Norfloxacin 400mg №20 pills

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Norfloxacin 400mg №20 pills

Title:
Norfloxacin 400mg
Norfloxacin

Release form:

coated pills.

Description

pills of blue color, round, biconvex, coated.

Composition:

On one tablet

Active ingredient: 400 mg.
Excipients:

pills of 400 mg: calcium phosphate dibasic, corn starch, lactose monohydrate, gelatin, talc, magnesium stearate, anhydrous colloidal silicon dioxide, croscarmellose sodium.

Shell: propylene glycol, Sankoat brilliant blue (hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, brilliant blue (E 133)).

Pharmacotherapeutic group:

Antimicrobial agents for systemic use. Antibacterial agents of the quinolone group. Norfloxacin.

Pharmacodynamics.

Inhibits bacterial DNA synthesis, which provides supercoiling and DNA stability, disrupts protein synthesis and leads to the death of microorganisms. Active against staphylococcus aureus , Campylobacter jejuni, Aeromonas plesiomonas, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia, Legionella. Enterococci, streptococci pyogenes, pneumoniae and viridans, Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis pneumoniae, Mycobacterium tuberculosis, as well as Mycobacterium fortium have variable sensitivity to norfloxacin. Not sensitive - most strains of Ureaplasmaurealyticum, Nocardiaasteroides, anaerobic bacteria (for example, Bacteroidesspp., Peptococci, peptostreptokokki, Eubacteriumspp., Fusobacteriumspp., Clostridiumdifficile), Treponemapallidum.

Pharmacokinetics.

Well absorbed from the gastrointestinal tract (absorption rate - more than 20-40%), food delays absorption. Therapeutic concentration is reached in the plasma within 1 hour after ingestion. Communication with plasma proteins - 10-15%. Distribution - the parenchyma of the kidneys, testicles, the fluid of the seminiferous tubules, prostate gland, uterus, abdominal organs and small pelvis, bile, mother's milk. The permeability through the BBB and the placental barrier is high. Metabolized to a small extent in the liver and excreted in the bile and urine. Excretion by the kidneys is carried out due to glomerular filtration and tubular secretion.During the day, 32% of the dose is excreted in the urine, about 30% in the feces; 5-8% is excreted in the form of metabolites.

Indications for use

Norfloxacin is indicated for the treatment of infections caused by susceptible organisms.
Urinary tract infections:
uncomplicated canal
complicated urinary tract infections caused by the following microorganisms: Enterococcus faecalis, Escherichia coli, Klebsiellapneumoniae, Proteusmirabilis, Pseudomonasaeruginosa, or Serratiamarcescens.
Sexually transmitted diseases:
uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhea;
prostatitis caused by Escherichiacoli. The production of penicillinase does not affect the activity of norfloxacin.

special instructions

Before starting treatment, it is necessary to determine the sensitivity of the pathogenic microorganism to norfloxacin. Norfloxacin therapy can be started before test results are obtained. In this case, before the start of the planned therapy, it is necessary to select the material for laboratory diagnostics in order to be able to change the treatment if the infectious agents are not sensitive to norfloxacin. Repeated tests for the sensitivity of the pathogenic microorganism to norfloxacin during therapy will provide information on the therapeutic effect of norfloxacin and on the possible development of bacterial resistance. In order to reduce the possibility of developing bacterial resistance and reduce the effectiveness of norfloxacin should be used only for the treatment of infections caused by pathogens that are sensitive to it.

Dosage and administration

Norfloxacin should be taken 2 hours before or 4 hours after the use of calcium supplements, multivitamin preparations containing calcium, nutrient solutions used by mouth, and dairy products.
Dosing for patients with normal renal function. The recommended daily dose of norfloxacin is described in the table:
 

Infections Dose
appointment
Reception frequency Carry on
strength
Daily dose
Urinary tract:
Uncomplicated infections
urinary tract (cystitis),
caused by E coli,
K.pneumoniae or P.Mirabilis
 
Uncomplicated infections
urinary tract caused
by others
the above microorganisms
400 mg
 
 
 
 
400 mg
 
 
12 hours
 
 
 
 
12 hours
 
 
3 days
 
 
 
 
7-10 days
 
 
800 mg
 
 
 

