Instructions Nitroxoline film-coated tablets 50 mg blister No. 50
Composition
active ingredient: nitroxoline;
1 tablet contains nitroxoline (calculated as 100% dry matter) – 50 mg;
excipients: potato starch, lactose monohydrate, calcium stearate, colloidal anhydrous silicon dioxide, talc;
film coating 85F35260 Opadry II Red: partially hydrolyzed polyvinyl alcohol, macrogol, talc, titanium dioxide (E 171), special red AG (E 129), sunset yellow FCF (E 110).
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a red film coating.
Pharmacotherapeutic group
Antimicrobials for systemic use. Other antibacterial agents. ATX code J01X X07.
Pharmacological properties
Pharmacodynamics.
A broad-spectrum antimicrobial and antiprotozoal drug for the treatment of urinary tract infections. Nitroxoline selectively inhibits bacterial DNA synthesis, forms complexes with metal-containing enzymes of the microbial cell and acts on both gram-positive microorganisms Staphylococcus spp. (including S.aureus), Streptococcus spp. (including beta-hemolytic streptococci, Streptococcus pneumoniae, Enterococcus faecalis), Corynebacterium spp., Bacillus subtilis, and gram-negative microorganisms N.gonorrhoeae, E.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, and some pathogens of deep mycoses).
Pharmacokinetics.
After oral administration, it is well absorbed from the digestive tract. It is excreted mainly by the kidneys in unchanged form. After a single dose of 100 mg of the drug, the minimum bacteriostatic concentration in the urine lasts up to 3 hours, after taking 400 mg - up to 7 hours.
Indication
Acute, chronic and recurrent urinary tract infections caused by gram-positive and gram-negative microorganisms and fungi sensitive to nitroxoline.
Prevention of recurrent urinary tract infections.
Before prescribing the drug, it is necessary to conduct a microbiological study to identify the infectious agent and check its sensitivity to Nitroxoline. However, if there is reason to believe that the infection is most likely caused by microorganisms sensitive to Nitroxoline, treatment can be started before receiving the results of the studies.
Contraindication
Hypersensitivity to nitroxoline or to any other component of the drug, as well as to other quinolines;
severe hepatic and renal failure (creatinine clearance less than 0.33 ml/s).
Interaction with other medicinal products and other types of interactions
Tetracycline group drugs: there is a summation of the effects of each drug, with nystatin and levorin – potentiation of the action.
Antacids containing magnesium: absorption of nitroxoline is slowed down.
Nitrofurans: simultaneous use is not possible due to the occurrence of summation of negative neurotropic effects.
Nalidixic acid: decreased effectiveness.
Hydroxyquinolines or their derivatives: should not be used concomitantly.
Application features
The drug should be prescribed with caution to patients with impaired renal function due to the possibility of nitroxoline cumulation, and to patients with cataracts.
Cases of peripheral neuritis and optic neuritis have been described with repeated and prolonged treatment with high doses of halogenated hydroxyquinoline derivatives. Nitroxoline is a quinoline nitro derivative, and such side effects have not been observed with it, however, caution is recommended when treating with nitroxoline - such patients should be under close medical supervision.
Treatment should not exceed 4 weeks without additional medical examination.
The drug contains the dye, Sunset Yellow FCF (E 110), which may cause allergic reactions, including bronchial asthma. The risk of allergy is higher in patients with hypersensitivity to acetylsalicylic acid.
The drug contains lactose, therefore patients with hereditary forms of galactose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency should not use this drug.
Since the drug is excreted by the kidneys, during treatment with nitroxoline, the urine turns saffron-yellow.
Use during pregnancy or breastfeeding
The safety and efficacy of the drug during pregnancy or breastfeeding have not been established, therefore nitroxoline should not be prescribed during these periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no evidence that the drug can negatively affect the reaction speed of drivers and people working with machinery.
Method of administration and doses
Children aged 3 to 5 years: the recommended daily dose is 200 mg (1 tablet 4 times a day).
Children over 5 years of age: the recommended daily dose is 200-400 mg (1-2 tablets 4 times a day).
The duration of the treatment course is 2-3 weeks.
Patients can take the drug continuously for 1 month. In chronic infections, the drug is prescribed in repeated courses lasting 2 weeks with a two-week break (the course of treatment can last several months).
Renal impairment: In patients with moderate renal insufficiency (creatinine clearance above 0.33 ml/s), the usual dose should be halved.
It is not recommended to prescribe the drug to patients with severe renal insufficiency (creatinine clearance less than 0.33 ml/s).
Liver dysfunction. In case of liver dysfunction, the usual dose should be halved.
Elderly patients: No dose adjustment is required.
Children
Children under 3 years of age should not use the drug in the form of film-coated tablets.
Overdose
There have been no reports of overdose. In case of overdose, symptomatic therapy is performed.
Adverse reactions
Allergic reactions: skin rashes, itching, which quickly disappear after stopping the drug; allergic reactions with the development of thrombocytopenia.
Digestive system: dyspeptic phenomena (nausea, vomiting, loss of appetite) are possible, which can be prevented by taking the drug with meals.
Nervous system: headache, ataxia, paresthesia, polyneuropathy.
Hepatobiliary system: decreased transaminase activity, impaired liver function.
Urinary system: decrease in uric acid content in blood plasma.
Other: tachycardia, general weakness.
Adverse reactions usually resolve on their own after discontinuation of the drug.
Expiration date
4 years.
Do not use the drug after the expiration date indicated on the package!
Storage conditions
In the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 5 blisters in a pack.
Vacation category
According to the recipe.
Producer
Public Joint Stock Company "Research and Production Center "Borshchagov Chemical and Pharmaceutical Plant".
Location of the manufacturer and address of its place of business
Ukraine, 03134, Kyiv, Myru St., 17.
