INSTRUCTION

for medical use of the medicinal product

 

OFLOXACIN

 

Composition:

active substance: ofloxacin;

100 ml of solution contain ofloxacin 200 mg;

excipients: sodium chloride, disodium edetate, concentrated hydrochloric acid, sodium hydroxide, water for injection.

 

Pharmaceutical form. Solution for infusion.

Basic physical and chemical properties: clear, colorless to yellowish solution.

 

Pharmacotherapeutic group. Antibacterials for systemic use. Fluoroquinolones.

ATC code J01MA01.

 

Pharmacological properties.

Pharmacodynamics.

Ofloxacin is a synthetic antimicrobial agent of the fluorinated quinolone class with a broad spectrum of action.

At concentrations equal to or slightly higher than the minimum inhibitory concentration (MIC), it exerts bactericidal action (by inhibiting DNA gyrase – an enzyme necessary for the replication and transcription of bacterial DNA).

The antimicrobial spectrum includes: Gram-negative and Gram-positive bacteria susceptible to ofloxacin: Enterobacteriaceae (Escherichia coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Proteus spp., Providencia spp., Salmonella spp., Serratia spp., Shigella spp., Yersinia spp.), 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 is also active against Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum (at borderline MIC values), Mycobacterium tuberculosis, Mycobacterium leprae, and some other mycobacteria.

The susceptibility 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 into tissues. It also distributes well into body fluids, including cerebrospinal fluid. Its concentrations are relatively high in bile. The volume of distribution is 1.5–2.5 L/kg. Plasma protein binding is 25%.

Ofloxacin is partially converted into desmethyl-ofloxacin and ofloxacin-N-oxide. Desmethyl-ofloxacin has weak antimicrobial activity.

The plasma half-life of ofloxacin is approximately 5–8 hours; in renal failure, it is prolonged depending on the degree of insufficiency to 15–60 hours. Ofloxacin is excreted mainly by the kidneys, via tubular secretion and glomerular filtration. 75–80% of the administered dose is excreted unchanged in the urine within 24–48 hours; less than 5% is excreted as metabolites. 4–8% of the administered dose is excreted in the feces. Ofloxacin excretion may be delayed in patients with severe liver damage (e.g., cirrhosis). Regardless of dose, renal excretion of ofloxacin is 173 ml/min, total excretion up to 214 ml/min. 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.

 

Clinical characteristics.

Indications.

Infectious and inflammatory diseases caused by pathogens susceptible to ofloxacin:

- Acute 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 guidelines for the appropriate use of antibacterial agents should be considered.

*when other antibacterial agents commonly used to treat this infection cannot be used.

 

Contraindications.

- Hypersensitivity to ofloxacin or to other components of the drug or to other fluoroquinolone drugs;

- Epilepsy;

- Central nervous system (CNS) lesions with a lowered seizure threshold (after head trauma, stroke, inflammatory processes of the brain and meninges);

- History of tendinitis;

- Glucose-6-phosphate dehydrogenase deficiency;

- Children or adolescents during the growth phase, as well as women during pregnancy or breastfeeding, since experimental use of the drug in animals suggests that a negative effect on the cartilage of growing joints cannot be completely ruled out.

Ofloxacin should not be prescribed to patients with QT interval prolongation, patients with uncorrected hypokalemia, or patients taking class IA (quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmic agents.

 

Interaction with other medicinal products and other forms of interaction.

Like other fluoroquinolones, ofloxacin should be used with caution in patients taking drugs known to prolong the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section "QT interval prolongation" in the "Precautions for use" section).

Increased bleeding time has been reported with concomitant use of ofloxacin and anticoagulants.

The risk of neurotoxic effects increases when used with non-steroidal anti-inflammatory drugs (NSAIDs), nitroimidazole derivatives, and methylxanthines.

Concomitant administration with glucocorticosteroids increases the risk of tendon rupture, especially in elderly patients.

Concomitant administration of ofloxacin with procainamide may lead to increased procainamide levels in patients; careful monitoring of plasma procainamide levels, ECG, and dose adjustment if necessary should be performed.

When ofloxacin is used concomitantly with antihypertensive agents or anesthetic barbiturates, a sudden drop in blood pressure may occasionally be observed.

If quinolones are taken simultaneously with other drugs that lower the seizure threshold, e.g., with theophylline, an additional lowering of the seizure threshold of the brain may be observed. However, ofloxacin, unlike some other fluoroquinolones, is believed not to interact pharmacokinetically with theophylline.

