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Active ingredients
Nitroxoline
Release form
Pills
Composition
1 coated tablet contains: Active substance: nitroxoline - 50 mg. Additional substances: calcium hydrophosphate, lactose monohydrate, corn starch, colloidal silicon dioxide, povidone K25, purified talc, crospovidone, magnesium stearate. sodium, povidone K25, sucrose, colloidal silicon dioxide, purified talcum, corn starch, calcium carbonate, titanium dioxide, sunset dye sunset yellow E110, dye yellow quinoline E104.
Pharmacological effect
Antimicrobial, 8-hydroxyquinoline derivative. It has a wide spectrum of action. Selectively inhibits the synthesis of bacterial DNA, forms complexes with metal-containing enzymes of the microbial cell. Active against: Gram-positive bacteria: Staphylococcus spp. (including Staphylococcus aureus); Streptococcus spp., Including: Beta-hemolytic streptococci; Streptococcus pneumoniae; Enterococcus faecalis; Corynebacterium spp; Bacillus subtilis. Gram negative bacteria: Escherichia coli; Proteus spp; Klebsiella spp; Salmonella spp; Shigella spp; Enterobacter spp; Haemophilus influenzae; Neisseria gonorrhoeae. Other microorganisms: Ureaplasma urealyticum; Mycoplasma hominis; Mycobacterium tuberculosis; Trichomonas vaginalis. Some species of fungi: candida, dermatophytes, mold fungi, some causative agents of deep mycoses.
Pharmacokinetics
Absorption Nitroxoline is well absorbed from the gastrointestinal tract (90%). Сmax in plasma is reached in 1.5-2 hours after ingestion. Metabolism and excretion Metabolized in the liver. Excreted mainly by the kidneys unchanged and partially with bile. There is a high concentration of conjugated and unconjugated drug in the urine.
Indications
Treatment of acute, chronic and recurrent urinary tract infections caused by microorganisms sensitive to nitroxoline: pyelonephritis, cystitis, urethritis, epididymitis, adenoma-infected or carcinoma of the prostate gland. medical manipulations: catheterization, cystoscopy. Prevention of recurrent urinary tract infections.
Contraindications
Cataract; severe renal failure (CC less than 20 ml / min); severe liver failure; children under 3 years; pregnancy; lactation (breastfeeding); hypersensitivity to nitroxoline or other components of the drug; hypersensitivity to quinolines.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation (breastfeeding).
Dosage and administration
For adults and adolescents: the standard dose is 400 mg / day, divided into 4 doses (2 pills, 4 times / day). The maximum dose is 800 mg / day. Children over 5 years old: the average dose is 200-400 mg / day, divided into 4 doses. Children 3-5 years old: the average dose is 200 mg / day, divided into 4 doses. Treatment course - 2-4 weeks, if necessary, therapy continues with intermittent courses (2 weeks during the month). Tablets should be taken before meals. Use for liver dysfunction Patients with liver failure are recommended to use half the standard daily dose of the drug - 200 mg / (1 tablet 4 times / day). Use for kidney dysfunction Patients with moderate renal insufficiency (CC more than 20 ml / min) it is recommended to use half the standard daily dose of the drug - 200 mg / (1 tablet 4 times / day).
Side effects
On the part of the digestive system: nausea, vomiting (can be prevented by taking the drug while eating), increased activity of hepatic transaminases. For the CNS and peripheral nervous system: ataxia, headache, paresthesia, polyneuropathy. reactions: skin rash.Other: thrombocytopenia, increased levels of uric acid in the serum.
Overdose
There is no data on overdose or clinical signs of nitroxolin poisoning.
Interaction with other drugs
Drug interaction of the drug 5-NOK is not described.
special instructions
It should not be prescribed simultaneously with drugs containing hydroxyquinolines or their derivatives. When used in patients with impaired renal function because of the possible cumulation of the drug, medical supervision is required. Do not prescribe treatment for more than 4 weeks without additional examination of the liver and kidney function urine is stained with nitroxoline with an intense yellow-red color. The effect on the ability to drive vehicles and other mechanisms that require an increased concentration of attention. There is no influence on the ability to drive a car or machinery.