Ofloxacin
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OFLOXACIN (OFLOXACIN)
Composition:
active substance: ofloxacin;
1 ml of solution contains 2 mg of ofloxacin;
excipient: water for injections.
Pharmaceutical form. Infusion solution.
Main physico-chemical properties: clear light-yellow liquid.
Pharmacotherapeutic group. Antibacterial agents for systemic use. Fluoroquinolones. ATC code J01M A01.
Pharmacological Properties
Pharmacodynamics
Ofloxacin is a synthetic broad-spectrum antimicrobial agent of the fluoroquinolone class. At concentrations equal to or slightly above the minimum inhibitory concentration (MIC), it exerts a bactericidal effect by inhibiting DNA gyrase—an enzyme essential for bacterial DNA replication and transcription.
The antimicrobial spectrum includes: Gram-negative and Gram-positive bacteria sensitive to ofloxacin: Enterobacteriaceae (Escherichia coli, species of Citrobacter, Enterobacter, Klebsiella, Proteus, Providencia, Salmonella, Serratia, Shigella, Yersinia), Pseudomonas spp., including Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus ducreyi, Branhamella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Acinetobacter spp., Campylobacter spp., Gardnerella vaginalis, Helicobacter pylori, Pasteurella multocida, Vibrio spp., Brucella melitensis; staphylococci, including penicillinase-producing strains and some methicillin-resistant strains; it also shows activity against Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum (at borderline MIC values), Mycobacterium tuberculosis, Mycobacterium leprae, and some other mycobacteria. Sensitivity of group A, B, and C streptococci is borderline. Most anaerobes, except Clostridium perfringens, are resistant. Ofloxacin is inactive against Treponema pallidum.
Pharmacokinetics
Ofloxacin penetrates tissues and is well distributed into body fluids, including cerebrospinal fluid. Relatively high concentrations are achieved in bile. The volume of distribution is 1.5–2.5 L/kg. Plasma protein binding is 25%. Ofloxacin is partially metabolized to desmethyl-ofloxacin and ofloxacin-N-oxide. Desmethyl-ofloxacin has weak antimicrobial activity. The elimination half-life of ofloxacin is approximately 5–8 hours; in renal impairment, it is prolonged depending on the degree of impairment to 15–60 hours. Ofloxacin is primarily excreted by the kidneys via tubular secretion and glomerular filtration. Within 24–48 hours, 75–80% of the administered dose is excreted unchanged in urine, less than 5% as metabolites. 4–8% of the administered dose is excreted in feces. Ofloxacin elimination may be delayed in patients with severe hepatic impairment (e.g., cirrhosis). Renal clearance of ofloxacin is 173 mL/min, and total clearance is up to 214 mL/min, independent of dose. Only a small amount can be removed by hemodialysis (15–25%); the biological half-life during hemodialysis is approximately 8–12 hours. During peritoneal dialysis, the biological half-life is 22 hours.
Ofloxacin exhibits a post-antibiotic effect.
Ofloxacin crosses the placenta and is excreted into breast milk.
Clinical characteristics.
Indications.
Infectious and inflammatory diseases caused by pathogens sensitive to ofloxacin:
- Exacerbation of chronic obstructive pulmonary disease (including chronic bronchitis)*, community-acquired pneumonia*;
- Uncomplicated acute cystitis*, urethritis*, acute pyelonephritis, and complicated urinary tract infections;
- Complicated skin and soft tissue infections*.
Official recommendations regarding appropriate use of antibacterial agents should be taken into account.
* When it is not possible to use other antibacterial agents typically used for treatment of these infections.
Contraindications.
Hypersensitivity to ofloxacin or to any of the excipients of the medicinal product.
History of tendinitis.
Ofloxacin, like other fluoroquinolones, is contraindicated in patients with epilepsy or a lowered seizure threshold.
Ofloxacin is contraindicated in children and adolescents, as well as in pregnant and breastfeeding women, because experimental data in animals do not fully exclude the risk of joint cartilage damage in the growing organism.
Glucose-6-phosphate dehydrogenase deficiency.
Ofloxacin must not be administered to patients with QT interval prolongation, to patients with uncompensated hypokalemia, or to patients receiving class IA (quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmic agents.
Central nervous system disorders with lowered seizure threshold (e.g., following head trauma, stroke, or inflammatory processes of the brain and meninges).
Interaction with other medicinal products and other forms of interaction.