Additional lowering of the seizure threshold may also occur with concomitant use of certain NSAIDs and drugs that lower the seizure threshold.

If seizures occur, ofloxacin should be discontinued.

Ofloxacin may cause a slight increase in serum concentrations of glibenclamide; careful monitoring of patients receiving this combination is necessary.

The excretion of quinolones may be impaired and serum levels may increase if taken concomitantly with other drugs that undergo renal tubular secretion (e.g., probenecid, cimetidine, furosemide, and methotrexate).

Effect on laboratory test results: false-positive results for opiates or porphyrins in urine may occur during ofloxacin treatment. Confirmation of positive opiate or porphyrin test results by more specific methods may be necessary.

Mycobacterium tuberculosis is moderately sensitive to ofloxacin, which may lead to false-negative results in the bacteriological diagnosis of tuberculosis.

Continuous monitoring is necessary with concomitant administration of insulin, caffeine, theophylline, cimetidine, cyclosporine, NSAIDs, anticonvulsants, and drugs metabolized via cytochrome P450.

Vitamin K antagonists

Cases of increased coagulation test results (prothrombin time/international normalized ratio (INR)) and/or bleeding, which could be severe, have been reported in patients receiving ofloxacin in combination with vitamin K antagonists (e.g., warfarin).

Careful monitoring of coagulation test results is required in patients taking vitamin K antagonists due to a possible increase in the effect of coumarin derivatives.

 

Precautions for use.

The use of the drug in patients who have had serious adverse reactions in the past with quinolones or fluoroquinolones should be avoided (see section "Adverse reactions"). Treatment of these patients with ofloxacin should only be initiated in the absence of alternative treatment options and after a careful benefit/risk assessment (see also section "Contraindications").

If the patient's condition permits, switching to treatment with appropriate doses of ofloxacin tablets is recommended.

If allergic reactions or pronounced adverse effects from the central nervous system (CNS) develop, the drug should be discontinued immediately.

Prescribe the drug with caution to patients with CNS diseases (severe cerebral atherosclerosis, history of acute cerebrovascular insufficiency), and with impaired renal function.

Patients with acute hepatic failure should not exceed a dose of 400 mg per day.

Patients should drink sufficient water to avoid crystalluria.

Ofloxacin should only be administered by slow intravenous infusion over 60 minutes. Rapid or bolus injections may lead to arterial hypotension. Ofloxacin is not a first-line drug for the treatment of pneumonia caused by pneumococci or mycoplasmas, or acute tonsillitis caused by β-hemolytic streptococci.

If ofloxacin for IV administration is prescribed simultaneously with hypotensive drugs, a sudden drop in blood pressure may occur. In such cases, or if the drug is administered concurrently with barbiturate anesthetics, monitoring of cardiovascular system functions is necessary.

For methicillin-resistant S. aureus (MRSA), there is a very high probability of concurrent resistance to fluoroquinolones, including ofloxacin. Therefore, ofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the microorganism to ofloxacin (antibacterial agents usually recommended for the treatment of MRSA infections cannot be used).

Infections caused by Escherichia coli

Resistance of E. coli – the most common pathogen of urinary tract infections – to fluoroquinolones varies across different countries of the European Union. Prescribing physicians are advised to consider the local prevalence of E. coli resistance to fluoroquinolones.

Infections caused by Neisseria gonorrhoeae

Due to increasing N. gonorrhoeae resistance, ofloxacin should not be used as an empiric approach to antibacterial therapy when gonococcal infection is suspected (gonococcal urethritis, pelvic inflammatory disease, and epididymo-orchitis), except when the pathogen has been identified and its susceptibility to ofloxacin has been confirmed. If clinical improvement is not achieved after 3 days of treatment, therapy should be reassessed.

Pelvic inflammatory disease

For the treatment of pelvic inflammatory disease, ofloxacin should only be used in combination with drugs active against anaerobic microorganisms.

Hypersensitivity and allergic reactions

Allergic reactions and hypersensitivity reactions have been reported after the initial dose of fluoroquinolones. Anaphylactic and anaphylactoid reactions can progress to life-threatening shock, even after the initial dose. In such cases, ofloxacin should be discontinued immediately and appropriate treatment (e.g., shock treatment) initiated.

