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

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Dosage form: & nbspfilm-coated tablets

Composition:

When manufacturing in Krka, dd, New place, Slovenia and KRKA-RUS LLC:

1 tablet, film-coated, contains:

CORE:

Active substance: norfloxacin - 400 mg.

Excipients: povidone, sodium carboxymethyl starch, microcrystalline cellulose, silicon dioxide colloidal, anhydrous, magnesium stearate, purified water (for hydration).

SHELL:

hypromellose, talc, titanium dioxide, dye sunset yellow, E110 (color disperse yellow, E110), propylene glycol.

In production at LLC "Krka-Rus":

1 tablet, film-coated, contains:

CORE:

Active substance:

Nolitsin® semi-finished granules -570 mg

[Active substance of semi-finished granules Norfloxacin 400 mg Excipients semi-finished pellets povidone, sodium carboxymethyl starch, purified water]

Excipients: cellulose microcrystalline, silicon dioxide colloidal, anhydrous, magnesium stearate

SHELL:

hypromellose, talc, titanium dioxide, dye sunset yellow, E110 (color disperse yellow, E110), propylene glycol.

Description:

Round, slightly biconvex tablets, covered with a film shell of orange color with a risk on one side.

Pharmacotherapeutic group:antimicrobial agent - fluoroquinolone.

Pharmacodynamics:

Antibacterial agent from the group of fluoroquinolones. Has a bactericidal effect. Affects the bacterial enzyme DNA hydrase, which provides super-convoliation and, thus, the stability of bacterial DNA. The destabilization of DNA chains leads to the death of bacteria. Has a wide range of antibacterial action. Sensitive: Staphylococcus aureus (including strains Staphylococcus spp., Resistant to methicillin), Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Hafiiia alvei, Proteus spp. (indol-positive and indolotric), Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter jejuni, Aeromonas spp., Plesiomons spp., Vibrion cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Clamydia spp., Legionella spp. Different sensitivity to the drug has: Enterococcus spp. (pyogenes, pneumoniae and viridans), Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter spp., Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuitum.

Pharmacokinetics:

Nolycin is fast, but not completely (20-40%) vsasAfter eating, food slows down absorption of the drug.

The maximum concentration in the blood plasma isligated after 1-2 hours and is from 0.8 up to 2.4 μg / ml depending on the dose. Low the binding of norfloxacin to plasma proteins (10-15%) and high solubilityin lipids cause a large volume distribution of the drug and good penetrationin the organs and tissues (parenchyma) kidney, ovaries, seminal tubular fluid, prostate, uterus, organs abdominal cavity and small pelvis, bile, maternitysome milk). Penetrates through hemato-the encephalic barrier and the placenta. Duration antimicrobial effect - about 12 h. To an insignificant degree is metabolized in the stoveene. The half-life is 3-4 hours. It is excreted by the kidneys, by glomerular filtration and tubular secretion. AT within 24 hours of taking 32% of the dosekidneys in unchanged form, at 5-8 % - in the form of metabolites, about 30 % the accepted dose.

Indications:

Infectious-inflammatory diseases caused by pathogens sensitive to the drug:

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

- infections of the genitals: cervicitis, endometritis, chronic bacterial prostatitis;

- gonorrhea uncomplicated;

- bacterial gastroenteritis (salmonellosis, shigellosis);

- prevention of recurrence of urinary tract infection;

- prevention of sepsis in patients with neutropenia;

- Prevention of travelers' diarrhea.

Contraindications:

- hypersensitivity to norfloxacin, the components of the drug and other quinolones;

- deficiency of glucose-6-phosphate dehydrogenase;

- children and adolescence (up to 18 years)

- pregnancy and lactation;

Carefully:cerebral atherosclerosis, stroke, epilepsy, epileptic syndrome, renal / hepatic failure, allergic reactions to the presence of acetylsalicylic acid.

Pregnancy and lactation:

The safety of use during pregnancy and lactation of breastfeeding has not been studied. To prescribe during pregnancy the drug costs only on "vital" indications, when the prospective benefit for the mother exceeds the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Inside, on an empty stomach (not less than 1 hour before or 2 hours after eating) and drink plenty of liquid.

In the absence of special doctor's instructions, the following doses are recommended: 1 tablet (400 mg) 2 times a day. Duration of treatment is from 7 to 14 days, if necessary, spend a longer treatment.

When chronic bacterial prostatitis is prescribed for 400 mg 2 times a day for 4-6 weeks or more.

When uncomplicated gonorrhea the drug is prescribed once in a dose of 800-1200 mg or twice a day for 400 mg for 3-7 days.

When bacterial gastroenteritis (shigellosis, salmonellosis) it is recommended for 400 mg 2 times a day for up to 5 days.

For prevention of travelers' diarrhea it is recommended to take 400 mg per day 1 day before departure, during the entire travel time and 2 days after the end (not more than 21 days).

