5-NOC - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrophosphate, lactose monohydrate, corn starch, silicon dioxide colloid, povidone K 25, purified talc, crospovidone, magnesium stearate; sheath gum acacia, carmellose sodium, povidone K 25, sucrose, silicon dioxide colloid, talc purified, corn starch, calcium carbonate, titanium dioxide, dye sunset yellow E 110, dye yellow quinoline E 104.

Description:Orange, round, biconcave, shiny coated tablets

Pharmacotherapeutic group:Antimicrobial agent - oxyquinoline

ATX: & nbsp

J.01.X.X.07 Nitroxoline

Pharmacodynamics:

Antimicrobial agent from the group of oxyquinolines. Has a wide range of action. Selectively inhibits the synthesis of bacterial DNA, forms complexes with metal-containing enzymes microbial cells.

Has an effect on gram-positive bacteria: Staphylococcus spp. (incl. Staphylococcus aureus), Streptococcus spp. (including beta-hemolytic streptococci, Streptococcus pneumoniae, Enterococcus faecalis), Corynebacterium spp., Bacillus subtilis and others and gram-negative bacteria: Escherichia coli, Proteus spp., Klebsiella spp., Salmonella spp., Shigella spp., Enterobacter spp., H. influenzae, Neisseria gonorrhoeae, some other microorganisms - Ureaplasma urealiticum, Mycoplasma hominis, Mycobacterium tuberculosis, Trichomonas vaginalis. Effective against some species of fungi (candida, dermatophytes, mold, some pathogens of deep mycoses).

Pharmacokinetics:

Nitroxoline is well absorbed from the gastrointestinal tract (90%). The maximum concentration (C max) in the plasma is achieved 1,5-2 hours after ingestion. There is a high concentration of conjugated and unconjugated drug in the urine. Metabolised in the liver. It is excreted mainly by the kidneys in unchanged form and partly with bile.

Indications:

Acute, chronic and recurrent infections of the urogenital system caused by micro-organisms sensitive to nitroxoline: pyelonephritis, cystitis, urethritis, epididymitis, infected adenoma or carcinoma of the prostate;
Prevention of infectious complications in the postoperative period with surgical interventions on the kidney and genitourinary tract, as well as in diagnostic and therapeutic manipulations (catheterization, cystoscopy);
Prevention of recurrent urinary tract infections.

Contraindications:

Hypersensitivity to nitroxoline or other components of the drug,
Hypersensitivity to drugs quinoline series,
Cataract,
Severe renal insufficiency (creatinine clearance below 20 ml / min),
Severe hepatic insufficiency,
Children under 3 years (for this dosage form),
Pregnancy and lactation.

Pregnancy and lactation:Contraindicated.

Dosing and Administration:

Inside, before eating.

Standard dose for adults and teenagers is 400 mg per day, divided into 4 doses (2 tablets 4 times a day). The maximum dose is 800 mg per day. Average dose for children over 5 years: 200-400 mg per day, divided into 4 doses;

for children 3-5 years old: 200 mg per day, divided into 4 doses.

The course of treatment is 2-4 weeks, if necessary, therapy is continued with intermittent courses (two weeks for a month).

Patients with moderate renal insufficiency (creatinine clearance above 20 ml / min) and liver failure are recommended to use half the standard daily dose of the drug - 200 mg per day (1 tablet 4 times a day).

Side effects:

On the part of the digestive system: nausea, vomiting (can be prevented by taking the drug while eating).

Allergic reactions: skin rash.

Other: tachycardia, ataxia, headache, paresthesia, polyneuropathy. Laboratory indicators: thrombocytopenia, increase in the level of "liver" transaminases and uric acid in the blood serum.

Overdose:No data on overdose or clinical signs of nitroxoline poisoning.

Interaction:

Nitroxoline should not be administered simultaneously with drugs containing hydroxyquinolines or their derivatives.

Special instructions:

In patients with impaired renal function, cumulation of the drug may occur, so they should take the drug under the supervision of a doctor.

Do not prescribe courses of treatment for more than 4 weeks without additional examination of the liver and kidney function.

Against the background of treatment with nitroxoline, urine is colored in an intense yellow-red color.

Effect on the ability to drive transp. cf. and fur:

Data on the effect of the drug on the ability to drive a car or machinery there.

Form release / dosage:Tablets, coated with a coating, 50 mg.

Packaging:For 50 tablets in a plastic bottle, 1 bottle together with instructions for medical use in a cardboard bundle.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N014133 / 01

Date of registration:02.04.2008

The owner of the registration certificate: Lek dd Lek dd Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp24.12.2014

Illustrated instructions

Instructions

5-NOK® (5-NOK®)