Medicinal products capable of prolonging the QT interval
Ofloxacin, like other fluoroquinolones, is contraindicated in patients receiving medicinal products capable of prolonging the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, neuroleptics).
Theophylline, or similar nonsteroidal anti-inflammatory medicinal products
Concomitant administration of quinolones with other agents that lower the seizure threshold, such as theophylline, may reduce the cerebral seizure threshold. However, unlike some other fluoroquinolones, ofloxacin is not considered to cause pharmacokinetic interactions with theophylline.
Further reduction of the cerebral seizure threshold may also occur when ofloxacin is administered concomitantly with certain nonsteroidal anti-inflammatory medicinal products.
If seizures occur, ofloxacin therapy must be discontinued.
Glibenclamide
Ofloxacin may cause a slight increase in serum glibenclamide concentrations; therefore, such patients should be closely monitored.
Probenecid, cimetidine, furosemide, and methotrexate
Concomitant administration of high doses of ofloxacin with medicinal products excreted via tubular secretion (e.g., probenecid, cimetidine, furosemide, methotrexate) may lead to increased plasma concentrations due to reduced elimination.
Anticoagulants (including vitamin K antagonists)
When administered concomitantly with anticoagulants (including vitamin K antagonists), prothrombin time or other appropriate coagulation tests should be monitored.
Effect on laboratory test results
During ofloxacin therapy, false-positive results may occur in urine tests for opiates or porphyrins. More specific methods may be required to confirm positive opiate or porphyrin test results.
Ofloxacin may inhibit the growth of Mycobacterium tuberculosis, potentially leading to false-negative bacteriological diagnosis of tuberculosis.
Other information
When used concomitantly with agents that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects is increased.
Special precautions for use.
The use of ofloxacin should be avoided in patients with a history of serious adverse reactions associated with quinolone and fluoroquinolone-containing medicinal products (see section "Adverse reactions"). Treatment with ofloxacin in such patients should only be initiated if there are no alternative treatment options and after careful evaluation of the benefit-risk ratio (see also section "Contraindications").
Resistance risk
For methicillin-resistant Staphylococcus aureus (MRSA), there is a very high likelihood of cross-resistance to fluoroquinolones, including ofloxacin. Therefore, ofloxacin is not recommended for the treatment of infections known or suspected to be caused by MRSA, except in cases where laboratory test results have confirmed susceptibility of the pathogen to ofloxacin (and usually when the use of antibacterial agents recommended for MRSA infections is considered inappropriate).
Ofloxacin is not a first-line agent for pneumonia caused by pneumococci or Mycoplasma, or for tonsillitis caused by β-hemolytic streptococci.
Infections caused by Escherichia coli
Resistance of E. coli — the most common cause of urinary tract infections — to fluoroquinolones varies across different countries of the European Union. Prescribers are advised to consider the local prevalence of E. coli resistance to fluoroquinolones.
Infections caused by Neisseria gonorrhoeae
Due to increasing resistance of N. gonorrhoeae, ofloxacin should not be used as empirical antibacterial therapy for suspected gonococcal infection (gonococcal urethritis, pelvic inflammatory disease, epididymo-orchitis), except when the pathogen has been identified and its susceptibility to ofloxacin confirmed. If no clinical improvement is observed after three days of treatment, therapy should be re-evaluated.
Pelvic inflammatory disease
For the treatment of pelvic inflammatory disease, ofloxacin should only be used in combination with agents active against anaerobic organisms.
Hypersensitivity (increased sensitivity)
Cases of hypersensitivity and allergic reactions after the first dose of fluoroquinolones have been reported. Anaphylactic/anaphylactoid reactions, including signs of anaphylaxis, tachycardia, fever, dyspnea, angioedema, vasculitis (which in rare cases may lead to necrosis), and eosinophilia, may develop immediately after administration of ofloxacin. Anaphylactic and anaphylactoid reactions may progress to life-threatening anaphylactic shock, even after the first dose of the drug. In such cases, the drug should be discontinued immediately and appropriate therapeutic measures should be initiated.
Severe bullous reactions
Cases of severe bullous skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with ofloxacin (see section "Adverse reactions"). If skin and/or mucosal reactions occur, patients should be advised to contact their physician immediately before continuing treatment.
