Levofloxacin

What is Levofloxacin?

• Levofloxacin (LEVAQUIN®) is a fluoroquinolone antibacterial.

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Levofloxacin ball-and-stick

Levofloxacin molecule ball

What are the uses of this medicine?

• LEVAQUIN® is a fluoroquinolone antibiotic medicine used in adults, 18 years or older, to treat certain infections caused by certain germs called bacteria.

This medicine is used in adults (≥18 years of age) with infections caused by designated, susceptible bacteria.

• Pneumonia: nosocomial and community acquired
• Acute bacterial sinusitis
• Acute bacterial exacerbation of chronic bronchitis
• Skin and skin structure infections: complicated and uncomplicated
• Chronic bacterial prostatitis
• Urinary tract infections: complicated and uncomplicated
• Acute pyelonephritis
• Inhalational anthrax, post-exposure.

How does this medicine work?

• Levofloxacin (lee" voe flox' a sin) is the L-enantiomer of ofloxacin and is considered a third generation fluoroquinolone.
• Like other fluoroquinolones, levofloxacin is active against a wide range of aerobic gram-positive and gram-negative organisms.
• The fluoroquinolones are believed to act by inhibition of type II DNA toposiomerases (gyrases) that are required for synthesis of bacterial mRNAs (transcription) and DNA replication.
• They demonstrate little inhibition of human, host enzymes and have had an excellent safety record.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to any of the ingredients in LEVAQUIN®

What drug interactions can this medicine cause?

• Concurrent administration of LEVAQUIN® Tablets and Oral Solution with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after oral LEVAQUIN® administration
• Fluoroquinolone shouldnot be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line.
• Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent. Carefully monitor blood glucose.
• The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including LEVAQUIN®, may increase the risk of CNS stimulation and convulsive seizures.
• Theophylline levels should be closely monitored and appropriate dosage adjustments made when LEVAQUIN® is co-administered.
• Some fluoroquinolones, including LEVAQUIN®, may produce false-positive urine screening results for opiates using commercially available immunoassay kits.

Is this medicine FDA approved?

• Levofloxacin was approved for use in the United States in 1996 and remains in wide use.
• Levofloxacin is used for mild-to-moderate infections, the typical indications including sinusitis, bronchitis, community acquired pneumonia, skin infections, urinary tract infections, pyelonephritis, prostatitis, plague and anthrax.

How should this medicine be used?

Recommended dosage:

• The usual dose of LEVAQUIN® Tablets or Oral Solution is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection is shown below:

Type of Infection	Dose Every 24 hours	Duration
(days)
Nosocomial Pneumonia (1.1)	750 mg	7–14
Community Acquired Pneumonia (1.2)	500 mg	7–14
Community Acquired Pneumonia (1.3)	750 mg	5
Acute Bacterial Sinusitis (1.4)	750 mg	5
500 mg	10–14
Acute Bacterial Exacerbation of Chronic Bronchitis (1.5)	500 mg	7
Complicated Skin and Skin Structure Infections (SSSI) (1.6)	750 mg	7–14
Uncomplicated SSSI (1.7)	500 mg	7–10
Chronic Bacterial Prostatitis (1.8)	500 mg	28
Complicated Urinary Tract Infection (1.9) or Acute Pyelonephritis (1.11)	750 mg	5
Complicated Urinary Tract Infection (1.10) or Acute Pyelonephritis (1.11)	250 mg	10
Uncomplicated Urinary Tract Infection (1.12)	250 mg	3
Inhalational Anthrax (Post-Exposure) (1.13)
Adults and Pediatric Patients > 50 kg and ≥ 6 months of age	500 mg	60
Pediatric Patients < 50 kg and ≥ 6 months of age	8 mg/kg BID (not to exceed 250 mg/dose)	60

Administration:

• Take LEVAQUIN® exactly as prescribed by your healthcare provider.
• Take LEVAQUIN® at about the same time each day.
• Drink plenty of fluids while taking LEVAQUIN®.
• LEVAQUIN® Tablets can be taken with or without food.
• Take LEVAQUIN® Oral Solution 1 hour before or 2 hours after eating.
• If you miss a dose of LEVAQUIN®, take it as soon as you remember. Do not take more than one dose in one day.
• LEVAQUIN® for Injection is given to you by intravenous (I.V.) infusion into your vein, slowly, over 60 or 90 minutes, as prescribed by your healthcare provider.
• Do not skip any doses, or stop taking LEVAQUIN® even if you begin to feel better, until you finish your prescribed treatment, unless:
• you have tendon effects
• you have a serious allergic reaction
• your healthcare provider tells you to stop.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As

• LEVAQUIN (levofloxacin) Tablet, Film Coated for Oral use
• LEVAQUIN (levofloxacin) Solution for Oral use
• LEVAQUIN (levofloxacin) Injection, Solution, Concentrate for Intravenous use
• LEVAQUIN (levofloxacin) Injection, Solution for Intravenous use

This medicine is available in fallowing brand namesː

• LEVAQUIN®

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• headache
• constipation
• nausea
• diarrhea
• In children 6 months and older who take LEVAQUIN® to prevent anthrax disease, vomiting is also common.
• Low blood pressure can happen with LEVAQUIN® given by IV injection if it is given too fast.

