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Nitroxoline 50s 50 mg coated tablets




The instruction for medical use

of NITROXOLINE medicine

the Trade name

the International unlicensed

name Nitroxoline Dosage Form
of the Tablet, coated 0.05 g

One tablet contains
active agent – nitroxoline of 50 mg,
kernel: sugar milk (lactose), potato starch, aerosil, talc, calcium stearate,
cover: granulated sugar, magnesium carbonate the main, polyvinylpirrolidone, aerosil, talc, titan dioxide pigmentary (E171), tropeolin 0 (E103), acid red 2C (carmoisin, azoruby) (E122), beeswax.

The description
of the Tablet, coated light orange or orange color, round shape with a biconvex surface. On cross section three layers are visible: internal – from yellow till grayish-yellow color, is allowed slightly greenish shade, average – white color and external – from light orange till orange color.

Pharmacotherapeutic group
Antibacterial drugs for system use. Other antibacterial drugs. Antibacterial drugs other. Nitroxoline.
The ATX J01XX07 code

the Pharmacological

Pharmacokinetics Later properties of intake nitroxoline is well and quickly absorbed from digestive tract. The maximum concentration (Cmax) in plasma is reached in 1.5-2 hours after intake. Elimination half-life (T1/2) makes about 2 hours.
It is removed mainly by kidneys in not changed look, at the same time in urine high concentrations are formed (100 mkg/ml and above).

The pharmacodynamics
Nitroxoline has bacteriostatic action at the expense of selection inhibition of synthesis of bacterial deoxyribonucleic acid (DNA). It is capable to damage a cytoplasmic membrane and to reduce adhesion of uropatogenny strains to cells of an epithelium of urinary tract.
Nitroxoline affects both gram-positive, and gram-negative microorganisms: Staphylococcus spp., Streptococcus spp., Enterococcus faecalis, Corynebacterium diphtheriae, Bacillus subtilis, Escherichia coli, Neisseria gonorrhoeae, Proteus spp., Klebsiella spp., Salmonella spp., Enterobacter spp.
It is active concerning Mycobacterium tuberculosis, Trichomonas vaginalis, some types of fungi (Candida spp., dermatophytes, a mold and some causative agents of deep mycoses).

– the Urethritis
– cystitis
– pyelonephritis
– an epididymite
– the infected prostate adenoma
– prevention of recurrent urinary tract infections

the Route of administration and doses
take the Drug inside in time or after a meal.
Swallow of tablets entirely, without chewing, washing down with a necessary amount of water.
Duration of a course of treatment and dose of drug is established by the attending physician individually for each patient.
The adult usually appoint 100-200 mg (2-4 tablets) of drug 4 times a day. A daily dose for adults: 400 mg (on 2 tablets 4 times a day). In hard cases it is possible to increase a daily dose to 600-800 mg. The highest daily dose for adult 800 mg.
Course of treatment 2-3 weeks.
In persistent infections of uric ways it is possible to appoint nitroxoline repeated courses within 2 weeks with a two-week break.

Side effects
– dispeptic reactions (nausea, vomiting, loss of appetite)
it is rare:
– skin allergic reactions
– reduction in serum of uric acid and aminotransferases
Very seldom:
– tachycardia
– allergic thrombocytopenia
– coloring of urine in rich yellow color
– an ataxy, paresthesias
– polyneuropathy
– a headache

Contraindication abnormal liver functions
– hypersensitivity to nitroxoline or any other components of drug
– hypersensitivity to drugs of a quinolinic row
– a heavy liver failure
– a heavy renal failure (oligo-, an anury)
– neuritis, a polyneuritis
– a cataract
– deficit glyukozo-6-fosfatdegidrogenazy
– pregnancy and the period of a lactation
– children’s and teenage age up to 18 years

Medicinal interactions
At combined use of nitroxoline with drugs of group of tetracycline is observed summation of effects of each drug, with nystatin and levorinum – action potentiation. It is impossible to combine nitroxoline with nitrofurans in order to avoid summation of negative neurotropic effect.

Special instructions
Should be applied with care in a renal failure (under control of a functional condition of kidneys) because of possible cumulation of drug.
During treatment the coloring of urine in saffron-yellow color is possible.

There is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of Data on influence on ability to run the vehicle or potentially dangerous mechanisms.

Symptoms: at prolonged use of drug, toxic peripheral neuritis, myelipathies, damages of an optic nerve can develop. The phenomena of possible cumulation are expressed in nausea, vomiting, the general weakness.
Treatment: at drug withdrawal all phenomena usually pass.

A form of release and packing
On 10 tablets in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished.
On 5 blister strip packagings with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions in the dry, protected from light place, at a temperature from 15 to 25C.
To store out of children’s reach!

4 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription

JSC Irbit Chemical Pharmaceutical Plant Producer,

Russian Federation 623856, Sverdlovsk Region, Irbit, Kirov St., 172 Ph. / fax (34355) 3-60-90

The owner of the registration certificate
of JSC Irbit Chemical Pharmaceutical Plant, the Russian Federation

the Address of the organization accepting claims from consumers on quality of products (goods)
of JSC Irbit Chemical Pharmaceutical Plant,

Russian Federation 623856, Sverdlovsk Region, Irbit, Kirov St., 172 Ph. / fax (34355) 3-60-90
E-mail address:

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