levofloxacin

Levofloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. Levofloxacin will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Levofloxacin is available under the following different brand names: Levaquin, and Levofloxacin Systemic.

Adult and Pediatric Dosage Forms and Strengths

Premix, ready-to-use injection

• 250mg/50mL
• 500mg/100mL
• 750mg/150mL (adult only)

Oral solution

• 25mg/mL

Tablet

• 250mg
• 500mg
• 750mg (adult only)

Dosage Considerations – Should be Given as Follows:

Community-Acquired Pneumonia

Adult: 500 mg orally/intravenously (IV) once daily for 7-14 days or 750 mg orally/intravenously (IV) once daily for 5 days

Pediatric (Off-label)

S. pneumonia

Children 6 months - 5 years: 16-20 mg/kg/day orally once/day for 10 days Children 5-16 years: 8-10 mg/kg/day orally once/day for 10 days; not to exceed 750 mg/day

M. pneumoniae, C. trachomatis, C. pneumoniae

Adolescents with skeletal maturity: 500 mg orally once/day for 10 days; not to exceed 750 mg/day

Nosocomial Pneumonia

750 mg orally/intravenously (IV) once daily for 7-14 days

Acute Bacterial Sinusitis

500 mg orally/intravenously (IV) once daily for 10-14 days or 750 mg orally/intravenously (IV) once daily for 5 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis

Acute Bacterial Exacerbation of Chronic Bronchitis

500 mg orally/intravenously (IV) once daily for 7 days or more

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis

Inhalational Anthrax

Postexposure therapy

Adult: 500 mg orally once daily for 60 days, beginning as soon as possible after exposure

Children 6 months and older and less than 50 kg: 8 mg/kg orally every 12 hours for 60 days, beginning as soon as possible after exposure; individual dose not to exceed 250 mg  

Children 6 months and older and greater than 50 kg: 500 mg orally once daily for 60 days, beginning as soon as possible after exposure

Safety in children for treatment duration more than 14 days has not been established

Skin/Skin Structure Infections

Uncomplicated: 500 mg orally/intravenously (IV) once daily for 7-10 days

Complicated: 750 mg orally/intravenously (IV) once daily for 7-14 days

Chronic Bacterial Prostatitis

500 mg orally/intravenously (IV) once daily for 28 days

Complicated Urinary Tract Infections and Acute Pyelonephritis

250 mg orally/intravenously (IV) once daily for 10 days or 750 mg orally/intravenously once daily for 5 days

Uncomplicated Urinary Tract Infections

250 mg orally/intravenously (IV) once daily for 3 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections

Plague

• Indicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or older
• Adult: 500 mg orally/intravenously (IV) once daily for 10-14 days
• Children 6 months and older and less than 50 kg: 8 mg/kg orally/intravenously (IV) every 12 hours for 10-14 days; individual dose not to exceed 250 mg 
• Children 6 months and older and 50 kg or greater: 500 mg orally/intravenously (IV) once daily for 10-14 days

Acne Vulgaris (Off-label)

• 100 mg orally every 8 hours for 4 weeks

Epididymitis (Off-label)

• 500 mg orally once/day for 10 days

Acute Bacterial Rhinosinusitis (Off-label), Pediatric

• 10-20 mg/kg/day orally once/day or divided every 12 hours
• Pseudomonas aeruginosa Pulmonary Infections (Orphan)
• Treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis

Orphan indication sponsor

• Mpex Pharmaceuticals, Inc, 11535 Sorrento Valley Road, San Diego, CA 92121

Dosage Modifications

• Renal impairment (normal dosage, 750 mg/day)
• CrCl 20-49 mL/min: 750 mg every other day CrCl 10-19 mL/min or hemodialysis (HD)/peritoneal dialysis (PD): 750 mg initially, then 500 mg every other day
• Renal impairment (normal dosage, 500 mg/day)
• CrCl 20-49 mL/min: 500 mg initially, then 250 mg once daily CrCl 10-19 mL/min or HD/PD: 500 mg initially, then 250 mg every other day
• Renal impairment (normal dosage, 250 mg/day)
• CrCl 20-49 mL/min: No dosage adjustment required CrCl 10-19 mL/min: 250 mg every other day; no dosage adjustment required for uncomplicated urinary tract infection (UTI) HD/PD: No data

Dosing Considerations

Susceptible organisms:

• Aeromonas hydrophila, Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Chlamydia pneumoniae, Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Morganella morganii, Moraxella catarrhalis, Proteus mirabilis, Providencia spp, Pseudomonas aeruginosa, Serratia spp, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Ureaplasma urealyticum
• First-line therapy: C jejuni, C freundii, Enterobacter spp; no unanimity on others (e.g., A hydrophila, L pneumophila, M morganii)

Common side effects of levofloxacin include:

• Nausea
• Headache
• Diarrhea
• Insomnia
• Constipation
• Dizziness
• Indigestion
• Rash
• Vomiting
• Chest pain
• Shortness of breath
• Swelling (edema)
• Fatigue
• Injection-site reaction
• Yeast infection
• Pain
• Itching
• Vaginitis

Less common side effects of levofloxacin include:

