Levofloxacin-Teva film-coated tablets 500 mg blister No. 10

Instructions Levofloxacin-Teva film-coated tablets 500 mg blister No. 10

Composition

active ingredient: levofloxacin;

1 film-coated tablet contains 256.23 mg of levofloxacin hemihydrate, equivalent to 250 mg of levofloxacin, or 512.46 mg of levofloxacin hemihydrate, equivalent to 500 mg of levofloxacin;

excipients:

core: sodium stearyl fumarate, crospovidone, colloidal anhydrous silica, copovidone, microcrystalline cellulose;

film coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, red iron oxide (E 172), yellow iron oxide (E 172).

Dosage form

Film-coated tablets.

Main physicochemical properties: pink, oval, biconvex tablets, 6 x 13 mm or 8 x 16 mm in size, film-coated, with a score on one side and on the sides; engraved with “L” on the side without a score.

Pharmacotherapeutic group

Antibacterial agents of the quinolone group. Fluoroquinolones.

ATX code J01M A12.

Pharmacological properties

Pharmacodynamics.

Levofloxacin is a synthetic antibacterial agent from the fluoroquinolone group, the S (-) enantiomer of the racemic mixture of the drug ofloxacin.

Mechanism of action

As an antibacterial agent from the fluoroquinolone group, levofloxacin acts on the DNA-DNA gyrase complex and topoisomerase IV.

Pharmacokinetics/pharmacodynamics relationship

The degree of bactericidal activity of levofloxacin depends on the ratio of the maximum serum concentration (Cmax) or the area under the pharmacokinetic concentration-time curve (AUC) and the minimum inhibitory concentration (MIC).

Mechanism of resistance development

Resistance to levofloxacin develops in a stepwise manner due to target site mutations in type II topoisomerases, DNA gyrase, and topoisomerase IV. Other resistance mechanisms, such as entry barriers (characteristic of Pseudomonas aeruginosa) and efflux mechanisms, may also influence levofloxacin susceptibility.

Cross-resistance between levofloxacin and other fluoroquinolones has been observed. Given the mechanism of action, there is usually no cross-resistance between levofloxacin and other classes of antibacterial agents.

Checkpoints

The recommended EUCAST (European Committee on Antimicrobial Susceptibility Testing) MIC breakpoints for levofloxacin, which distinguish susceptible from intermediately susceptible organisms and intermediately susceptible from resistant organisms, are presented in the table below for MIC testing (mg/L).

Table 1

Clinically determined EUCAST MICs for levofloxacin (version 2.0, 2012-01-01)

The prevalence of resistance for individual species may vary geographically and over time, so local information on resistance is important, particularly in the treatment of severe infections. Expert advice should be sought when the local prevalence of resistance is such that the usefulness of the medicinal product in at least some types of infection is questionable.

Typically sensitive species

Aerobic Gram-positive bacteria: Bacillus anthracis, methicillin-sensitive Staphylococcus aureus, Staphylococcus saprophyticus, Streptococci, groups 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.

Others: Chlamydophila pneumoniae, Chlamydophila psittaci, Chlamydia trachomatis, Legionella pneumophila, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum.

Aerobic Gram-positive bacteria: Enterococcus faecalis, methicillin-resistant Staphylococcus aureus (most likely co-resistant to fluoroquinolones, including levofloxacin), coagulase-negative Staphylococcus spp.

Aerobic gram-negative bacteria: Acinetobacter baumannii, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens.

Anaerobic bacteria: Bacteroides fragilis.

Naturally resistant strains

Aerobic Gram-positive bacteria: Enterococcus faecium.

Pharmacokinetics.

Absorption. When taken orally, levofloxacin is rapidly and almost completely absorbed, C max in blood plasma is reached 1–2 hours after administration. Absolute bioavailability is 99–100%. Food intake slightly affects its absorption. Stable values are achieved within 48 hours after administration of the drug at a dose of 500 mg 1–2 times a day.

