levofloxacin

REMS

PO: IV: Treatment of the following infections:
- Urinary tract infections (should be used for uncomplicated urinary tract infections only when there are no other alternative treatment options),
- Chronic bacterial prostatitis,
- Nosocomial pneumonia,
- Community-acquired pneumonia,
- Acute bacterial exacerbations of chronic bronchitis (should be used only when there are no other alternative treatment options),
- Acute bacterial sinusitis (should be used only when there are no other alternative treatment options),
- Uncomplicated and complicated skin and skin structure infections.
Post-exposure treatment of inhalational anthrax.
Treatment and prophylaxis of plague.

Action ⬆ ⬇

Inhibits bacterial DNA synthesis by inhibiting DNA gyrase enzyme.

Therapeutic effects:

Death of susceptible bacteria.

Spectrum:

Active against gram-positive pathogens, including:
- Staphylococcus aureus,
- Staphylococcus epidermidis,
- Staphylococcus saprophyticus,
- Streptococcus pyogenes,
- Streptococcus pneumoniae,
- Enterococcus faecalis,
- Bacillus anthracis.
Gram-negative spectrum notable for activity against:
- Escherichia coli,
- Klebsiella pneumoniae,
- Enterobacter cloacae,
- Proteus mirabilis,
- Pseudomonas aeruginosa,
- Serratia marcescens,
- Haemophilus influenzae,
- Moraxella catarrhalis.
Additional spectrum includes:
- Chlamydophylia pneumoniae,
- Legionella pneumoniae,
- Mycoplasma pneumoniae, and Yersinia pestis

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed (99%) after oral administration; IV administration results in complete bioavailability.

Distribution: Widely distributed. High tissue and urinary levels are achieved. Appears to cross the placenta.

Protein Binding: 24–38%

Metabolism/Excretion: 87% excreted unchanged in urine, small amounts metabolized.

Half-Life: 8 hr.

Time/Action Profile ⬆ ⬇

(blood levels)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	1–2 hr	24 hr
IV	rapid	end of infusion	24 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity (cross-sensitivity within class may exist);
QTc interval prolongation;
Uncorrected hypokalemia or hypomagnesemia;
Concurrent use of Class IA antiarrhythmics (disopyramide, quinidine, procainamide) or Class III antiarrhythmics (amiodarone, sotalol) (↑risk of QTc interval prolongation and torsades de pointes);
History of myasthenia gravis (may worsen symptoms including muscle weakness and breathing problems);
Lactation: Avoid breastfeeding during treatment and for 2 days after final dose (for all indications other than post-exposure prophylaxis of inhalational anthrax).

Use Cautiously in:

Known or suspected CNS disorder;
Depression;
Renal impairment (dose ↓ recommended if CCr ≤50 mL/min);
Cirrhosis;
Concurrent use of corticosteroids (↑ risk of tendonitis/tendon rupture);
Kidney, heart, or lung transplant patients (↑ risk of tendonitis/tendon rupture);
Patients with or at risk for aortic aneurysms;
Dialysis patients (↑ risk of adverse reactions);
OB: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk;
Lactation: Can be used while breastfeeding for post-exposure prophylaxis of inhalational anthrax if potential maternal benefit justifies potential risk to infant;
Pedi: Children 18 yr [except for inhalational anthrax (post-exposure) and anthrax] ( risk of arthralgia, arthritis, tendinopathy, and gait disturbances);
Geri: risk for tendon disorders/rupture, hepatotoxicity, aortic aneurysm/dissection (within 2 mo following discontinuation), and QT interval prolongation.

Adv. Reactions/Side Effects ⬆ ⬇

CV: QT interval prolongation, AORTIC ANEURYSM/DISSECTION, TORSADES DE POINTES

Derm: acute generalized exanthematous pustulosis, photosensitivity, rash, STEVENS-JOHNSON SYNDROME

Endo: hyperglycemia, hypoglycemia

GI: nausea, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), abdominal pain, diarrhea, HEPATOTOXICITY, vomiting

GU: vaginitis

Local: phlebitis at IV site

MS: arthralgia, myalgia, tendinitis, tendon rupture

Neuro: agitation, anxiety, confusion, depression, dizziness, ELEVATED INTRACRANIAL PRESSURE (INCLUDING PSEUDOTUMOR CEREBRI), hallucinations, headache, insomnia, lightheadedness, nightmares, paranoia, peripheral neuropathy, SEIZURES, SUICIDAL THOUGHTS/BEHAVIORS, toxic psychosis, tremor

