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Side Effects & Adverse Reactions
NOT FOR INJECTION.
Levofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
In patients receiving systemic quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
Legal Issues
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FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
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 iwoffii*
Haemophilus influenzae
Serratia marcescens*
*Efficacy for this organism was studied in fewer than 10 infections.
History
There is currently no drug history available for this drug.
Other Information
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 at neutral pH than ofloxacin. Its structural formula is:
Chemical Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[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.
Contains:
Active: Levofloxacin 0.5% (5 mg/mL); Preservative: Benzalkonium Chloride 0.005%; Inactives: Sodium Chloride and Purified Water. May also contain Sodium Hydroxide and/or Hydrochloric Acid 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.
Sources
Levofloxacin Solution Manufacturers
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Akorn Inc.
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Hi-tech Pharmacal Co., Inc.
Levofloxacin Solution | Hi-tech Pharmacal Co., Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe 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 [see Dosage and Administration (2.3)].
* Due to the designated pathogens [ see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)] ß 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. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10 ), Specific Populations (8.4), and Clinical Studies (14.9)] Prolonged Levofloxacin therapy in adults should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of Levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection* Dose Every 24 hoursDuration
(days)† Nosocomial Pneumonia 750 mg 7-14 Community Acquired Pneumonia‡ 500 mg 7-14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10-14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 Chronic Bacterial Prostatitis 500 mg 28 Complicated Urinary Tract Infection(cUTI) or Acute Pyelonephritis (AP)¶ 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)# 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3Inhalational Anthrax (Post-Exposure)
Adult and Pediatric Patients > 50 kgÞß
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
* Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [ see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)] § The safety of Levofloxacin in pediatric patients for durations of therapy beyond 14 has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9).] Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of infection* Dose Freq. Once every Duration† Inahalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg 500 mg 24 hr 60 days§ Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 60 days§ Plague,¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric Patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days 2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister Levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance<50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6).]
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min) Dosage in Normal Renal Function Every 24 hours Creatinine Clearance 20 to 49 mL/min Creatinine Clearance 10 to 19 mL/min Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD) 750 mg 750 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 500 mg 500 mg initial dose, then 250 mg every 24 hours 500 mg initial dose, then 250 mg every 48 hours 500 mg initial dose, then 250 mg every 48 hours 250 mg No dosage adjustment required 250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required No information on dosing adjustment is available 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin Oral SolutionLevofloxacin Oral Solution should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Oral SolutionIt is recommended that Levofloxacin Oral Solution be taken 1 hour before or 2 hours after eating.
Hydration for Patients Receiving Levofloxacin Oral SolutionAdequate hydration of patients receiving oral or intravenous Levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
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