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Levofloxacin information from DrugsUpdate  

See Available Brands of Levofloxacin in India

P - Caution when used during pregnancy
L - Caution when used during lactation
LI - Lab*

Levofloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class and is used to treat severe or life-threatening bacterial infections or bacterial infections which have failed to respond to other antibiotic classes. It is sold under various brand names, such as Levaquin and Tavanic, the most common. In form of ophthalmic solutions it is known as Oftaquix, Quixin and Iquix.

Pharmacodynamics

Pharmacokinetics

Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gram-negative and gram-positive microorganisms.

Absorption
Rapid and complete absorption from the GIT (oral); peak plasma concentrations within 1-2 hr.

Distribution
Widely distributed in bronchial mucosa, lungs; CSF (relatively poor). Protein-binding: 30-40%.

Metabolism
Limited.

Excretion
Mainly via urine (largely as unchanged drug); 6-8 hours (elimination half-life).

Levofloxacin Indications / Levofloxacin Uses

Information Not Available

Levofloxacin Adverse Reactions / Levofloxacin Side Effects

Oral/IV
Nausea, diarrhoea, constipation, headache, insomnia, inj site reactions (IV). Ophthalmic: Transient decrease in vision, ocular burning, ocular pain or discomfort, foreign body sensation, headache, fever, pharyngitis, photophobia.

Potentially Fatal: Anaphylaxis.

Precautions

Warnings
Tendonitis

Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendonitis and tendon rupture in patients of all ages. The risk is further increased in patients older than 60 years of age, in patients taking corticosteroids, and in patients with kidney, heart, or lung transplants.

Special Precautions

Known or suspected CNS disorders (e.g. severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures. Avoid unnecessary exposure to sunlight or artificial UV light. History of prolonged QT interval, uncorrected electrolyte disturbances. DM (carefully monitor blood glucose levels). Periodically monitor renal, hepatic and haematopoietic functions during treatment. Pregnancy and lactation. Elderly. May impair ability to drive or operate machinery.

Other Drug Interactions

Increased concentration of ciclosporin or tacrolimus. Reduced absorption with didanosine, ferrous sulfate or dietary supplements containing zinc, calcium, magnesium or iron. May increase plasma levels of theophylline. Increased risk of tendon rupture with corticosteroids. Reduced absorption with sucralfate and antacids containing magnesium and aluminium; administer at least 2 hours before or 2 hours after antacids. Increased half-life and decreased clearance of procainamide. Altered glucose levels with antidiabetic agents (e.g. insulin, glyburide).

Potentially Fatal: Increased risks of ventricular arrhythmias with QT prolonging drugs e.g. class IA (quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmics, fluoxetine, imipramine. Increased risk of CNS stimulation and seizures with NSAIDs. Increased prothrombin time with warfarin.

Other Interactions

Information Not Available

Dosage

Oral
Acute bacterial sinusitis
Adult: 500 mg once daily for 10-14 days. Alternatively, 750 mg once daily for 5 days.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours. Alternatively: Initially, 750 mg daily, then 750 mg every   48 hours.
10-19               Initially, 500 mg daily, then 250 mg every 48 hours. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours.

Oral
Acute bacterial exacerbation of chronic bronchitis
Adult: 500 mg once daily for 7 days.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours.
10-19               Initially, 500 mg daily, then 250 mg every 48 hours.

Oral
Community-acquired pneumonia
Adult: 500 mg once for 7-14 days. Alternatively, 750 mg once daily for 5 days.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours. Alternatively: Initially, 750 mg daily, then 750 mg every 48 hours.
10-19               Initially, 500 mg daily, then 250 mg every 48 hours. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours.

Oral
Nosocomial pneumonia
Adult: 750 mg once daily for 7-14 days.
Renal impairment: Haemodialysis/CAPD: Initially, 750 mg daily, then 500 mg every 48 hours.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 750 mg daily, then 750 mg every 48 hours.
10-19               Initially, 750 mg daily, then 500 mg every 48 hours.

Oral
Complicated skin and skin structure infections
Adult: 750 mg once daily for 7-14 days.
Renal impairment: Haemodialysis/CAPD: Initially, 750 mg daily, then 500 mg every 48 hours.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 750 mg daily, then 750 mg every 48 hours.
10-19               Initially, 750 mg daily, then 500 mg every 48 hours.

Oral
Uncomplicated urinary tract infections
Adult: 250 mg once daily for 3 days.


Oral
Complicated urinary tract infections
Adult: 250 mg once daily for 10 days.
CrCl (ml/min)    Dosage Recommendation
10-19               Initially 250 mg daily, then 250 mg every 48 hours.

Oral

Acute pyelonephritis
Adult: 250 mg once daily for 10 days.
CrCl (ml/min)    Dosage Recommendation
10-19               Initially 250 mg daily, then 250 mg every 48 hours.

Oral
Uncomplicated skin and skin structure infections
Adult: 500 mg once daily for 7-10 days.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours.
10-19               Initially, 500 mg daily, then 250 mg every 48 hours.

Oral
Chronic bacterial prostatitis
Adult: 500 mg once daily for 28 days.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours
10-19               Initially, 500 mg daily, then 250 mg every 48 hours.

Oral
Treatment and postexposure prophylaxis of inhalation anthrax
Adult: 500 mg once daily for 60 days.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours.
10-19               Initially, 500 mg daily, then 250 mg every 48 hours.