Clostridium difficile-associated disease
Diarrhea occurring during or after ofloxacin treatment (including several weeks after treatment), especially if severe, prolonged, and/or associated with bleeding, may be a symptom of pseudomembranous colitis. The severity of Clostridium difficile-associated diseases ranges from mild to life-threatening, with pseudomembranous colitis being the most severe form (see section "Adverse reactions"). It is therefore important to consider this diagnosis in patients who develop severe diarrhea during or after ofloxacin therapy. If pseudomembranous colitis is suspected, ofloxacin should be discontinued immediately. Appropriate specific antibiotic therapy should be initiated promptly (e.g., oral vancomycin, oral teicoplanin, or metronidazole). In this clinical situation, drugs that inhibit intestinal motility are contraindicated.
Patients with predisposition to seizures
Quinolones may lower the seizure threshold and provoke seizures. Ofloxacin is contraindicated in patients with a history of epilepsy (see section "Contraindications"). As with other quinolones, it should be used with extreme caution in patients predisposed to seizures and in those receiving concomitant medications that lower the seizure threshold, such as theophylline (see section "Interaction with other medicinal products and other forms of interaction"). If seizures occur, ofloxacin should be discontinued (see also section "Interaction with other medicinal游戏副本 products and other forms of interaction").
Prolonged, disabling, and potentially irreversible serious adverse reactions
Rare, prolonged (months or years), disabling, and potentially irreversible serious adverse reactions affecting various body systems (musculoskeletal, nervous, and psychiatric systems, sensory organs) have been reported in patients receiving quinolones or fluoroquinolones, regardless of patient age or presence of risk factors. If any signs or symptoms of serious adverse reactions appear, ofloxacin should be discontinued immediately and medical advice should be sought.
Tendinitis and tendon rupture
Tendinitis and tendon rupture (especially of the Achilles tendon), sometimes bilateral, may occur within 48 hours of starting quinolone or fluoroquinolone therapy, and occasionally even several months after discontinuation of the drug. The risk of tendinitis and tendon rupture is increased in elderly patients, patients with renal impairment, patients after solid organ transplantation, and in patients receiving concomitant corticosteroids. Concomitant use of corticosteroids and fluoroquinolones should be avoided. If early signs of tendinitis (e.g., painful swelling or joint inflammation) occur, ofloxacin therapy should be discontinued immediately and alternative treatment considered. The affected limb should be appropriately managed (e.g., immobilized) and orthopedic consultation sought. Corticosteroids should not be used if signs of tendinopathy appear.
Patients with renal impairment
The drug should be administered with caution to patients with impaired renal function. Dose and dosing interval adjustments are necessary for patients with renal impairment and elderly patients, taking into account reduced elimination.
QT interval prolongation
Very rare cases of QT interval prolongation have been reported in patients receiving fluoroquinolones. Caution should be exercised when using fluoroquinolones, including ofloxacin, in patients with known risk factors for QT interval prolongation, such as:
- congenital long QT syndrome;
- concomitant use of medicinal products known to prolong the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, neuroleptics);
- uncorrected electrolyte imbalance (e.g., hypokalemia, hypomagnesemia);
- cardiac disease (e.g., heart failure, myocardial infarction, bradycardia).
Elderly patients and women may be more sensitive to drugs that prolong the QT interval. Therefore, caution should be exercised when prescribing fluoroquinolones, including ofloxacin, to these patient groups.
Aortic aneurysm and aortic dissection, and valvular regurgitation/insufficiency
Epidemiological studies suggest an increased risk of aortic aneurysm and aortic dissection, particularly in elderly patients, as well as aortic and mitral valve regurgitation/insufficiency following fluoroquinolone use. Cases of aortic aneurysm and aortic dissection, sometimes complicated by rupture (including fatal cases), and valvular regurgitation/insufficiency of any heart valve have been reported in patients receiving fluoroquinolones (see section "Adverse reactions").
Therefore, fluoroquinolones should only be used after careful evaluation of the benefit-risk ratio and consideration of alternative therapies in patients with a significant family history (presence of aortic aneurysm or congenital heart valve defect), patients with diagnosed aortic aneurysm and/or aortic dissection, or diagnosed valvular heart disease, or in the presence of other risk factors, namely:
- risk factors for both aortic aneurysm and aortic dissection, and valvular regurgitation/insufficiency: connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Behçet’s disease, arterial hypertension, rheumatoid arthritis;
- risk factors for aortic aneurysm and aortic dissection: vascular diseases such as Takayasu arteritis or giant cell arteritis, atherosclerosis, Sjögren’s syndrome;
- risk factors for valvular regurgitation/insufficiency: infective endocarditis.
