RiteMED Levofloxacin

RiteMED Levofloxacin

levofloxacin

Manufacturer:

RiteMED

Distributor:

United Lab
Concise Prescribing Info
Contents
Levofloxacin hemihydrate
Indications/Uses
Adults ≥18 yr w/ mild, moderate, or severe infections eg, acute bacterial sinusitis; acute bacterial exacerbation of chronic bronchitis; community-acquired pneumonia; healthcare-associated pneumonia; complicated skin & skin structure infections; uncomplicated skin & skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections; complicated UTI; acute pyelonephritis; chronic bacterial prostatitis; uncomplicated UTI. Reduce incidence or progression of inhalational anthrax in adults & childn ≥6 mth following exposure to aerosolized Bacillus anthracis. Treatment of plague, including pneumonic & septicemic plague, due to Yersinia pestis & prophylaxis for plague in adults & childn ≥6 mth.
Dosage/Direction for Use
Usually 500 mg or 750 mg once every 24 hr. Adult w/ normal renal function (CrCl ≥50 mL/min) Acute bacterial sinusitis 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days. Acute bacterial exacerbation of chronic bronchitis 500 mg once daily for 7 days. Community-acquired pneumonia 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days. Healthcare-associated pneumonia 750 mg once daily for 7-14 days. Complicated skin & skin structure infections (SSSI) 750 mg once daily for 7-14 days. Uncomplicated SSSI 500 mg once daily for 7-10 days. Complicated UTI 250 mg once daily for 10 days, or 750 mg once daily for 5 days. Acute pyelonephritis 250 mg once daily for 10 days, or 750 mg once daily for 5 days. Chronic bacterial prostatitis 500 mg once daily for 28 days. Uncomplicated UTI 250 mg once daily for 3 days. Inhalational anthrax (post-exposure) 500 mg once daily for 60 days. Plague 500 mg once daily for 10-14 days. Adult w/ renal impairment CrCl 20-49 mL/min 750 mg every 48 hr, or initially 500 mg then 250 mg every 24 hr, CrCl 10-19 mL/min Initially 750 mg then 500 mg every 48 hr, or initially 500 mg then 250 mg every 48 hr, or 250 mg every 48 hr, hemodialysis or chronic ambulatory peritoneal dialysis Initially 750 mg then 500 mg every 48 hr, or initially 500 mg then 250 mg every 48 hr. Childn Inhalational anthrax (post-exposure) ≥50 kg 500 mg once every 24 hr for 60 days, <50 kg & ≥6 mth 8 mg/kg/dose (not to exceed 250 mg/dose) every 12 hr for 60 days. Plague ≥50 kg 500 mg once every 24 hr for 10-14 days, <50 kg & ≥6 mth 8 mg/kg/dose (not to exceed 250 mg/dose) every 12 hr for 10-14 days.
Administration
May be taken with or without food: Take at least 2 hr before or 2 hr after antacids containing Ca/Mg/Al, after sucralfate or metal cations (eg, Fe), multivit prep w/ Zn, or didanosine.
Contraindications
Hypersensitivity to levofloxacin or other quinolones. Patients w/ epilepsy; history of tendinitis or tendon rupture associated w/ use of any member of the quinolone group.
Special Precautions
Discontinue use immediately at 1st appearance of skin rash, jaundice, or any other sign of hypersensitivity; at 1st signs or symptoms of any disabling & potentially irreversible serious adverse reaction eg, tendinitis & tendon rupture, peripheral neuropathy, & CNS effects eg, psychiatric & CNS adverse reactions; if patient develops signs & symptoms of hepatitis; if Clostridium difficile-associated diarrhea is suspected or confirmed; if hypoglycemic reaction occurs; if photosensitivity/phototoxicity occurs. Avoid use in patients w/ history of myasthenia gravis; known prolongation of QT interval, uncorrected electrolyte imbalance (eg, hypokalemia & hypomagnesemia), cardiac disease (eg, heart failure, MI & bradycardia), & those receiving drugs known to prolong QT interval eg, class IA (quinidine, procainamide), or III (amiodarone, sotalol) antiarrhythmic agents, TCAs, macrolides & antipsychotics. Post-exposure prevention of inhalation anthrax. Duration of >28 days in adults or >14 days in childn. Long-term or repeated use may result in overgrowth of non-susceptible organisms including fungi. Vision disorders. Reserve for use in patients w/ no alternative treatment options for uncomplicated UTI, acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis. Patients w/ peripheral atherosclerotic vascular disease, HTN, or those w/ +ve family history of aneurysm, or those diagnosed w/ preexisting aortic aneurysm &/or aortic dissection, or conditions predisposing for aortic aneurysm & dissection eg, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, HTN, known atherosclerosis; latent or actual defects in G6PD activity who may be prone to hemolytic reactions. Avoid excessive exposure to sun or UV light. Ensure adequate hydration in patients. Carefully monitor blood glucose in patients receiving concomitant oral hypoglycemic agent (eg, glyburide) or insulin. Perform periodic assessment of organ system functions including renal, hepatic, & hematopoietic during prolonged treatment. May give false +ve urine screening results for opiates; false -ve results in bacteriological diagnosis of Tb. Avoid performing tasks requiring complete mental alertness eg, driving & operating machinery. Renal (CrCl <50 mL/min) & hepatic impairment. Not to be used during pregnancy. Lactation. Increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, & gait abnormality) in childn. Childn <6 mth. Elderly.
Adverse Reactions
GI effects (eg, nausea, diarrhea, constipation), headache, insomnia, & dizziness.
Drug Interactions
GI absorption may be interfered resulting in lower systemic levels by antacids containing Ca, Mg, or Al, sucralfate, didanosine, metal cations (eg, Fe), & multivit prep w/ Zn or any products containing these components. Potential pharmacologic interaction (additive effects on QT interval prolongation) w/ class IA (eg, quinidine, procainamide) or III (eg, amiodarone, sotalol) antiarrhythmic agents; fluoxetine or imipramine. Disturbances of blood glucose including hyperglycemia & hypoglycemia w/ antidiabetic agent. Possible pharmacokinetic interactions (increased AUC of immunosuppressive agent) w/ ciclosporin & tacrolimus. May increase risk of tendon rupture w/ corticosteroids particularly in the elderly. Prolonged QT interval w/ fluconazole. May increase risk of CNS stimulation & convulsive seizures w/ NSAIDs. Prolonged elimination t½, elevated serum levels & subsequent increase in risk of related adverse reactions of theophylline. Enhanced effects of warfarin.
MIMS Class
Quinolones
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
RiteMED Levofloxacin FC tab 500 mg
Packing/Price
100's (P5,400/box, P54/film-coated tab)
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