Norbaktin® (Norbactin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceNorfloxacinNorfloxacin
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    • Dosage form: & nbspfilm-coated tablets
    Composition:

    Active substance: norfloxacin - 400 mg.

    Excipients: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, corn starch, silicon dioxide colloid, magnesium stearate, talc purified.

    Sheath: hypromellose, macrogol - 400, talc purified, titanium dioxide, purified water (lost during production).
    Description:

    The film-coated tablets are oval in shape with beveled edges, white to almost white, engraved in a squared quadrangle "NBT 400 "on one side and risk on the other side.

    Pharmacotherapeutic group:antimicrobial agent, fluoroquinolone.
    ATX: & nbsp

    S.01.A.E.02   Norfloxacin

    Pharmacodynamics:Antibacterial agent from the group of fluoroquinolones. Has a bactericidal effect. The bacterial DNA enzyme acts on the bacterial enzyme, which ensures super-shrinkage and thus the stability of bacterial DNA. The destabilization of the DNA chain 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 meningitis, Escherichia coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Hafnia, Proteus spp. (indol-positive and indolotricative), Salmonella spp., Shigella spp., Yersinis enterocolitica, Campilobacter jejuni, Aeromonas Plesiomonas, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Leg onella spp. Different sensitivity to the drug has: Enterococcus faecalis, Streptococcus spp. (pyogenes, pneumoniae and viridans), Serrratio marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuim. 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 to reach Maksim(Tcmah) in plasma - 1 hour. Connection with plasma proteins - 10-15%. It is well distributed in the body (renal parenchyma, ovaries, seminal tubular fluid, prostate gland, uterus,organs of the abdominal cavity and small pelvis, bile, mother's milk). Penetrates through the blood-brain barrier (GEB) and the placenta. It is metabolized to an insignificant degree in the liver.

    It is excreted by the kidneys, by glomerular filtration and tubular secretion. Within 24 hours after receiving 32% of the dose is excreted by the kidneys unchanged, 5-8% - in the form of metabolites; with bile, about 30% of the dose is allocated.

    Indications:

    Treatment of infectious and inflammatory diseases caused by sensitive microorganisms, including: urinary tract infections; infection of the genitals; uncomplicated gonorrhea; infections of the gastrointestinal tract (GIT); prevention of sepsis in patients with neutropenia; travelers diarrhea.

    Contraindications:

    Hypersensitivity to norfloxacin or other drugs from the group of fluoroquinolones, pregnancy, lactation, children and adolescence (up to 18 years), deficiency of leukemia-6-phosphate dehydrogenase, cerebrovascular atherosclerosis, cerebral circulation disorder, epilepsy, convulsive syndrome, renal / hepatic failure.

    Dosing and Administration:

    Norbaktin® is taken orally on an empty stomach (at least 1 hour before or 2 hours after eating) and drink plenty of liquid.

    When acute uncomplicated cystitis prescribe 200-400 mg 2 times / day for 3-5 days.

    When acute urinary tract infections - 400 mg 2 times / day for 7-10 days.

    When recurrent or chronic recurrent urinary tract infections - 400 mg 2 times / day for 4 weeks and 400 mg / day for up to 12 weeks in case of relapse.

    When infections of genital organs - 400-600 mg 2 times / day for 7 days.

    When acute uncomplicated gonococcal infection - prescribe 800 mg once.

    For prevention of sepsis in patients with neutropenia - 400 mg 3 times / day for 8 weeks.

    When infections of the gastrointestinal tract (GIT) - 400 mg 2 times / day for 3-5 days.

    For prevention of bacterial diarrhea in epidemically unfavorable regions - 400 mg 1 time / day.

    In patients with impaired renal function with creatinine clearance (CC) greater than 20 ml / min, correction of the dosing regimen is not required. At CC below 20 ml / min (or serum creatinine level more than 5 mg / 100 ml) and patients on hemodialysis, appoint 1/2 therapeutic dose 2 times a day or a full dose once a day.

    Side effects:

    From the digestive system: anorexia, bitter taste 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, hypercreatininaemia.

    From the nervous system: headache, dizziness, insomnia, hallucinations.

    From the cardiovascular system: tachycardia, arrhythmias, lowering blood pressure, fainting, vasculitis.

    Allergic reactions: skin itching, urticaria, swelling, Stevens-Johnson syndrome.

    From the musculoskeletal system: arthralgia, tendinitis, tendon ruptures.

    On the part of the organs of hematopoiesis: leukopenia, eosinophilia, a decrease in hematocrit.

    Other: candidiasis.

    Overdose:

    Symptoms (3 g for 45 min): dizziness, nausea, vomiting, drowsiness, "cold" sweat, puffy face without changes in the basic hemodynamic parameters.

    Treatment: gastric lavage, adequate hydration therapy with forced diuresis.It requires a survey and observation in the hospital for several days.

    There is no specific antidote.
    Interaction:

    Simultaneous reception of antacids containing aluminum or magnesium hydroxide, as well as preparations containing iron, zinc, sucralfate reduces the absorption of norfloxacin (the interval between their appointment should be at least 4 hours).

    Reduces the clearance of theophylline by 25%, so with simultaneous use should reduce the dose of theophylline.

    Simultaneous administration of norfloxacin with drugs that have the potential to reduce blood pressure (BP), can cause a sharp decrease in it. In this regard, in such cases, as well as with the simultaneous administration of barbiturate-containing, anesthetics, it is necessary to control the heart rate, blood pressure, ECG parameters.

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

    Increases the concentration of indirect anticoagulants, cyclosporine (mutually) in serum blood.

    Reduces the effect of nitrofurans.

    Special instructions:

    If it is necessary to prescribe Norbaktin® during lactation, the question of stopping breastfeeding should be solved.

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

    During the treatment of norfloxacin, an increase in the prothrombin index was noted.

    When performing surgical interventions, the condition of the blood coagulation system should be monitored.

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

    When pain occurs in the tendons or at the first signs of tendovaginitis, it is recommended to cancel the drug.

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

    In connection with the possible occurrence of dizziness, patients taking Norbaktin® should be careful when driving a car and engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions (especially with simultaneous use of alcohol).

    Form release / dosage:Coated tablets, 400 mg.
    Packaging:For 10 tablets in a strip of aluminum foil or 10 tablets in a blister of aluminum foil and PVC film. For 1, 2 or 3 strips or blisters in a cardboard box with instructions for use.
    Storage conditions:

    List B. In a dry place, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:4 years.
    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N002845
    Date of registration:02.08.2011
    The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India
    Manufacturer: & nbsp
    Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED
    Information update date: & nbsp21.08.2015
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