Levofloxacin (oral)

Levofloxacin (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. * Fluoroquinolones, including Levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Fluoroquinolones, including Levofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Levofloxacin in patients with a known history of myasthenia gravis

Overview

Levofloxacin (oral) is a fluoroquinolone that is FDA approved for the treatment of infections caused by designated, susceptible bacteria including pneumonia, acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, skin and skin structure infections, chronic bacterial prostatitis, urinary tract infections, acute pyelonephritis, inhalational anthrax, and plague. There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, nausea, dizziness, headache, and insomnia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• To reduce the development of drug-resistant bacteria and maintain the effectiveness of Levofloxacin and other antibacterial drugs, Levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

• Levofloxacin Oral Solution are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.

Culture and susceptibility testing

• Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin. Therapy with Levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.

• As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

Dosage in Adult Patients with Normal Renal Function

• The usual dose of Levofloxacin Oral Solution is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.

• These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required.

This image is provided by the National Library of Medicine.

Nosocomial Pneumonia

• Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended.

Community-Acquired Pneumonia: 7–14 day Treatment Regimen

• Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.

• MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Bacteremia associated with intravascular line

• Dosing Information

• 750 mg q24h

Bacterial infectious disease; Prophylaxis - Febrile neutropenia, Chemotherapy-induced Chlamydial infection Epididymitis Infectious enteritis Nongonococcal urethritis Otitis mediaView additional information. Postoperative infection Traveler's diarrhea Tuberculosis

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Levofloxacin (oral) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levofloxacin (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Levofloxacin (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Levofloxacin (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levofloxacin (oral) in pediatric patients.

Contraindications

• Condition1

Warnings

WARNING See full prescribing information for complete Boxed Warning. * Fluoroquinolones, including Levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Fluoroquinolones, including Levofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Levofloxacin in patients with a known history of myasthenia gravis

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Levofloxacin (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Levofloxacin (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Levofloxacin (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Levofloxacin (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Levofloxacin (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Levofloxacin (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Levofloxacin (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Levofloxacin (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Levofloxacin (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Levofloxacin (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Levofloxacin (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Levofloxacin (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Levofloxacin (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Levofloxacin (oral) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Levofloxacin (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Levofloxacin (oral) in the drug label.

Pharmacology

There is limited information regarding Levofloxacin (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Levofloxacin (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Levofloxacin (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Levofloxacin (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Levofloxacin (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Levofloxacin (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Levofloxacin (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Levofloxacin (oral) in the drug label.

Precautions with Alcohol

• Alcohol-Levofloxacin (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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