Levofloxacin Kabi

Levofloxacin.

The solution for infusion is a yellow to greenish yellow solution.
100 ml filled in 100 ml bottle: Each ml of solution for infusion contains 5 mg levofloxacin (as levofloxacin hemihydrate).
100 ml of solution for infusion contains 500 mg of levofloxacin as active substance.
Excipients/Inactive Ingredients: The medicinal product contains 3.5 mg of sodium per ml.
Sodium chloride, Sodium hydroxide (for pH adjustment), Hydrochloric acid (for pH adjustment), Water for injection.

Pharmacotherapeutic group: quinolone antibacterials, fluoroquinolones. ATC code: J01MA12.
Pharmacology: Pharmacodynamics: Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic active substance ofloxacin.
Mechanism of action: As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA-gyrase complex and topoisomerase IV.
PK/PD relationship: The degree of the bactericidal activity of levofloxacin depends on the ratio of the maximum concentration in serum (Cmax) or the area under the curve (AUC) and the minimal inhibitory concentration (MIC).
Mechanism of resistance: Resistance to levofloxacin is acquired through a stepwise process by target site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV. Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also affect susceptibility to levofloxacin.
Cross-resistance between levofloxacin and other fluoroquinolones is observed. Due to the mechanism of action, there is generally no cross-resistance between levofloxacin and other classes of antibacterial agents.
Breakpoints: The EUCAST recommended MIC breakpoints for levofloxacin, separating susceptible from intermediately susceptible organisms and intermediately susceptible from resistant organisms are presented in Table 1 for MIC testing (mg/l). (See Table 1.)

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The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Commonly susceptible species: Aerobic Gram-positive bacteria: Bacillus anthracis, Staphylococcus aureus methicillin-susceptible, Staphylococcus saprophyticus, Streptococci group C and G, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.
Aerobic Gram-negative bacteria: Eikenella corrodens, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella oxytoca, Moraxella catarrhalis, Pasteurella multocida, Proteus vulgaris, Providencia rettgeri.
Anaerobic bacteria: Peptostreptococcus.
Other: Chlamydophila pneumoniae, Chlamydophila psittaci, Chlamydia trachomatis, Legionella pneumophila, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum.
Species for which acquired resistance may be a problem: Aerobic Gram-positive bacteria: Enterococcus faecalis, Staphylococcus aureus methicillin-resistant^#, coagulase negative Staphylococcus spp.
Aerobic Gram-negative bacteria: Acinetobacter baumannii, Citrobacter freundii, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens.
Anaerobic bacteria: Bacteroides fragilis.
Inherently Resistant Strains: Aerobic Gram-positive bacteria: Enterococcus faecium.
^# Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin.
Pharmacokinetics: Absorption: Orally administered levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within 1-2 h. The absolute bioavailability is 99-100%.
Food has little effect on the absorption of levofloxacin.
Steady state conditions are reached within 48 hours following a 500 mg once or twice daily dosage regimen.
Distribution: Approximately 30-40% of levofloxacin is bound to serum protein.
The mean volume of distribution of levofloxacin is approximately 100 l after single and repeated 500 mg doses, indicating widespread distribution into body tissues.
Penetration into tissues and body fluids: Levofloxacin has been shown to penetrate into bronchial mucosa, epithelial lining fluid, alveolar macrophages, lung tissue, skin (blister fluid), prostatic tissue and urine. However, levofloxacin has poor penetration into cerebrospinal fluid.
Biotransformation: Levofloxacin is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide. These metabolites account for <5% of the dose excreted in urine. Levofloxacin is stereochemically stable and does not undergo chiral inversion.
Elimination: Following oral and intravenous administration of levofloxacin, it is eliminated relatively slowly from the plasma (t½: 6-8 h). Excretion is primarily by the renal route (>85% of the administered dose).
The mean apparent total body clearance of levofloxacin following a 500 mg single dose was 175 +/- 29.2 ml/min.
There are no major differences in the pharmacokinetics of levofloxacin following intravenous and oral administration, suggesting that the oral and intravenous routes are interchangeable.
Linearity: Levofloxacin obeys linear pharmacokinetics over a range of 50 to 1000 mg.
Special populations: Subjects with renal insufficiency: The pharmacokinetics of levofloxacin are affected by renal impairment. With decreasing renal function renal elimination and clearance are decreased, and elimination half-lives increased as shown in Table 2. (See Table 2.)