Distribution: Approximately 30–40% of levofloxacin is bound to serum proteins. The mean volume of distribution of levofloxacin is approximately 100 L after single and repeated doses of 500 mg, indicating extensive distribution into body tissues.

Penetration into tissues and body fluids. Levofloxacin has been shown to penetrate bronchial mucosa, epithelial lining fluid, alveolar macrophages, lung tissue, skin (blister contents), prostate tissue, and urine. However, levofloxacin has poor penetration into cerebrospinal fluid.

Metabolism: Levofloxacin is metabolized to a very small extent, the metabolites are desmethyl-levofloxacin and levofloxacin N-oxide. These metabolites account for less than 5% of the amount of drug excreted in the urine. The levofloxacin molecule is stereochemically stable and does not undergo chiral inversion.

Elimination. After oral and intravenous administration, levofloxacin is eliminated from plasma relatively slowly (half-life is 6–8 hours). Elimination is mainly renal (more than 85% of the administered dose). The mean apparent total clearance of levofloxacin after a single 500 mg dose is 175 ± 29.2 ml/min. There is no significant difference in the pharmacokinetics of levofloxacin after intravenous and oral administration, indicating the interchangeability of these routes.

Linearity: Levofloxacin exhibits linear pharmacokinetics over the dose range of 50 to 1000 mg.

Patients with renal impairment. The pharmacokinetics of levofloxacin are affected by renal impairment. With decreased renal function, renal excretion and creatinine clearance are reduced, and the half-life is increased (see Table 2).

Table 2

Pharmacokinetics in renal failure after a single oral dose of 500 mg

Elderly patients: There are no significant differences in the pharmacokinetics of levofloxacin between young and elderly patients, except for differences related to creatinine clearance.

Gender: A separate analysis of male and female patients demonstrated slight differences in the pharmacokinetics of levofloxacin based on gender. There is no evidence that these differences are clinically relevant.

Indication

Levofloxacin-Teva is indicated for the treatment of the following infections in adults caused by microorganisms sensitive to levofloxacin:

acute bacterial sinusitis;

exacerbation of chronic obstructive pulmonary disease, including bronchitis;

community-acquired pneumonia;

complicated skin and soft tissue infections;

uncomplicated cystitis.

In the treatment of the above infections, the drug is used only when the use of other antibacterial agents, which are usually prescribed for the initial treatment of these infections, is not possible.

Complicated urinary tract infections and acute pyelonephritis;

chronic bacterial prostatitis;

Pulmonary anthrax: post-exposure prophylaxis and treatment.

Levofloxacin-Teva in this dosage form (film-coated tablets) can be used to complete the course of therapy in patients who have shown improvement during initial treatment with levofloxacin solution for infusion.

Official recommendations on the appropriate use of antibacterial agents should be considered.

Contraindication

Hypersensitivity to levofloxacin, other fluoroquinolones or to any component of the drug.

Epilepsy.

History of tendon damage associated with the use of fluoroquinolones.

Childhood.

Pregnancy and breastfeeding.

Interaction with other medicinal products and other types of interactions

Effects of other medicinal products on levofloxacin

Levofloxacin absorption is significantly reduced when iron salts or magnesium or aluminum antacids or didanosine (only for formulations containing aluminum or magnesium buffering agents) are administered concomitantly with levofloxacin tablets. Concomitant administration of fluoroquinolones with zinc-containing multivitamins results in reduced oral absorption. It is not recommended to administer medicinal products containing divalent or trivalent cations such as iron salts, zinc salts, magnesium or aluminum antacids or didanosine (this applies only to didanosine formulations containing aluminum or magnesium buffering agents) within 2 hours before or after taking levofloxacin tablets (see section 4.2).

Calcium salts have minimal effect on the absorption of levofloxacin when administered orally.

Sucralfate

The bioavailability of levofloxacin tablets is significantly reduced when the drug is co-administered with sucralfate. If a patient needs to receive both sucralfate and levofloxacin, it is best to take sucralfate 2 hours after taking levofloxacin tablets.

