Norbaktin, 400 mg 20 pcs

Pharmacological action – broad spectrum antibacterial (bactericidal).

Pharmacodynamics

An antibacterial agent of the group of fluoroquinolones. It has a bactericidal effect. It affects the bacterial enzyme DNA-gyrase, which provides superspiralization and thus the stability of bacterial DNA. Destabilization of DNA chain leads to the death of bacteria. It has a broad spectrum of antibacterial action.

Sensitive: Staphylococcus aureus (including strains of Staphylococcus spp. resistant to methicillin), Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitis, Escherichia coli, Citrobacter spp., Klebsiella spp., Enterobacter spp, Hafnia, Proteus spp. (indole-positive and indole-negative), Salmonella spp., Shigella spp., Yersinis enterocolitica, Campilobacter jejuni, Aeromonas plesiomonas, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp.

Different sensitivity to the drug has: Enterococcus faecalis, Streptococcus spp. (pyogenes, pneumoniae and viridans), Serratio marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuim.

Intolerant: Ureaplasma urealyticum, Nocardia asteroides, anaerobic bacteria (e.g. Bacteroides spp.,, Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile), Treponema pallidum. Duration of effect – about 12 hours.

Pharmacokinetics

Absorption – 20-40% (food slows down). Tmax in plasma – 1 h. Binding to plasma proteins – 10-15%. Well distributed in the body (renal parenchyma, ovaries, seminal tubules fluid, prostate, uterus, abdominal and pelvic organs, bile, mother’s milk). It penetrates through the BBB and the placenta. It is metabolized in liver to a small extent.

Extracted by the kidneys through glomerular filtration and tubular secretion. Within 24 hours after the dose 32% of it is excreted unchanged by kidneys, 5-8% – as metabolites; about 30% of dose taken is excreted in bile.

Indications

Inflammation of the female genitalia, Prostatitis, Diarrhea, Urinary tract infections, Enteritis, Intestinal infections, Salmonellosis, Urethritis

Treatment of infectious and inflammatory diseases caused by susceptible microorganisms, including:

– urinary tract infections;

– genital infections;

– uncomplicated gonorrhea;

– gastrointestinal infections;

– prevention of sepsis in patients with neutropenia;

– traveler’s diarrhea.

Active ingredient

Norfloxacin

Composition

1 Shell-coated tablet:

Active ingredient:

norfloxacin – 400.00 mg,

excipients: MCC; croscarmellose sodium; sodium lauryl sulfate; corn starch; colloidal silica; magnesium stearate; purified talc,

shell: hypromellose; macrogol 400; purified talc; titanium dioxide; purified water (lost in manufacturing process).

How to take, the dosage

Overly, on an empty stomach (at least 1 hour before or 2 hours after a meal), with plenty of fluids.

In acute uncomplicated cystitis, 200-400 mg 2 times a day for 3-5 days.

In acute urinary tract infections, 400 mg 2 times a day for 7-10 days.

In recurrent or chronic recurrent urinary tract infections, 400 mg 2 times/day for 4 weeks and 400 mg/day up to 12 weeks in cases of relapse.

In genital tract infections, 400-600 mg 2 times daily for 7 days.

In acute uncomplicated gonococcal infection, 800 mg once.

For prophylaxis of sepsis in patients with neutropenia – 400 mg 3 times daily for 8 weeks.

Infections of the gastrointestinal tract – 400 mg 2 times a day for 3-5 days.

For prophylaxis of bacterial diarrhea in epidemic-prone areas – 400 mg once daily.

In patients with impaired renal function, in creatinine Cl over 20 ml/min, dosage regimen adjustment is not required. In patients with creatinine Cl below 20 ml/min (or serum creatinine level more than 5 mg/100 ml) and in patients on hemodialysis 1/2 therapeutic dose 2 times daily or full dose 1 time daily is administered.

Interaction

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

Decreases clearance of theophylline by 25%; therefore, if used concomitantly, theophylline dose should be reduced.

The concomitant administration of norfloxacin with drugs that have the potential to decrease BP may cause a sharp decrease in BP. Therefore, in these cases, as well as when concomitant administration of barbiturates and anesthetics, heart rate, BP and ECG parameters should be monitored.

The concomitant use with drugs that lower the seizure threshold may lead to the development of epileptiform seizures.

Increases the serum concentration of indirect anticoagulants, cyclosporine (reciprocally).

Decreases the effect of nitrofurans.

Special Instructions

If it is necessary to prescribe Norbaktin® during lactation, discontinuation of breastfeeding should be considered.

During treatment with the drug, patients should get enough fluids (under diuresis control).

An increase in prothrombin index has been noted during therapy with norfloxacin.

The clotting system should be monitored during surgical interventions.

At the time of treatment with Norbaktin® exposure to direct sunlight should be avoided.

In case of tendon pain or at first signs of tendovaginitis, it is recommended to discontinue the drug.

Impact on the ability to drive vehicles and operate machinery. Because of possible dizziness patients taking Norbaktin® should be careful when driving and engaging in other potentially dangerous activities requiring increased attention and rapid psychomotor reactions (especially if alcohol is simultaneously used).

Contraindications

– hypersensitivity to norfloxacin or other drugs from the group of fluoroquinolones;

– deficiency of glucose-6-phosphate dehydrogenase;

– atherosclerosis of cerebral vessels;

– cerebral circulation disorder;

– epilepsy, seizure syndrome;

– renal/liver failure;

– pregnancy;

– lactation period;

– childhood and adolescence (under 18).

Side effects

Digestive system disorders: anorexia, bitter taste in the mouth, nausea, vomiting, abdominal pain, diarrhea, pseudomembranous enterocolitis (in long-term use), increased liver transaminases activity.

Urinary system disorders: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, urethral bleeding, hypercreatininemia.

Nervous system disorders: headache, dizziness, insomnia, hallucinations.

Cardiovascular system disorders: tachycardia, arrhythmias, decreased BP, syncope, vasculitis.

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

Musculoskeletal system disorders: arthralgia, tendinitis, tendon ruptures.

Hematopoietic disorders: leukopenia, eosinophilia, decrease in hematocrit.

Others: candidiasis.

Overdose

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

Treatment: gastric lavage, adequate hydration therapy with forced diuresis. Examination and observation in the hospital for several days is required.

There is no specific antidote.

Similarities

Norfloxacin, Normax, Nolycin