Biopharm Levo

Biopharm Levo





Concise Prescribing Info
Community-acquired pneumonia, skin & skin structure infections, complicated UTI, acute pyelonephritis.
Dosage/Direction for Use
Usual dose: 500 mg by slow infusion over 60 min every 24 hr or 750 by slow infusion over 90 min every 24 hr. Adult w/ normal renal function (CrCl ≥50 mL/min) Community-acquired pneumonia 500 mg once daily for 7-14 days or 750 mg once daily for 5 days. Uncomplicated skin & skin structure infection (SSSI) 500 mg once daily for 7-10 days. Complicated skin & skin structure infection (SSSI) 750 mg once daily for 7-14 days. Complicated UTI or acute pyelonephritis 250 mg once daily for 10 days or 750 mg once daily for 5 days. Adult w/ renal impairment CrCl 20-49 mL/min Initially 500 mg then 250 mg every 24 hr or 750 mg every 48 hr, CrCl 10-19 mL/min 250 mg every 48 hr if for uncomplicated UTI; initially 500 mg then 250 mg every 48 hr or initially 750 mg then 500 mg every 48 hr, hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) Initially 500 mg then 250 mg every 48 hr or initially 750 mg then 500 mg every 48 hr.
Hypersensitivity to levofloxacin or other quinolone antibacterials.
Special Precautions
Not for IM, intrathecal, IP or SC administration. Avoid in patient w/ history of myasthenia gravis; increased risk of tendinitis & tendon rupture. Discontinue if pain, swelling, inflammation or rupture of tendon occurs; if 1st appearance of skin rash, jaundice or other sign of hypersensitivity; if develop signs & symptoms of hepatitis; if experiences symptoms of neuropathy; if photosensitivity/phototoxicity occurs. Known or suspected CNS disorder that may predispose to seizures or lower seizure threshold. Clostridium difficile-associated diarrhea may occur; ensure fluid & electrolyte management, protein supplementation, antibiotic treatment of C. difficile & surgical evaluation if suspected or confirmed. Avoid in patients w/ known QT interval prolongation, uncorrected hypokalemia, receiving class IA (quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmic agents. Carefully monitor blood glucose of diabetics in concomitant use w/ hypoglycemics or insulin. Avoid excessive exposure to sun or UV light. Childn (increased risk of musculoskeletal disorders). Pregnancy & lactation. Elderly.
Adverse Reactions
Tendon effects, hypersensitivity, other serious & sometimes fatal reactions, hepatotoxicity, CNS effects, Clostridium difficile-associated diarrhea, peripheral neuropathy, QT interval prolongation, musculoskeletal disorders in ped patients, blood glucose disturbances, photosensitivity/phototoxicity, development of drug resistant bacteria.
Drug Interactions
Elevated prothrombin time w/ warfarin. Blood glucose disturbances w/ antidiabetics. Increased risk of CNS stimulation & convulsive seizures w/ NSAIDs. Prolong elimination t½, elevate serum levels & subsequently increase risk of drug-related adverse reactions of theophylline.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Biopharm Levo inj 750 mg/150 mL
150 mL x 1's
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