Theophylline, fenbufen, or similar nonsteroidal anti-inflammatory drugs (NSAIDs)

No pharmacokinetic interaction of levofloxacin with theophylline has been observed. However, a significant decrease in the seizure threshold may occur when quinolones are used concomitantly with theophylline, NSAIDs, and other agents that lower the seizure threshold. Levofloxacin concentrations were approximately 13% higher when administered with fenbufen than when levofloxacin was administered alone.

Probenecid and cimetidine

Probenecid and cimetidine have a statistically significant effect on the elimination of levofloxacin. The renal clearance of levofloxacin is reduced by 24% in the presence of cimetidine and by 34% in the presence of probenecid. This is because both drugs are able to block the tubular secretion of levofloxacin. However, at the doses tested in the study, it is unlikely that statistically significant kinetic differences will have clinical significance. Levofloxacin should be administered with caution with drugs that affect tubular secretion, such as probenecid and cimetidine, especially in patients with renal insufficiency.

Other medicines

It is known that no clinically significant effect was caused on the pharmacokinetics of levofloxacin when levofloxacin was used together with calcium carbonate, digoxin, glibenclamide, ranitidine.

Effect of levofloxacin on other drugs

Cyclosporine

The half-life of cyclosporine increases by 33% when co-administered with levofloxacin.

Vitamin K antagonists

Coagulation tests (prothrombin time [PT]/international normalized ratio [INR]) and/or bleeding, which may be severe, have been reported with concomitant use of vitamin K antagonists (e.g. warfarin). Therefore, coagulation parameters should be monitored in patients receiving concomitant vitamin K antagonists.

QT-prolonging drugs

Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving medicinal products known to prolong the QT interval (e.g. class IA and III antiarrhythmics, tricyclic antidepressants, macrolides and antipsychotics) (see section "Special warnings and precautions for use. QT interval prolongation").

Other important information

No effect of levofloxacin on the pharmacokinetics of theophylline (which is a marker substrate for the CYP1A2 enzyme) was observed, indicating that levofloxacin is not a CYP1A2 inhibitor.

Other types of interactions

Corticosteroids

The risk of tendinitis and tendon rupture is increased in patients treated with corticosteroids and levofloxacin. Therefore, concomitant use of corticosteroids with levofloxacin should be avoided.

Eating

No clinically significant interaction with food was observed, therefore, Levofloxacin-Teva tablets can be taken regardless of food intake.

Application features

Levofloxacin should be avoided in patients who have had a history of serious adverse reactions to quinolones or fluoroquinolones (see section 4.8). Levofloxacin should only be initiated in these patients if no alternative treatment options are available and after careful benefit-risk assessment (see section 4.8).

Methicillin-resistant S. aureus

Methicillin-resistant S. aureus (MRSA) has a very high probability of being co-resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of infections where MRSA is known or suspected to be the causative agent, unless laboratory tests have confirmed susceptibility to levofloxacin (and when it is considered inappropriate to use commonly recommended antibacterial agents for the treatment of MRSA infections).

Resistance of E. coli (the most common cause of urinary tract infections) to fluoroquinolones varies between countries. The local prevalence of E. coli resistance to fluoroquinolones should be taken into account when prescribing fluoroquinolones.

In the case of pulmonary anthrax, the use of the medicinal product is based on in vitro susceptibility data of Bacillus anthracis and experimental data in animals, as well as limited data on human use. Physicians should take into account national and/or international guidelines for the treatment of anthrax.

Prolonged, disabling and potentially irreversible serious adverse reactions

In patients treated with quinolones and fluoroquinolones, regardless of age or risk factors, very rare cases of prolonged (months or years), disabling and potentially irreversible serious adverse drug reactions affecting various, sometimes multiple, body systems (musculoskeletal, nervous, mental, sensory) have been observed. Levofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and a doctor should be consulted.

