Universal reference book for medicines
Name of the preparation: OFLOXACIN ZENTIVA (OFLOXACIN ZENTIVA)

Active substance: ofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: ZENTIVA (Czech Republic)
Composition, form of production and packaging
Tablets covered with a film shell of
white or almost white color, round, biconcave, with a half-and-half risk on one side and engraving "200" on the other;
on the bend - white or almost white.
1 tab.

ofloxacin 200 mg

Excipients: lactose monohydrate - 95.2 mg, corn starch - 47.6 mg, povidone 25 - 12 mg, crospovidone - 20 mg, poloxamer - 200 μg, magnesium stearate - 8 mg, talc - 4 mg.

The composition of the film membrane: hypromellose 2910/5 - 9.42 mg, macrogol 6000 - 530 μg, talc - 700 μg, titanium dioxide - 2.35 mg.

7 pcs.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
The tablets covered with a film shell of white or almost white color, oblong, biconcave, with risk from both sides and engraving "400" on one side.

1 tab.

ofloxacin 400 mg

Excipients: lactose monohydrate 190.4 mg, corn starch 95.2 mg, povidone 25-24 mg, crospovidone 40 mg, poloxamer 400 μg, magnesium stearate 16 mg, talc 8 mg.

The composition of the film membrane: hypromellose 2910/5 - 18.84 mg, macrogol 6000 - 1.06 mg, titanium dioxide - 4.7 mg, talc - 1.4 mg.

10 pieces.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Ofloxacin is a synthetic antibacterial broad-spectrum drug from the group of fluoroquinolones, it has a bactericidal effect.
The main mechanism of action of quinolones is specific inhibition of bacterial DNA gyrase. DNA-gyrase is necessary for replication, transcription, repair and recombination of bacterial DNA. Its inhibition leads to the unwinding and destabilization of bacterial DNA and, as a result, to the death of the microbial cell.
Fluoroquinolones have bactericidal activity, dependent on concentration, and moderate post-antibacterial action.
The ratio of AUC and MIC or C max in blood plasma and BMD is a predictive factor for successful therapy.
Sensitive microorganisms

Irregularly sensitive microorganisms (possibly due to acquired resistance): Citrobacter freundii, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia spp., Staphylococcus spp.
(coagulase-negative strains), Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae.
Resistant microorganisms

Acinetobacter baumannii, Bacteroides spp., Clostridium difficile, Enterococci, Listeria monocytogenes, Staphylococcus spp.
(methicillin-resistant strains), Nocardia spp.
Resistance

The resistance to ofloxacin develops as a result of a phased mutation process of genes encoding both topoisomerases of type II: DNA gyrase and topoisomerase IV.Other resistance mechanisms, for example, the effect on the permeability of the external structures of a microbial cell (the mechanism characteristic of Pseudomonas aeruginosa), the mechanism of efflux (active excretion of an antimicrobial from a microbial cell), may also affect the sensitivity of microorganisms to ofloxacin.

Marginal values ​​of the IPC

The boundary values ​​of MPC (mg / l) of ofloxacin approved by the European Committee for the Determination of Sensitivity to Antibiotics (EUCAST)

Microorganisms Sensitive (mg / L) Resistant (mg / L)

Enterobacteriaceae? 0.5> 1

Staphylococcus spp.
? 1> 1
Streptococcus pneumoniae? 0.12> 4

Haemophilus influenzae 0.5 0.5

Moraxella catarrhalis? 0.5> 0.5

Neisseria gonorrhoeae? 0.12> 0.25

Boundary values ​​of BMD that are not associated with a particular type of microorganism? 0.5> 1

PHARMACOKINETICS

Suction

Absorption after ingestion is rapid and complete.
Bioavailability is almost 100%, C max after taking the drug inside at a dose of 200 mg averages 2.5-3 μg / ml and is reached within 1 hour.
Distribution

Binding to plasma proteins - 25%.
Apparent V d is 120 liters. The concentrations of ofloxacin in the urine and in the infected urinary tracts exceed the concentrations of ofloxacin in the blood plasma from 5 to 100 times.
After repeated administration, serum concentrations increase slightly (the accumulation coefficient is about 1.5).

Metabolism

Metabolised in the liver (about 5%) with the formation ofloxacin N-oxide and N-desmethylofloxacin.

