Names and pronunciation
(lee-voh-floks′a-sin)
Source page 779
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Individual generic drug information
Extracted information for levofloxacin only.
(lee-voh-floks′a-sin)
Source page 779
Func. class.: Antiinfective
Source page 779
Chem. class.: Fluoroquinolone
Source page 779
Do not confuse: levofloxacin/levetiracetam
Source page 779
ACTION: Interferes with conversion of intermediate DNA fragments into high- molecular-weight DNA in bacteria; DNA gyrase inhibitor; inhibits topoisomerase IV
Source page 779
USES: Acute sinusitis, acute chronic bronchitis, community-acquired pneu- monia, uncomplicated skin infections, UTI, cellulitis, prostatitis, inhalational anthrax (postexposure); acute pyelone- phritis caused by Streptococcus pneu- moniae, Streptococcus pyogenes, Hae- mophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Escherichia coli, Serratia marcescens, Klebsiella pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Enterococ- cus faecalis, Staphylococcus epidermi- dis, Staphylococcus pyogenes, Staphy- lococcus aureus, Bacillus anthracis; inhalation anthrax in children
Source page 779
Unlabeled uses: Adnexitis, Bartholin abscess, bartholinitis, cervicitis, epididymi- tis, gastroenteritis, H. pylori eradication, mastitis, MAC, nongonococcal urethritis, obstetric infections, PID, plague, SARS, shigellosis, TB, typhoid fever, dissemi- nated; otitis media, otitis externa, tonsilli- tis, pharyngitis, sialadenitis
Source page 779
Extracted information for levofloxacin only.
CONTRAINDICATIONS: Hyper- sensitivity to quinolones Precautions: Pregnancy, breastfeeding, children, photosensitivity, acute MI, atrial fibrillation, colitis, dehydration, diabetes, QT prolongation, myasthenia gravis, renal disease, seizure disorder, syphilis
Source page 779
Black Box Warning: Tendon pain/rupture, tendinitis, myasthenia gravis, neurotoxicity, peripheral neuropathy, psychiatric events L Black Box Warning: Increase: tendon rupture—corticosteroids; assess for ten- don pain • Do not use with magnesium in same IV line Increase: QT prolongation—products causing a QT prolongation; avoid concur rent use Increase: levofloxacin levels—probenecid Increase: CNS stimulation, seizures— NSAIDs, foscarnet, cycloSPORINE Increase: bleeding risk—warfarin; mon- itor INR/PT Decrease: levofloxacin absorption—ant- acids containing aluminum, magnesium; sucralfate, zinc, iron, calcium; give 2 hr before or after products Decrease: clearance of theophylline; tox- icity may result; monitor theophylline level Drug/Herb Increase: photosensitivity—St. John’s wort Drug/Lab Test Increase: PT, INR Decrease: glucose, lymphocytes Black Box Warning: Tendon rupture: dis- continue product at first sign of tendon pain or inflammation, usually the Achilles tendon is affected; can occur up to a few months after treatment and may require surgical repair; risk is increased in elderly patients, transplant patients, or with use of steroids Black Box Warning: Myasthenia gravis: do not use this product with this disease; may lead to life-threatening weakness of the respiratory muscles Black Box Warning: Neurotoxicity: may occur within hours to weeks after starting use; may be irreversible; avoid use in those who have experienced peripheral neu- ropathy (numbness, tingling, burning in ex- tremities); report to prescriber immediately • Increased fluid intake to 2 L/day to L prevent crystalluria • Seizures: use with caution in those with CNS disorder • Hepatotoxicity: acute hepatitis, liver failure has occurred; LFTs baseline and periodically • Pregnancy/breastfeeding: avoid use in pregnancy; do not use in breastfeeding Black Box Warning: To notify prescriber of tendon pain, inflammation; to avoid corticosteroids with this product • Pregnancy/breastfeeding: identify if pregnancy is planned or suspected or if breastfeeding See Appendix B
Source pages 779, 780, 781, 782
SIDE EFFECTS CNS: Headache, dizziness, insomnia, anxiety, seizures, encephalopathy, par- esthesia, pseudotumor cerebri CV: Chest pain, palpitations, vasodilation, QT prolongation, hypotension (rapid infusion) EENT: Dry mouth, visual impairment, tinnitus GI: Nausea, flatulence, vomiting, diar- rhea, abdominal pain, CDAD, hepatotox icity, esophagitis, pancreatitis GU: Vaginitis, crystalluria HEMA: Eosinophilia, hemolytic anemia, lymphopenia INTEG: Rash, pruritus, photosensitivity, epidermal necrolysis, injection-site reac- tion, edema MISC: Hypoglycemia, hypersensitivity, tendinitis, tendon rupture, rhabdomyolysis RESP: Pneumonitis SYST: Anaphylaxis, multisystem organ failure, Stevens-Johnson syndrome, angioedema, toxic epidermal necrolysis
Source page 780
INTERACTIONS
Source page 780
Extracted information for levofloxacin only.