Tendinitis and tendon rupture

Tendinitis and tendon rupture (especially but not limited to the Achilles tendon), sometimes bilateral, may occur as early as 48 hours after starting treatment with quinolones and fluoroquinolones and have been reported to occur even several months after stopping treatment. The risk of tendinitis and tendon rupture is increased in elderly patients, patients receiving 1000 mg levofloxacin per day, patients with impaired renal function, patients after solid organ transplantation and patients receiving concomitant corticosteroid therapy. Therefore, concomitant corticosteroid therapy should be avoided.

At the first signs of tendinitis (e.g. painful swelling, inflammation), treatment with levofloxacin should be discontinued and alternative treatment should be considered. Appropriate treatment of the affected limb(s) should be provided (e.g. immobilization). Corticosteroids should not be used if signs of tendinopathy appear.

The daily dose should be adjusted for elderly patients based on creatinine clearance. Elderly patients should be monitored if levofloxacin is prescribed.

Diseases caused by Clostridium difficile

Diarrhoea, particularly severe, persistent and/or haemorrhagic during or after treatment with levofloxacin (including within a few weeks after treatment), may be a symptom of Clostridium difficile disease. Clostridium difficile disease can range in severity from mild to life-threatening; the most severe form of this disease is pseudomembranous colitis (see section 4.8). It is therefore important to consider this diagnosis in patients who develop severe diarrhoea during or after treatment with levofloxacin. If Clostridium difficile-associated disease is suspected or confirmed, the drug should be discontinued immediately and appropriate treatment should be initiated immediately. Medicinal products that inhibit intestinal motility are contraindicated in this clinical situation.

Patients prone to seizures

Quinolones may lower the seizure threshold and precipitate seizures. Levofloxacin is contraindicated in patients with a history of epilepsy (see section "Contraindications"). As with other quinolones, Levofloxacin-Teva should be used with extreme caution in patients prone to seizures and when using drugs that lower the seizure threshold, such as theophylline (see section "Interaction with other medicinal products and other types of interactions"). If a seizure occurs, levofloxacin should be discontinued.

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with latent or present defects in glucose-6-phosphate dehydrogenase activity may be prone to hemolytic reactions when treated with quinolone antibacterial agents, therefore levofloxacin should be used with caution and monitored for possible hemolysis.

Patients with renal insufficiency

Since levofloxacin is excreted mainly by the kidneys, patients with impaired renal function (renal failure) require dose adjustment (see section "Method of administration and dosage").

Hypersensitivity reactions

Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. angioedema up to anaphylactic shock), in isolated cases after the first dose (see section 4.8). Patients should stop treatment immediately and contact their doctor or seek emergency medical attention.

Serious skin reactions such as toxic epidermal necrolysis (also known as Lyell's syndrome), Stevens-Johnson syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with levofloxacin, which can be life-threatening or fatal (see section 4.8). Patients should be advised of the signs and symptoms of these serious skin reactions and monitored closely when prescribing the drug. If signs and symptoms suggestive of these reactions occur, levofloxacin should be discontinued immediately and alternative treatment should be considered. If a patient develops a serious reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS with levofloxacin, levofloxacin should not be restarted in this patient.

Change in blood glucose levels

Changes in blood glucose levels (both hyperglycemia and hypoglycemia) have been reported with the use of quinolones, especially in diabetic patients receiving concomitant oral hypoglycemic agents (including glibenclamide) or insulin (see section 4.8). Cases of hypoglycemic coma have been reported. Blood sugar levels should be monitored in patients with diabetes. If a patient's blood glucose levels change, levofloxacin treatment should be discontinued immediately and alternative therapy with non-fluoroquinolone antibiotics should be considered.

Prevention of photosensitivity

Although photosensitivity occurs very rarely with levofloxacin, to prevent its development, patients are advised to avoid intense sunlight or artificial UV radiation (e.g. artificial ultraviolet lamps, solariums) during treatment and for 48 hours after its discontinuation.