For prevention of sepsis in neutropenia Assign 400 mg twice a day to 8 weeks.

When acute uncomplicated cystitis prescribe 400 mg twice a day for 3-5 days.

For prevention of recurrent uncomplicated urinary tract infections with frequent exacerbations (more than 3 episodes a year or more than 2 in the course of six months), the drug is prescribed 200 mg (1/2 Nolycin tablet) once a night for a long time (from 6 months to several years).

Patients with impaired renal function with a creatinine clearance of more than 20 ml / min, no dosage adjustment is required.

When creatinine clearance is less than 20 ml / min (with a serum creatinine level above 5 mg / 100 ml) and patients on hemodialysis,appoint a half of the therapeutic dose of Nolycin 2 times a day or a full dose of the drug 1 time per day.

Side effects:

From the digestive system: loss of appetite, bitterness in the mouth, nausea, vomiting, abdominal pain, diarrhea, pseudomembranous enterocolitis (with prolonged use), increased activity of "liver" transaminases.

From the urinary system: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, urethral bleeding, increased urea and plasma creatinine.

From the nervous system: headache, dizziness, fainting, insomnia, hallucinations. In elderly patients, fatigue, drowsiness, anxiety, irritability, a sense of fear, depression, tinnitus are possible.

From the cardiovascular system: tachycardia, arrhythmias, lowering of arterial pressure, vasculitis.

Allergic reactions: rash, itchy skin, urticaria, edema, malignant exudative erythema (Stevens-Johnson syndrome).

From the musculoskeletal system: arthralgia, tendenitis, tendon ruptures (usually in the case of a combination with contributing factors).

On the part of the hematopoiesis system: eosinophilia, leukopenia, reduction of hematocrit.

Other: candidiasis.

Overdose:

In case of an overdose, the following symptoms may occur: nausea, vomiting, diarrhea. In more severe cases: dizziness, drowsiness, "cold" sweat, seizures, puffy face without changing the basic hemodynamic indications.

Treatment: gastric lavage, adequate hydration therapy with forced diuresis and symptomatic therapy. It requires a survey and observation in the hospital for several days. There is no specific antidote.

Interaction:

With the simultaneous use of norfloxacin and theophylline, the concentration of theophylline in the blood plasma should be monitored and its dose adjusted. norfloxacin reduces the clearance of theophylline by 25%, and the development of corresponding undesirable side effects can occur.

Reduces the effect of nitrofurans.

Norfloxacin can enhance the therapeutic effects of cyclosporine and warfarin, in some cases, with the use of norfloxacin with cyclosporine, an increase in the serum creatinine concentration was observed, therefore, in such patients monitoring of this parameter is necessary.

The simultaneous use of norfloxacin and antacid agents containing aluminum or magnesium hydroxide, as well as preparations containing iron, zinc, sucralfate, reduces the absorption of norfloxacin (the interval between their intake should be at least 2 hours).

Simultaneous use with drugs that reduce the convulsive threshold can lead to the development of epileptiform seizures.

Simultaneous use of glucocorticosteroids may increase the risk of tendonitis or cases of rupture of tendons.

Norfloxacin can enhance the therapeutic effect of hypoglycemic drugs (sulfonylurea derivatives).

Simultaneous reception of norfloxacin with drugs that have the potential to lower blood pressure can cause a sharp decrease in it. In this regard, in such cases, as well as with simultaneous administration with barbiturates and other drugs for general anesthesia, it is necessary to control the heart rate, blood pressure and ECG parameters.

Special instructions:

During treatment with norfloxacin, patients should receive a sufficient amount of fluid (under the control of diuresis).

During the period of therapy, an increase in the prothrombin index is possible (during surgical interventions it is necessary to monitor the state of the blood coagulation system).

During treatment with norfloxacin, exposure to direct sunlight should be avoided.

When pain occurs in the tendons or at the first signs of tendovaginitis, it is necessary to cancel the drug. During therapy with norfloxacin it is recommended to avoid excessive physical exertion.

In the presence of an allergic reaction to acetylsalicylic acid, the azo dye E110 (colorant dispersed yellow, E110), can cause a hypersensitive reaction, up to the bronchospasm.

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

Care must be taken whencar and other activities potentially hazardous activities, demandhigh concentration attention and speed of psychomotor reactions(especially with simultaneous consumption of ethanol).

Form release / dosage:

The tablets covered with a film cover, on 400 mg.

Packaging:For 10 tablets in a blister (a planar cell pack). For 1 or 2 blisters (contour packs) in a cardboard bundle along with instructions for use.

Storage conditions:

List B.

Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013660 / 01

Date of registration:11.12.2007

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

KRKA-RUS, LLC Russia

VECTOR-MEDICA, CJSC Russia

Representation: & nbspKRKA KRKA Slovenia

Information update date: & nbsp10.08.2015

Illustrated instructions

Instructions

Nolicin® (Nolicin®)