RiteMED Levofloxacin

Levofloxacin hemihydrate.

500 mg Film-coated Tablet: Light peach, film-coated biconvex caplet, debossed with "500" on one side.
Each film-coated tablet contains: Levofloxacin (as hemihydrate) 500 mg.

Antibacterial.
Pharmacology: Pharmacodynamics: Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antibacterial agent. The mechanism of action of levofloxacin and other quinolones involves inhibition of bacterial topoisomerase II (DNA gyrase) and topoisomerase IV enzymes which are essential for DNA replication, transcription, repair, and recombination.
Pharmacokinetics: Levofloxacin pharmacokinetics are linear and predictable after single and multiple oral/intravenous (IV) dosing regimens. Steady-state conditions are reached within 48 hours after a 500 mg or 750 mg once daily dosage regimen. The oral and IV route of administration may also be considered interchangeable since levofloxacin's plasma concentration profiles are nearly superimposable in the post-peak, distribution-elimination phase.
The mean volume of distribution generally ranges from 74 to 112 L after single and multiple 500 mg or 750 mg doses, indicating widespread distribution into body tissues. Penetration of levofloxacin in skin tissues and in blister fluid is rapid and extensive. It also penetrates well into lung tissues. Protein binding is approximately 24% to 38% and is independent of drug concentration.
Levofloxacin is stereochemically stable in plasma and urine and undergoes limited metabolism in humans with less than 5% of an administered dose recovered in the urine.
Plasma half-life (t_1/2) ranges from approximately 6 to 8 hours. The mean apparent total body clearance and renal clearance range from approximately 144 to 226 mL/min and 96 to 142 mL/min, respectively. Renal clearance in excess of the glomerular filtration rate suggests that tubular secretion of levofloxacin occurs in addition to its glomerular filtration.
Microbiology: Antimicrobial Spectrum of Activity: Levofloxacin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: See Table 1.

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Levofloxacin has been shown to be active in vitro against most strains of the following organisms; however, the clinical significance of these data is unknown: See Table 2.

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It is suggested to carry out susceptibility tests.

For the treatment of adults (≥18 years old) with mild, moderate, or severe infections caused by susceptible strains of the designated microorganisms for the following conditions: Acute bacterial sinusitis; Acute bacterial exacerbation of chronic bronchitis; Community-acquired pneumonia; Healthcare-associated pneumonia; Complicated skin and skin structure infections; Uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections; Complicated urinary tract infections; Acute pyelonephritis; Chronic bacterial prostatitis; Uncomplicated urinary tract infections.
To reduce the incidence or progression of inhalational anthrax in adults and children ≥6 months old, following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
For the treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis and prophylaxis for plague in adults and children ≥6 months old. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. The approval of this indication was based on an efficacy study done in animals.

Patients receiving oral or intravenous (IV) levofloxacin should be well hydrated to prevent formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones.
Levofloxacin should be given or taken at the same time each day.
Levofloxacin Tablet: Levofloxacin tablet can be taken with or without food. Administer dose at least 2 hours before or 2 hours after antacids containing calcium, magnesium or aluminum, after sucralfate or metal cations such as iron, multivitamin preparations with zinc, or didanosine. Concomitant administration with these drugs may significantly decrease levofloxacin absorption.
Usual Recommended Dose: Orally, 500 mg or 750 mg once every 24 hours.
The dose and duration of treatment are based on the type of infection and severity of infection being treated (see table as follows).
Levofloxacin Solution for Infusion: Levofloxacin solution for infusion should only be administered by IV infusion. It is NOT for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Caution: Rapid or bolus IV infusion must be avoided because it may result to hypotension.
Usual Recommended Dose: 250 mg or 500 mg administered by slow IV infusion over 60 minutes once every 24 hours. 750 mg administered by slow IV infusion over 90 minutes once every 24 hours.
The dose and duration of treatment are based on the type and severity of infection being treated (see table as follows).
As with other parenteral antibiotic therapy in general, administration of levofloxacin solution for infusion should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained. It is usually possible to switch from initial IV treatment to the oral route after a few days, depending on the patient's condition and the physician's discretion.
Levofloxacin Oral or IV Dosing in Adult Patients with Normal Renal Function (creatinine clearance ≥50 mL/min): See Table 3.

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Levofloxacin Oral or IV Dosing in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min): See Table 4.

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When only the serum creatinine value is available, the following formula may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function: See equation.

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Levofloxacin IV Dosing in Children: See Table 5.