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Elderly subjects: There are no significant differences in levofloxacin kinetics between young and elderly subjects, except those associated with differences in creatinine clearance.
Gender differences: Separate analysis for male and female subjects showed small to marginal gender differences in levofloxacin pharmacokinetics. There is no evidence that these gender differences are of clinical relevance.

Levofloxacin Kabi solution for infusion is indicated in adults for the treatment of the following infections (see Precautions).
Community-acquired pneumonia; Complicated skin and soft tissue infections.
For the previously mentioned infections Levofloxacin Kabi should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Pyelonephritis and complicated urinary tract infections (see Precautions); Chronic bacterial prostatitis; Inhalation anthrax [post-exposure prophylaxis and curative treatment (see Precautions)].
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Levofloxacin Kabi solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen.
Treatment with Levofloxacin Kabi after initial use of the intravenous preparation may be completed with an appropriate oral presentation as considered appropriate for the individual patient. Given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
Posology: The following dose recommendations can be given for Levofloxacin Kabi: Dosage in patients with normal renal function (creatinine clearance >50 ml/min): See Table 3.

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Special populations: Impaired renal function (creatinine clearance ≤50 ml/min): See Table 4.

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Impaired liver function: No adjustment of dose is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
Elderly population: No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function (see Tendinitis and tendon rupture and QT interval prolongation under Precautions).
Paediatric population: Levofloxacin Kabi is contraindicated in children and growing adolescents (see Contraindications).
Method of administration: Levofloxacin Kabi solution for infusion is only intended for slow intravenous infusion; it is administered once or twice daily. The infusion time must be at least 60 minutes for 500 mg Levofloxacin Kabi solution for infusion (see Precautions).
For incompatibilities, see Incompatibilities under Cautions for Usage. For compatibility with other infusion solutions, see Pharmaceutical precautions under Cautions for Usage.

According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdosage of Levofloxacin Kabi solution for infusion are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval.
CNS effects including confusional state, convulsion, hallucination, and tremor have been observed in post-marketing experience.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body. No specific antidote exists.

Levofloxacin Kabi solution for infusion must not be used: in patients hypersensitive to levofloxacin or any other quinolone and any of the excipients listed in Description; in patients with epilepsy; in patients with history of tendon disorders related to fluoroquinolone administration; in children or growing adolescents; during pregnancy; in breast-feeding women.

