NOLICIN

Active material: Norfloxacin
When ATH: J01MA06
CCF: Fluoroquinolone antibacterial drug
ICD-10 codes (testimony): A09, A54, K81.0, K81.1, K83.0, N10, N11, N30, N34, N41, N70, N71, N72, Z29.2
When CSF: 06.17.02.01
Manufacturer: KRKA d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Pills, coated orange, round, slightly biconcave, with Valium on one side.

Excipients: povidone, sodium starch glycolate, microcrystalline cellulose, Colloidal anhydrous silica, magnesium stearate.

The composition of the shell: hydroxypropyl, talc, Titanium dioxide, dye dispersion yellow (E104), propylene glycol.

10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (2) – packs cardboard.

Pharmacological action

Antibacterial broad-spectrum fluoroquinolones group.

It has bactericidal activity. Affects DNK-girazu bacterial enzyme, provides sverhspiralizaciû and, thus, the stability of the DNA of bacteria. Destabilization of the DNA chain leads to death of bacteria. Has a wide spectrum antibacterial action.

C drug sensitive Staphylococcus aureus (including strains of Staphylococcus spp., resistant to metitillino), Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Haffia hive, Proteus spp. (indole-positive and indole-negative strains), Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter jejuni, Aeromonas spp., Plesiomonas spp., Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp.

Different sensitivity to the drug have: Enterococcus faecalis, Streptococcus spp. (Streptococcus pyogenes, Streptococcus pneumoniae and Streptococcus viridans), Serratia wilting, Pseudomonas aeruginosa, Acinetobacter spp., Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuitum.

Duration of antimicrobial action – about 12 no.

Pharmacokinetics

Absorption

After intake of norfloxacin quickly, but not completely (30-40%) absorbed from the gastrointestinal tract. C_max observed through 1-2 h and range from 0.8 to 2.4 µg/ml depending on the dose. Meal slows absorption of the drug.

Distribution and metabolism

The low value of norfloxacin binding to plasma proteins (10-15%) and High solubility in lipids make big V_d preparation and good penetration in organs and tissues (Renal parenchyma, ovary, liquid seminiferous tubules, prostate, uterus, organs of the abdominal cavity and pelvic, bile, mother's milk). Penetrates the GEB and placental barrier.

To a small extent, is metabolized in the liver.

Deduction

T_1/2 is 3-4 no. Report the news, by clubockova filtering and kanalzeva secreta. During 24 hours from the moment of reception 32% dose appears kidneys in an unmodified form, 5-8% – as metabolites, with jelchew is about 30% the dose.

Testimony

Infectious-inflammatory diseases, caused by pathogens, susceptible to malaria:

-acute and chronic infectious diseases of the urinary tract (uretrit, cystitis, pyelonephritis);

-infections of the reproductive organs (cervicitis, endometritis, Chronic bacterial prostatitis);

-gonorrhoea neoslojnennaya;

-bacterial gastroenteritis (salmonellosis, dysenteries);

-Prevention of the recurrence of urinary tract infections;

-Prevention of sepsis in patients with neutropenia;

-Prevention of traveler's diarrhea.

Dosage regimen

Inside, fasting (at least 1 hours before or after 2 h postprandial) and wash down with a sufficient quantity of liquid.

Recommended dose – by 400 mg 2 times / day. Duration of treatment 7 to 14 days, If necessary, conduct longer treatment.

At Chronic bacterial prostatitis – by 400 mg 2 times / day for 4-6 weeks or more.

At uncomplicated gonorrhea – one dose of 800-1200 mg or 400 mg 2 times / day for 3-7 days.

At bacterial gastroenteritis (dysenteries, sal″monellez) – by 400 mg 2 times / day for 5 days.

To Prevention of traveler's diarrhea It is recommended to take 400 mg / day for 1 day before check-out, during all time of travel and 2 days after the end (no more 21 day).

To Prevention of sepsis with neutropenia – by 400 mg 2 times / day for 8 weeks.

At acute uncomplicated cystitis – by 400 mg 2 times / day for 3-5 days.

To Prevention of recurrent urinary tract infections uncomplicated with frequent flare-ups (more than 3 episodes a year or more of 2-x for six months) – by 200 mg 1 Once at night long (from 6 months up to several years).

Patients with impaired kidney function if more QC 20 ml / min correction dosing regime is not required.

At CC less than 20 ml / min (or level of whey creatinine more than 5 mg / dL) and patients, hemodialysis, appoint half therapeutic dose Nolicina^® 2 times per day or full dose 1 time / day.