800 mg
 
 
Infections Dose
appointment
Reception frequency Duration Daily dose
Complicated Infections
urinary tract
400 mg
12 hours 10-21 days 800 mg
Diseases transmitted
sexually
800 mg Once 1 800 mg
Prostatitis. Acute
or chronic
400 mg 12 hours 28 days 800 mg

Dosing in patients with renal insufficiency: Norfloxacin can be used to treat urinary tract infections in patients with renal insufficiency. In patients with creatinine clearance 30 ml / min / 1.73 m3 or less, the recommended dose is 400 mg once a day for the duration of treatment indicated above. In this dose, the concentration in the urine of the drug exceeds the MIC for most urinary infectious pathogens susceptible to norfloxacin, even if the patient's creatinine clearance is less than 10 ml / min / 1.73 m2.

At a known level of creatinine clearance, the following formula is used to calculate the dose (taking into account sex, weight and age of the patient):
 
Men =
Women = (0.85) x (value above)
Elderly patients. In the absence of renal failure (creatinine clearance more than 30 ml / min / 1.73 m3a) need for dose adjustment is not. For elderly patients whose creatinine clearance is 30 ml / min / 1.73 m3or less, the recommended dose is 400 mg once a day for the duration of treatment as in renal failure.

Side effects

Since the cardiovascular system:
very rarely when taking Norfloxacin, prolongation of the QT interval and ventricular arrhythmia (including pirouette ventricular tachycardia) may occur. When combined use of norfloxacin with drugs with an established risk factor for lengthening the QT interval, as well as when prescribing to patients with known risk factors for lengthening the QT interval, the possibility of prolongation of the QT interval increases dramatically.
On the part of the digestive tract: vomiting, heartburn, pancreatitis.
From the nervous system:
dizziness, hallucinations, mood changes, paresthesias, insomnia, depression, anxiety, irritability, euphoria, disorientation, anxiety, polyneuropathy, including Guillain-Barré syndrome, epileptiform seizures, hypoesthesia, mental disorders, including psychotic reactions, tremor, myocilia.
From the hematopoietic system: neutropenia, hemolytic anemia, thrombocytopenia.
On the part of the urinary system: interstitial nephritis.
From the musculoskeletal system and connective tissue:
arthralgia, tendinitis, tendovaginitis, tendon ruptures, myalgia, arthritis. Very rarely - inflammation of the Achilles tendon, which can lead to its rupture
From the skin and subcutaneous tissue:
pruritus, edema, exanthema, petechiae, hemorrhagic bulls and papules with the formation of a crust as a manifestation of vascular involvement (vasculitis)
On the part of the immune system:
angioedema; in rare cases - exfoliative dermatitis, Stevenson-Johnson syndrome, Lyell's syndrome, exudative erythema polymorphism, photosensitization.
Changes in laboratory parameters:
increased levels of glutomat-oxaloacetate transaminase, glutamate pyruvate transaminase, and serum alkaline phosphatase.
Others: vaginal candidiasis, dysopia, increased lacrimation, tinnitus, hearing loss, shortness of breath, dysgeusia.

Contraindications

  • Hypersensitivity to quinolones;
  • Liver failure;
  • End-stage chronic renal failure;
  • Deficiency of glucose-6-phosphate dehydrogenase;
  • Pregnancy (arthropathy may develop in the fetus);
  • Lactation;
  • Children and adolescents (up to 18 years);
  • A history of tendinitis or tendon ruptures associated with the treatment of quinolone derivatives.

Overdose

  • Symptoms:
  • Dizziness, nausea, vomiting, drowsiness, the appearance of cold sweat (without changes in the basic hemodynamic parameters), convulsive syndrome.
  • Treatment:
  • Gastric lavage, adequate hydration therapy with forced diuresis, the appointment of symptomatic agents.