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Or, as prescribed by a physician.

Clinical features of acute overdosage of levofloxacin may include CNS symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval as well as GI reactions such as nausea and mucosal erosions.
CNS effects including hallucination and tremor have been observed in post marketing experience.
In the event of overdose, symptomatic treatment should be implemented. The patient should be observed and proper hydration maintained. ECG monitoring should be undertaken because of the possibility of QT interval prolongation.
The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic levofloxacin exposure. Antacids may be used for protection of the gastric mucosa.
Hemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body. No specific antidote exists.

Known hypersensitivity to levofloxacin, other quinolones or to any component of the product.
Patients with epilepsy.
Patients with history of tendinitis or tendon rupture associated with the use of any member of the quinolone group of antimicrobial agents.

Warning: Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects and exacerbation of myasthenia gravis.
Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warning as follows and Precautions], including: Tendinitis and tendon rupture; Peripheral neuropathy; Central nervous system effects.
Discontinue levofloxacin immediately and avoid using fluoroquinolones in patients who experience any of these serious adverse reactions [see Warning as follows and Precautions].
Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see Warning as follows and Precautions].
Because fluoroquinolones, including levofloxacin have been associated with serious adverse reactions [see Warning as follows and Precautions], reserve levofloxacin 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.

Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects: Fluoroquinolones, including levofloxacin, 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 Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
Discontinue levofloxacin immediately at the first signs or symptoms of any serious adverse reaction. Avoid the use of fluoroquinolones, including levofloxacin in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinitis and Tendon Rupture: Fluoroquinolones, including levofloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites. Tendinitis or tendon rupture can occur within hours or days of starting levofloxacin or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the previously mentioned risk factors. Discontinue levofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug. Avoid levofloxacin in patients who have a history of tendon disorders or tendon rupture.
Peripheral Neuropathy: Fluoroquinolones, including levofloxacin, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, 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 in some patients.
Discontinue levofloxacin immediately if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation. Avoid fluoroquinolones, including levofloxacin, in patients who have previously experienced peripheral neuropathy.
Central Nervous System Effects: Psychiatric Adverse Reactions: Fluoroquinolones, including levofloxacin, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychoses, hallucinations, or paranoia; depression, or suicidal thoughts; anxiety, agitation, restlessness, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. Attempted or completed suicide have been reported, especially in patients with a medical history of depression, or an underlying risk factor for depression. These reactions may occur following the first dose. If these reactions occur in patients receiving levofloxacin, discontinue levofloxacin and institute appropriate measures.
Central Nervous System Adverse Reactions: Fluoroquinolones, including levofloxacin have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri), tremors, and lightheadedness. As with other fluoroquinolones, levofloxacin should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction). If these reactions occur in patients receiving levofloxacin, discontinue levofloxacin and institute appropriate measures.
Exacerbation of Myasthenia Gravis: Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Post-marketing reports of serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Levofloxacin should be avoided in patients with known history of myasthenia gravis.
Other Serious and Sometimes Fatal Reactions: Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with fluoroquinolones, including levofloxacin These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency or failure; hepatitis; jaundice; acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
Discontinue levofloxacin immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and institute supportive measures.
Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including levofloxacin. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Hepatotoxicity: Post-marketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with levofloxacin. No evidence of serious drug-associated hepatotoxicity was detected in clinical trials of over 7,000 patients. Severe hepatotoxicity generally occurred within 14 days of initiation of therapy and most cases occurred within 6 days. Most cases of severe hepatotoxicity were not associated with hypersensitivity. The majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity. Levofloxacin should be discontinued immediately if the patient develops signs and symptoms of hepatitis.