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Concurrent use of amiodarone, disopyramide, procainamide, quinidine, dofetilide, or sotalol↑ risk of torsade de pointes in susceptible individuals (avoid concurrent use).
↑serum theophylline levels and may lead to toxicity.
Administration with antacids, iron salts, bismuth subsalicylate, sucralfate, and zinc salts↓ absorption.
May ↑ the effects of warfarin.
Serum levels may be ↓ by antineoplastic agents.
Cimetidine may interfere with elimination.
Probenecid↓ renal elimination.
May ↑ the risk of nephrotoxicity from cyclosporine.
Concurrent therapy with corticosteroids may ↑ the risk of tendon rupture.
May ↑ risk of hypoglycemia when used with antidiabetic agents.

Absorption is impaired by concurrent enteral feeding (because of metal cations).

Route/Dosage ⬆ ⬇

Nosocomial Pneumonia

PO IV (Adults ): 750 mg once daily for 7–14 days.

Community-Acquired Pneumonia

PO IV (Adults ): Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus influenzae/parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae: 500 mg once daily for 7–14 days; Streptococcus pneumoniae (not multi-drug resistant strains), Haemophilus influenzae/parainfluenzae, Mycoplasma pneumoniae, or Chlamydia pneumoniae: 750 mg once daily for 5 days.

Skin/Skin Structure Infections

PO IV (Adults ): Complicated: 750 mg once daily for 7–14 days; Uncomplicated: 500 mg once daily for 7–10 days.

Chronic Bacterial Prostatitis

PO IV (Adults ): 500 mg once daily for 28 days.

Inhalational Anthrax (Post-Exposure)

PO IV (Adults and Children >50 kg): 500 mg once daily for 60 days.
PO IV (Children ≥6 mo and <50 kg): 8 mg/kg (max dose = 250 mg) every 12 hr for 60 days.

Plague

PO IV (Adults and Children >50 kg): 500 mg once daily for 10–14 days.
PO IV (Children ≥6 mo and <50 kg): 8 mg/kg (max dose= 250 mg) every 12 hr for 10–14 days.

Urinary Tract Infections

PO IV (Adults ): Complicated urinary tract infection due to Enterococcus faecalis, Enterobacter cloacae, E. coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa or acute pyelonephritis due to E. coli: 250 mg once daily for 10 days; Complicated urinary tract infection due to E. coli, Klebsiella pneumoniae, or Proteus mirabilis, or acute pyelonephritis due to E. coli: 750 mg once daily for 5 days; Uncomplicated: 250 mg once daily for 3 days.

Acute Bacterial Exacerbations of Chronic Bronchitis

PO IV (Adults ): 500 mg once daily for 7 days.

Acute Sinusitis

PO IV (Adults ): 500 mg once daily for 10–14 days or 750 mg once daily for 5 days.

Renal Impairment

PO IV (Adults ): Normal renal function dosing of 750 mg/day: CCr 20–49 mL/min: 750 mg every 48 hr; CCr 10–19 mL/min, hemodialysis, or CAPD: 750 mg initially, then 500 mg every 48 hr; Normal renal function dosing of 500 mg/day: CCr 20–49 mL/min: 500 mg initially then 250 mg every 24 hr; CCr 10–19 mL/min, hemodialysis, or CAPD: 500 mg initially then 250 mg every 48 hr. Normal renal function dosing of 250 mg/day: CCr 10–19 mL/min: 250 mg every 48 hr.

Availability ⬆ ⬇

(Generic available)

Tablets: 250 mg; 500 mg; 750 mg
Oral solution: 25 mg/mL
Solution for injection (requires dilution): 5 mg/mL; 25 mg/mL
Premixed infusion: 250 mg/50 mL D5W; 500 mg/100 mL D5W; 750 mg/150 mL D5W

Assessment ⬆ ⬇

Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC; urinalysis; frequency and urgency of urination; cloudy or foul-smelling urine) at beginning of and during therapy.
Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue drug and notify healthcare professional immediately if these problems occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in case of an anaphylactic reaction.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of
Clostridioides difficile
-associated diarrhea (CDAD). May begin up to several wk following cessation of therapy.
Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Assess for signs and symptoms of peripheral neuropathy (pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation) periodically during therapy. Symptoms may be irreversible; discontinue levofloxacin if symptoms occur.
Assess for suicidal tendencies, depression, or changes in behavior periodically during therapy.

Lab Test Considerations:

May cause ↑ serum AST, ALT, LDH, bilirubin, and alkaline phosphatase.
- May also cause ↑ or ↓ serum glucose.

