Noroxin (norfloxacin)

Brand name: Noroxin

Generic Name: norfloxacin

Dosage form: tablets, film-coated.

Ingredients:
1 tablet, film-coated, includes:

NUCLEUS:

Active ingredient: norfloxacin - 400 mg.
Other ingredients: povidone, sodium carboxymethyl starch, microcrystalline cellulose, colloidal silicon dioxide, anhydrous, magnesium stearate, purified water (for hydration).

SHELL:

gapromelloza, talc, titanium dioxide, dye Sunset Yellow, E110 (Disperse Yellow, E110), propylene glycol.

Description

Round, slightly biconvex tablets, film-coated orange scored on one side.

Pharmacotherapeutic group: anti-microbial agents - fluoroquinolone.

Code ATX: J01MA06

Pharmacological properties

Pharmacodynamics

Antibacterial agent of the fluoroquinolones. Bactericidal action. Affects the bacterial enzyme DNA gyrase, which provides supercoiling and, thus, the stability of the DNA of bacteria. Destabilization of the DNA chain leads to the death of bacteria. Has a broad spectrum of antibacterial action. Sensitive: Staphylococcus aureus (including strains of Staphylococcus spp., Resistant to methicillin), Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Hafhia alvei, Proteus spp. (Indolpolozhitelnye and indolotritsatelnye), 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. (Pyogenes, pneumoniae and viridans), Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter spp., Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuitum.

Pharmacokinetics

Nolitsin quickly, but not all (20-40%) absorbed after ingestion, the food slows the absorption of the drug.
Maximum plasma concentrations are reached after 1-2 h and ranged from 0.8 to 2.4 mg / ml depending on the dose. Low value of the binding of norfloxacin to plasma proteins (10-15%) and high lipid solubility and produces a greater volume of distribution of the drug and good penetration into the organs and tissues (parenchyma of kidneys, ovaries, the fluid of seminiferous tubules, prostate, uterus, abdominal organs and small pelvis, bile, breast milk). Penetrates through the blood-brain barrier and placenta. Duration of antimicrobial effect - about 12 hours to a small extent is metabolized in the liver. The half-life of 3-4 hours. Excreted by the kidneys by glomerular filtration and tubular secretion. Within 24 hours after receiving 32% of the dose is excreted by the kidneys in unchanged form, 5-8% - in the form of metabolites, the bile is allocated about 30% of the dose.

Statement

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

acute and chronic infections of the urinary tract (urethritis, cystitis, pyelonephritis);
genital infection: cervicitis, endometritis, chronic bacterial prostatitis;
uncomplicated gonorrhea;
bacterial gastroenteritis (salmonellosis, shigellosis);
prevention of recurrence of urinary tract infections;
prevention of sepsis in patients with neutropenia;
prevention of travelers' diarrhea.
Contraindications

Hypersensitivity to norfloxacin, the drug's components and other quinolones;
deficiency of glucose-6-phosphate dehydrogenase;
childhood and adolescence (18 years);
pregnancy and lactation;
Caution: cerebral arteriosclerosis, stroke, epilepsy, epileptic syndrome, renal / hepatic failure, the presence of an allergic reaction to acetylsalicylic acid.

Pregnancy and Lactation

Safety of use during pregnancy and lactation, breast-feeding has not been studied. Prescribe the drug during pregnancy is only for "life" readings, when the intended benefits to the mother outweighs the potential risk to the fetus. If necessary, use during lactation should stop breastfeeding.