Severe bullous reactions

Cases of severe bullous skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with ofloxacin use (see section "Adverse reactions"). If skin and/or mucosal reactions occur, patients should be advised to contact their doctor immediately before continuing treatment.

Clostridium difficile-associated disease

Diarrhea during or after ofloxacin treatment (including several weeks after treatment), especially severe, persistent, and/or with bleeding, may be a symptom of pseudomembranous colitis. The severity of Clostridium difficile-associated disease varies from mild to life-threatening, with pseudomembranous colitis being the most severe form (see section "Adverse reactions"). Therefore, it is important to consider this diagnosis in patients who develop severe diarrhea during or after ofloxacin treatment. If pseudomembranous colitis is suspected, ofloxacin should be discontinued immediately. Appropriate specific antibiotic therapy should be started immediately (e.g., oral vancomycin, oral teicoplanin, or metronidazole). Drugs that inhibit intestinal peristalsis are contraindicated in this clinical situation.

Patients predisposed to seizures

Quinolones may lower the seizure threshold and provoke seizures. Ofloxacin is contraindicated in patients with a history of epilepsy (see section "Contraindications"). Like other quinolones, it should be used with extreme caution in patients predisposed to seizures and during concomitant treatment with active substances that lower the seizure threshold, e.g., theophylline (see section "Interaction with other medicinal products and other forms of interaction"). If seizures occur, ofloxacin should be discontinued.

Prolonged, disabling, and potentially irreversible serious adverse reactions

Very rarely, prolonged (lasting months or years), disabling, and potentially irreversible serious adverse reactions affecting various, and sometimes multiple, body systems (including, e.g., musculoskeletal, nervous, psychiatric, and sensory systems) have been reported in patients receiving quinolones and fluoroquinolones, regardless of age and pre-existing risk factors. The drug should be discontinued immediately at the first signs or symptoms of any serious adverse reaction, and medical advice should be sought.

Tendinitis and tendon rupture

Tendinitis and tendon rupture (not limited to the Achilles tendon), sometimes bilateral, can occur within 48 hours of starting quinolone/fluoroquinolone treatment and have been reported even several months after treatment discontinuation. The risk of tendinitis and tendon rupture is increased in elderly patients, patients with renal impairment, patients with solid organ transplants, and patients treated concomitantly with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided.

At the first sign of tendinitis (e.g., painful swelling, inflammation), treatment with the drug should be discontinued, and alternative treatment should be considered. The affected limb(s) should be treated appropriately (e.g., immobilization). Corticosteroids should not be used if signs of tendinopathy occur.

Patients with renal impairment

Prescribe the drug with caution to patients with renal impairment. Dose and administration timing adjustments are necessary for patients with renal insufficiency and elderly patients, considering slowed elimination (see section "Method of administration and dosage").

QT interval prolongation

Very rare cases of QT interval prolongation have been reported in patients taking fluoroquinolones. Fluoroquinolones, including ofloxacin, should be used with caution in patients with known risk factors for QT interval prolongation, which include:

• Uncorrected electrolyte imbalance (e.g., hypokalaemia, hypomagnesaemia);
• Congenital long QT syndrome;
• Acquired QT prolongation;
• Heart disease (e.g., heart failure, myocardial infarction, bradycardia);
• Concomitant use of drugs known to prolong the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics);
• Elderly patients and women may be more sensitive to drugs that prolong the QT interval. Thus, caution should be exercised when prescribing fluoroquinolones, including ofloxacin, to these patient groups.

Aortic aneurysm and dissection, and heart valve regurgitation/incompetence.

Epidemiological studies indicate an increased risk of aortic aneurysm and dissection, particularly in elderly patients, as well as aortic and mitral valve regurgitation after fluoroquinolone use. Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatalities), and regurgitation/incompetence of any heart valve have been reported in patients receiving fluoroquinolones (see section "Adverse reactions").

Therefore, fluoroquinolones should be used only after a careful benefit/risk assessment and after considering other therapeutic options for patients with a history of aneurysm or congenital heart valve disease, as well as for patients diagnosed with aortic aneurysm and/or aortic dissection or heart valve disease, or in the presence of other risk factors:

- Risk factors for aortic aneurysm and dissection and heart valve regurgitation/incompetence: connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behçet's disease, arterial hypertension, rheumatoid arthritis);

- Risk factors for aortic aneurysm and dissection: vascular disorders such as Takayasu arteritis or giant cell arteritis, atherosclerosis, or Sjögren's syndrome;

- Risk factors for heart valve regurgitation/incompetence: infective endocarditis.

