Norfloxacin, 400 mg 20 pcs

Pharmacotherapeutic group: antimicrobial agent – fluoroquinolone

ATC code: S01AE02

Pharmacodynamics:

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to norfloxacin: urinary tract infections (except acute and chronic complicated pyelonephritis) chronic bacterial prostatitis uncomplicated gonorrhea salmonellosis shigellosis.

Prevention of traveler’s diarrhea prevention of sepsis in patients with neutropenia.

Active ingredient

Composition

Per 1 tablet:

The active ingredient:

Norfloxacin 400.0 mg.

Excipients (core): lactose monohydrate (milk sugar) – 85.0 mg, microcrystalline cellulose – 98.0 mg, croscarmellose sodium – 37.0 mg, water – 10.0 mg, povidone-K25 – 24.0 mg, magnesium stearate – 6.0 mg.

Excipients (coating): hypromellose -11.0 mg, macrogol-4000 – 3.0 mg, titanium dioxide – 6.0 mg.

How to take, the dosage

Ingestion on an empty stomach (at least 1 hour before or 2 hours after a meal) and drink plenty of fluids.

If there are no special doctor’s orders, the following doses are recommended: 1 tablet (400 mg) 2 times a day. The course of treatment is from 7 to 14 days; if necessary, treatment may be prolonged.

In urinary tract infections – 400 mg 2 times a day for 7-10 days; in uncomplicated cystitis – 3-7 days; in chronic recurrent urinary tract infections – up to 12 weeks; in acute bacterial gastroenteritis (shigellosis salmonellosis) – 5 days; in acute gonococcal urethritis pharyngitis proctitis cervicitis – once 800 mg. For prophylaxis of infections (in patients with neutropenia) – 400 mg 2 times a day; for prophylaxis of bacterial gastroenteritis – 400 mg/day. For prophylaxis of travelers’ diarrhea – 400 mg/day 1 day before departure and during the whole period of travel (not more than 21 days). For prevention of recurrent urinary tract infections – 200 mg/day. For bacterial prostatitis (acute and chronic) – 400 mg 2 times a day for 28 days.

In patients with impaired renal function with creatinine clearance (CK) more than 30 ml/min, it is not necessary to correct the dosage regimen. In patients with blood circulation of less than 30 ml/min and in patients undergoing hemodialysis a 1/2 of therapeutic dose 2 times a day or a full dose once a day is administered.

Interaction

In concomitant use of norfloxacin and theophylline, plasma concentrations of theophylline should be monitored and the dose should be adjusted because norfloxacin reduces the clearance of theophylline by 25%.

Limits the effect of nitrofurans.

Norfloxacin may potentiate therapeutic effects of cyclosporine and indirect anticoagulants in individual cases when using norfloxacin with cyclosporine increased plasma creatinine concentration was observed so that this index and plasma concentration of cyclosporine should be controlled in these patients.

The simultaneous use of norfloxacin and antacids containing aluminum or magnesium hydroxide as well as agents containing zinc ions sucralfate leads to decreased absorption of norfloxacin (interval between doses should be at least 2 hours).

The concomitant use with drugs (including non-steroidal anti-inflammatory drugs) which lower the seizure threshold may lead to seizures.

The concomitant use with glucocorticosteroids may increase the risk of tendinitis or tendon rupture.

Norfloxacin may increase the therapeutic effect of hypoglycemic drugs (sulfonylurea derivatives) in connection with which plasma glucose concentrations should be monitored.

The concomitant use of norfloxacin with drugs with a potential ability to lower blood pressure can cause a sharp decrease in blood pressure. In this regard, in such cases, as well as when concomitant administration with barbiturates and other drugs for general anesthesia the heart rate, blood pressure and ECG parameters should be monitored.

Norfloxacin in vitro inhibits CYP1A2 isoenzyme which may increase plasma concentrations of its substrates (including caffeine clozapine ropinirole tacrine theophylline tizanidine) in connection with which monitoring of patients taking these drugs concomitantly with norfloxacin is necessary.

Probenecid may decrease excretion of norfloxacin.

Concomitant use with medications that prolong the QT interval may cause greater prolongation of the QT interval.

Special Instructions

In some cases hypersensitivity reactions (anaphylactic/anaphylactoid reactions) may develop already after the first use of the drug and the physician should be informed immediately. Very rarely even after the first use of the drug anaphylactic reactions may progress to life-threatening anaphylactic shock. In these cases treatment with norfloxacin should be stopped and necessary treatment measures (including anti-shock measures) should be started immediately.

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

The prothrombin index may increase during therapy (during surgical interventions the clotting system should be monitored).

During treatment with norfloxacin, exposure to ultraviolet rays including direct sunlight should be avoided.

Norfloxacin like other fluoroquinolones can cause tendinitis and tendon rupture. Risk factors: age over 60 years old taking glucocorticosteroids kidney or lung transplantation increased physical activity chronic renal insufficiency tendon diseases in anamnesis (including rheumatoid arthritis). These phenomena can also occur several months after the end of the drug administration. If tendon pain appears or at the first signs of tendovaginitis it is necessary to cancel the drug and consult a physician. During therapy with norfloxacin, it is recommended to avoid excessive physical activity. Norfloxacin can lower seizure threshold and cause seizures; fluoroquinolones can also stimulate the central nervous system causing tremors toxic psychosis anxiety confusion and hallucinations; increase intracranial pressure. If seizures develop, the use of the drug should be discontinued.