The risk of aortic aneurysm, aortic dissection, and their rupture is increased in patients receiving systemic corticosteroids concomitantly.
If sudden abdominal, chest, or back pain occurs, patients should seek immediate medical attention at an emergency department.
Patients should be advised to seek immediate medical help if they experience dyspnea, palpitations, or swelling of the abdomen or lower limbs.
Patients with central nervous system disorders
The drug should be administered with caution to patients with central nervous system disorders (e.g., severe atherosclerosis of cerebral vessels, history of acute cerebrovascular accident).
Patients with history of psychotic disorders
Psychotic reactions have been reported in patients receiving fluoroquinolones. In some cases, these reactions progressed to suicidal ideation or self-destructive behavior, including suicide attempts, sometimes even after the first dose. If such reactions occur, ofloxacin therapy should be discontinued and appropriate treatment measures initiated. Ofloxacin should be used with caution in patients with a history of psychotic disorders or psychiatric illness.
Patients with hepatic impairment
Ofloxacin should be used with caution in patients with hepatic impairment due to the potential for drug-induced liver injury. Cases of fulminant hepatitis, which may lead to liver failure (including fatal cases), have been reported during fluoroquinolone therapy. Patients should be advised to discontinue treatment and consult their physician if symptoms or signs of liver disease occur, such as anorexia, jaundice, dark urine, pruritus, or abdominal tenderness on palpation (see section "Adive reactions").
Patients taking vitamin K antagonists
Due to the possible increase in coagulation test parameters (prothrombin time/international normalized ratio) and/or bleeding in patients receiving fluoroquinolones, including ofloxacin, in combination with vitamin K antagonists (e.g., warfarin), monitoring of coagulation parameters is recommended when these two drug groups are used concomitantly (see section "Interaction with other medicinal products and other forms of interaction").
Myasthenia gravis
Fluoroquinolones, including ofloxacin, have neuromuscular blocking effects and may exacerbate muscle weakness in patients with myasthenia gravis. In the post-marketing period, serious adverse reactions, including fatal cases and conditions requiring respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Ofloxacin is not recommended for use in patients with a history of myasthenia gravis.
Prevention of photosensitization
Cases of photosensitization have been reported with ofloxacin (see section "Adverse reactions"). Patients taking ofloxacin should avoid exposure to intense sunlight and ultraviolet radiation (mercury-vapor lamps, tanning beds) during treatment and for 48 hours after discontinuation of the drug to prevent photosensitization.
Superinfection
Antibiotic use, especially over prolonged periods, may lead to overgrowth of resistant microorganisms; therefore, the patient's condition should be monitored periodically during treatment. If a secondary infection occurs, appropriate measures should be taken.
Peripheral neuropathy
Cases of peripheral sensory or sensorimotor polyneuropathy have been reported in patients receiving quinolones and fluoroquinolones (including ofloxacin), leading to paresthesia, hyposthesia, dysesthesia, or weakness. Patients being treated with ofloxacin should be instructed to inform their physician if they develop symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness. In such cases, ofloxacin should be discontinued to prevent irreversible damage.
Blood glucose fluctuations
Fluctuations in blood glucose levels, including hyperglycemia and hypoglycemia, have been reported during use of quinolones, including ofloxacin, particularly in diabetic patients receiving concomitant therapy with oral hypoglycemic agents (e.g., glyburide) or insulin. Cases of hypoglycemic coma have been reported. Diabetic patients are advised to closely monitor their blood glucose levels.
Patients with glucose-6-phosphate dehydrogenase deficiency
Patients with latent or confirmed glucose-6-phosphate dehydrogenase deficiency may be susceptible to hemolytic reactions during quinolone therapy. Therefore, ofloxacin should be prescribed with caution in such patients, with monitoring for potential hemolysis.
Visual disturbances
If any visual disturbances or adverse reactions affecting the eyes occur during ofloxacin therapy, patients should consult an ophthalmologist immediately (see sections "Ability to influence reaction rate when driving or operating machinery" and "Adverse reactions").
Patients with rare hereditary disorders
Patients with rare hereditary disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Other important information
If ofloxacin for intravenous administration is given concomitantly with antihypertensive agents, a sudden drop in blood pressure may occur. In such cases, or when the drug is administered concomitantly with barbiturate anesthetics, monitoring of cardiovascular function is required.