Patients receiving vitamin K antagonists

Due to the possible increase in coagulation tests (PT/INR) and/or bleeding in patients receiving levofloxacin in combination with a vitamin K antagonist (e.g. warfarin), coagulation parameters should be monitored if these medicinal products are used concomitantly (see section 4.5).

Psychotic reactions

Psychotic reactions have been reported in patients taking quinolones, including levofloxacin. In very rare cases, these have progressed to suicidal ideation and self-harm, sometimes after only a single dose of levofloxacin (see section 4.8). If such reactions occur, levofloxacin should be discontinued and appropriate measures should be taken. Levofloxacin should be used with caution in patients with psychotic disorders or a history of psychiatric illness.

QT prolongation

Fluoroquinolones, including levofloxacin, should be used with caution in patients with known risk factors for QT prolongation:

congenital long QT syndrome;

concomitant use of drugs that can prolong the QT interval (e.g., class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics);

uncorrected electrolyte imbalance (e.g., hypokalemia, hypomagnesemia);

heart disease (e.g., heart failure, myocardial infarction, bradycardia).

Elderly patients and women may be more sensitive to drugs that prolong the QTc interval, therefore caution should be exercised when using fluoroquinolones, including levofloxacin, in these categories of patients (see sections “Interaction with other medicinal products and other types of interactions”, “Method of administration and dosage. Elderly patients”, “Overdose” and “Adverse reactions”).

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy resulting in paresthesia, hypoesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. To prevent the development of a potentially irreversible condition, if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness occur, patients receiving levofloxacin should inform their physician before continuing treatment (see section 4.8).

Genitourinary disorders

Cases of hepatic necrosis up to and including fatal hepatic failure have been reported with levofloxacin (predominantly in patients with severe underlying diseases such as sepsis) (see section 4.8). Patients should be advised to discontinue treatment and seek medical advice if signs and symptoms of liver disease such as anorexia, jaundice, dark urine, pruritus or abdominal pain occur.

Exacerbation of myasthenia gravis

Fluoroquinolones, including levofloxacin, block neuromuscular transmission and may exacerbate muscle weakness in patients with myasthenia gravis. Serious adverse reactions, including fatalities and the need for respiratory support, have been reported post-marketing with fluoroquinolones in patients with myasthenia gravis. Levofloxacin is not recommended for use in patients with a history of myasthenia gravis.

If visual impairment or other effects on the organs of vision are observed, an ophthalmologist should be consulted immediately (see sections “Ability to affect the speed of reactions when driving vehicles or using other mechanisms” and “Adverse reactions”).

Superinfection

When using levofloxacin, especially long-term, excessive growth of microorganisms insensitive (resistant) to the drug is possible. If superinfection develops during therapy, appropriate measures should be taken.

Aortic aneurysm and dissection, regurgitation/valvular insufficiency

Epidemiological studies have shown an increased risk of aortic aneurysm and dissection, especially in the elderly, and of aortic and mitral valve regurgitation after the use of fluoroquinolones. Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal cases), and regurgitation/insufficiency of any of the heart valves have been reported in patients treated with fluoroquinolones (see section 4.8). Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with a family history of aneurysm or congenital heart valve disease, or in patients with a known history of aortic aneurysm and/or dissection, or heart valve disease, or in the presence of other risk factors or predisposing conditions:

both for aortic aneurysm and dissection, and for heart valve regurgitation/insufficiency (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behçet's disease, hypertension, rheumatoid arthritis) or additionally,

in case of aortic aneurysm and dissection (e.g. vascular disorders such as Takayasu arteritis or giant cell arteritis, or diagnosed atherosclerosis, or Sjögren's syndrome) or additionally,

with regurgitation/insufficiency of the heart valve (e.g. infective endocarditis).

The risk of aortic aneurysm and dissection and their rupture may be increased in patients receiving concomitant systemic corticosteroids.

