Norbactin, pills 400mg, 10pcs

Composition

Active ingredient:

norfloxacin 400 mg;

Auxiliary substances:

MCC;

croscarmellose sodium;

sodium lauryl sulfate;

corn starch;

colloidal silicon dioxide;

magnesium stearate;

purified talc

shell:

hypromellose; macrogol 400; purified talc; titanium dioxide; purified water (lost during production)

Pharmacological action

NORBACTIN is a broad-spectrum antibacterial (bactericidal) agent.

Pharmacodynamics

Antibacterial agent from the group of fluoroquinolones. It has a bactericidal effect. It acts on the bacterial enzyme DNA gyrase, which ensures supercoiling and, thus, the stability of bacterial DNA. Destabilization of the DNA chain leads to the death of bacteria. It has a wide spectrum of antibacterial action.

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

They have different sensitivity to the drug:  Enterococcus faecalis, Streptococcus spp. (pyogenes, pneumoniae and viridans), Serratio 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), Treponema pallidum. The duration of the effect is about 12 hours

. Pharmacokinetics

Absorption — 20-40% (food slows down). Tmax in plasma is 1 h. Binding to plasma proteins is 10-15%. It is well distributed in the body (kidney parenchyma, ovaries, seminal tubule fluid, prostate, uterus, abdominal and pelvic organs, bile, mother’s milk). Penetrates through the BBB and placenta. It is slightly metabolized in the liver.

It is excreted by the kidneys, glomerular filtration and tubular secretion. Within 24 hours from the moment of use,32% of the dose is excreted unchanged by the kidneys,5-8% – in the form of metabolites; about 30% of the dose is excreted in the bile.

Indications

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

• urinary tract infections;
• genital infections;
• uncomplicated gonorrhea;
• gastrointestinal infections;
• prevention of sepsis in patients with neutropenia;
• traveler’s diarrhea.

Contraindications

• hypersensitivity to norfloxacin or other drugs from the group of fluoroquinolones;
• glucose-6-phosphate dehydrogenase deficiency;
• cerebral vascular atherosclerosis;
• cerebral circulation disorders;
• epilepsy, convulsive syndrome;
• renal / hepatic insufficiency;
• pregnancy;
• lactation;
• children and adolescents (up to 18 years).

Side effects

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

From the urinary system:  crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, urethral bleeding, hypercreatininemia.

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

From the cardiovascular system:  tachycardia, arrhythmias, decreased heart rate HELL, fainting, vasculitis.

Allergic reactions:  pruritus, urticaria, edema, Stevens-Johnson syndrome.

From the musculoskeletal system:  arthralgia, tendonitis, tendon tears.

From the side of hematopoietic organs:  leukopenia, eosinophilia, decreased hematocrit.

Other services:  candidiasis.

Interaction

Simultaneous use 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 when used simultaneously, the dose of theophylline should be reduced.

Concomitant use of norfloxacin with drugs that have the potential to reduce blood pressure can cause a sharp decrease in blood pressure. In this regard, in such cases, as well as with the simultaneous use of barbiturate-containing anesthetics, heart rate, blood pressure, ECG indicators should be monitored.

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

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

Reduces the effect of nitrofurans.

How to take, course of use and dosage

Acute urinary tract infections – 400 mg twice daily for 7-10 days. Acute uncomplicated cystitis – 400 mg twice a day for 3 days. Recurrent or chronic urinary tract infections with exacerbations – 400 mg twice a day for 4 weeks, then, if necessary,400 mg per day for up to 12 weeks. There is evidence of a significant reduction in the frequency of recurrent urinary tract infections in women with frequent recurrent infections with prophylactic use of 200 mg of Norbactin once after sexual intercourse. Chemoprophylaxis for urological interventions, operations and postoperative infections – 400 mg twice a day before and after surgery, as needed. Acute uncomplicated gonococcal infections-800 mg once. Bacterial intestinal infections – 400 mg twice a day for 5 days. Prevention of travelers ‘ diarrhea-400 mg once a day (no more than 21 days). The widespread use of antibacterial agents for the prevention of diarrhea is not recommended, they can be used in high-risk areas, in the presence of aggravating factors (hypochlorhydria, the use of antacids and secretion inhibitors, dishammaglobulinemia) and a high risk of complications due to dehydration in somatic diseases, taking diuretics, cardiac glycosides. For better efficacy and tolerability, Norbactin should be taken one hour before or two hours after a meal. It should not be taken together with antacids. Patients are advised to drink enough fluids to prevent crystalluria. Patients with renal insufficiency (creatinine clearance from 10 to 30 ml / min/1.73 m2) – 400 mg once a day.

Overdose

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

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

There is no specific antidote.

Special instructions

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

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

During norfloxacin therapy, an increase in the prothrombin index was observed.

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

Direct sunlight should be avoided during treatment with Norbactin®.

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

Influence on the ability to drive motor vehicles and manage mechanisms. Due to the possible occurrence of dizziness, patients taking Norbactin® should exercise caution when driving a car and engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions (especially when drinking alcohol at the same time).

Form of production

Tablets

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Norfloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Enteritis, Urinary Tract Infections, Prostatitis, Salmonellosis, Intestinal Infections, Inflammation of the female genital organs, Diarrhea, Urethritis