Norfloxacin may lead to the development of pseudomembranous colitis caused by Clostridium difficile. In this case the drug should be discontinued and appropriate treatment (including oral vancomycin or metronidazole) should be prescribed. Drugs which inhibit intestinal peristalsis are contraindicated.

In cases of cholestatic hepatitis have been reported with norfloxacin. The patient should be informed that if symptoms of liver dysfunction occur (anorexia jaundice darkened urine itching abdominal pain) it is necessary to consult a physician before continuing treatment with norfloxacin.

It is not effective in syphilis.

In patients treated with quinolones including norfloxacin, there have been cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons and resulting in paresthesia, hyposthesia, dysesthesia and weakness. Symptoms may appear soon after initiation of use and may be irreversible. Patients being treated with norfloxacin should be warned to seek immediate medical attention in the event of symptoms of neuropathy including pain burning tingling numbness weakness or other sensory disturbances including tactile pain temperature vibration sensitivity and sense of position (see section “Side effects”) Norfloxacin should be stopped immediately.

In order to avoid formation of norfloxacin crystals in the kidneys, the recommended doses should not be exceeded; sufficient fluids should be taken with the tablets.

Cautious driving and other potentially hazardous activities that require increased concentration and quick psychomotor reactions are necessary.

Synopsis

Contraindications

– hypersensitivity to norfloxacin components of the drug and other quinolones;

– deficiency of glucose-6-phosphate dehydrogenase;

– tendinitis tendon rupture caused by taking fluoroquinolones (including history).

– hereditary lactose intolerance lactase deficiency or glucose-galactose malabsorption;

– childhood and adolescence (under 18 years);

– pregnancy and lactation.

. Atherosclerosis of cerebral blood vessels cerebral circulation disorder (in anamnesis) epilepsy organic diseases of the central nervous system predisposition to seizure reactions psychosis and other mental disorders in anamnesis renal/liver failure myasthenia gravis liver porphyria diabetes syndrome congenital prolongation of interval QT heart disease (heart failure myocardial infarction bradycardia) electrolyte imbalance (eg hypokalemia hypomagnesemia) advanced age in women concomitant use of drugs prolonging the QT interval (antiarrhythmic drugs of class IA and III tricyclic and tetracyclic antidepressants neuroleptics macrolides antifungal imidazole derivatives some antihistamines includingincluding astemizole terfenadine ebastine) medicines for general anesthesia from the group of barbiturates; medicines reducing blood pressure.

Side effects

Nervous system disorders: dizziness headache anxiety tingling in the fingers sleepiness anxiety depression insomnia sleep disturbance.

Digestive system disorders: nausea abdominal pain anorexia diarrhea pain in the rectum or anus constipation dyspepsia flatulence vomiting dry oral mucosa heartburn loose stools bitter taste in the mouth ulceration of the oral mucosa itching anus.

Hematopoietic organs: leukopenia thrombocytopenia eosinophilia neutropenia.

Skin disorders: itching rash erythema urticaria.

Sensory organs: blurred vision.

Musculoskeletal disorders: bursitis swollen hands and feet.

Cardiovascular system: myocardial infarction, palpitations.

Perior urinary system disorders: renal colic.

Laboratory measures: increased activity of “hepatic” transaminases (alanine aminotransferase aspartate aminotransferase alkaline phosphatase lactadehydrogenase) proteinuria decrease hematocrit and hemoglobin increase blood urea concentration hypercreatininemia glucosuria.

Others: hyperhidrosis asthenia back pain fever chills chest pain dysmenorrhea edema allergic reactions fatigue.

Postmarketing experience.

Nervous system disorders: convulsions myoclonia tremor peripheral neuropathy Guillain-Barré syndrome ataxia paresthesia hypoesthesia mental disorders (including confusion) irritability feeling of fear.

Allergic reactions: anaphylactic/anaphylactoid reactions angioedema dyspnea vasculitis urticaria.

Skin disorders: toxic epidermal necrolysis Stevens-Johnson syndrome erythema multiforme exfoliative dermatitis photosensitization leukocytoclastic vasculitis drug rash with eosinophilia and systemic symptoms (DRESS syndrome).

Digestive system disorders: pseudomembranous colitis hepatitis cholestatic jaundice pancreatitis stomatitis liver failure (including fatal).

Cardiovascular system disorders: prolongation of QT interval ventricular arrhythmia including pirouette-type tachycardia.

Treatment of the urinary system: increase in plasma urea content interstitial nephritis renal failure.

Musculoskeletal system: arthritis arthralgia myalgia tendinitis tendon rupture exacerbation myasthenia gravis increased creatine phosphokinase activity muscle cramps.

Hematopoietic organs: agranulocytosis hemolytic anemia.

Sensory organs: decreased hearing tinnitus diplopia dysgeusia.

Other side effects when taking quinolones: agranulocytosis albuminuria candiduria crystalluria cylinduria dysphagia hyperglycemia hypercholesterolemia hyperkalemia hypertriglyceridemia hematuria liver necrosis hypoglycemia nystagmus postural hypotension prolongation of prothrombin time vaginal candidiasis.

Overdose

Symptoms: nausea vomiting diarrhea dizziness drowsiness “cold” sweat cramps puffy face.

Treatment: gastric lavage adequate hrdational therapy with forced diuresis and symptomatic therapy. Examination and observation in hospital for several days is required. There is no specific antidote.

Pregnancy use

Similarities