Norbaktin

General characteristics. Structure:

Active agent: norfloxacin – 400 mg.
Excipients: microcrystallic cellulose, croscarmellose sodium, sodium lauryl sulfate, starch corn, silicon dioxide colloid, magnesium the stearate, talc purified.
Cover: a gipromelloza, a macrogoal – 400, the talc purified titanium dioxide, the water purified (it is lost in the course of production).
Description. Tablets, film coated, an oval form with slanted edges, white till almost white color, with engraved in the squeezed-out quadrangle of "NBT 400" on one party and risky on other party.

Pharmacological properties:

Pharmacodynamics. Antibacterial agent from group of ftorkhinolon. Has bactericidal effect. Influences bacterial DNK-girazu enzyme, the providing superspiralling and thus stability of DNA of bacteria. Destabilization of a chain of DNA leads to death of bacteria. Possesses a wide range of antibacterial action. Are sensitive: Staphylococcus aureus (including Staphylococcus spp strains., resistant to Methicillinum), Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitis, Escherichia coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Hafnia, Proteus spp. (indolpositive and indolnegative), Salmonella spp., Shigella spp., Yersinis enterocolitica, Campilobacter jejuni, Aeromonas Plesiomonas, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp. Have various sensitivity to drug: Enterococcus faecalis, Streptococcus spp. (pyogenes, pneumoniae and viridans), Serrratio marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuim. Are insensitive: Ureaplasma urealyticum, Nocardia asteroides, anaerobic bacteria (for example, Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile), Treponella pallidum. Effect duration - about 12 h.

Pharmacokinetics. Absorption - 20-40% (food slows down). Time of achievement of the maximum concentration (Tcmax) in plasma - 1 h. Communication with proteins of plasma - 10-15%. It is well distributed in an organism (a parenchyma of kidneys, ovaries, liquid of seed tubules, a prostate gland, a uterus, abdominal organs and a small pelvis, bile, maternal milk). Gets through a blood-brain barrier (GEB) and a placenta. In insignificant degree it is metabolized in a liver. It is removed by kidneys, by glomerular filtering and canalicular secretion. During 24 h from the moment of reception of 32% of a dose 5-8% - in the form of metabolites are removed by kidneys in not changed look; with bile about 30% of the accepted dose are allocated.

Indications to use:

Treatment of the infectious and inflammatory diseases caused by sensitive microorganisms in т.ч: infections of urinary tract; infections of generative organs; uncomplicated gonorrhea; infections of the digestive tract (DT); prevention of sepsis at patients with a neutropenia; diarrhea of travelers.

Route of administration and doses:

Норбактин® take inside on an empty stomach (not less than for 1 h to or in 2 h after food) and wash down with enough liquid.
At acute uncomplicated cystitis appoint on 200-400 mg of 2 times/days within 3-5 days.
At acute infections of urinary tract - on 400 mg of 2 times/days within 7-10 days.
At recurrent or persistent recurrent infections of urinary tract - on 400 mg of 2 times/days within 4 weeks and on 400 mg/days up to 12 weeks in case of a recurrence.
At infections of generative organs - on 400-600 mg of 2 times/days within 7 days.
At an acute uncomplicated gonococcal infection - appoint 800 mg once.
For prevention of sepsis at patients with a neutropenia - on 400 mg of 3 times/days within 8 weeks.
At infections of the digestive tract (DT) - on 400 mg of 2 times/days within 3-5 days.
For prevention of bacterial diarrhea in epidemic adverse areas - 400 mg of 1 times/days.
With renal failures at the clearance of creatinine (CC) more than 20 ml/min. of correction of the mode of dosing are not required from patients. At KK it is lower than 20 ml/min. (or the level of serumal creatinine more than 5 mg / 100 of ml) and to the patients who are on a hemodialysis appoint 1/2 therapeutic doses 2 times a day or a full dose of 1 times a day.

Features of use:

In need of purpose of the drug Norbaktin® in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.
During treatment by drug patients have to receive enough liquid (under control of a diuresis).
During therapy of norfloxacin increase in a prothrombin ratio was noted.
When carrying out surgical interventions it is necessary to control a condition of system of a blood coagulation.
During treatment by the drug Norbaktin® it is necessary to avoid impact of a direct sunlight.
At emergence of pains in sinews or at the first symptoms of a tendovaginitis recommend to cancel drug.
Influence on ability to driving of motor transport and to control of mechanisms: Due to the possible developing of dizziness, the patients accepting Norbaktin® should be careful during the driving of the car and occupations other potentially dangerous types of activity requiring special attention and speed of psychomotor reactions (especially at simultaneous alcohol intake).

Side effects:

From the alimentary system: anorexia, bitterness in a mouth, nausea, vomiting, abdominal pains, diarrhea, a pseudomembranous coloenteritis (at prolonged use), increase in activity of "hepatic" transaminases.
From an urinary system: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, urethral bleedings, giperkreatininemiya.
From a nervous system: headache, dizziness, sleeplessness, hallucinations.
From cardiovascular system: tachycardia, arrhythmias, lowering of arterial pressure, faint, vasculitis.
Allergic reactions: skin itch, small tortoiseshell, hypostases, Stephens-Johnson's syndrome.
From a musculoskeletal system: arthralgia, tendinites, ruptures of sinews.
From bodies of a hemopoiesis: leukopenia, eosinophilia, decrease in a hematocrit.
Others: candidiasis.

Interaction with other medicines:

The concomitant use of the antacids containing aluminum hydroxide or magnesium, and also the drugs containing iron, zinc сукральфат reduces norfloxacin absorption (the interval between their appointment has to be not less than 4 h).
Reduces clearance of theophylline by 25% therefore at simultaneous use it is necessary to reduce a theophylline dose.
Simultaneous administration of norfloxacin with the medicines having potential ability to reduce the arterial pressure (AP) can cause its sharp decrease. In this regard in such cases, and also at simultaneous introduction barbituratsoderzhashchy, anesthetics, it is necessary to control heart rate, the ABP, ECG indicators.
Simultaneous use with the drugs reducing a convulsive threshold can lead to development of epileptiform attacks.
Increases concentration of indirect anticoagulants, cyclosporine (mutually) in blood serum.
Reduces effect of nitrofurans.

Contraindications:

Hypersensitivity to norfloxacin or other drugs from group of ftorkhinolon, pregnancy, the lactation period, children's and teenage age (up to 18 years), deficit glyukozo-6-fosfatdegidrogenazy, atherosclerosis of vessels of a brain, disturbance of cerebral circulation, epilepsy, a convulsive syndrome, a renal/liver failure.

Overdose:

Symptoms (3 g in 45 min.): dizziness, nausea, vomiting, drowsiness, "cold" sweat, a bloated face without changes of the main hemodynamic indicators.
Treatment: a gastric lavage, adequate hydration therapy with an artificial diuresis. Inspection and observation in a hospital within several days is required.
There is no specific antidote.

Storage conditions:

List B. In the dry place, at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity: 3 years. Not to use after expiry date.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated, 400 mg. On 10 tablets in a strip from aluminum foil  or on 10 tablets in the blister from aluminum foil and PVC of a film. On 1,2 or 3 strip or the blister in a cardboard pack with the application instruction.