Dosing and Administration

Inside an empty stomach (at least 1 hour before or 2 hours after meals), and drinks plenty of fluids.
In the absence of specific instructions the doctor recommended the following dose: 1 tablet (400 mg) 2 times a day. The duration of treatment from 7 to 14 days, if necessary, spend a longer period of treatment.
In chronic bacterial prostatitis is assigned to 400 mg 2 times a day for 4-6 weeks or more.
In uncomplicated gonorrhea drug is prescribed single dose of 800 - 1200 mg or 2 times a day to 400 mg for 3-7 days.
In bacterial gastroenteritis (Shigella, Salmonella) recommended 400 mg 2 times a day for 5 days.
For the prevention of traveler's diarrhea is recommended to take 400 mg a day for 1 day before departure, during the whole time travel and 2 days after it (no more than 21 days).
For the prevention of sepsis in neutropenic appoint 400 mg 2 times a day to 8 weeks.
In acute uncomplicated cystitis prescribe 400 mg 2 times a day for 3-5 days.
For the prevention of recurrent uncomplicated urinary tract infections with frequent exacerbations (more than 3 episodes per year, or more than 2 in six months), the medication prescribed at 200 mg (1 / 2 tablets Nolitsina) 1 times a night for a long time (from 6 months to a few years).
Patients with impaired renal function with creatinine clearance 20 ml / min correction dosing regimen is not required. At creatinine clearance below 20 ml / min (or serum creatinine above 5mg/100ml) and patients in hemodialysis, appoint half the therapeutic dose Nolitsina 2 times a day or a full dose 1 per day.

Side Effects

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

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

The nervous system: headache, dizziness, fainting, insomnia, hallucinations. In elderly patients the opportunity to: fatigue, drowsiness, restlessness, irritability, anxiety, depression, tinnitus.

Cardio-vascular system: tachycardia, arrhythmias, lowering blood pressure, vasculitis.

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

From the musculoskeletal: arthralgia, tendenity, tendon rupture (usually in the case of a combination of contributing factors).

From the hemopoietic system: eosinophilia, leucopenia, decreased hematocrit.

Other: candidiasis.

Overdose

In case of overdose may experience the following symptoms: nausea, vomiting, diarrhea. In severe cases: dizziness, drowsiness, and "cold" sweat, cramps, puffy face without changing the basic hemodynamic indications.
Treatment: gastric lavage, adequate hydration therapy with forced diuresis and symptomatic therapy. Required examination and observation in hospital for several days. No specific antidote.

Interaction with other drugs:

With the simultaneous application of norfloxacin and theophylline should be monitored concentration of theophylline in plasma and adjust the dose as norfloxacin reduces the clearance of theophylline by 25%, and can be observed the development of the undesirable side effects. Reduces the effect of nitrofuranov.
Norfloxacin may increase the therapeutic effect of cyclosporine and warfarin, in some cases, the application of norfloxacin with cyclosporine, an increase in serum creatinine, and therefore such patients should be monitored this indicator.

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

The simultaneous use of drugs, lowering the seizure threshold, may lead to the development of epileptiform seizures.
The simultaneous use of corticosteroids may increase the risk of tendinitis or tendon rupture cases. Norfloxacin may increase the therapeutic effect of hypoglycemic agents (sulfonylureas). Simultaneous treatment with norfloxacin drugs have the potential to lower blood pressure, it can cause a sharp decline. In this regard, in such cases, as well as while the introduction of barbiturates and other drugs for general anesthesia should be monitored heart rate, blood pressure and ECG.

Cautions

During treatment, patients should receive norfloxacin plenty of fluids (under the control of diuresis).
During the therapy may increase the prothrombin index (during surgery should control the state of the blood coagulation system).
During treatment with norfloxacin should avoid direct sunlight.
When a pain in the tendon or at the first sign tendovaginitah need to remove the drug. Norfloxacin during therapy is recommended to avoid excessive physical exertion.
In the presence of an allergic reaction to acetylsalicylic acid azo dye E ON (Disperse Yellow, E 110), may cause hypersensitivity reactions, even bronchospasm.

Effects on ability to drive vehicles and management mechanisms:

must be careful when driving and busy with other potentially hazardous activities that require high concentration of attention and quickness of psychomotor reactions (especially when the simultaneous use of ethanol).

Form release
Tablets, film-coated, 400 mg. 10 tablets in a blister. 1 or 2 blisters in a carton box with instructions for use.

Storage conditions
In a dry, dark place at a temperature not exceeding 25 ° C. Keep out of reach of children.

Expiration date
5 years.
Do not use after expiry date.