Risks of resistance: Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).
Resistance to fluoroquinolones of E. coli - the most common pathogen involved in urinary tract infections - varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in E. coli to fluoroquinolones.
Inhalation Anthrax: Use in humans is based on in vitro Bacillus anthracis susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.
Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects: Fluoroquinolones, including Levofloxacin Kabi, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting Levofloxacin Kabi. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
Discontinue Levofloxacin Kabi immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including Levofloxacin Kabi, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Because fluoroquinolones, including Levofloxacin Kabi, have been associated with serious adverse reactions, reserve Levofloxacin Kabi for use in patients who have no alternative treatment options for the following indications: Uncomplicated urinary tract infection; Acute bacterial exacerbation of chronic bronchitis; Acute bacterial sinusitis.
Infusion Time: The recommended infusion time of at least 60 minutes for 500 mg Levofloxacin Kabi solution for infusion should be observed. It is known for ofloxacin that during infusion tachycardia and a temporary decrease in blood pressure may develop. In rare cases, as a consequence of a profound drop in blood pressure, circulatory collapse may occur. Should a conspicuous drop in blood pressure occur during infusion of levofloxacin (l-isomer of ofloxacin), the infusion must be halted immediately.
Sodium content: This medicinal product contains 15.4 mmol (354.2 mg) sodium per 100 ml dose. To be taken into consideration by patients on a controlled sodium diet.
Prolonged, disabling and potentially irreversible serious adverse drug reactions: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors. Levofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.
Tendinitis and tendon rupture: Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in patients receiving daily doses of 1000 mg levofloxacin in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided.
At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.
Clostridium difficile-associated disease: Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with Levofloxacin Kabi (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD). CDAD may range in severity from mild to life-threatening, the most severe form of which is pseudomembranous colitis (see Adverse Reactions). It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with levofloxacin. If CDAD is suspected or confirmed, levofloxacin should be stopped immediately and appropriate treatment initiated without delay. Anti-peristaltic medicinal products are contraindicated in this clinical situation.
Patients predisposed to seizures: Quinolones may lower the seizure threshold and may trigger seizures. Levofloxacin is contraindicated in patients with a history of epilepsy (see Contraindications) and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures or concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline (see Interactions). In case of convulsive seizures (see Adverse Reactions), treatment with levofloxacin should be discontinued.
Patients with G-6-phosphate dehydrogenase deficiency: Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents. Therefore, if levofloxacin has to be used in these patients, potential occurrence of haemolysis should be monitored.
Patients with renal impairment: Since levofloxacin is excreted mainly by the kidneys, the dose of Levofloxacin Kabi should be adjusted in patients with renal impairment (see Dosage & Administration).
Hypersensitivity reactions: Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. angioedema up to anaphylactic shock), occasionally following the initial dose (see Adverse Reactions). Patients should discontinue treatment immediately and contact their physician or an emergency physician, who will initiate appropriate emergency measures.
Severe cutaneous adverse reactions: Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN: also known as Lyell's syndrome), Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be life-threatening or fatal, have been reported with levofloxacin (see Adverse Reactions). At the time of prescription, patients should be advised of the signs and symptoms of severe skin reactions, and be closely monitored. If signs and symptoms suggestive of these reactions appear, levofloxacin should be discontinued immediately and an alternative treatment should be considered. If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of levofloxacin, treatment with levofloxacin must not be restarted in this patient at any time.
Dysglycaemia: As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g. glibenclamide) or with insulin. Cases of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose is recommended. (See Adverse Reactions.)
Prevention of photosensitisation: Photosensitisation has been reported with levofloxacin (see Adverse Reactions). It is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium), during treatment and for 48 hours following treatment discontinuation in order to prevent photosensitisation.
Patients treated with Vitamin K antagonists: Due to possible increase in coagulation tests (PT/INR) and/or bleeding in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin), coagulation tests should be monitored when these drugs are given concomitantly (see Interactions).
Psychotic reactions: Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin. In very rare cases these have progressed to suicidal thoughts and self-endangering behaviour - sometimes after only a single dose of levofloxacin (see Adverse Reactions). In the event that the patient develops these reactions, levofloxacin should be discontinued and appropriate measures instituted. Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
QT interval prolongation: Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example: congenital long QT syndrome; concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmic, tricyclic antidepressants, macrolides, antipsychotics); 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 QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations. (See Dosage & Administration, Interactions, Adverse Reactions, and Overdosage.)
Peripheral neuropathy: Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paraesthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including levofloxacin. Symptoms may occur soon after initiation of levofloxacin and may be irreversible. Levofloxacin should be discontinued immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation.
Hepatobiliary disorders: Cases of hepatic necrosis up to fatal hepatic failure have been reported with levofloxacin, primarily in patients with severe underlying diseases, e.g. sepsis (see Adverse Reactions). Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop, such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
Exacerbation of myasthenia gravis: Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Post-marketing serious adverse reactions, including deaths and the requirement for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Levofloxacin is not recommended in patients with a known history of myasthenia gravis.
Vision disorders: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see Effects on ability to drive and use machines as follows and Adverse Reactions).
Superinfection: The use of levofloxacin, especially if prolonged, may result in overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.
Interference with laboratory test: In patients treated with levofloxacin, determination of opiates in urine may give false-positive results. It may be necessary to confirm positive opiate screens by more specific method.
Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
Aortic aneurysm and dissection, and heart valve regurgitation/incompetence: Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones. Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see Adverse Reactions).
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection or congenital heart valve disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection or heart valve disease, or in presence of other risk factors or conditions predisposing: for both aortic aneurysm and dissection and heart valve regurgitation/incompetence (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behcet's disease, hypertension, rheumatoid arthritis); or additionally, for aortic aneurysm and dissection (e.g. vascular disorders such as Takayasu arteritis or giant cell arteritis, or known atherosclerosis, or Sjörgen's syndrome); or additionally, for heart valve regurgitation/incompetence (e.g. infective endocarditis).
The risk of aortic aneurysm and dissection, and their rupture may also be increased in patients treated concurrently with systemic corticosteroids.
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Patients should be advised to seek immediate medical attention in case of acute dyspnoea, new onset of heart palpitations, or development of oedema of the abdomen or lower extremities.
Effects on ability to drive and use machines: Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

Pregnancy: There are limited amount of data from the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. However in the absence of human data and due to that experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Levofloxacin Kabi solution for infusion must not be used in pregnant women (see Contraindications).
Breast-feeding: Levofloxacin Kabi is contraindicated in breast-feeding women. There is insufficient information on the excretion of levofloxacin in human milk; however other fluoroquinolones are excreted in breast milk. In the absence of human data and due to that experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Levofloxacin Kabi solution for infusion must not be used in breast-feeding women (see Contraindications).
Fertility: Levofloxacin caused no impairment of fertility or reproductive performance in rats.