• Cardiac: Cardiac arrest, palpitation, ventricular tachycardia, irregular heart beat (arrhythmia)
• Nervous system: Tremor, convulsions, numbness and tingling, spinning sensation (vertigo), muscle stiffness, muscle spasms, abnormal gait, somnolence, lightheadedness/fainting
• Metabolic: Low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), hyperkalemia
• Blood/lymphatic system: Anemia, thrombocytopenia, granulocytopenia
• Musculoskeletal/connective tissue: Joint pain, tendonitis, muscle pain, skeletal pain
• Gastrointestinal (GI): Gastritis, swelling and sores inside the mouth, pancreatitis, esophagitis, gastroenteritis, swollen tongue, pseudomembranous/C difficile colitis
• Hepatobiliary: Abnormal liver function, increased liver enzymes, increased alkaline phosphatase
• Psychiatric: Anxiety, agitation, confusion, depression, hallucinations, nightmares, sleep disorder, loss of appetite, abnormal dreaming
• Other: Immune hypersensitivity reaction, acute renal failure, hives, phlebitis, nosebleed

Postmarketing side effects of levofloxacin reported include:

• Cardiac: Prolonged QT interval, torsades de pointes, fast heart rate
• Musculoskeletal/connective tissue: Tendon rupture, muscle injury, muscle wasting
• Skin/subcutaneous tissue: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity/phototoxicity, leukocytoclastic vasculitis
• Renal and urinary disorders: Interstitial nephritis
• Vascular disorders: Vasodilation
• Blood/lymphatic system: Pancytopenia, aplastic anemia, leukopenia, hemolytic anemia, eosinophilia
• Hepatobiliary: Hepatic failure, hepatitis, yellow skin or eyes (jaundice)
• Psychiatric: Psychosis, paranoia, suicidal ideation, isolated reports of suicide attempts
• Nervous system: Exacerbation of myasthenia gravis, anosmia, loss of taste, changes in taste, abnormal sense of smell, numbness and tingling in extremities, abnormal electroencephalogram (EEG), dysphonia, isolated reports of encephalopathy, pseudotumor cerebri
• Central nervous system: Hallucinations, anxiety, depression, insomnia, severe headaches, and confusion
• Respiratory, thoracic and mediastinal disorders: Isolated reports of allergic pneumonitis
• Immune system disorders: Hypersensitivity reactions, sometimes fatal including: anaphylactic/anaphylactoid reactions, anaphylactic shock, angioneurotic edema, serum sickness
• Eye disorders: Uveitis, vision disturbance (including double vision), visual acuity reduced, vision blurred, partial loss of vision/blind spot
• Otologic: Hearing impairment, ringing in the ears
• General disorders and administration site conditions: Multi-organ failure, fever

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe Interactions of levofloxacin include: None
• Levofloxacin has serious interactions with at least 41 different drugs.
• Levofloxacin has moderate interactions with at least 177 different drugs.
• Levofloxacin has mild interactions with at least 36 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects.
• Discontinue the drug immediately and avoid the use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions.
• May exacerbate muscle weakness in patients with myasthenia gravis; fluoroquinolones should be avoided in patients with a known history of myasthenia gravis.

Serious adverse effects and limitations-of-use:

• Both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves, and the central nervous system
• These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
• Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options
• For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option

This medication contains levofloxacin. Do not take Levaquin or Levofloxacin Systemic if you are allergic to levofloxacin or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Documented hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after the first dose.
• See "What Are Side Effects Associated with Using Levofloxacin?"

Long-Term Effects

• Both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves, and the central nervous system. These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.
• Superinfections may occur with prolonged or repeated antibiotic therapy.
• See "What Are Side Effects Associated with Using Levofloxacin?"

Cautions

• Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after the first dose.
• Use caution in hematologic and renal toxicities.
• Hepatotoxicity was reported with therapy.
• Peripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent.
• Central nervous system (CNS) effects, including toxic psychosis, convulsions, increased intracranial pressure (pseudotumor cerebri), anxiety, confusion, depression, and insomnia reported with therapy.
• Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion); these reactions can occur within hours to weeks after starting therapy, including in patients of any age or without pre-existing risk factors; discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid the use of fluoroquinolones, in patients who have experienced any serious adverse reactions associated with fluoroquinolones.
• The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants; other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.
• Use with caution in patients with known or suspected disorders that predispose to seizures or take medications that will lower the seizure threshold.
• May increase the risk of tendon rupture in patients with rheumatoid arthritis; use caution.
• Excessive sunlight may result in moderate-to-severe phototoxicity.
• Fatal hypoglycemia is reported in elderly patients with or without diabetes; prompt treatment when symptoms are present is essential.
• May cause C difficile-associated colitis.
• Prolonged use may result in fungal or bacterial superinfection.
• Prolongation of QT interval and isolated cases of torsades de pointes; avoid use in patients with known QT prolongation, those with hypokalemia, and those taking other QT-prolonging drugs.
• May produce false-positive urine opiate screens.
• No longer recommended for gonorrhea in the United States, because of widespread resistance.
• In prolonged therapy, perform periodic evaluations of organ system function (e.g., renal, hepatic, hematopoietic); adjust dosage in renal impairment; superinfections may occur with prolonged or repeated antibiotic therapy.
• Pediatric patients may experience an increased incidence of musculoskeletal disorders (e.g., arthralgia, arthritis, tendinopathy, gait abnormality).
• Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190.
• Clostridium difficile-associated diarrhea (CDAD) has been reported; if CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Pregnancy and Lactation

• Use levofloxacin with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies done.
• Levofloxacin is excreted in breast milk; it is not recommended for use while breastfeeding.