DOSAGE AND ROUTES Most infections • Adult: PO/IV 250-750 mg q24hr Inhalational anthrax postexposure • Adult: PO/IV 500 mg daily × 60 days • Child >50 kg: PO/IV 500 mg daily × 60 days • Child <50 kg, ≥6 mo: PO/IV 8 mg/kg q12hr × 60 days, max 250 mg/dose Plague • Adult: PO/IV 500 mg q24hr × 10-14 days • Child >50 kg: PO/IV 500 mg daily × 10-14 days • Child <50 kg ≥6 mo: PO/IV 8 mg/kg q12hr × 10-14 days, max 250 mg/dose Renal disease • Adult: PO/IV CCr 20-49 mL/min for 750-mg doses, give 750 mg q48hr; for 500-mg doses, give 500 mg once, then 250 mg q24hr; for 250-mg doses, no ad justment; CCr 10-19 mL/min for 750-mg dose, give 750-mg once, then 500 mg q48hr; for 500-mg dose, give 500 mg once, then 250 mg q48hr; for 250-mg dose, give 250 mg q48hr, except when treating complicated UTI, then no dose adjustment; CCr <10 mL/min for 750 mg, give 500 mg, then 500 mg q2days, if 500 mg, give 500 mg, then 250 mg q2days, if 250 mg then 250 mg q2days
Source pages 779, 780
Available forms: Single-use vials 500, 750 mg; premixed flexible containers 250 mg/50 mL D5W, 500 mg/100 mL D5W, 750 mg/150 mL D5W; tabs 250, 500, 750 mg; oral sol 25 mg/mL; oph- thalmic solution 0.5%
Source page 780
Administer: • Obtain C&S before treatment and peri- odically to determine resistance to prod- uct, treatment can start before results are obtained • PO 2 hr before or after antacids, iron, calcium, zinc, sucralfate; give fluids • Oral solution: Give 1 hr before or 2 hr after food Intermittent IV INFUSION route • Discard any unused sol in single-dose vial • Visually inspect for particulate matter/ discoloration before use • Do not give by rapid or bolus IV, only slow infusion ≥60 min 250-, 500-mg dose, ≥90 min 750-mg dose • Do not use flexible containers in series connections, could result in air embolism • Do not admix with levofloxacin in 5% dextrose injections or infused through the same IV line; if the same line is used for additional infusions of multiple drugs, flush prior to and after use IV (single-use vial) • 500-mg/20-mL vials: To prepare a dose of 500 mg, withdraw 20 mL from a 20-mL vial and dilute with a compatible IV solution (D5W, NS) to a total volume of 50 mL; to prepare a 500-mg dosage, withdraw all 20 mL from the vial and di- lute with a compatible intravenous solu- tion to a total volume of 100 mL • 750-mg/30-mL vials: To prepare a dose of 750 mg, withdraw 30 mL from a 30-mL vial and dilute with a compatible intravenous solution (D5W, NS) to a total volume of 150 mL • The concentration of the diluted solu- tion should be 5 mg/mL before adminis- tration; solutions contain no preservatives; any unused portions must be discarded • Storage: The diluted solution may be stored for up to 72 hr at room tempera- ture or 14 days refrigerated; solutions may be frozen for up to 6 mo Premixed IV solution • No dilution is necessary Ophthalmic • Do not share with others • Do not touch tip to eye
Source page 780
Extracted information for levofloxacin only.