Risk of Aortic Aneurysm and Dissection: Epidemiologic studies report an increased risk of aortic aneurysm and dissection within two months after intake of fluoroquinolones, particularly in the older population. The cause for the increased risk has not been identified.
Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with peripheral atherosclerotic vascular disease, hypertension, or those with positive family history of aneurysm, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department. Imaging assessment should be considered if necessary, for patients complicated with aortic aneurysm or aortic dissection, or patients who have a previous history, a family history, or risk factors of aortic aneurysm or aortic dissection.
Clostridium difficile-Associated diarrhea: Clostridium difficile-associated diarrhea (CDAD) has been observed with the use of nearly all antibacterial agents, including levofloxacin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Prolongation of the QT Interval: Some fluoroquinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including levofloxacin. Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected electrolyte imbalance (e.g., hypokalemia and hypomagnesemia) patients with cardiac disease (e.g., heart failure, myocardial infarction and bradycardia), and in patients receiving drugs that are known to prolong the QT interval such as Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents, tricyclic antidepressants, macrolides and antipsychotics. Elderly patients and women may be more susceptible to drug-associated effects on the QT interval.
Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals: Levofloxacin is indicated in pediatric patients (6 months of age and older) only for the prevention of inhalational anthrax (post-exposure) and for plague. An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving levofloxacin (see Use in Children as follows).
In immature rats and dogs, the oral and intravenous administration of levofloxacin resulted in increased osteochondrosis. Histopathological examination of the weight-bearing joints of immature dogs dosed with levofloxacin revealed persistent lesions of the cartilage. Other fluoroquinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species.
Blood Glucose Disturbances: Fluoroquinolones, including levofloxacin, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported. If a hypoglycemic reaction occurs in a patient being treated with levofloxacin discontinue levofloxacin and initiate appropriate therapy immediately.
Photosensitivity/Phototoxicity: Moderate to severe photosensitivity or phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, "V" area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs.
Patients with Glucose-6-phosphate dehydrogenase deficiency: Use with caution in patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity who may be prone to hemolytic reactions when treated with fluoroquinolones. If levofloxacin has to be used in these patients, potential occurrence of hemolysis should be monitored.
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).
IV Administration: Since rapid or bolus IV injection may result in hypotension, Levofloxacin 250 mg/50 mL or 500 mg/100 mL injection should only be administered by slow IV infusion over a period of 60 minutes while levofloxacin 750 mg/150 mL injection should only be administered by slow IV infusion over a period of 90 minutes.
Other Precautions: As with any potent antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged treatment.
Prescribing levofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Effects on Ability to Drive and Use Machines: Levofloxacin may cause dizziness, lightheadedness, vertigo and visual disturbances. Patients should be advised to avoid performing tasks which require complete mental alertness such as driving and operating machinery until effects of drug to the individual are known.
Renal Impairment: Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with renal impairment (creatinine clearance <50 mL/min). Dosage adjustment in such patients is necessary to avoid drug accumulation (see Dosage & Administration).
Hepatic Impairment: Pharmacokinetic studies in patients with liver impairment have not been conducted. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.
Use in Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: Quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species (see previous text).
Levofloxacin is indicated in pediatric patients ≥6 months old, for inhalational anthrax (post-exposure) and for the treatment of plague, including pneumonic and septicemic plague due to Yersinia pestis and prophylaxis for plague. The risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate.
Safety and effectiveness in pediatric patients <6 months old have not been established.
Use in the Elderly: No dosage adjustment is necessary for elderly patients with normal renal function. However, since levofloxacin is excreted by the kidneys and some elderly patients experience age-related reduction in renal function, care should be taken in dose selection and renal function monitoring is recommended.
Elderly patients are at increased risk of developing severe tendon disorders including tendon rupture, or prolonged QT interval leading to ventricular arrhythmias when being treated with a fluoroquinolone such as levofloxacin (see previous text).