Patients should drink sufficient fluids to avoid crystalluria.
Prescribers are advised not to prescribe fluoroquinolones to patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis of bacterial etiology, or uncomplicated urinary tract infections if alternative treatment options are available. Fluoroquinolones should be discontinued immediately if patients report symptoms such as tendon pain, muscle weakness, tingling, numbness in hands or legs, confusion, or hallucinations, and patients should be switched to other antibacterial agents to complete the treatment course.
Use during pregnancy or breastfeeding.
Animal studies have shown damage to joint cartilage in immature animals, but no teratogenic effects were observed. Therefore, ofloxacin is contraindicated during pregnancy.
Ofloxacin is excreted in breast milk in small amounts. Due to the potential for arthropathy and other serious toxicities in the breastfed infant, breastfeeding should be discontinued during ofloxacin treatment.
Ability to influence reaction rate when driving or operating machinery.
Since somnolence, impaired coordination, dizziness, and visual disturbances have occasionally been reported, patients should be aware of their individual response to ofloxacin before driving or operating machinery. These effects may be enhanced by alcohol consumption.
Administration and Dosage
Administered intravenously by drip infusion to adult patients.
The dose of Ofloxacin is determined individually, depending on the sensitivity of microorganisms, type and severity of the infectious process.
Exacerbation of chronic obstructive pulmonary disease (including chronic bronchitis), community-acquired pneumonia: the medicinal product should be administered at a dose of 200 mg twice daily.
Urinary tract infections: 200 mg once daily.
Complicated skin and soft tissue infections: the medicinal product should be administered at a dose of 400 mg twice daily.
The 200 mg dose should be administered over at least 30 minutes. Administration must be performed at regular intervals.
For severe or complicated infections, a dose of 400 mg twice daily may be administered.
Dosage in patients with renal impairment
After the usual initial dose, the dose should be reduced in patients with impaired renal function.
If creatinine clearance is 20–50 mL/min (serum creatinine level 1.5–5.0 mg/dL), the dose should be halved (100–200 mg daily).
When creatinine clearance is < 20 mL/min (serum creatinine level > 5 mg/dL), the dose should be 100 mg every 24 hours.
Patients undergoing hemodialysis or peritoneal dialysis should receive 100 mg every 24 hours.
Dosage in patients with hepatic impairment
In patients with severe hepatic dysfunction, ofloxacin excretion may be reduced.
Elderly patients
Dosage adjustment is not required in elderly patients, except in cases of renal or hepatic insufficiency.
Duration of treatment depends on the course of the disease and is usually 7–10 days. After normalization of body temperature and improvement in the patient's general condition, administration of the drug should be continued for another 3 days.
Upon improvement of the patient's condition, continuation of treatment with the oral form of the medicinal product is recommended.
Duration of treatment should not exceed 2 months.
Children.
Ofloxacin should not be used in children (under 18 years of age).
Overdose.
The most important signs expected after acute overdose include neurological symptoms such as dizziness, impaired consciousness, and seizures, as well as gastrointestinal reactions, including nausea and erosive mucosal damage.
Elimination of ofloxacin can be accelerated by forced diuresis with high fluid volume.
In case of overdose, symptomatic treatment should be initiated. Due to the potential for QT interval prolongation, ECG monitoring is required.
Adverse reactions.
The adverse reactions listed below are classified by organ systems and frequency of occurrence. Frequency of occurrence is classified as follows: common (≥ 1/100 – < 1/10), uncommon (≥ 1/1000 – < 1/100), rare (≥ 1/10000 – < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated from available data).
