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LEVAQUIN ORAL SOLN
Bacterial infections
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Drug Name:

LEVAQUIN ORAL SOLN Rx

Generic Name and Formulations:
Levofloxacin 25mg/mL; contains benzyl alcohol.

Company:
Janssen Pharmaceuticals, Inc.

Therapeutic Use:

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.

Adult:

≥18yrs (CrCl ≥50mL/min): Regimen depends on pathogen type (see full labeling). 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.

Children:

<6mos: not established. ≥6mos: Inhalation anthrax (post–exposure): <30kg: use other forms; 30–<50kg: 250mg every 12hrs for 60 days; ≥50kg: 500mg once daily for 60 days. Plague: <30kg: use other forms; 30–<50kg: 250mg every 12hrs for 10–14 days; ≥50kg: 500mg once daily for 10–14 days.

Boxed Warning:

Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, CNS effects. Exacerbation of myasthenia gravis.

Warnings/Precautions:

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/psychiatric 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, proarrhythmic conditions (eg, bradycardia, recent MI), or hypokalemia; avoid. Discontinue at 1st sign of skin rash, jaundice, any other hypersensitivity, hepatitis, or photosensitivity. Monitor blood glucose in diabetic patients; discontinue if hypoglycemia occurs. Renal impairment. Maintain adequate hydration. Avoid excessive sun or UV light. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

See Also:

LEVAQUIN

LEVAQUIN INJ PREMIXED

Pharmacological Class:

Quinolone.

Interactions:

Avoid drugs that prolong QT interval (eg, Class IA or Class III antiarrhythmics). Oral forms: take at least 2hrs before or 2hrs after magnesium- or aluminum-containing antacids, sucralfate, metal cations, multivitamins containing zinc or iron, or didanosine (buffered forms). Increased risk of tendinitis/tendon rupture with corticosteroids. Concomitant antidiabetics may increase blood glucose disturbances. Increased seizure risk with concomitant NSAIDs. Monitor theophylline, warfarin. May cause false (+) urine screening results for opiates using commercially available immunoassays.

Adverse Reactions:

Nausea, headache, diarrhea, insomnia, constipation, dizziness; tendinitis/tendon rupture, peripheral neuropathy, CNS effects, hypersensitivity reactions, hepatotoxicity, C. difficile-associated diarrhea, torsades de pointes, dysglycemia, phototoxicity. Children: also musculoskeletal disorders.

Generic Availability:

YES

How Supplied:

Tabs 250mg, 500mg—50; 750mg—20; Oral soln—480mL; Inj premixed 50mL, 100mL, 150mL—1

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