Intravenous
Acute bacterial sinusitis
Adult: 500 mg once daily for 10-14 days. Alternatively, 750 mg once daily for 5 days. Infuse slowly over 60-90 minutes.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours. Alternatively: Initially, 750 mg daily, then 750 mg every 48 hours.
10-19               Initially, 500 mg daily, then 250 mg every 48 hours. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours.

Intravenous
Acute bacterial exacerbation of chronic bronchitis
Adult: 500 mg once daily for 7 days. Infuse slowly over 60 minutes.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours.
10-19               Initially, 500 mg daily, then 250 mg every 48 hours.

Intravenous
Community-acquired pneumonia
Adult: 500 mg once for 7-14 days. Alternatively, 750 mg once daily for 5 days. Infuse slowly over 60-90 min.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours. Alternatively: Initially, 750 mg daily, then 750 mg every 48 hours.
10-19                Initially, 500 mg daily, then 250 mg every 48 hours. Alternatively: Initially, 750 mg daily, then 500 mg every 48 hours.

Intravenous
Nosocomial pneumonia
Adult: 750 mg once daily for 7-14 days. Infuse slowly over 60-90 minutes.
Renal impairment: Haemodialysis/CAPD: Initially, 750 mg daily, then 500 mg every 48 hours. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 750 mg daily, then 750 mg every 48 hours.
10-19               Initially, 750 mg daily, then 500 mg every 48 hours.

Intravenous
Complicated skin and skin structure infections
Adult: 750 mg once daily for 7-14 days. Infuse slowly over 60-90 minutes.
Renal impairment: Haemodialysis/CAPD: Initially, 750 mg daily, then 500 mg every 48 hours. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 750 mg daily, then 750 mg every 48 hours.
10-19               Initially, 750 mg daily, then 500 mg every 48 hours.

Intravenous

Uncomplicated urinary tract infections
Adult: 250 mg once daily for 3 days. Infuse slowly over 60-90 minutes.

Intravenous
Complicated urinary tract infections
Adult: 250 mg once daily for 10 days. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
10-19               Initially 250 mg daily, then 250 mg every 48 hours.

Intravenous
Acute pyelonephritis
Adult: 250 mg once daily for 10 days. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
10-19               Initially 250 mg daily, then 250 mg every 48 hours.

Intravenous
Uncomplicated skin and skin structure infections
Adult: 500 mg once daily for 7-10 days. Infuse slowly over 60-90 minutes.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours.
10-19               Initially, 500 mg daily, then 250 mg every 48 hours.

Intravenous
Chronic bacterial prostatitis
Adult: 500 mg once daily for 28 days. Infuse slowly over 60-90 minutes.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
20-49                Initially, 500 mg daily, then 250 mg every 24 hours.
10-19                Initially, 500 mg daily, then 250 mg every 48 hours.

Intravenous
Treatment and postexposure prophylaxis of inhalation anthrax
Adult: 500 mg once daily for 60 days. Infuse slowly over 60-90 minutes.
Renal impairment: Haemodialysis/CAPD: Initially, 500 mg daily, then 250 mg every 48 hours. Infuse slowly over 60-90 minutes.
CrCl (ml/min)    Dosage Recommendation
20-49               Initially, 500 mg daily, then 250 mg every 24 hours.
10-19                Initially, 500 mg daily, then 250 mg every 48 hours.

Ophthalmic
Ocular infections
Adult: 1-2 drops of 0.5% solution every 2 hours while awake (up to 8 times daily) for 2 days, then 1-2 drops every 4 hours while awake (up to 4 times daily) for the next 5 days.
Child: >1 year: 1-2 drops of 0.5% solution every 2 hours while awake (up to 8 times daily) for 2 days, then 1-2 drops every 4 hours while awake (up to 4 times daily) for the next 5 days.

Food(before/after)

Tablet
May be taken with or without food. (Ensure adequate fluid intake.)

Oral Solution
Should be taken on an empty stomach. (Take on an empty stomach 1 hour before or 2 hours after meals. Ensure adequate fluid intake.)

List of Contraindications

Levofloxacin and Pregnancy

Caution when used during pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Levofloxacin and Lactation

Caution when used during lactation

Levofloxacin and Children

Oral/IV
Except for inhalational anthrax (postexposure), safety and efficacy have not been established in children.

Inhalational anthrax (postexposure)

Safety and efficacy not established in children younger than 6 months of age.

Ophthalmic

Safety and efficacy not established in children younger than 1 year of age.

Levofloxacin and Geriatic

Elderly patients are at increased risk for developing severe tendon disorder and severe and sometimes fatal hepatotoxicity. In addition, because elderly patients are more likely to have decreased renal function, use caution in dose selection and consider monitoring renal function.

Levofloxacin and Other Contraindications

Hypersensitivity to levofloxacin or other quinolones. Child <18 years.

Storage

Intravenous
Store below 25°C (77°F).

Ophthalmic

Store at 15-25°C (59-77°F).

Oral
Tablet
Store at 15-30°C (59-86°F).

Oral solution
Store at 25°C (77°F).

Lab interference

Intravenous
Store below 25°C (77°F).

Ophthalmic

Store at 15-25°C (59-77°F).

Oral
Tablet
Store at 15-30°C (59-86°F).

Oral solution
Store at 25°C (77°F).

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