Instructions for Nolicin (Norfloxacin)
ANTIMICROBIAL DRUG
Nolicin Description:
An antibacterial drug of the fluoroquinolone group.
Structure:
Active ingredient: Norfloxacin 400.00 mg.
Excipients:
Povidone, sodium carboxymethyl starch, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, purified water (for hydration).
Film
casing : Hypromellose, talc, titanium dioxide (E171), sunset yellow dye (E110), propylene glycol
Indications for use:
Infectious and inflammatory diseases caused by microorganisms sensitive to norfloxacin: complicated and uncomplicated, acute and chronic infections of the upper and lower urinary tract (including cystitis, pyelitis and chronic prostatitis).
When using the drug Nolicin, official national recommendations on the appropriate use of antibacterial drugs Nolicin, as well as the sensitivity of pathogenic microorganisms in a particular country, should be taken into account.
Nolicin Pharmacokinetics:
Absorption
Norfloxacin is rapidly, but not completely (30-40%) absorbed after oral administration. Food intake slows down the absorption of the drug. The maximum concentration in blood plasma is reached after 1-2 hours and ranges from 0.8 to 1.5 μg / ml, depending on the dose (200-400 mg).
Distribution
Low binding of norfloxacin with blood plasma proteins (10-15%) and high solubility in lipids determine a large volume of distribution of the drug and good penetration into organs and tissues (renal parenchyma, ovaries, seminiferous tubule fluid, prostate gland, uterus, abdominal organs and small pelvis, bile, breast milk). Penetrates the blood-brain and placental barriers.
2-3 hours after oral administration of norfloxacin at a dose of 400 mg, the concentration in the urine exceeds 200 μg / ml, within 12 hours it is maintained at 30 μg / ml. At a urine pH of 7.5, the solubility of norfloxacin decreases.
Metabolism
Metabolized in the liver.
Withdrawal
The half-life is 3-4 hours. It is excreted by the kidneys by glomerular filtration and tubular secretion. Within 24 hours from the moment of administration, 32% of the dose is excreted by the kidneys unchanged, 5-8% - in the form of metabolites, about 30% of the dose taken is excreted in the bile.
Pharmacodynamics Nolicin:
Progivomicrobial agent from the group of fluoroquinolones. Has a bactericidal effect. It acts on the bacterial enzyme DNA gyrase, which ensures supercoiling and, thus, the stability of bacterial DNA. Destabilization of the DNA chain leads to the death of bacteria. Possesses a wide spectrum of antibacterial action.
It is active in vitro and in vivo against the following microorganisms:
gram-positive aerobes - Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus saprophytics, Streptococcus agalactiae; literate aerobes
- Citrobacter freundii, Enterohacter aerogenes, Enterobacter cloacae, Escherichia coli,
Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens, Salmonella spp., Shigella spp.
It is active under in vitro conditions against the following microorganisms:
gram-negative aerobes - Citrobacter diversus, Edwardsiella tarda, Enterohacter agglomerans, Haemophilus ducreyi, Klebsiella oxytoca, Morganella morganii, Providencia alcalifaciens, Providencia rettgerueri, Providensei studomonasi, Pudomonasia rettgerutzeri, Providensei. others - Ureaplasma urealyticum.
Inactive against obligate anaerobes.
Contraindications:
Hypersensitivity to norfloxacin, auxiliary components of the drug and other quinolones;
tendinitis, tendovaginig, tendon rupture associated with fluoroquinolones, including a history;
deficiency of glucose-6-phosphate dehydrogenase;
children and adolescents (up to 18 years old);
pregnancy and breastfeeding period.
Nolicin Side effects:
Disorders of the blood and lymphatic system: often: neutropenia, thrombocytopenia;
infrequently: eosinophilia, leukopenia, decreased hematocrit, decreased hemoglobin; frequency unknown: agranulocytosis, hemolytic anemia.
Immune system disorders: frequency unknown: anaphylactoid reactions, aigioneurotic edema, dyspnea, vasculitis, toxic epidermal necrolysis, leukocytoclastic vasculitis, drug rash with eosinophilia and systemic symptoms (DRESS-syidrome), malignant exudative Steve syndrome erythema, exfoliative dermatitis, photosensitivity.
Mental disorders: infrequently: anxiety, depression; very rarely: anxiety, irritability, fear, hallucinations; frequency unknown: mental disorders (including confusion).
Nervous system disorders: infrequently: tingling sensation in the fingers, headache, dizziness; rarely: fatigue, insomnia; very rare: drowsiness;
frequency unknown: ataxia, peripheral neuropathy, hypesthesia, paresthesia, convulsions, myoclonus, tremor, Guillain-Barré syndrome, fainting.
Violations of the organ of vision: infrequently: blurred visual perception; frequency unknown: diplopia, nystagmus.
Hearing disorders and labyrinthine disorders: frequency unknown: hearing loss / hearing loss, tinnitus.
Cardiac disorders: infrequent: myocardial infarction, palpitations; frequency unknown: tachycardia, arrhythmias, including ventricular arrhythmias and tachycardia of the "pirouette" type (registered mainly in patients with risk factors for prolongation of the QT interval on the electrocardiogram [ECG]), lengthening the QT interval on the ECG.
Vascular disorders: rarely: vasculitis; frequency unknown: postural hypotension, decreased blood pressure.
Digestive system disorders: infrequently: constipation, pain in the rectum or anus, dryness of the oral mucosa. heartburn, indigestion, flatulence, ulceration of the oral mucosa. itching of the anus, anorexia. abdominal pain, diarrhea, nausea; rarely: vomiting, loss of appetite, pseudomembranous enterocolitis (with prolonged use); frequency unknown: pancreatitis, stomatitis, dysgeusia, bitterness in the mouth.
Disorders from the liver and biliary tract: infrequently: increased activity of "hepatic" transaminases in the blood plasma, frequency unknown: hepatitis, jaundice, liver failure (including fatal), liver necrosis.
Violation of the skin and subcutaneous tissues: infrequently: rash; rarely: itching, urticaria, edema.
Musculoskeletal and connective tissue disorders: infrequently: bursitis; very rare: tendinitis, tendon ruptures (usually in the presence of predisposing factors); frequency unknown: arthritis, myalgia, arthralgia, exacerbation of myasthenia gravis, muscle spasm.
Disorders from the kidneys and urinary tract: infrequently: renal colic, crystalluria; rarely: an increase in the concentration of urea and creatinine in the blood plasma;
frequency unknown: interstitial nephritis, dysuria, polyuria, albuminuria, renal failure, glomerulonephritis, urethral bleeding.
For urinary tract infections, 400 mg is prescribed 2 times a day for 7-10 days, in the case of a complicated infection - 10-21 days.
In chronic bacterial prostatitis, 400 mg is prescribed 2 times a day for 4 weeks or more.
In acute uncomplicated cystitis, 400 mg is prescribed 2 times a day for 3-7 days.
Patients with impaired renal function with creatinine clearance of more than 30 ml / min do not require correction of the dosage regimen.
When creatinine clearance is less than 30 ml / min (or serum creatinine concentration is higher than 5 mg / 100 ml) and patients on hemodialysis are prescribed half of the therapeutic dose of Nolitsin 2 times a day or the full dose of Nolitsin 1 time a day.