Precautionary measures

Hypersensitivity / Anaphylaxis. Cases of the development of serious hypersensitivity reactions (anaphylactoid and anaphylactic) have been reported while taking the first dose of quinolones. In some cases, these reactions were accompanied by cardiac collapse, loss of consciousness, fainting, swelling of the pharynx or face, dyspnea, urticaria, itching. In case of development of allergic reactions to norfloxacin, the drug should be discontinued.
Pseudomembrane colitis.Treatment with antibacterial agents leads to a modification of the normal flora of the large intestine and can lead to increased growth of clostridia producing toxin, which is the root cause of "antibiotic-associated colitis." If patients develop diarrhea while using norfloxacin, the possibility of developing pseudomembranous enterocolitis should be taken into account. When a diagnosis of “pseudomembranous colitis” is established, the doctor should consider, depending on the evidence, the discontinuation of treatment with norfloxacin and immediately begin an appropriate treatment. It should not be used drugs that suppress peristalsis.

Peripheral neuropathy. When a patient has symptoms of neuropathy, including pain, burning, tingling, numbness and / or weakness, fever, etc., you should stop taking norfloxacin and consult your doctor.
Extension of the QT / torsades de pointes. There are rare reports of the development of prolongation of the QT interval during post-marketing studies in patients treated with quinolones, including norfloxacin. These are rare cases associated with the following factors: age over 60 years, female gender, previous heart disease, and / or use of combination therapy. Norfloxacin is not recommended or used with extreme caution in patients with prolongation of the QT interval or with known risk factors for prolongation of the QT interval (including hypokalemia), as well as when co-prescribed with other drugs with an established risk factor for the prolongation of the QT interval, including with antiarrhythmics of class I A (quinidine, procainamide) or class III
(amiodarone, sotalol).
Tendonitis, tendon ruptures. When using norfloxacin, as with other quinolones, there are cases of tendonitis and / or tendon ruptures (especially the Achilles tendon), for which elderly patients are most susceptible, patients treated with corticosteroids or patients with kidney, heart, and lung transplants. When the first signs of pain in the tendons or inflammation in the joints occur, the stiffness of the joints should be fixed in the immobile joints and consulted with the doctor. If the occurrence of tendinitis or tendon rupture cannot be excluded, treatment with norfloxacin should be stopped.Tendon rupture is possible both during quinolone therapy (including norfloxacin), and after completion of treatment.
Norfloxacin is not indicated for the treatment of syphilis. Antimicrobial drugs used in high doses for a short period of time to treat gonorrhea can mask or delay the onset of symptoms of developing syphilis. In all patients with gonorrhea, it is necessary to conduct a serological test for syphilis during diagnosis, as well as repeatedly (3 months) after the appointment of norfloxacin.
Quinolones can also cause CNS stimulation, leading to tremor, anxiety, mild dizziness, confusion and hallucinations. When such reactions occur on the background of norfloxacin, the drug should be discontinued immediately.
Norfloxacin, like other quinolones, must be used with caution in patients who take cisapride, erythromycin, antipsychotics, tricyclic antidepressants.
Quinolones, including norfloxacin, can exacerbate the symptoms of myasthenia and lead to life-threatening weakness of the respiratory muscles. Care should be taken when using quinolones, including norfloxacin, in patients with myasthenia. If dyspnea occurs during treatment with norfloxacin, you should contact your doctor and take appropriate urgent measures.
With the use of norfloxacin, as well as other drugs of the quinolone group, an increase in photosensitivity is possible, therefore during treatment it is necessary to avoid prolonged and strong effects of solar irradiation. During this period, you also can not use the solarium. If you experience signs of photosensitivity, treatment should be discontinued.
When using norfloxacin, as well as other drugs of the quinolone group, hemolytic reactions may occur in patients with a latent or pronounced deficiency of glucose-6-phosphate dehydrogenase. When conducting surgical interventions, monitoring of the state of the blood coagulation system is required (during the period of therapy, an increase in the prothrombin index is possible).
The drug contains lactose, so it is not prescribed to patients with hereditary intolerance to galactose, lactose deficiency or impaired glucose / galactose absorption.
Restrictions on the use of: atherosclerosis of cerebral vessels, impaired cerebral circulation, epilepsy and convulsive syndrome, disorders of the kidneys and liver.
The safety of prescribing children of pre-pubertal age and lactating women has not been established. Therefore, the drug should be prescribed to these categories of patients with caution.
Caution must also be observed in patients with renal insufficiency. With creatinine clearance less than 30 ml / min, the dose must be halved.