Excretion

T 1/2 is 6-7 hours.
It is excreted mainly by the kidneys - 80-90% (unchanged), about 4% is excreted with bile in the form of glucuronide.
Pharmacokinetics in specific patient groups

In elderly patients there is an increase in T 1/2 ,
but C max does not change.
In patients with renal insufficiency, T 1/2 is more prolonged, with renal clearance decreasing depending on QC values.

INDICATIONS

Infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin:

- a pyelonephritis;

- prostatitis, epididymitis, orchitis;

- infection of the pelvic organs;

- Cystitis, urinary tract infections (as an alternative to other antimicrobial drugs).

As an alternative to other antimicrobials, ofloxacin can be used to treat the following infectious-inflammatory diseases:

- infections of bones and joints;

- skin and soft tissue infections;

- Acute sinusitis;

- exacerbation of chronic bronchitis, community-acquired pneumonia;

- prophylaxis of infections caused by orloxacin-sensitive microorganisms, in patients with a significant decrease in immune status (eg, neutropenia).

When using the drug Ofloxacin Zentiva should take into account the official national recommendations for the proper use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country.

DOSING MODE

The drug is taken orally, regardless of food intake.
Tablets should be washed down with a sufficient amount of liquid. It is necessary to avoid simultaneous reception with antacids (preparations containing aluminum, calcium, iron or zinc).
The dose of ofloxacin and the duration of treatment depend on the severity and type of infection, the general condition of the patient and the function of the kidneys.

Adult patients with normal renal function (QC greater than 50 mL / min)

Ofloxacin Zentiva is prescribed in a daily dose of 400 mg divided into 2 divided doses (every 12 hours).

The daily dose can be increased to 600-800 mg in severe infections or in the treatment of patients with excessive body weight .
A dose of up to 400 mg / day can be given in one session, preferably in the morning. Doses over 400 mg / day should be divided into 2 divided doses with an equal time interval.
In uncomplicated infections of the lower urinary tract, the drug is prescribed at a dose of 200 mg / day for 3-5 days.

With gonorrhea prescribed 400 mg once.

Patients with impaired renal function

For patients with impaired renal function, the following dosing regimen is recommended:

KK (ml / min) Dosing units (mg) * Number of receptions Intervals (h)

50-20 100 *** - 200 1 24

<20 ** or hemodialysis or peritoneal dialysis 100 *** or 200 1 1 24 48

* In accordance with the testimony.

** Serum concentrations of ofloxacin should be monitored in patients with severe renal dysfunction and in patients on dialysis.

*** When choosing a dose of 100 mg / day, a dosage of 200 mg should be used.

If QC is not possible, it should be calculated from the serum creatinine concentration using the Cockcroft formula for adults.

Men:

KK (ml / min) = body weight (kg) (140 - age (years)) / 72 ° serum creatinine concentration (mg / dL)

or

KK (ml / min) = body weight (kg)? (140 - age (years)) / 0.814? Serum creatinine concentration (μmol / L)

Women: CK (mL / min) = 0.85 (men's score).

In patients with hepatic insufficiency it is not recommended to exceed the maximum daily dose of 400 mg.

In elderly patients with normal renal function, dose adjustment is not required.
However, special attention should be paid to monitoring kidney function and ECG (risk of prolonging the QT interval) by selecting the appropriate dose.
Duration of treatment

The duration of treatment depends on the severity of the disease.
As with any treatment with antimicrobials, treatment with Ofloxacin Zentiva should be continued for at least 48-72 hours after the normalization of body temperature or if there is evidence of eradication of the pathogen.
A few days after the improvement of the patient's condition, the started treatment with the drug Ofloxacin Zentiva in the form of intravenous infusions can be continued by taking the drug in the form of tablets at the same dose.

SIDE EFFECT

The information presented below is based on data obtained from clinical studies and data from a broad post-marketing experience of the drug.

Determination of the frequency of adverse reactions according to WHO classification: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1 / 10 000, <1/1000), very rarely (<1/10 000), the frequency is unknown (it is not possible to establish the frequency of occurrence according to available data).

Infectious and parasitic diseases: infrequently - fungal infection, resistance of pathogenic microorganisms.

