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Levofloxacin in 5% Dextrose Injection, USP
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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
Levofloxacin in 5% Dextrose Injection, USP Quick Finder
Highlights
Boxed Warning
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
- Fluoroquinolones, including...
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Indications and Usage
1 INDICATIONS AND USAGE
Levofloxacin Injection is 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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
INJECTION (5 mg/mL in 5% Dextrose) Premix in Single-Use Flexible Containers, for intravenous infusion
- 100 mL container, fill volume 50 mL (equivalent to 250 mg levofloxacin)
- ...
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Contraindications
4 CONTRAINDICATIONS
Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions (5.7)...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System...
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Adverse Reactions
6 ADVERSE REACTIONS
6.1 Serious and Otherwise Important Adverse Reactions
The following serious and otherwise important adverse drug reactions are discussed in...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Levofloxacin was not teratogenic in rats at oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest...
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Overdosage
10 OVERDOSAGE
In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal...
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Description
11 DESCRIPTION
Levofloxacin is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
In a lifetime bioassay in rats, levofloxacin exhibited no carcinogenic potential...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Nosocomial Pneumonia
Adult patients with clinically and radiologically documented nosocomial pneumonia were enrolled in a multicenter,...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Levofloxacin in 5% Dextrose Injection is supplied as a single-use, premixed solution in flexible containers. Each bag contains a dilute solution with the equivalent of 250, 500, or 750 mg...
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Medication Guide
MEDICATION GUIDE
Levofloxacin [Lee-voe-FLOX-a-sin] (in 5% Dextrose) Injection
for Intravenous Use
Read this Medication Guide before you start taking levofloxacin and each time you get a...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.