The information given as follows is based on data from clinical studies in more than 8300 patients and on extensive post-marketing experience.
Frequencies in Table 5 are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 5.)

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Other undesirable effects which have been associated with fluoroquinolone administration include: attacks of porphyria in patients with porphyria.

Effect of other medicinal products on Levofloxacin Kabi: Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs: No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study. However a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, non-steroidal anti-inflammatory drugs, or other agents which lower the seizure threshold.
Levofloxacin concentrations were about 13% higher in the presence of fenbufen than when administered alone.
Probenecid and cimetidine: Probenecid and cimetidine had a statistically significant effect on the elimination of levofloxacin. The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%). This is because both drugs are capable of blocking the renal tubular secretion of levofloxacin. However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.
Caution should be exercised when levofloxacin is co-administered with drugs that affect the tubular renal secretion such as probenecid and cimetidine, especially in renally impaired patients.
Other relevant information: Clinical pharmacology studies have shown that the pharmacokinetics of levofloxacin were not affected to any clinically relevant extent when levofloxacin was administered together with the following drugs: calcium carbonate, digoxin, glibenclamide, ranitidine.
Effect of Levofloxacin Kabi on other medicinal products: Ciclosporin: The half-life of ciclosporin was increased by 33% when co-administered with levofloxacin.
Vitamin K antagonists: Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin). Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists (see Precautions).
Drugs known to prolong QT interval: Levofloxacin like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III antiarrhythmic, tricyclic antidepressants, macrolides, antipsychotics). (See QT interval prolongation under Precautions.)
Other relevant information: In a pharmacokinetic interaction study, levofloxacin did not affect the pharmacokinetics of theophylline (which is a probe substrate for CYP1A2), indicating that levofloxacin is not a CYP1A2 inhibitor.

Pharmaceutical precautions: As for all medicines, any unused medicinal product should be disposed of accordingly and in compliance with local environmental regulations.
Mixture with other solutions for infusion: Levofloxacin Kabi solution for infusion is compatible with the following solutions for infusion: Glucose 50 mg/ml (5%); Glucose-Ringer 25 mg/ml (2.5%); Sodium chloride 9 mg/ml (0.9%); Amino acid solution.
See Incompatibilities as follows.
Handling Instructions of Bottle: General preparations: 1. Check the bottle to ensure it is the desired infusion solution. Check the expiry date as indicated on the bottle, and ensure that the bottle is intact, and the solution is clear and does not contain solid particles.
2. Select the suitable port for injection (arrow pointing towards the bottle) or infusion (arrow pointing outwards from the bottle).
3. To open the protective cap of injection/infusion port, lightly push the arrow tab forward with the thumb. The membrane is sterile and does not require immediate disinfection after opening.
Preparation of infusion: 1. Place the bottle on a stable and level surface. Identify and open the infusion port (arrow pointing outwards from the bottle).
2. Insert the spike of infusion set vertically into the infusion port by slightly twisting the handset. Hold the neck of bottle with another hand. The package is compatible with commonly used infusion sets. The roller clamp should be opened when inserting the spike of the infusion set and then clamped.
3. Hang the bottle on the infusion rack using the ring hanger at the bottom of the bottle. Fill the condenser with solution. The medicine is now ready for infusion.
Addition of medicine with a syringe: 1. Place the bottle on a stable and level surface. Identify and open the injection port (arrow pointing towards the bottle).
2. Use 18-23 gauge needles. Insert the needle into the center of injection port and inject the medicine into the bottle. Carefully mix the solution after adding the medicine.
Incompatibilities: Levofloxacin Kabi solution for infusion should not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate). This medicinal product must not be mixed with other medicinal products except those previously mentioned in Pharmaceutical precautions.

Keep container in the outer carton in order to protect from light.
Do not refrigerate or freeze.
Diluted solution: Dilution is not necessary prior to administration.
For the diluted product chemical and physical in-use stability has been demonstrated for 3 hours at 25°C.
After first opening: From the microbiological point of view, the product should be used immediately (within 3 hours). If not used immediately (within 3 hours), in-use storage times and conditions prior to use are the responsibility of the user, unless reconstitution/dilution has taken place in controlled and validated conditions.
No protection from light is necessary during infusion.

Quinolones

J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

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