On the part of the blood and lymphatic system: very rarely - anemia, hemolytic anemia, leukopenia, eosinophilia, thrombocytopenia;
frequency unknown - agranulocytosis, pancytopenia, oppression of bone marrow hematopoiesis.
From the side of the immune system: rarely - anaphylactic reaction, anaphylactoid reaction, angioedema;
very rarely - anaphylactic shock, anaphylactoid shock.
From the side of metabolism and nutrition: rarely - anorexia;
frequency unknown - hyperglycemia, hypoglycemia, hypoglycemic coma (in patients with diabetes, receiving hypoglycemic drugs).
Mental disorders: infrequent - agitation, sleep disturbance, insomnia;
rarely - psychotic disorders (hallucinations), anxiety, nervousness, confusion, nightmares, depression; frequency is unknown - psychotic disorders and depression with self-destructive behavior, including suicidal thoughts and suicide attempts.
From the nervous system: infrequently - dizziness, headache;
rarely - drowsiness, paresthesia, dysgeusia (a disorder of perception of taste), parosmia (smell disorder);very rarely - peripheral sensory neuropathy, peripheral sensory-motor neuropathy, seizures, extrapyramidal symptoms, including tremor, and other disorders of muscle coordination; frequency unknown - agevzia (loss of ability to taste), increased intracranial pressure.
From the side of the organ of vision: infrequently - irritation of the mucous membrane of the eye, conjunctivitis;
rarely - visual impairment (diplopia, violation of color perception); frequency is unknown - uveitis.
On the part of the hearing organs and labyrinthine disturbances: infrequently - vertigo;
very rarely - ringing or noise in the ears, hearing loss.
Disturbances from the heart: rarely - tachycardia;
infrequent - a feeling of heartbeat; frequency unknown - ventricular arrhythmia of the type "pirouette" (noted predominantly in patients with risk factors for prolongation of the QT interval), prolongation of the QT interval on the ECG.
Disorders from the vessels: rarely - increased blood pressure, lower blood pressure.

From the respiratory system: infrequently - cough, nasopharyngitis;
rarely shortness of breath, bronchospasm; frequency unknown - allergic pneumonitis, severe dyspnea.
On the part of the digestive system: infrequently - abdominal pain, diarrhea, nausea, vomiting, decreased appetite;
rarely - enterocolitis (sometimes hemorrhagic); very rarely - pseudomembranous colitis; frequency is unknown - dyspepsia, flatulence, constipation, pancreatitis, stomatitis.
On the part of the liver and bile ducts: rarely - an increase in the activity of hepatic transaminases (ACT, ALT, LDH, GGT and / or AP) and / or bilirubin concentrations;
very rarely - cholestatic jaundice, frequency unknown - hepatitis (can be severe) with ofloxacin (mainly in patients with impaired liver function). There have been reports of severe hepatic insufficiency, including acute hepatic insufficiency, sometimes fatal.
From the skin and subcutaneous tissues: infrequently - rash, itching;
rarely - urticaria, "tides" of blood to the skin, increased sweating, pustular rash; very rarely erythema multiforme, toxic epidermal necrolysis, photosensitization reaction, drug rash, vascular purpura, vasculitis (which may lead in some cases to skin necrosis);frequency unknown - Stevens-Johnson syndrome; acute generalized exanthematous pustulosis, exfoliative dermatitis.
From the musculoskeletal system and connective tissue: rarely - tendonitis;
very rarely - arthralgia, myalgia, tendon rupture (Achilles tendon, as with the use of other fluoroquinolones, this side effect can be observed within 48 hours after the start of treatment and can be bilateral); frequency is unknown - rhabdomyolysis and / or myopathy, muscle weakness (which may be particularly important in patients with pseudo-paralytic myasthenia gravis), muscle tearing, muscle rupture, ligament rupture, arthritis.
From the side of the urinary system: rarely - an increase in the concentration of creatinine in the blood serum;
very rarely - acute renal failure; frequency unknown - acute interstitial nephritis, increased urea concentration in the blood.
General disorders: the frequency is unknown - asthenia, fever, back pain, chest, limbs.

Congenital, hereditary and genetic disorders: the frequency is unknown - exacerbation of porphyria in patients with porphyria.

CONTRAINDICATIONS

- hypersensitivity to ofloxacin, other quinolones or auxiliary components of the drug;

- epilepsy;

- pseudo-paralytic myasthenia gravis (myasthenia gravis);

- damage to the tendons during the previous treatment with quinolones;

- age to 18 years (the risk of affection of the cartilaginous bone growth zones in the child can not be completely excluded);

- pregnancy (you can not completely exclude the risk of damage to the cartilaginous growth zones in the fetus);

- the period of breastfeeding;

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully

In patients who are prone to seizures (in patients with CNS lesions, such as severe atherosclerosis of cerebral vessels, history of cerebral circulation, organic lesions of the central nervous system, traumas of the brain in the anamnesis, in patients simultaneously receiving drugs that reduce the threshold of convulsive activity of the head brain, such as fenbufen or other NSAIDs, theophylline .In the development of seizures, treatment with the drug Ofloxacin Zentiva should be discontinued.