Assess: • Previous sensitivity reaction to quino- lones • Signs, symptoms of infection: charac- teristics of sputum, WBC >10,000/mm3, fever; obtain baseline information be- fore, during treatment • C&S before beginning product ther- apy to identify if correct treatment ini- tiated • Allergic reactions, anaphylaxis: rash, urticaria, pruritus, chills, fever, joint pain; may occur a few days after therapy begins; EPINEPHrine and resuscitation equipment should be available for ana phylactic reaction • CDAD: bowel pattern daily; if severe diarrhea, fever occur, product should be discontinued; assess for signs/symptoms of CDAD daily, diarrhea, abdominal pain/ cramping, blood/pus in stool, fever • Overgrowth of infection: perineal itch- ing, fever, malaise, redness, pain, swell- ing, drainage, rash, diarrhea, change in cough, sputum • Renal function (BUN/creatinine) in- crease fluid to 2 L/day to prevent crys- talluria • Peripheral neuropathy: tingling, pain, numbness, burning in extremities, can be permanent • Retinal detachment: may occur up to 1 yr after last dose of oral treatment
Source page 781
Evaluate: • Therapeutic response: absence of signs, symptoms of infection (WBC <10,000/mm3, temperature WNL)
Source page 781
CLINICAL CONSIDERATIONS
Source page 781
Patient and caregiver information: • Superinfection: To contact prescriber if vaginal itching; loose, foul-smelling stools; furry tongue occur (may indicate superinfection); to report itching, rash, pruritus, urticaria, change in heartbeat • CDAD: To notify prescriber of diarrhea with blood or purulent discharge in stool • To take product 2 hr before or after antacids, iron, calcium, zinc products • To complete full course of therapy, not to skip or double doses • To avoid driving or other hazardous activities until response is known, dizzi- ness may occur • To use frequent rinsing of mouth, sug- arless candy, or gum for dry mouth • To avoid other medication unless ap- proved by prescriber • To prevent sun exposure or to use sunscreen to prevent photosensitivity • To monitor glucose (diabetes); to no- tify prescriber of changes • Not to use contact lenses if using oph- thalmic product
Source pages 781, 782
Extracted information for levofloxacin only.
PHARMACOKINETICS Excreted in urine unchanged, half-life 6-8 hr, peak 1-2 hr
Source page 780
Filter the extracted dose blocks for this individual drug.
Most infections
• Adult: PO/IV 250-750 mg q24hr Inhalational anthrax postexposure
Candidate age grouping · source pages 779, 780
Most infections
• Adult: PO/IV 500 mg daily × 60 days
Candidate age grouping · source pages 779, 780
Most infections
• Child >50 kg: PO/IV 500 mg daily × 60 days
Candidate age grouping · source pages 779, 780
Most infections
• Child <50 kg, ≥6 mo: PO/IV 8 mg/kg q12hr × 60 days, max 250 mg/dose Plague
Candidate age grouping · source pages 779, 780
Most infections
• Adult: PO/IV 500 mg q24hr × 10-14 days
Candidate age grouping · source pages 779, 780
Most infections
• Child >50 kg: PO/IV 500 mg daily × 10-14 days
Candidate age grouping · source pages 779, 780
Most infections
• Child <50 kg ≥6 mo: PO/IV 8 mg/kg q12hr × 10-14 days, max 250 mg/dose Renal disease
Candidate age grouping · source pages 779, 780
Most infections
• Adult: PO/IV CCr 20-49 mL/min for 750-mg doses, give 750 mg q48hr; for 500-mg doses, give 500 mg once, then 250 mg q24hr; for 250-mg doses, no ad justment; CCr 10-19 mL/min for 750-mg dose, give 750-mg once, then 500 mg q48hr; for 500-mg dose, give 500 mg once, then 250 mg q48hr; for 250-mg dose, give 250 mg q48hr, except when treating complicated UTI, then no dose adjustment; CCr <10 mL/min for 750 mg, give 500 mg, then 500 mg q2days, if 500 mg, give 500 mg, then 250 mg q2days, if 250 mg then 250 mg q2days
Candidate age grouping · source pages 779, 780