The risk of aortic aneurysm and dissection and their rupture is also increased in patients concomitantly using systemic corticosteroids.

If sudden abdominal pain, chest pain, or back pain occurs, patients should be advised to seek immediate medical attention at an emergency department.

Patients should be advised to seek immediate medical attention if they experience acute shortness of breath, a new onset of palpitations, or the development of abdominal or lower limb swelling.

Patients with a history of psychotic disorders

Psychotic reactions have been reported in patients taking fluoroquinolones. In some cases, these reactions progressed to suicidal thoughts or self-destructive behaviour, including suicide attempts, sometimes even after a single dose. If these reactions develop in a patient, ofloxacin should be discontinued and appropriate therapeutic measures taken. Ofloxacin should be used with caution in patients with a history of psychotic disorders or patients with mental illness.

Patients with hepatic impairment

Ofloxacin should be used with caution in patients with hepatic impairment due to possible drug-induced liver injury. Cases of fulminant hepatitis potentially leading to hepatic failure (including fatalities) have been reported during fluoroquinolone treatment. Patients should be advised to discontinue treatment and consult their doctor if symptoms and signs of liver disease such as anorexia, jaundice, dark urine, pruritus, or abdominal tenderness occur (see section "Adverse reactions").

Patients taking vitamin K antagonists

Due to possible increases in coagulation test results (prothrombin time/INR) and/or bleeding in patients receiving fluoroquinolones, including ofloxacin, in combination with vitamin K antagonists (e.g., warfarin), coagulation test results should be monitored when these two drug classes are used concomitantly (see section "Interaction with other medicinal products and other forms of interaction").

Myasthenia gravis

Fluoroquinolones, including ofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. In the post-marketing period, serious adverse reactions, including fatalities 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 use (see section "Adverse reactions"). Patients taking ofloxacin should avoid exposure to intense sunlight and ultraviolet radiation (mercury-quartz lamps, tanning beds) during treatment and for 48 hours after drug discontinuation to prevent photosensitization.

Superinfection

Antibiotic use, especially over prolonged periods, may lead to overgrowth of resistant microflora; therefore, the patient's condition should be checked periodically during treatment. If secondary infection occurs, appropriate measures should be taken.

Peripheral neuropathy

Cases of peripheral sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypoesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones (including ofloxacin). If symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness occur, patients being treated with the drug should inform their doctor to prevent the development of a potentially irreversible condition (see section "Adverse reactions").

Dysglycemia

Disturbances in blood glucose levels, including both hyperglycaemia and hypoglycaemia, have been reported with quinolone use, including ofloxacin, especially in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or insulin. Cases of hypoglycaemic coma have been reported. Careful monitoring of blood glucose levels is recommended for diabetic patients (see section "Adverse reactions").

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with latent or confirmed glucose-6-phosphate dehydrogenase deficiency may be predisposed to haemolytic reactions when treated with quinolones. Therefore, ofloxacin should be prescribed to these patients with caution, monitoring for potential signs of haemolysis.

Visual disturbances

If any visual disturbances or adverse reactions from the visual organs occur while taking ofloxacin, an ophthalmologist should be consulted immediately (see sections "Effects on ability to drive and use machines" and "Adverse reactions").

Effect on laboratory test results

False-positive results for opiates or porphyrins in urine may occur during ofloxacin treatment. More specific methods may be required to confirm positive opiate or porphyrin test results.

Patients with rare hereditary disorders

Patients with rare hereditary disorders such as galactose intolerance, lactase deficiency (Lapland type), or glucose-galactose malabsorption should not take this medicinal product.

The medicinal product contains 365.47 mg of sodium per dose; caution should be exercised in patients on a sodium-controlled diet.

 

Pregnancy and lactation.

Animal studies have shown damage to articular cartilage in immature animals, but no teratogenic effects. Therefore, ofloxacin is contraindicated during pregnancy.

Ofloxacin is excreted into breast milk in small amounts. Due to the potential for arthropathy and other serious types of toxicity in the breastfed infant, breastfeeding should be discontinued during ofloxacin treatment.

 

Effects on ability to drive and use machines.

Psychomotor reaction speed may be impaired; therefore, patients should refrain from driving vehicles or operating machinery.