Use during pregnancy or lactation

The drug is contraindicated for use during pregnancy.
Norfloxacin, like other quinolones, penetrates into the mother's milk, so if you need to use norfloxacin during lactation, you must stop breastfeeding.

Children
Norfloxacin is not recommended for use in children and adolescents under the age of 18 years.

Use in elderly patients
Elderly patients have an increased risk of tendon rupture when using fluoroquinolones. This risk is further increased in patients receiving concomitant corticosteroid therapy.

The ability to influence the speed of reaction in the management of vehicles

During treatment with norfloxacin should refrain from driving or working with other mechanisms.

Interaction with other drugs

With simultaneous use of norfloxacin with other drugs with an established risk factor for prolongation of the QT interval, including antiarrhythmic drugs of class I and III, the risk of arrhythmias and prolongation of the QT interval increases. In these cases, norfloxacin should be used with extreme caution, as well as in patients with known risk factors for lengthening the QT interval.
Nitrofurantoin. Under the conditions of invitro-shown antagonism between norfloxacin and nitrofurantoin, it is therefore necessary to avoid their combined use.
Probenecid. Probenecid reduces the secretion of norfloxacin in the urine, but does not affect its normal concentration in serum.
Caffeine. Norfloxacin, like other quinolones, inhibits the degradation of caffeine, which can lead to a decrease in secretion and an increase in the half-life of caffeine from blood plasma.This should be taken into account when drinking coffee, as well as when using medications containing caffeine (pain killers).
Cyclosporine. With simultaneous use with norfloxacin may increase the concentration of cyclosporine in the serum. Therefore, the concentration of cyclosporine in the serum should be monitored and, if necessary, the dosage should be adjusted accordingly.
Warfarin. Norfloxacin, like other quinolones, can potentiate the action of oral anticoagulant warfarin or its derivatives (for example, fenprocumone, acenocoumarol), therefore, while using these medicines, you should carefully monitor prothrombin time or other coagulation parameters.

Hormonal contraceptives. The contraceptive effect of oral contraceptives in isolated cases may be questioned during treatment with antibiotics, therefore, with simultaneous use of norfloxacin and oral contraceptives, the use of non-hormonal contraceptive methods is additionally recommended.
Fenbufen It has been experimentally proven that the simultaneous use of quinolones with fenbufen can be the cause of epileptic seizures, therefore, the use of quinolones with fenbufen should be avoided.
Clozapine, ropinirole. If you start or stop taking norfloxacin, you may need a dose adjustment of clozapine or ropinirole for patients who are already taking these drugs.
Tizanidine. It is not recommended to take tizanidine and norfloxacin at the same time.
Glibenclamide. Simultaneous administration of quinolones, including norfloxacin, with glibenclamide (sulfonylurea derivatives) can cause severe hypoglycemia. Therefore, while taking these drugs is recommended to monitor blood glucose levels.
Didanosine. Drugs containing didanosine should not be taken with norfloxacin or within 2 hours after taking norfloxacin, since such drugs can interfere with one another, which leads to a low concentration of norfloxacin in serum and urine.
Nonsteroidal anti-inflammatory drugs (NSAIDs).Simultaneous use of NSAIDs with quinolones, including norfloxacin, may increase the risk of central nervous system stimulation and convulsive seizures. Therefore, norfloxacin should be taken with caution by persons taking NSAIDs.
The simultaneous use of norfloxacin and antacid agents containing aluminum or magnesium hydroxide, as well as preparations containing calcium, iron and zinc salts, reduces the absorption of norfloxacin. In this regard, norfloxacin should be taken 1-2 hours before or no less than 4 hours after taking these drugs.
With simultaneous use of norfloxacin and theophylline should be monitored the concentration of theophylline in the blood plasma and adjust its dose, because There may be an undesirable increase in theophylline concentration in the blood and the development of corresponding side effects.
Simultaneous administration with drugs that have the potential to reduce blood pressure can cause severe hypotension, with drugs that reduce the convulsive threshold of the brain (for example, theophylline) - epileptiform seizures.
Norfloxacin reduces the effect of nitrofurans.

Storage conditions

To store in the place protected from moisture and light, at a temperature not above 25 ° C. Keep out of the reach of children.

Shelf life -

3 years.



It is a drug. Consultation with a doctor is required.