Side effect

From the digestive system: decreased appetite, bitter taste in the mouth, nausea, vomiting, abdominal pain, diarrhea, pseudomembranous enterocolitis (prolonged use), increase in liver transaminases.

From the urinary system: kristallurija, glomerulonephritis, dizurija, polyuria, albuminuria, Urethral bleeding, increasing urea and creatinine blood plasma.

From the nervous system: headache, dizziness, fainting, insomnia, hallucinations. Older patients possible fatigue, drowsiness, anxiety, irritability, a sense of fear, depression, noise in ears.

Cardio-vascular system: tachycardia, Arrhythmia, decrease in blood pressure, vasculitis.

On the part of the musculoskeletal system: arthralgia, tendenity, tendon rupture (Typically, in the case of combinations with the contributing factors).

From the hematopoietic system: eozinofilija, leukopenia, decrease in hematocrit.

Allergic reactions: rash, itching, hives, swelling, malignant exudative erythema (Stevens-Johnson syndrome).

Other: candidiasis.

Contraindications

- Deficiency of glucose-6-fosfatdegidrogenazы;

- Pregnancy;

- Lactation (breast-feeding);

- Childhood and adolescence up 18 years;

-hypersensitivity to norfloksacinu and other drugs group of fluoroquinolones.

FROM caution should designate product in atherosclerosis cerebrovascular, violation of cerebral circulation, epilepsy, Freiburg epilepsy syndrome, renal / hepatic insufficiency, you have an allergic reaction to acetylsalicylic acid.

Pregnancy and lactation

Security application during pregnancy and lactation breastfeeding has not been studied.

Assign Nolicin^® when pregnancy only for health reasons, when the intended benefits to the mother outweighs the potential risk to the fetus.

If necessary, the appointment during lactation should stop breastfeeding.

Cautions

During treatment norfloksacinom patients should receive adequate amounts of fluids (under the control of diuresis).

During therapy can increase prothrombin index (When performing surgical interventions should monitor the State of blood coagulation system).

Norfloksacinom during treatment should avoid exposure to direct sunlight.

When you see the pain in the joints or at the first signs of the drug must be abolished. During therapy norfloksacinom are advised to avoid excessive physical exertion.

If there is an allergic reaction to acetylsalicylic acid azokrasitel′ (e) 110 (dye dispersion yellow, E110), may cause giperčuvstvitel′nuû reactions, until bronchospasm.

Effects on ability to drive vehicles and management mechanisms

Use caution when driving and other potentially hazardous activities, require high concentration and speed of psychomotor reactions (especially while use of ethanol).

Overdose

Symptoms: nausea, vomiting, diarrhea; In more severe cases, – dizziness, drowsiness, cold sweat, convulsions, puffy face without changing the basic hemodynamic readings.

Treatment: gastric lavage, adequate gidratacionnaâ therapy with enhanced diurezom and symptomatic therapy. Requires examination and observation in the hospital for a few days. No specific antidote.

Drug Interactions

Together with the use of norfloxacin and theophylline should monitor theofillina concentration in plasma and adjust his dose, tk. Norfloxacin lowers klirens theofillina 25%, and there may be development of undesirable side effects.

Norfloxacin reduces the effect of nitrofuran.

Norfloxacin may intensify therapeutic effects of Cyclosporine and racumin, in some cases, when the application of norfloxacin with ziklosporinom, there has been an increase in the concentration of serum creatinine, Therefore, such patients requires control of this indicator.

Simultaneous application of norfloxacin and antatsidnykh funds, containing aluminium or magnesium hydroxide, as well as preparations, containing iron, zinc, sucralfate, reduces the absorption of norfloxacin (the interval between their admission must be at least 2 no).

The simultaneous use of drugs, lowering the seizure threshold, It can lead to the development of epileptiform seizures.

Simultaneous application of GCS can contribute to an increased risk of tendinitis or tendon rupture.

Norfloxacin may intensify therapeutic effects of hypoglycemic drugs (sulfonylureas).

Simultaneous reception of norfloxacin with drugs, possessing the potential lowering of the HELL, it can cause a sharp decrease. Therefore in such cases, as well, while the introduction with barbiturates and other drugs for general anesthesia should monitor HEART RATE, Ad and ECG.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in a dark and dry place at a temperature of no higher than 25° c. Shelf life – 5 years. It should not be used after the expiration date, on the package.