| Classes and organ systems |
Common (≥ 1/100 – |
Uncommon (≥ 1/1000 |
Rare (≥ 1/10000 |
Very rare (< 1/10000) |
Frequency not known (cannot be estimated from available data) |
| Infections and infestations |
mycosis; resistance of pathogenic organisms |
||||
| Blood and lymphatic system disorders |
anaemia, haemolytic anaemia; leucopenia, eosinophilia; thrombocytopenia |
agranulocytosis, bone marrow dysfunction |
|||
| Immune system disorders |
hypersensitivity reactions, including anaphylactic/anaphylactoid reactions***, |
anaphylactic/anaphylactoid shock*** |
|||
| Metabolism and nutrition disorders |
anorexia |
hypoglycaemia in diabetic patients taking glucose-lowering agents; hyperglycaemia, hypoglycaemic coma |
|||
| Psychiatric disorders* |
excitation, sleep disorders, insomnia |
psychotic disorders (e.g. hallucinations); restlessness, confusion, nightmares, depression, delirium |
psychotic disorders and depression with self-destructive behaviour, including suicidal thoughts or suicide attempts; nervousness |
||
| Nervous system disorders* |
dizziness, |
drowsiness, paraesthesia, dysgeusia, parosmia |
peripheral sensory neuropathy***, peripheral sensorimotor neuropathy***, muscle spasms***, extrapyramidal symptoms or other muscle coordination disorders |
tremor, dyskinesia, ageusia (loss of taste sensation), syncope, benign intracranial hypertension |
|
| Eye disorders* |
eye mucosa irritation |
vision disorders |
uveitis |
||
| Ear and labyrinth disorders* |
vertigo |
tinnitus, hearing loss |
hearing impairment |
||
| Cardiac disorders** |
tachycardia |
ventricular arrhythmias, polymorphic ventricular tachycardia of torsades de pointes type (mainly in patients with risk factors for QT interval prolongation); QT interval prolongation on ECG |
|||
| Vascular disorders** |
phlebitis |
arterial hypotension |
During ofloxacin infusion, tachycardia, ventricular flutter (mainly in patients with risk factors for QT interval prolongation) on ECG and arterial hypotension may occur. In very rare cases, such decrease in blood pressure may be severe |
||
| Respiratory, thoracic and mediastinal disorders |
cough, |
dyspnoea, bronchospasm |
allergic pneumonitis, severe dyspnoea |
||
| Gastrointestinal disorders |
abdominal pain, diarrhoea, |
enterocolitis, sometimes haemorrhagic |
pseudo-membranous colitis*** |
dyspepsia, flatulence, constipation, pancreatitis |
|
| Hepatobiliary disorders |
increased levels of liver enzymes (alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, |
cholestatic jaundice |
hepatitis, which may sometimes be severe***, severe liver damage, including cases of fatal acute liver failure, primarily in patients with severe underlying liver diseases (see section "Special precautions") |
||
| Skin and subcutaneous tissue disorders |
pruritus, rash |
urticaria, flushing, increased |
multiform erythema, toxic epidermal necrolysis, |
Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, drug rash, stomatitis, exfoliative dermatitis |
|
| Musculoskeletal and connective tissue disorders* |
tendinitis |
arthralgia, myalgia, |
rabdomyolysis and/or myopathy, muscle weakness, muscle strain, |
||
| Renal and urinary disorders |
increased serum creatinine levels |
acute renal failure |
acute interstitial nephritis |
||
| Congenital and genetic disorders |
porphyria attacks in patients with porphyria |
||||
| General disorders and administration site conditions* |
infusion site reaction (pain, redness) |
asthenia, pyrexia, |
* Cases of very rare, prolonged (several months or years), disabling and potentially irreversible serious adverse reactions affecting various organ systems have been reported (including such reactions as tendinitis, tendon rupture, arthralgia, limb pain, gait disturbance, neuropathies associated with paresthesia and neuralgia, fatigue, psychiatric symptoms (including sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts), memory and concentration impairment, hearing, vision, taste and smell disturbances) associated with the use of quinolones and fluoroquinolones, regardless of the presence of risk factors (see section "Special precautions").
** Cases of aneurysm and aortic dissection, sometimes complicated by rupture (including fatal cases), and regurgitation/insufficiency of any cardiac valve have been reported in patients receiving fluoroquinolones (see section "Special precautions").
*** Post-marketing surveillance data.
Reporting suspected adverse reactions
Reporting suspected adverse reactions after a medicinal product has been authorized is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national pharmacovigilance system.
Shelf life. 2 years.
Storage conditions.
Store at temperatures not exceeding 25 °C. Keep out of reach of children.
Incompatibility.
The medicinal product is compatible with the following infusion solutions: 0.9% sodium chloride solution, Ringer's solution, and 5% glucose solution.
Do not mix with heparin (risk of precipitation).
Packaging.
100 ml or 200 ml in a bottle, 1 bottle in a carton. 100 ml or 200 ml in bottles.
Prescription status. Prescription only.
Manufacturer.
Yuria-Pharm LLC.
Manufacturer's address and location of its business activity.
108, Kobzarska Street, Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.