Since drowsiness, impaired ability to operate machinery, dizziness, and visual disturbances have been reported in some cases after taking the drug, patients should know how they react to ofloxacin before driving or operating machinery.

 

Method of administration and dosage.

For use in adults. Administer intravenously as a drip infusion. A skin allergy test should be performed before starting the infusion.

The dose of Ofloxacin is determined individually by the physician, depending on the susceptibility of the microorganisms, the type, and severity of the infectious process.

Acute exacerbation of chronic obstructive pulmonary disease (including chronic bronchitis), community-acquired pneumonia: 200 mg twice daily.

Uncomplicated acute cystitis, urethritis, acute pyelonephritis, and complicated urinary tract infections: 200 mg twice daily.

Complicated skin and soft tissue infections: 400 mg twice daily.

The infusion time should be at least 30 minutes per 200 mg. In general, individual doses should be administered at equal intervals. A dose of 400 mg twice daily may be used for severe or complicated infections.

Dosage for patients with renal impairment. Patients with renal impairment may require dose reduction, depending on creatinine clearance. If creatinine clearance is 20–50 ml/min, the dose should be reduced to 100–200 mg every 24 hours. For creatinine clearance < 20 ml/min, the dose should be 100 mg every 24 hours. For patients on haemodialysis or peritoneal dialysis, the dose of ofloxacin should be 100 mg every 24 hours.

The duration of ofloxacin use depends on the type of infectious process and clinical indicators. After body temperature normalizes and the patient's general condition improves, treatment should be continued for another 3 days.

In most cases of acute infection, the treatment duration is 7–10 days. The physician may switch the patient from parenteral to oral administration without changing the dose.

The duration of treatment should not exceed 2 months.

 

Children.

The drug is contraindicated in children and adolescents.

 

Overdose.

The most important expected signs of acute overdose are CNS symptoms, including dizziness, disorientation, drowsiness, confusion, lethargy, seizures, QT interval prolongation, as well as gastrointestinal reactions such as nausea, vomiting, and erosive mucosal lesions.

There is no antidote. Treatment is symptomatic. Ofloxacin is mainly excreted by the kidneys (75–80% of the administered dose is excreted unchanged in the urine within 24–48 hours); its elimination can be accelerated by forced volume diuresis. Only a limited amount of ofloxacin can be removed by haemodialysis (average 15–25%) or peritoneal dialysis (less than 2%).

ECG monitoring should be performed due to possible QT interval prolongation. Antacids are recommended to protect the gastric mucosa.

 

Adverse reactions.

The adverse reactions listed below are classified by system organ class and frequency. Frequency is classified as: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency unknown (cannot be estimated from available data).

Infections and infestations: uncommon – mycosis; resistance of pathogenic organisms.

Blood and lymphatic system disorders: very rare – anaemia, haemolytic anaemia; leukopenia, eosinophilia; thrombocytopenia; frequency unknown – agranulocytosis, bone marrow dysfunction.

Immune system disorders: rare – hypersensitivity reactions, including anaphylactic/anaphylactoid reactions**, angioedema** (including swelling of the tongue, larynx, pharynx, facial oedema/swelling); very rare – anaphylactic/anaphylactoid shock**.

Metabolism and nutrition disorders: rare – anorexia; frequency unknown – hypoglycaemia in diabetic patients taking antidiabetic drugs, hyperglycaemia, hypoglycaemic coma.

Psychiatric disorders*: uncommon – agitation, sleep disorders, insomnia; rare – psychotic disorders (e.g., hallucinations); restlessness, confusion, nightmares, depression, delirium; frequency unknown – psychotic disorders and depression with self-destructive behaviour, including suicidal thoughts or suicide attempts, nervousness.

Nervous system disorders*: uncommon – dizziness, headache; rare – drowsiness, paraesthesia, dysgeusia, parosmia; very rare – peripheral sensory neuropathy**, peripheral sensorimotor neuropathy**, muscle seizures**, extrapyramidal symptoms or other muscle coordination disorders; frequency unknown – tremor, dyskinesia, ageusia (loss of taste), syncope, benign intracranial hypertension.

Eye disorders*: uncommon – eye mucosal irritation; rare – visual disturbances; frequency unknown – uveitis.

Ear and labyrinth disorders*: uncommon – vertigo; very rare – tinnitus, hearing loss; frequency unknown – hearing impairment.

