Levofloxacin (ophthalmic)
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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Overview
Levofloxacin (ophthalmic) is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Levofloxacin (ophthalmic) FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Levofloxacin (ophthalmic) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Levofloxacin (ophthalmic) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Levofloxacin (ophthalmic) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Levofloxacin (ophthalmic) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Levofloxacin (ophthalmic) in pediatric patients.
Contraindications
There is limited information regarding Levofloxacin (ophthalmic) Contraindications in the drug label.
Warnings
There is limited information regarding Levofloxacin (ophthalmic) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Levofloxacin (ophthalmic) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Levofloxacin (ophthalmic) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Levofloxacin (ophthalmic) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Levofloxacin (ophthalmic) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Levofloxacin (ophthalmic) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Levofloxacin (ophthalmic) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Levofloxacin (ophthalmic) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Levofloxacin (ophthalmic) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Levofloxacin (ophthalmic) in geriatric settings.
Gender
There is no FDA guidance on the use of Levofloxacin (ophthalmic) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Levofloxacin (ophthalmic) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Levofloxacin (ophthalmic) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Levofloxacin (ophthalmic) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Levofloxacin (ophthalmic) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Levofloxacin (ophthalmic) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Levofloxacin (ophthalmic) Administration in the drug label.
Monitoring
There is limited information regarding Levofloxacin (ophthalmic) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Levofloxacin (ophthalmic) and IV administrations.
Overdosage
There is limited information regarding Levofloxacin (ophthalmic) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Levofloxacin (ophthalmic) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Levofloxacin (ophthalmic) Mechanism of Action in the drug label.
Structure
- Levofloxacin Ophthalmic Solution 0.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin is the pure (-)-(s)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water neutral pH than ofloxacin.
- Chemical Name: (-)-(s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Levofloxacin (hemihydrate) is a yellowish-white crystalline powder. Each mL of Levofloxacin Ophthalmic Solution contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg levofloxacin.
- Active: Levofloxacin 0.5% ( mg/mL); Preservative: benzalkonium chloride 0.005%;
- Inactives: sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Levofloxacin Ophthalmic Solution is isotonic and formulated at pH 6.5 with an osmolality of approximately 300 mOsm/kg. Levofloxacin is a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.
Pharmacodynamics
MICROBIOLOGY:
- Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. The antibacterial activity of ofloxacin resides primarily in the L-isomer. The mechanism of action of levofloxacin and other fluoroquinolone antimicrobials involves the inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoismerases), enzymes required for DNA replication, transcription, repair, and recombination. Levofloxacin has in vitro activity against a wide range of Gram-negative and Gram-positive microorganisms and is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
- Fluoroquinolones, including levofloxacin, differ in chemical structure and mode of action from β-lactam antibiotics and aminoglycosides, and therefore may be active against bacteria resistant to β-lactam antibiotics and aminoglycosides. Additionally, β-lactam antibiotics and aminoglycosides may be active against bacteria resistant to levofloxacin. Resistance to levofloxacin due to spontaneous mutation in vitro is a rare occurrence (range: 10-9 to 10-10). Levofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:
AEROBIC GRAM-POSITIVE MICROORGANISMS
Corynebacterium species*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Groups C/F)
Streptococcus (Group G)
Viridans group streptococci
AEROBIC GRAM-NEGATIVE MICROORGANISMS
Acinetobacter lwoffii*
Haemophilus influenzae
Serratia marcescens*
- Efficacy for this organism was studied in fewer than 10 infections. The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of levofloxacin in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials. These organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections.
Levofloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2μg/mL or less (systemic susceptible breakpoint) against most (≥90%) strains of the following ocular pathogens:
Aerobic gram-positive microorganisms
Enterococcus faecalis
Streptococcus agalactiae
Staphylococcus saprophyticus
Streptococcus pyogenes
Aerobic gram-negative microorganisms
Acinetobacter anitratus
Legionella pneumophila
Acinetobacter baumannii
Moraxella catarrhalis
Citrobacter diversusi
Morganella morgqanii
Citrobacter freudii
Neisseria gonorrhoeae
Enterobacter aerogenes
Proteus mirabilis
Enterobacter agglomerans
Proteus vulgaris
Enteroacter cloacae
Providencia rettgeri
Escherichia coli
Providencia stuartii
Haemophilus arainfluenzae
Pseudomonas aeruginosa
Klebsiella oxytoca
Pseudomonas fluorescens
Klebsiella pneumoniae
Pharmacokinetics
- Levofloxacin concentration in plasma was measured in 15 healthy adult volunteers at various time points during a 15 day course of treatment with Levofloxacin Ophthalmic Solution. The mean levofloxacin concentration in plasma 1 hour postdose, ranged from 0.86 ng/mL on Day 1 to 2.05 ng/mL on Day 15. The highest maximum mean levofloxacin concentration of 2.5 ng/mL was measured on Day 4 following 2 days of dosing every 2 hours for a total of 8 doses per day. Maximum mean levofloxacin concentrations increased from 0.94 ng/mL on Day 1 to 2.15 ng/mL on Day 15, which is more than 1,000 times lower than those reported after standard oral doses of levofloxacin. Levofloxacin concentration in tears was measured in 30 healthy adult volunteers at various time points following instillation of a single drop of Levofloxacin Ophthalmic Solution. Mean levofloxacin concentrations in tears ranged from 34.9 to 221.1 μg/mL during the 60-minute period following the single dose. The mean tear concentrations measured 4 and 6 hours postdose were 17.0 and 6.6 μg/mL. The clinical significance of these concentrations is unknown.
Nonclinical Toxicology
There is limited information regarding Levofloxacin (ophthalmic) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Levofloxacin (ophthalmic) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Levofloxacin (ophthalmic) How Supplied in the drug label.
Storage
There is limited information regarding Levofloxacin (ophthalmic) 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 Levofloxacin (ophthalmic) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Levofloxacin (ophthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Levofloxacin (ophthalmic) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Levofloxacin (ophthalmic) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.