Norfloxacin tablets is covered.pl.ob. 400 mg 10 pcs. (norfloxacin)

film release s rdlkp film-coated tablets



packaging 10 pcs

Pharmacological action

Pharmaceutical group:

antimicrobial agent - fluoroquinolone.

Pharmacodynamics:

Antimicrobial agent from the group of fluoroquinolones. It has a bactericidal effect, inhibiting DNA gyrase, which ensures the supercoiling and stability of bacterial DNA, leads to destabilization of the DNA chain and the death of bacteria.

In vivo sensitive to norfloxacin:

Absorption by ingestion is fast (30-40%), food reduces absorption. The maximum concentration of norfloxacin in blood plasma (Cmax) when taking 200 mg, 400 mg and 800 mg is 0.8 μg / ml, 1.5 μg / ml and 2.4 μg / ml, respectively. The time to reach maximum plasma concentration (TCmax) is 1 hour. The effective half-life (T1 / 2) is 3-4 hours. The equilibrium concentration of the drug in blood plasma (Css) is achieved within 2 days.

In the elderly, excretion is slowed down (due to an age-related decrease in renal function): after ingestion of 400 mg of norfloxacin, the area under the pharmacokinetic curve of the concentration of the substance depending on time parameters (AUC) is 6.97-12.63 mg * h / ml and Cmax - 1 , 25-2.79 μg / ml (in young people - 6.4 mg * h / ml and 1.5 μg / ml, respectively), T1 / 2 - 4 hours.

Communication with plasma proteins - 10-15%. Klebsiella oxytoca, Morganella morganii, Providencia alcalifaciens, Providencia rettgeri, Providencia stuartii, Pseudomonas fluorescens, Pseudomonas stutzeri

others - Ureaplasma urealyticum.

The drug is inactive against obligate anaerobes.

Pharmacokinetics:

Absorption upon oral administration is fast (30-40%), food reduces absorption. The maximum concentration of norfloxacin in blood plasma (Cmax) when taking 200 mg, 400 mg and 800 mg is 0.8 μg / ml, 1.5 μg / ml and 2.4 μg / ml, respectively. The time to reach maximum plasma concentration (TCmax) is 1 hour. The effective half-life (T1 / 2) is 3-4 hours. The equilibrium concentration of the drug in blood plasma (Css) is achieved within 2 days.

In the elderly, elimination is slowed down (due to an age-related decline in kidney function):

2-3 hours after ingestion of 400 mg by mouth, the concentration in the urine exceeds 200 μg / ml, for 12 hours it is maintained above 30 μg / ml. At pH 7.5, the solubility of norfloxacin decreases.

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 sodium,

-

10.8 mg

- 21.6 mg

crospovidone]

-

mg 43rd mgp

Average weight of a tablet without a shell

-

360 mg

- 720 mg

Auxiliaries for a shell

hypromellose (hydroxypropyl methylcellulose),

-

6.57 mg

13.14 mg

macrogol 6000 (

macrogol 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 the 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.

From 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, shortness of breath, 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, hypostasis, postural hypotension.

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.

Concurrent use of antacids, containing aluminum or magnesium hydroxide, as well as drugs containing Fe, Zn2 +, sucralfate, reduces the absorption of norfloxacin (the interval between their appointment 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, multivitamins containing zinc, 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

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

Expiration

2 years.

Do not use after the expiry date stated on the packaging.

Deystvuyuschee substances

norfloxacin

dosage form

Dosage form

tablets



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