In patients with latent or manifested deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions in the treatment of quinolones).

In patients with impaired renal function (mandatory monitoring of renal function, as well as correction of dosing regimens) is required.

In patients with hepatic insufficiency (control of liver function tests).

In patients with porphyria (risk of exacerbation of porphyria).

In patients with risk factors for prolonging the QT interval: in elderly patients;
with uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia); with the syndrome of congenital extension of the QT interval; with heart diseases (heart failure, myocardial infarction, bradycardia); while taking medications that can prolong the QT interval (antiarrhythmic drugs IA and III classes, tricyclic antidepressants, macrolides, neuroleptics).
In patients with diabetes mellitus, receiving oral hypoglycemic agents (eg, glibenclamide) or insulin (increases the risk of hypoglycemia).

In patients with severe adverse reactions to other quinolones, such as severe neurologic reactions (increased risk of similar undesirable reactions with ofloxacin).

In patients with psychoses and other psychiatric disorders in the anamnesis.

PREGNANCY AND LACTATION

The use of the drug Ofloxacin Zentiva during pregnancy is contraindicated.

Because
ofloxacin penetrates into breast milk, then in connection with the possible risk for the child, the use of the drug Ofloxacin Zentiva is contraindicated. If it is necessary to use it, the question of stopping breastfeeding should be resolved.
APPLICATION FOR FUNCTIONS OF THE LIVER

Caution should be given to patients with chronic renal failure.
In patients with renal failure, the dose should be selected in accordance with QC.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Caution should be given to patients with chronic hepatic impairment.
Do not exceed the maximum daily dose of 400 mg.
APPLICATION FOR CHILDREN

Contraindicated use of the drug in children and adolescents under the age of 18 years.

APPLICATION IN ELDERLY PATIENTS

In elderly patients with normal renal function, dose adjustment is not required.
However, special attention should be paid to monitoring kidney function and ECG (risk of prolonging the QT interval) by selecting the appropriate dose.
SPECIAL INSTRUCTIONS

Hypersensitivity reactions and allergic reactions

When fluoroquinolones were used, the development of hypersensitivity reactions and allergic reactions was reported.
Anaphylactic and anaphylactoid reactions can progress to a state of life-threatening shock, even after the first application. In these cases, the use of the drug Ofloxacin Zentiva should be discontinued and appropriate treatment initiated.
Diseases associated with Clostridium difficile

Diarrhea, especially severe, persistent and / or with an admixture of blood, during or after treatment of ofloxacin, may be a symptom of pseudomembranous colitis.
If suspected of pseudomembranous colitis, treatment with Ofloxacin Zentiva should be stopped immediately. It should immediately begin appropriate supportive and specific antibiotic therapy. Drugs that inhibit peristalsis are contraindicated in this clinical situation.
Patients who are predisposed to develop seizures

Like the other quinolones, drug Ofloxacin Zentiva should be used with caution in patients who are predisposed to the development of seizures (patients with CNS lesions in history, patients taking fenbufen or other NSAIDs, as well as other drugs that lower seizure threshold of the brain activity, such as theophylline ). With the development of seizures, treatment with Ofloxacin Zentiva should be stopped immediately.
tendinitis
Tendonitis which rarely observed in treatment quinolones, can sometimes lead to rupture of the tendons, in particular Achilles tendons. Elderly patients are more likely to develop tendinitis. The risk of tendon rupture can be increased while the application of corticosteroids. This undesirable effect may occur within 48 hours after the start of treatment and to be bilaterally. If tendinitis is suspected treatment with Ofloxacin Zentiva should be stopped immediately. It should begin appropriate treatment (e.g., immobilization) of the damaged tendon.
Severe adverse cutaneous reactions
When receiving ofloxacin reported with severe bullous reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis. Patients should be informed that in the development of skin reactions and / or mucosal lesions, you should immediately consult a doctor before continuing treatment with Ofloxacin Zentiva.
Patients with impaired renal function
As ofloxacin mainly excreted by the kidneys, the dose Ofloxacin Zentiva should be adjusted in patients with renal dysfunction.
Patients with psychotic disorders in history
Psychotic reactions, including suicidal ideation / attempts were reported in patients receiving fluoroquinolones, including ofloxacin. With the development of these reactions treatment with Ofloxacin Zentiva should be discontinued and appropriate measures should be initiated. Zentiva Ofloxacin drug should be used with caution in patients with the presence of psychotic disorders in history or in patients with mental illness.
Patients with impaired hepatic function

