LEVAQUIN ORAL SOLN Rx
Generic Name and Formulations:
Levofloxacin 25mg/mL; contains benzyl alcohol.
Janssen Pharmaceuticals, Inc.
Indications for LEVAQUIN ORAL SOLN:
Susceptible bacterial infections including acute bacterial sinusitis (ABS), acute bacterial exacerbations of chronic bronchitis (ABECB), nosocomial or community-acquired pneumonia (CAP), UTIs, acute pyelonephritis, chronic bacterial prostatitis, skin and skin structure infections. Inhalation anthrax (post-exposure): to reduce incidence or progression of disease (see full labeling). Plague. For ABS, ABECB, and uncomplicated UTIs: reserve for those who have no alternative treatment options.
≥18yrs: Regimen depends on pathogen type (see full labeling). Tabs: take with water. Oral soln: take on empty stomach. IV: infuse over 60 mins (250mg or 500mg), or over 90 mins (750mg). ABS: 500mg once daily for 10–14 days or 750mg once daily for 5 days. ABECB: 500mg once daily for 7 days. Nosocomial pneumonia: 750mg once daily for 7–14 days. CAP: 500mg once daily for 7–14 days or 750mg once daily for 5 days. Uncomplicated skin and skin structure: 500mg once daily for 7–10 days; complicated: 750mg once daily for 7–14 days. Prostatitis: 500mg once daily for 28 days. Uncomplicated UTIs: 250mg once daily for 3 days. Complicated UTIs, acute pyelonephritis: 250mg once daily for 10 days or 750mg once daily for 5 days. Postexposure inhalational anthrax: 500mg once daily for 60 days (start as soon as possible after exposure). Plague: 500mg once daily for 10–14 days. Renal impairment (CrCl <50mL/min): adjust dose; see full labeling.
Inhalation anthrax (post–exposure): ≥6 months: <50kg: 8mg/kg twice daily for 60 days; max 250mg/dose. >50kg: 500mg once daily for 60 days. Plague: ≥6 months: <50kg: 8mg/kg twice daily for 10–14 days; max 250mg/dose. >50kg: 500mg once daily for 10–14 days.
Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, CNS effects. Exacerbation of myasthenia gravis.
Increased risk of disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture [esp. in patients >60yrs, or those with kidney, heart or lung transplants], peripheral neuropathy, or CNS effects); discontinue immediately if signs/symptoms occur. History of depression. CNS disorders (eg, cerebral arteriosclerosis, epilepsy) that increase seizure risk. History of myasthenia gravis; avoid. History of QT prolongation, ventricular arrhythmias, proarrhythmic conditions (eg, bradycardia, acute myocardial ischemia), or hypokalemia; avoid. Discontinue at 1st sign of skin rash, jaundice, any other hypersensitivity, hypoglycemic reactions, phototoxicity, or hepatitis. Renal impairment. Monitor blood, renal, hepatic, and hematopoietic function. Maintain adequate hydration. Avoid excessive sun or UV light. Elderly. Pregnancy (Cat.C), nursing mothers: not recommended.
Avoid drugs that prolong QT interval (eg, Class IA or Class III antiarrhythmics). Avoid oral form with antacids containing magnesium or aluminum, sucralfate, didanosine, iron, zinc, other metal cations (separate dosing by at least 2 hours). Increased risk of tendinitis/tendon rupture with corticosteroids. Monitor theophylline, warfarin, antidiabetic agents. Caution with other drugs that may lower seizure threshold (eg, NSAIDs). May cause false (+) urine screening results for opiates using commercially available immunoassays.
Nausea, headache, diarrhea, insomnia, constipation, dizziness, CNS stimulation, pruritus, rash, abdominal pain, tendinitis/tendon rupture, local reactions (inj); rarely: peripheral neuropathy, hepatotoxicity, photosensitivity, convulsions, torsades de pointes, C. difficile-associated diarrhea. Children: also musculoskeletal disorders.
Tabs 250mg, 500mg—50; 750mg—20; Oral soln—480mL; Inj premixed 50mL, 100mL, 150mL—1
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