Nitroxoline - instructions for use, dose, side effects, contraindications

Excipients (core): lactose monohydrate 18.8 mg, potato starch 26.0 mg, silicon dioxide colloid 0.6 mg, talc 2.8 mg, calcium stearate 0.9 mg, polysorbate 80 (Tween 80) 0 , 9 mg;

Auxiliary substances (shell): sugar (sucrose) - 83.13 mg, magnesium hydroxycarbonate - 10.77 mg, povidone K17 - 1.66 mg, silicon dioxide colloid - 0.81 mg, talc - 0.3 mg, titanium dioxide - 2.82 mg, tropeolin O - 0.18 mg, azorubin (acidic red 2C for pharmaceutical purposes) - 0.03 mg, beeswax - 0.3 mg.

Description:The tablets covered with a cover of light orange or orange color, round, biconcave. On the fracture are visible three layers: internal - from yellow to grayish-yellow, a slightly greenish tint is permissible; Medium - white and outer - from light orange to orange.

Pharmacotherapeutic group:antimicrobial agent - oxyquinoline

ATX: & nbsp

J.01.X.X.07 Nitroxoline

Pharmacodynamics:

Antimicrobial agent of a wide spectrum of action.

Nitroxoline selectively inhibits the synthesis of bacterial DNA and has an effect on both gram-positive microorganisms: Staphylococcus spp. (incl. S.aureus), Streptococcus spp. (including beta-hemolytic streptococci, Streptococcus pneumoniae, Enterococcus faecalis), Corynebacterium diphtheriae, 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 in relation to Mycobacterium tuberculosis, Trichomonas vaginalis, some species of fungi (Candida spp., dermatophytes, molds, some pathogens of deep mycoses).

Pharmacokinetics:

Absorption is high. It is excreted by the kidneys unchanged, with a high concentration in the urine (100 μg / ml and more).

Indications:Infectious and inflammatory diseases mainly of the genitourinary tract (including pyelonephritis, cystitis, urethritis, epididymitis, infected adenoma or carcinoma of the prostate, etc.) caused by micro-organisms sensitive to nitroxoline.

Prevention of infectious complications in diagnostic and therapeutic manipulations (catheterization, cystoscopy) in the postoperative period with surgical interventions on the kidney and urinary tract.

Contraindications:

Impaired renal function, accompanied by oligo- or anuria; severe liver disease; deficiency of glucose-6-phosphate dehydrogenase; children's age to three years (taking into account the solid indivisible dosage form), cataracts, neuritis, polyneuritis, pregnancy (III trimester), lactation.

Hypersensitivity to quinoline preparations.

Dosing and Administration:

The drug is taken orally.

For adults The daily dose is 400-800 mg.

Multiplicity of admission 3-4 times a day with an interval of 6-8 hours.

The course of treatment is 2-3 weeks.

With chronic infections of the urinary tract the drug can be given again for 2 weeks with a 2-week break.

Average daily dose for children over 5 years - 0,2-0,4 g (0,05-0,1 g, 4 times a day), younger than 5 years - 0,2 g per day.

To prevent infections in kidney and urinary tract surgery appoint 0.1 g per reception 4 times a day for 2-3 weeks.

Children appoint a daily dose of 10-30 mg / kg in 3-4 divided doses.

Side effects:

Sometimes nausea, vomiting, loss of appetite, very rarely skin allergic reactions are possible.

In rare cases - tachycardia, ataxia, headache, paresthesia, polyneuropathy, liver dysfunction.

With prolonged use, the case of the development of neuritis of the optic nerve is described.

Special instructions:

During treatment, urine is colored in saffron-yellow color.

Packaging:DFor preparations manufactured at OAO Irbitsky Chemical Pharmaceutical Plant:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 50 tablets in a jar of orange glass, or a bottle of polyethylene, or a can of polymeric materials.

5 contour cellular packs or a can of orange glass with instructions for use, put in a pack of cardboard. 100 bottles of polyethylene or cans of polymer materials with instructions for use are placed in a cardboard box (for hospitals).

DFor preparations manufactured at OOO Anzhero-Sudzhensky Chemical and Pharmaceutical Plant:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

50 tablets per can of polymeric materials.

For 5 contour packs or 1 can of polymeric materials, together with instructions for medical use, put in a pack of cardboard.

Storage conditions:

Store in a dry, protected from light place, at a temperature not exceeding 25 FROM.

Keep out of the reach of children.

Shelf life:

4 years.

After the expiration of the drug does not apply.

Terms of leave from pharmacies:On prescription

Registration number:LSR-008832/08

Date of registration:06.11.2008 / 06.06.2016

Expiration Date:Unlimited

The owner of the registration certificate:AVEKSIMA, JSC AVEKSIMA, JSC Russia

Manufacturer: & nbsp

IRBITSK HFZ, OJSC Russia

Anzhero-Sudzhensky Chemical-Pharmaceutical Plant, LLC Russia

Information update date: & nbsp03.12.2016

Illustrated instructions

Instructions

Nitroxoline (Nitroxoline)