Implementation ⬆ ⬇

alemtuzumab
amifostine
amikacin
aminocaproic acid
aminophylline
ampicillin
ampicillin/sulbactam
anidulafungin
argatroban
arsenic trioxide
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butorphanol
caffeine citrate
calcium gluconate
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ceftaroline
ceftazidime
ceftolozane/tazobactam
ceftriaxone
cefuroxime
chlorpromazine
cisatracurium
cisplatin
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cyclophosphamide
cyclosporine
cytarabine
dacarbazine
dactinomycin
daptomycin
dexamethasone
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dexrazoxane
digoxin
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diphenhydramine
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docetaxel
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doxorubicin liposomal
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droperidol
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ephedrine
epinephrine
epirubicin
eptifibatide
eravacycline
ertapenem
erythromycin
esmolol
etoposide
etoposide phosphate
famotidine
fentanyl
filgrastim
fluconazole
fludarabine
foscarnet
fosphenytoin
gemcitabine
gemtuzumab ozogamicin
gentamicin
granisetron
haloperidol
hetastarch
hydrocortisone
hydromorphone
idarubicin
ifosfamide
imipenem/cilastatin
irinotecan
isavuconazonium
isoproterenol
labetalol
LR
leucovorin calcium
lidocaine
linezolid
mannitol
meperidine
meropenem/vaborbactam
mesna
methylprednisolone
metoclopramide
metoprolol
metronidazole
midazolam
milrinone
mitomycin
mitoxantrone
mycophenolate
nalbuphine
naloxone
nicardipine
octreotide
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oxacillin
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oxytocin
paclitaxel
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potassium acetate
potassium chloride
promethazine
propranolol
remifentanil
rocuronium
sargramostim
sodium bicarbonate
succinylcholine
sufentanil
tacrolimus
tedizolid
theophylline
thiotepa
tigecycline
tirofiban
tobramycin
topotecan
trimethoprim/sulfamethoxazole
vancomycin
vasopressin
vecuronium
verapamil
vinblastine
vincristine
vinorelbine
voriconazole
zidovudine
zoledronic acid

Y-Site Incompatibility:

Do not confuse levofloxacin with levetiracetam.
PO: May be administered without regard to meals. Products or foods containing calcium, magnesium, aluminum, iron, zinc should not be ingested for 4 hr before and 2 hr after administration.
Intermittent Infusion: Diluent: Dilute with 0.9% NaCl, D5W, D5/0.9% NaCl, D5/0.45% NaCl, or D5/LR.Concentration: 5 mg/mL. Also available in premixed bottles and flexible containers with D5W, which need no further dilution. Discard unused solution. Diluted solution is stable for 72 hr at room temperature and 14 days if refrigerated.
Rate: Administer by infusion over at least 60 min for 250–mg or 500–mg doses and over 90 min for 750–mg dose. Avoid rapid bolus injection to prevent hypotension.

IV Administration:

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed at evenly spaced times and to finish drug completely, even if feeling better. Take missed doses as soon as possible, unless almost time for next dose. Do not double doses. Advise patient that sharing of this medication may be dangerous.
Advise patients to notify health care professional immediately if they are taking theophylline.
Encourage patient to maintain a fluid intake of at least 1500–2000 mL/day to prevent crystalluria.
Advise patient that antacids or medications containing calcium, magnesium, aluminum, iron, or zinc will decrease absorption and should not be taken within 4 hr before and 2 hr after taking this medication.
May cause dizziness and drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional of any personal or family history of QTc prolongation or proarrhythmic conditions such as recent hypokalemia, significant bradycardia, or recent myocardial ischemia or if fainting spells or palpitations occur. Patients with this history should not receive levofloxacin.
Advise patient to stop taking levofloxacin and notify health care professional immediately if signs and symptoms of peripheral neuropathy occur.
Caution patient to use sunscreen and protective clothing to prevent phototoxicity reactions during and for 5 days after therapy. Notify health care professional if a sunburn-like reaction or skin eruption occurs.
Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
Instruct patient to notify health care professional immediately if rash, jaundice, signs of hypersensitivity, or tendon (shoulder, hand, Achilles, and other) pain, swelling, or inflammation occur. If tendon symptoms occur, avoid exercise and use of the affected area. Increased risk in >65 yr old, kidney, heart and lung transplant recipients, and patients taking corticosteroids concurrently. Therapy should be discontinued.
Advise patient, family, and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care professional immediately if thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, or other changes in mood or behavior.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy and for 2 days after last dose.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