
60 pcs. – polymer jars.
100 pcs. – polymer jars.
![Nitroxoline [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Nitroxoline [Tablets] 2")