Zentiva Ofloxacin drug should be used with caution in patients with impaired hepatic function. In applying fluoroquinolones cases of fulminant hepatitis were noted leading to acute liver failure (including fatal cases). Patients should be advised to stop treatment and contact your doctor if you develop symptoms of liver damage, such as anorexia, jaundice, dark urine, itching, or pain in the abdomen.
Gravis (myasthenia gravis)
Fluoroquinolones, including ofloxacin, characterized by blocking neuromuscular activity holding and may enhance muscle weakness in patients with gravis. In the post-registration period we observed serious adverse reactions, including pulmonary failure (a ventilator) and deaths which were associated with the use of fluoroquinolones in patients with gravis. Application of Ofloxacin Zentiva drug in patients with an established diagnosis of gravis is not recommended.
Prevention of photosensitivity
due to the risk of photosensitivity should avoid exposure to strong sunlight and UV radiation during treatment with Ofloxacin Zentiva.
consecutive infection
As with other antimicrobial agents, while taking ofloxacin, especially long-term, may develop secondary infection associated with an increase in drug-resistant micro-organisms to eliminate and confirm which should reassess the patient's condition. If during therapy developed a secondary infection, you should take the necessary measures for its treatment.
QT prolongation
Cases of QT interval prolongation have been observed in patients receiving fluoroquinolones, including ofloxacin.
Caution must be exercised when using the drug Ofloxacin Zentiva in patients with known presence of risk factors lengthening QT interval:
-pozhiloy age;
-neskorrektirovanny electrolyte imbalance (e.g., hypokalemia, hypomagnesemia);
-sindrom elongate congenital QT interval;
-zabolevaniya heart (e.g., cardiac insufficiency, myocardial infarction, bradycardia);
Simultaneous use of drugs that cause a lengthening of the interval QT (e.g., antiarrhythmic agents of class IA and III, tricyclic antidepressants, macrolides, antipsychotics).
Dysglycemia (hypo- and hyperglycemia)
When using fluoroquinolones, including ofloxacin, reported cases of hypo- and hyperglycemia. In patients with diabetes receiving concomitant oral hypoglycemic agent (eg, glibenclamide) or insulin, reported on the development of hypoglycemic coma. In these patients, it is recommended to closely monitor blood glucose levels.
peripheral neuropathy
In patients receiving fluoroquinolones, including ofloxacin, reported on the development of sensory and sensorimotor neuropathy, which may have a rapid onset. If the patient has symptoms of neuropathy, treatment with Ofloxacin Zentiva should be discontinued, which contributes to minimize the possible risk of irreversible states.
Patients with a deficiency of glucose-6-phosphate dehydrogenase
Patients diagnosed with latent or deficiency of glucose-6-phosphate dehydrogenase may be predisposed to the treatment of hemolytic reactions quinolones. Zentiva drug Ofloxacin should be used with caution in these patients.
Patients with rare hereditary disease
Ofloxacin drug Zentiva is contraindicated in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption, because in the tablet includes lactose monohydrate.
Patients taking vitamin K antagonists
Due to possible increase in prothrombin time values / INR and / or of bleeding in patients treated with both drug Ofloxacin Zentiva and vitamin K antagonists (e.g. warfarin), recommended careful monitoring of blood coagulation parameters.
The risk of developing resistance
The prevalence of acquired resistance of microorganisms may vary geographically and with time for selected species. Therefore, a local information on resistance; microbiological diagnosis should be carried out with isolation of the pathogen and defining its sensitivity, particularly in severe infections or no therapeutic effect.
Infections caused by Escherichia coli
resistance to fluoroquinolones Escherichia coli - the most common causative agent of urinary tract infections - varies in different geographical areas. Doctors are advised to take into account local resistance of Escherichia coli to fluoroquinolones.
Infection caused by Neisseria gonorrhoeae
Due to the increasing resistance of Neisseria gonorrhoeae, Zentiva Ofloxacin formulation should not be used as empirical therapy for suspected gonococcal infection of the urinary tract. It is necessary to carry out tests on the sensitivity of the pathogen to ofloxacin in order to provide targeted therapy.
Methicillin-resistant Staphylococcus aureus (Staphylococcus aureus)
There is a high probability that the methicillin-resistant staphylococcus aureus is resistant to fluoroquinolones, including ofloxacin. Therefore Ofloxacin Zentiva drug is not recommended for the treatment of established or suspected of infection by methicillin-resistant Staphylococcus aureus, if the laboratory tests did not confirm the sensitivity of the microorganism to ofloxacin.
Bone and Joint Infections
With infections of bones and joints should consider the need for the combined use of the drug Ofloxacin Zentiva with other antibacterial drugs.
Influence on laboratory values and diagnostic tests
Ofloxacin may inhibit the growth of Mycobacterium tuberculosis, leading to false negative results when bacteriological diagnosis of tuberculosis.
When determining opiates in urine and porphyrins during treatment with Ofloxacin Zentiva possible false positive result. It may be necessary to confirm positive results by using more specific methods.
Etc.
In the period of treatment is not recommended to use liquid containing ethanol.
Effects on ability to drive and use machinery
When taking the drug Ofloxacin Zentiva may cause dizziness, drowsiness, violations of the view, therefore, when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions, caution should be exercised .
OVERDOSE

