Description
Latin name
Norfloxacin
release form
film-coated tablets
Packing
Per pack 20 pcs.
Indications
Infections caused by microorganisms sensitive to norfloxacin: urinary tract infections (except for acute and chronic complicated pyelonephritis), prostatitis, uncomplicated gonorrhea.
Use during pregnancy and lactation
The drug is contraindicated for use by pregnant women and women during lactation.
If used during lactation, breast-feeding must be discontinued.
Composition of
per 1 tablet:
Norfloxacin – 200 mg – 400 mg
Excipients
[silicon dioxide colloidal (aerosil),
–
3, 6 mg
– 7.2 mg
magnesium stearate,
–
3.6 mg
– 7.2 mg
microcrystalline cellulose,
–
120.4 mg
– 240.8 mg
croscarmellose 10, , 8 mg
– 21.6 mg
crospovidone]
–
21.6 mg
– 43.2 mg
Average weight of a tablet without a
shell –
360 mg
– 720 mg
Auxiliaries for a srdlkiprometer hyprome ,
–
6.57 mg
13.14 mg
macrogol 6000 (polyethylene glycol 6000)
–
2.2 mg
– 4.4 mg
titanium dioxide,
–
2.2 mg
– 4.4 mg
dye quinoline yellow
–
0.03 mg
– 0.06 mg
Dosage and Administration
Inside.
In case of urinary tract infections – 400 mg 2 times a day for 7-10 days with uncomplicated cystitis – 3-7 days for chronic recurrent urinary tract infections – up to 12 weeks.
In acute bacterial gastroenteritis – 5 days.
In acute gonococcal urethritis, pharyngitis, proctitis, cervicitis – once 800 mg.
With typhoid fever – 400 mg 3 times a day for 14 days.
For the prevention of sepsis – 400 mg 2 times a day.
For the prevention of bacterial gastroenteritis – 400 mg / day.
For the prevention of travelers’ diarrhea – 400 mg / day 1 day before departure and during the entire period of the trip (no more than 21 days).
For the prevention of recurrence of urinary tract infections – 200 mg / day.
In patients with impaired renal function with a CC more than 20 ml / min, dosage adjustment is not required. With CC below 20 ml / min (or a serum creatinine concentration of more than 5 mg / 100 ml), hemodialysis patients are prescribed 1/2 therapeutic dose 2 times a day or a full dose 1 time per day.
Side effects
From the central nervous system (CNS): dizziness, headache, tingling in fingers, drowsiness, anxiety, depression, insomnia, sleep disturbance.
From the digestive system: nausea, abdominal pain, anorexia, diarrhea, pain in the rectum or anus, constipation, dyspepsia, flatulence, vomiting, dry mucous membrane of the oral cavity, heartburn, loose stools, bitter taste in the mouth, ulceration of the mucous membrane oral cavity, itching of the anus.
From the hemopoietic organs: leukopenia, thrombocytopenia, eosinophilia, neutropenia.
From the skin: itching, rash, erythema, urticaria.
On the part of the sensory organs: blurred visual perception.
From the side of the musculoskeletal system: bursitis, swelling of the hands and feet.
From the side of the cardiovascular system (CVS): myocardial infarction, sensation of palpitations.
From the urinary system: renal colic.
Laboratory indicators: increased activity of AST, ALT, alkaline phosphatase, LDH, proteinuria, decreased hematocrit and Hb, increased blood urea concentration, hypercreatininemia, glucosuria.
Other: hyperhidrosis, asthenia, back pain, fever, chills, chest pain, dysmenorrhea, edema, allergic reactions.
Post-marketing experience.
From the side of the central nervous system: convulsions, myoclonus, tremor, peripheral neuropathy, Guillain-Barré syndrome, ataxia, paresthesia, hypesthesia, mental disorders (including confusion).
Allergic reactions: anaphylactoid reactions, angioedema, dyspnea, vasculitis, arthritis, arthralgia, myalgia.
From the skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, photosensitivity.
From the digestive system: pseudomembranous colitis, hepatitis, cholestatic jaundice, pancreatitis, stomatitis, liver failure (including fatal).
From the CCC side: lengthening of the QT interval, ventricular arrhythmia, including pirouette type tachycardia.
From the urinary system: interstitial nephritis, renal failure.
From the musculoskeletal system: tendonitis, tendon rupture, exacerbation of myasthenia gravis, increased activity of CPK.
From the side of hematopoiesis: agranulocytosis, hemolytic anemia.
On the part of the sensory organs: hearing loss, tinnitus, diplopia, dysgeusia.
Other side effects when taking quinolones: albuminuria, candiduria, crystalluria, cylindruria, dysphagia, hyperglycemia, hypercholesterolemia, hyperkalemia, hypertriglyceridemia, hematuria, liver necrosis, hypoglycemia, nystagmus, postural hypotension, lengthening of PV, vaginal candidiasis.
Drug Interaction
Reduces theophylline clearance by 25%, so a simultaneous use of theophylline dose should be reduced.
Increases the concentration of indirect anticoagulants, cyclosporine in serum.
Reduces the effectiveness of nitrofuran.
Simultaneous administration of antacids containing aluminum or magnesium hydroxide, as well as drugs containing Fe, Zn2 +, sucralfate, reduces the absorption of norfloxacin (their interval should be at least 4 h).
Concomitant use with drugs (drugs) that reduce the seizure threshold (including non-steroidal anti-inflammatory drugs) can lead to seizures.
Norfloxacin inhibits the CYP1A2 isoenzyme in vitro, which can lead to increased concentrations of its substrates in the blood (including caffeine, clozapine, ropinirole, tacrine, theophylline, tizanidine).
The development of severe hypoglycemia may occur with concomitant administration with glibenclamide.
Probenecid may reduce the excretion of norfloxacin.
Antacids, sucralfate, zinc-containing multivitamins, didanosine should be taken 2 h before or 2 h after administration of norfloxacin (may reduce its absorption).
Overdose
Symptoms of overdose: dizziness, nausea, vomiting, drowsiness, cold sweat, puffy face without changes in basic hemodynamic parameters.
Treatment: gastric lavage, adequate hydration therapy with forced diuresis. Inpatient examination and observation within a few days is required. There is no specific antidote.
Storage conditions
Store the drug at a temperature not exceeding 25 ° C, out of the reach of children.
Expiration
2 years.
Do not use after the expiry date stated on the packaging.
Deystvuyuschee substances
norfloxacin
Sardlkp pharmacy terms for prescription
dosage form
dosage form
tablets
Obolenskoye FP, Russia