Cardiac disorders**:**: rare – tachycardia; frequency unknown – ventricular arrhythmias, polymorphic ventricular tachycardia (torsade de pointes) (these reactions were reported mainly in patients with risk factors for QT prolongation); QT interval prolongation on ECG.

Vascular disorders**:**: common – phlebitis; rare – arterial hypotension; frequency unknown – tachycardia and arterial hypotension may occur during ofloxacin infusion. In very rare cases, this decrease in blood pressure may be severe.

Respiratory, thoracic, and mediastinal disorders: uncommon – cough, nasopharyngitis; rare – dyspnoea, bronchospasm; frequency unknown – allergic pneumonitis, severe dyspnoea.

Gastrointestinal disorders: uncommon – abdominal pain, diarrhea, nausea, vomiting; rare – enterocolitis, sometimes haemorrhagic; very rare – pseudomembranous colitis*; frequency unknown – dyspepsia, flatulence, constipation, pancreatitis.

Hepatobiliary disorders: rare – increased liver enzyme levels (alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma-glutamyltransferase and/or alkaline phosphatase), increased blood bilirubin levels; very rare – cholestatic jaundice; frequency unknown – hepatitis, which may sometimes be severe**, severe liver injury, including cases of fatal acute liver failure, especially in patients with severe underlying liver disease (see section "Precautions for use").

Skin and subcutaneous tissue disorders: uncommon – pruritus, rash; rare – urticaria, flushing, hyperhidrosis, pustular rash; very rare – erythema multiforme, toxic epidermal necrolysis, photosensitivity reactions**, drug dermatitis, vascular purpura, vasculitis which in exceptional cases may lead to skin necrosis; frequency unknown – Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, drug eruption, stomatitis, exfoliative dermatitis.

Musculoskeletal and connective tissue disorders*: rare – tendinitis; very rare – arthralgia, myalgia, tendon rupture (including Achilles tendon), which may be bilateral and occur within 48 hours of starting treatment; frequency unknown – rhabdomyolysis and/or myopathy, muscle weakness, muscle strain, muscle rupture, ligament rupture, arthritis.

Renal and urinary disorders: rare – increased serum creatinine levels; very rare – acute renal failure; frequency unknown – acute interstitial nephritis.

Congenital, hereditary, and genetic disorders: frequency unknown – porphyria attacks in patients with porphyria.

General disorders and administration site conditions*: common – infusion site reaction (pain, redness); frequency unknown – asthenia, pyrexia, pain (including back pain, chest pain, and pain in extremities).

* Some cases of very rare prolonged (months or years), disabling, and potentially irreversible serious adverse reactions affecting various, and sometimes multiple, body systems (including such reactions as tendinitis, tendon rupture, arthralgia, limb pain, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disturbance, hearing impairment, visual disturbance, taste and smell disturbance) have been reported in association with the use of quinolones and fluoroquinolones, regardless of the presence of risk factors (see section "Precautions for use").

** Post-marketing surveillance data.

*** Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatalities), and regurgitation/incompetence of any heart valve have been reported in patients receiving fluoroquinolones (see section "Precautions for use").

Description of selected adverse reactions

Anxiety, suicidal thoughts, panic attacks, neuralgia, and impaired concentration have been reported as potential aspects of prolonged and disabling adverse reactions with fluoroquinolone use.

 

Adverse Reactions Reporting

Adverse reactions reporting after the registration of a medicinal product is of great importance. It enables the monitoring of the benefit/risk ratio associated with the use of the medicinal product. Healthcare professionals, pharmacists, as well as patients or their legal representatives, should report all suspected adverse reactions and cases of lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

 

Shelf life. 3 years.

 

Storage conditions.

Store at a temperature not exceeding 25 ºC in the original package.

Keep out of reach of children.

Any unused medicinal product should be discarded.

 

Incompatibility.

Ofloxacin solution must not be mixed with heparin or other infusion solutions, except those for which compatibility with ofloxacin has been demonstrated.

When prescribed with drugs that alkalinize the urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases.

The medicinal product is compatible with the following infusion solutions: 0.9% sodium chloride solution, Ringer's solution, and 5% glucose solution.

 

Packaging. 100 ml of drug in a container. 1 container in a polyvinyl chloride film with instruction for medical use in a box.

 

Terms of dispensing. On prescription.

 

Date of last update.

18.07.2025