Pregnancy: Pregnancy Category C. There are no adequate and well controlled studies to date using levofloxacin in pregnant women. The drug should not be used in pregnant women unless the potential benefits justify the potential risks to the fetus (see Precautions).
Lactation: Levofloxacin has not been measured in human milk. However, based on the ofloxacin data, it can be presumed that levofloxacin will be excreted in human milk. Therefore, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother as well as the possible serious adverse effects to the infant.

The most common adverse reactions reported with the use of levofloxacin include gastrointestinal effects (e.g., nausea, diarrhea, constipation), headache, insomnia, and dizziness.
Infections and infestations: Candida infection, fungal infection, pathogen resistance, pseudomembranous/Clostridium difficile colitis.
Blood and lymphatic system disorders: Agranulocytosis, anemia (aplastic and hemolytic), epistaxis, eosinophilia, granulocytopenia, leukopenia, neutropenia, pancytopenia, prolongation of prothrombin time, thrombocytopenia including thrombotic thrombocytopenic purpura.
Immune system disorders: Hypersensitivity reactions, sometimes fatal including anaphylactic/anaphylactoid reaction/shock, angioedema, bronchospasm, exacerbation of myasthenia gravis, laryngeal edema, serum sickness.
Metabolism and nutrition disorders: Anorexia, hyperglycemia, hypoglycemia, hypoglycemic coma, hypokalemia, moniliasis.
Psychiatric disorders: Agitation, anxiety, confusional states, depression, dysphonia, hallucinations, nervousness, paranoia, sleep disorder, suicidal ideation or suicidal attempt.
Nervous system disorders: Abnormal dreams, abnormal gait, ageusia, amnesia, convulsion, dysgeusia, dyskinesia, encephalopathy (isolated reports), extrapyramidal disorder, hyperkinesias, nightmares, paresthesia, peripheral sensory motor neuropathy, peripheral sensory neuropathy, pseudotumor cerebri, somnolence, tremor.
Eye disorders: Blurred vision, diplopia, scotoma, transient visual loss, uveitis, vision disturbances.
Ear and labyrinth disorders: Hypoacusis, tinnitus, vertigo.
Cardiac disorders: Cardiac arrest, chest pain, palpitation, tachycardia, torsades de pointes, ventricular arrhythmia, ventricular tachycardia.
Vascular disorders: Aortic aneurysm, aortic dissection, benign intracranial hypertension, hypotension, phlebitis, syncope, vasculitis, vasodilatation.
Respiratory, thoracic and mediastinal disorders: Allergic pneumonitis, anosmia, bronchospasm, dyspnea, interstitial pneumonia, parosmia.
Gastrointestinal disorders: Abdominal pain, dyspepsia, esophagitis, flatulence, gastritis, gastroenteritis, glossitis, pancreatitis, stomatitis, vomiting.
Hepatobiliary disorders: Abnormal hepatic function, acute liver failure, hepatic failure (including fatal cases), hepatic necrosis, hepatitis, jaundice, severe liver injury.
Skin and subcutaneous tissue disorders: Bullous eruptions including acute generalized exanthematous pustulosis (AGEP), erythema multiforme, fixed drug eruption, Stevens-Johnson syndrome and toxic epidermal necrolysis; hyperhidrosis, leukocytoclastic vasculitis, photosensitivity/phototoxicity reaction, pruritus, rash, tendon rupture, urticaria.
Musculoskeletal and connective tissue disorders: Achilles tendon, arthralgia, arthritis, hypertonia, ligament rupture, muscle rupture myalgia, myositis, rhabdomyolysis, skeletal pain, tendinitis.
Renal and urinary disorders: Abnormal renal function, acute renal failure, glomerulonephritis, interstitial nephritis, nephrosis.
Reproductive system and breast disorders: Vaginitis.
General disorders and administration site conditions: Asthenia, edema, injection site reaction, malaise, multiple organ failure, pain (including pain in back, chest and extremities), pyrexia.
Investigations: Abnormal electroencephalogram (EEG), increased blood bilirubin, blood creatinine, hepatic enzymes [alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT)], muscle enzymes, prolonged Electrocardiogram QT.

See Table 6.

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Interference with Laboratory Tests: Some fluoroquinolones, including levofloxacin, may give false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screen by more specific methods may be necessary.
Levofloxacin may inhibit the growth of Mycobacterium tuberculosis, and therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.

Directions for Use, Compatibility and Stability: No further dilution of levofloxacin solution for infusion is necessary.
Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.
Observe strict aseptic technique when inserting the cannula of the infusion set into the spout of levofloxacin solution for infusion. If contaminated, it has the potential to become a source of infection to patients. The cannula of the infusion set should be inserted fully and not halfway into the spout of the levofloxacin solution for infusion container to avoid leakage.
Since only limited data are available on the compatibility of levofloxacin solution for infusion with other IV substances, additives or other medications should not be added to levofloxacin IV or infused simultaneously through the same IV line. If the same IV line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin IV with an infusion solution compatible with levofloxacin IV and with any other drugs administered via this common line.
Levofloxacin solution for infusion should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same IV line.
Levofloxacin 250 mg/50 mL and 500 mg/100 mL solution for infusion is compatible with 0.9% Sodium Chloride Solution, 5% Dextrose Injection, 2.5% Dextrose in Ringer's Solution, and combination solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).
Levofloxacin 750 mg/150 mL solution for infusion should not be mixed with heparin or alkaline solution (e.g., sodium bicarbonate, etc.). It should be used within 3 hours after rubber stopper opening in order to prevent bacterial contamination.
Levofloxacin solution for infusion is for single-use only; any unused portion should be discarded properly.

Store at temperatures not exceeding 30°C. Protect from light and moisture.

Quinolones

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

Rx