LEVAQUIN®can cause side effects include:

• Liver damage (hepatotoxicity)
• Central Nervous System Effects
• Serious allergic reactions
• Skin rash
• Intestine infection (Pseudomembranous colitis)
• Changes in sensation and possible nerve damage (Peripheral Neuropathy)
• Serious heart rhythm changes
• Changes in blood sugar
• Sensitivity to sunlight
• Joint Problems

What special precautions should I follow?

• Risk of tendinitis and tendon rupture is increased with LEVAQUIN. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants. Discontinue if pain or inflammation in a tendon occurs.
• Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose of LEVAQUIN.
• Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses of LEVAQUIN.
• Severe, and sometimes fatal, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur.
• Central nervous system effects, including convulsions, anxiety, confusion, depression, and insomnia may occur after the first dose of LEVAQUIN. Use with caution in patients with known or suspected disorders that may predispose them to seizures or lower the seizure threshold.
• Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including LEVAQUIN®. evaluate if diarrhea occurs
• Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including LEVAQUIN®. discontinue if symptoms occur in order to prevent irreversibility.
• Some fluoroquinolones, including LEVAQUIN®, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval.
• An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving LEVAQUIN®.
• Moderate to severe photosensitivity/phototoxicity reactions may occur. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions.

Management of 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 dialysis.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well-controlled studies in pregnant women.
• LEVAQUIN® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Levofloxacin is indicated in pediatric patients for inhalational anthrax (post-exposure).
• In children 6 months and older who have breathed the anthrax bacteria germ:

• LEVAQUIN® is used to prevent anthrax disease (inhalation anthrax).
• It is not known if it is safe to use LEVAQUIN® in children for more than 14 days.
• It is not known if LEVAQUIN® is safe and works in children under the age of 6 months.

What are the active and inactive ingredients in this medicine?

250 mg LEVAQUIN® Film-Coated Tablets:

• Active ingredient: levofloxacin.
• Inactive ingredients: hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide.

500 mg LEVAQUIN® Film-Coated Tablets:

• Active ingredient: levofloxacin.
• Inactive ingredients: hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides.

750 mg LEVAQUIN® Film-Coated Tablets:

• Active ingredient: levofloxacin.
• Inactive ingredients: hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.

LEVAQUIN® Oral Solution (25 mg/mL):

• Active ingredient: levofloxacin.
• Inactive ingredients: sucrose, glycerin, sucralose, hydrochloric acid, purified water, propylene glycol, artificial and natural flavors, benzyl alcohol, ascorbic acid, and caramel color. It may also contain a solution of sodium hydroxide for pH adjustment.
• LEVAQUIN® Oral Solution may look clear yellow to clear greenish-yellow in color.

LEVAQUIN® Injection in Single-Use Vials:

• Active ingredient: levofloxacin.
• Inactive ingredients: water for injection. LEVAQUIN® for Injection Single Use Vials do not contain any preservatives.

LEVAQUIN® Injection Premix in Single-Use Flexible Containers:

• Active ingredient: levofloxacin.
• Inactive ingredients: Dextrose (D5W). Solutions of hydrochloric acid and sodium hydroxide may have been added to adjust the pH.

Who manufactures and distributes this medicine?

Manufactured by:Bold

• Janssen Ortho LLC, Gurabo, Puerto Rico 00778 (Tablets).
• Janssen Pharmaceutica N.V., Beerse, Belgium (Oral Solution, Injection Single-Use Vials).
• Hospira, Inc., Lake Forest
• Manufactured for:
• PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ (Tablets, Oral Solution)
• Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ (Injection Single-Use Vials, Injection Premix)

What should I know about storage and disposal of this medication?

• Store LEVAQUIN® Film-Coated Tablets at 59° to 86° F (15°C to 30°C). Keep the container closed tightly.
• Store LEVAQUIN® Oral Solution at 59° to 86° F (15°C to 30°C).
• Keep LEVAQUIN® and all medicines out of the reach of children.

List of flouroquinolones

• Ciprofloxacin
• Delafloxacin
• Gemifloxacin
• Levofloxacin
• Moxifloxacin
• Norfloxacin
• Ofloxacin

• Dailymed label info on Levofloxacin
• FDA Levofloxacin

Levofloxacin Resources
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