Nitroxoline, 50 mg 50 pcs.

Nitroxoline is a broad-spectrum antimicrobial and antiprotozoal drug for the treatment of urinary tract infections.

Nitroxoline selectively inhibits the synthesis of bacterial DNA, forms complexes with metal-containing enzymes of the microbial cell and acts both on Gram-positive microorganisms: Staphylococcus spp. (including S.aureus), Streptococcus spp. (including beta-haemolytic streptococci, Streptococcus pneumoniae, Enterococcus faecalis), Corynebacterium spp, Bacillus subtilis; and on 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, some types of fungi (Candida spp., dermatophytes, molds, some deep mycosis agents).

Pharmacokinetics

Nitroxoline is well absorbed from the digestive tract after oral administration. It is excreted mainly by the kidneys unchanged. After a single dose of 100 mg of the drug the minimum bacteriostatic concentration in the urine is retained up to 3 hours, after 400 mg – up to 7 hours.

Indications

Acute, chronic and recurrent urinary tract infections caused by nitroxolin-sensitive microorganisms: pyelonephritis, cystitis, urethritis, epididymitis, infected adenoma or carcinoma of the prostate;

Prevention of infectious complications in the post-operative period in renal and urinary tract surgical interventions as well as in diagnostic and therapeutic manipulations (catheterization, cystoscopy, after renal and urinary tract operations);

Prevention of recurrent urinary tract infections.

Active ingredient

Composition

active ingredient: nitroxoline – 50.00 mg;

excipients (core): lactose monohydrate – 18.80 mg, potato starch – 26.00 mg, colloidal silica – 0.60 mg, talc – 2.80 mg, calcium stearate – 0.90 mg, polysorbate-80 (tween-80) – 0.90 mg;

auxiliary substances (shell): saccharose – 83.13 mg, magnesium hydroxycarbonate – 10.77 mg, povidone K17 – 1.66 mg, colloidal silicon dioxide – 0.81 mg, talc – 0.30 mg, titanium dioxide – 2.82 mg, dye tropeolin 0 – 0.18 mg, dye azorubin (acid red 2C for pharmaceutical purposes) – 0.03 mg, beeswax – 0.30 mg.

How to take, the dosage

Overly, with or after meals.

The standard dose for adults and adolescents is 400 mg per day divided into 4 doses (2 tablets 4 times a day). The maximum daily dose is 800 mg per day.

The average dose for children 3-5 years old is 200 mg per day divided into 4 doses.

For children over 5 years of age: 200-400 mg per day, divided into 4 doses.

The course of treatment is 2-3 weeks; if necessary, the therapy is continued with intermittent courses (two weeks within a month).

Patients with moderate renal insufficiency (creatinine clearance greater than 20 ml/min) and hepatic insufficiency should use half of the standard daily dose of the drug – 200 mg per day (1 tablet 4 times per day).

For prophylaxis of infections during kidney and urinary tract surgeries it is prescribed 100 mg per day 4 times per day for 2-3 weeks. Repeated courses (if necessary) are carried out with a 2-week break. In chronic recurrent processes the course of treatment is several months.

Interaction

When combining Nitroxolin with drugs of tetracycline group the summation of the effects of each drug is observed, with nystatin and levorin – potentiation of action.

In order to avoid summation of the negative neurotropic effect, Nitroxoline should not be combined with nitrofurans.

Special Instructions

The urine is stained saffron yellow during treatment.

Synopsis

An antimicrobial agent of the oxyquinoline group. It has a wide spectrum of action. It selectively inhibits bacterial DNA synthesis, forms complexes with metal-containing enzymes of the microbial cell. It acts on Gram-positive bacteria: Staphylococcus spp. (including Staphylococcus aureus), Streptococcus spp. (including beta-hemolytic streptococci, Streptococcus pneumoniae), Enterococcus spp, Bacillus subtilis, etc. and gram-negative bacteria: Escherichia coli, Proteus spp., Klebsiella spp., Salmonella spp., Shigella spp., Enterobacter spp., some other microorganisms – Mycobacterium tuberculosis, Trichomonas vaginalis. Effective against some types of fungi (Candida spp., dermatophytes, molds, some pathogens of deep mycosis).

Contraindications

Hypersensitivity (including to other 8-oxyquinoline derivatives), renal dysfunction accompanied by oliguria, anuria; severe liver disease, cataract, neuritis, polyneuritis, glucose-6-phosphate dehydrogenase deficiency, pregnancy, lactation.

Side effects

Dyspepsia (nausea, vomiting), loss of appetite, allergic reactions (skin rash); tachycardia, ataxia, headache, paresthesias, polyneuropathy, liver function disorders.