Symptoms: CNS - dizziness, confusion, disorientation, convulsions; on the part of the digestive system - nausea, vomiting, erosive lesions of the gastrointestinal mucosa.
Treatment: gastric lavage, the appointment of activated carbon and other adsorbents, symptomatic therapy. To protect the gastric mucosa can be used antacids. It is required to conduct an ECG monitoring due to the potential QT interval elongation. Ofloxacin fractions can be removed from the body by hemodialysis. There is no specific antidote.
DRUG INTERACTION

Antacids containing aluminum hydroxide, sucralfate, magnesium hydroxide, aluminum phosphate, or preparations containing zinc or iron
Antacids containing aluminum hydroxide, sucralfate, magnesium hydroxide, aluminum phosphate, or preparations containing zinc or iron, reduce the absorption of ofloxacin, forming insoluble complexes . When applying the above drugs and drug Ofloxacin Zentiva interval between their doses should be approximately 2 hours.
Theophylline, fenbufen, or the like NSAIDs
In clinical studies, there was no evidence of pharmacokinetic interactions of ofloxacin with theophylline. However, a marked reduction of the convulsive threshold of brain can be observed while the use of quinolones with theophylline, NSAIDs or other means which reduce the seizure threshold of the brain activity (including with fenbufenom).
Drugs that cause lengthening of the interval QT
Ofloxacin Zentiva, like other fluoroquinolones, should be used with caution in patients receiving drugs that cause the ECG lengthening the interval QT (e.g., antiarrhythmic agents of class IA and III, tricyclic antidepressants, macrolide antibiotics, antipsychotics) .
Vitamin K antagonists (coumarin derivatives including warfarin)
Increasing values of prothrombin time / INR and / or development of bleeding (including severe) noted in patients in the combined use of ofloxacin and vitamin K antagonists (e.g. warfarin). With simultaneous use of vitamin K antagonists, and drug Ofloxacin Zentiva requires monitoring of blood coagulation parameters.
Glibenclamide
Ofloxacin may cause a slight increase in the concentration of glibenclamide in the blood serum, so patients receiving both ofloxacin and glibenclamide, recommends careful monitoring of blood glucose.
Other hypoglycemic agents for oral and insulin
Ofloxacin increases the risk of hypoglycemia, requires more careful monitoring of blood glucose concentration.
Probenecid, cimetidine, furosemide and methotrexate
When applying quinolones with drugs outputting excreted by renal tubular secretion (such as probenecid, cimetidine, furosemide, methotrexate) may mutual deceleration excretion and increased serum concentrations (especially in the case of use in high doses) .
GCS
With simultaneous use of the drug Ofloxacin Zentiva with corticosteroids increase the risk of tendon rupture, particularly in elderly patients.
Medicaments alkalizing urine (carbonic anhydrase inhibitors, citrates, sodium hydrogen carbonate)
In applying the drug Ofloxacin Zentiva conjunction with pharmaceuticals, urine alkalizing (carbonic anhydrase inhibitors, citrates, sodium hydrogencarbonate), increases the risk of crystalluria and nephrotoxic effects.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The preparation should be stored in a dry place inaccessible to children at a temperature of from 10 ° to 25 ° C.
Shelf life - 3 years.
Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y
Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!