In case of sudden abdominal, chest or back pain, patients should seek immediate medical attention in the emergency department.

Patients should be advised to seek immediate medical attention in the event of acute shortness of breath, new onset of palpitations, or development of abdominal or lower extremity edema.

Impact on laboratory tests

In patients who have used levofloxacin, urine tests for opiates may give false-positive results. It may be necessary to confirm positive results for opiates with more specific methods.

Levofloxacin inhibits the growth of Mycobacterium tuberculosis, therefore a false-negative result is possible when conducting a bacteriological study in patients with tuberculosis.

Excipients

The medicinal product contains lactose, therefore it should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

The sodium content in one tablet of this medicine is less than 1 mmol (23 mg), i.e. it is essentially sodium-free.

Use during pregnancy or breastfeeding

Pregnancy: There are limited data from the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Due to the lack of human studies and the possible damage of quinolones to articular cartilage in the growing body, levofloxacin is contraindicated in pregnant and lactating women. If pregnancy occurs during treatment with the drug, the doctor should be informed.

Breastfeeding. Levofloxacin is contraindicated during breastfeeding. There is insufficient information on the excretion of levofloxacin into breast milk, although other fluoroquinolones are excreted in breast milk. Due to the lack of human studies and the possible damage of fluoroquinolones to articular cartilage in the growing body, Levofloxacin-Teva should not be prescribed to women who are breastfeeding.

Fertility: Levofloxacin did not impair fertility or reproductive function in rats.

Ability to influence reaction speed when driving vehicles or other mechanisms

Some adverse reactions (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react quickly and thus pose an increased risk in situations where these qualities are of particular importance (e.g. when driving a car or operating other machinery).

Method of administration and doses

Levofloxacin-Teva in this dosage form (film-coated tablets) can be used to complete the course of therapy in patients who have demonstrated improvement during the initial treatment with levofloxacin, solution for infusion, using the same dosages, taking into account the bioequivalence of the parenteral and oral forms of the drug.

Levofloxacin-Teva tablets should be swallowed without chewing, with sufficient liquid. For convenience of dosing, the tablet can be divided along the dividing line. The tablets can be taken regardless of food intake.

The drug should be administered at least 2 hours before or after the use of iron salts, zinc salts, antacids containing magnesium or aluminum, didanosine (only for forms containing aluminum or magnesium in buffering agents) and sucralfate (see section "Interaction with other medicinal products and other types of interactions").

Table 3

Recommended dosage for adult patients with normal renal function

(creatinine clearance >50 ml/min)

Special populations

Table 4

Dosage for patients with renal impairment (creatinine clearance ≤ 50 mL/min)

1 No additional doses are required after hemodialysis or chronic ambulatory peritoneal dialysis (CHAPD).

Patients with impaired liver function: No dose adjustment is required, since levofloxacin is metabolized to a small extent in the liver and excreted mainly by the kidneys.

Elderly patients: If renal function is not impaired, no dose adjustment is required (see section "Special warnings and precautions for use": tendinitis and tendon ruptures, QT prolongation).

Children. Levofloxacin-Teva is contraindicated in children, as damage to articular cartilage cannot be ruled out (see the Contraindications section).

Overdose

Symptoms: Based on animal toxicity studies and clinical pharmacology studies conducted at doses higher than therapeutic, the most important signs to be expected after acute overdose of levofloxacin are CNS symptoms (confusion, dizziness, impaired consciousness and seizures); possible prolongation of the QT interval; gastrointestinal reactions such as nausea and mucosal erosions.

In the post-marketing period, cases of CNS effects, including confusion, seizures, hallucinations and tremor, have been observed.

Treatment. Treatment is symptomatic. ECG monitoring should be considered as QT prolongation may occur. Antacids are used to protect the gastric mucosa. Hemodialysis, including peritoneal dialysis or HAPD, is not effective in removing levofloxacin from the body. There are no specific antidotes.

P