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.
Postexposure 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 ⬆ ⬇

(plasma concentrations)

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;
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 postexposure 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 postexposure prophylaxis of inhalational anthrax if potential maternal benefit justifies potential risk to infant;
Pedi: Children <18 yr [except for inhalational anthrax (postexposure) 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: AORTIC ANEURYSM/DISSECTION, myocardial ischemia, QT interval prolongation, TORSADES DE POINTES

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

Endo: hyperglycemia, hypoglycemia

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

GU: vaginitis

Local: phlebitis at IV site

MS: arthralgia, myalgia, tendinitis, tendon rupture

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

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Amiodarone, disopyramide, procainamide, quinidine, dofetilide, or sotalol↑ risk of torsades de pointes in susceptible individuals; avoid concurrent use.
May ↑ theophylline levels and risk of toxicity.
Antacids, iron salts, bismuth subsalicylate, sucralfate, and zinc salts may ↓ absorption.
May ↑ the effects of warfarin.
Cimetidine and probenecid may ↑ levels and risk of toxicity.
May ↑ risk of nephrotoxicity from cyclosporine.
Corticosteroids may ↑ risk of tendon rupture.
May ↑ risk of hypoglycemia when used with antidiabetic agents.

Drug-Food:

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 (Postexposure)

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: 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 signs and symptoms of particular infection at beginning of and during therapy.
Assess for anaphylaxis (rash, pruritus, laryngeal edema, wheezing). If symptoms occur, discontinue levofloxacin immediately and treat as clinically indicated. Keep epinephrine, antihistamine, and resuscitation equipment close by.
Monitor for diarrhea, abdominal cramping, fever, and bloody stools. If Clostridioides difficile occurs, treat as clinically indicated. May begin up to several wk following cessation of therapy.
Assess for rash periodically during therapy. If severe dermatologic reactions occur, discontinue therapy and treat as clinically indicated.
Assess for signs and symptoms of peripheral neuropathy, seizures, tremors, and dizziness periodically during therapy. If peripheral neuropathy or CNS reactions occur, discontinue levofloxacin.
Assess for psychiatric and mood changes as soon as the first dose. If psychiatric reactions occur, discontinue levofloxacin and provide appropriate measures as clinically indicated.

Lab Test Considerations:

Obtain specimens for culture and sensitivity before initiating therapy. 1st dose may be given before receiving results.
May ↑ serum AST, ALT, LDH, bilirubin, and alkaline phosphatase. If hepatitis occurs, discontinue levofloxacin immediately.
- May ↑ or ↓ serum glucose, especially in patients with diabetes.
- May cause anemia (hemolytic, aplastic), thrombocytopenia, leukopenia, agranulocytosis, and pancytopenia.
- May cause interstitial nephritis. Monitor renal function as clinically indicated.

Implementation ⬆ ⬇

Do not confuse levofloxacin with levetiracetam.
PO: May be administered without regard to food.
Intermittent Infusion: Premixed single use containers do not require dilution. Do not use if solution is cloudy or contains precipitates. Concentration: 5 mg/mL. Store at room temperature and protect from light. Do not freeze. Discard any unused solution.
Rate: Infuse 250-mg or 500-mg doses over 60 min and 750-mg dose over 90 min. Avoid rapid bolus injection to prevent hypotension.
Y-Site Compatibility:
- alemtuzumab
- amifostine
- amikacin
- aminocaproic acid
- aminophylline
- ampicillin
- ampicillin/sulbactam
- anidulafungin
- argatroban
- arsenic trioxide
- atracurium
- aztreonam
- bivalirudin
- bleomycin
- bumetanide
- buprenorphine
- busulfan
- butorphanol
- caffeine citrate
- calcium gluconate
- cangrelor
- carboplatin
- carmustine
- caspofungin
- cefepime
- cefotetan
- ceftaroline
- ceftazidime
- ceftolozane/tazobactam
- ceftriaxone
- cefuroxime
- chlorpromazine
- cisatracurium
- cisplatin
- clindamycin
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- dactinomycin
- daptomycin
- dexamethasone
- dexmedetomidine
- dexrazoxane
- digoxin
- diltiazem
- diphenhydramine
- dobutamine
- docetaxel
- dopamine
- doxorubicin liposomal
- doxycycline
- droperidol
- enalaprilat
- 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
- hydroxyzine
- idarubicin
- ifosfamide
- imipenem/cilastatin
- irinotecan
- isavuconazonium
- isoproterenol
- labetalol
- LR
- leucovorin calcium
- lidocaine
- linezolid
- mannitol
- meperidine
- meropenem/vaborbactam
- mesna
- methadone
- methylprednisolone
- metoclopramide
- metoprolol
- metronidazole
- midazolam
- milrinone
- mitomycin
- mitoxantrone
- mycophenolate
- nalbuphine
- naloxone
- nicardipine
- octreotide
- ondansetron
- oxacillin
- oxaliplatin
- oxytocin
- paclitaxel
- palonosetron
- pamidronate
- pemetrexed
- penicillin G sodium
- pentamidine
- phenylephrine
- posaconazole
- potassium acetate
- potassium chloride
- promethazine
- propranolol
- remifentanil
- rocuronium
- sargramostim
- sodium acetate
- 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:
- acyclovir
- alprostadil
- amiodarone
- amphotericin B lipid complex
- amphotericin B liposomal
- cefazolin
- cefoxitin
- daunorubicin hydrochloride
- diazepam
- fluorouracil
- furosemide
- ganciclovir
- heparin
- indomethacin
- ketorolac
- letermovir
- methotrexate
- micafungin
- nitroglycerin
- nitroprusside
- pantoprazole
- pentobarbital
- phenytoin
- piperacillin/tazobactam
- plazomicin
- prochlorperazine
- propofol
- rituximab
- sulbactam/durlobactam
- telavancin
- thiopental
- trastuzumab

IV Administration:

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise to read Patient Information before starting therapy.
Instruct patient to finish drug completely, even if feeling better. Take missed doses as soon as possible up to 8 hr before next dose. If <8 hr remain, omit and wait until next scheduled dose.
Advise patient to notify health care professional immediately if they are taking theophylline or if they have myasthenia gravis.
Encourage patient to maintain a fluid intake of ≥1500–2000 mL/day to prevent crystalluria.
Advise patient that antacids or medications containing calcium, magnesium, aluminum, iron, or zinc will ↓ 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 interval 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 (numbness, tingling, pain/burning to extremities) or CNS symptoms (seizure, tremors, dizziness) occur.
Caution patient to use sunscreen and protective clothing to prevent photosensitivity 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) pain, swelling, or inflammation occur. If tendon symptoms occur, avoid exercise and use of the affected area. ↑ risk in patients >65 yr old; kidney, heart, and lung transplant recipients; and patients taking corticosteroid.
Advise patient, family, and caregivers to look for psychiatric and mood changes, including 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, aggression, acting on dangerous impulses, or mania occur.
Rep: Advise women 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 ⬆ ⬇