Levox

Levox

levofloxacin

Manufacturer:

Westmont

Distributor:

United Lab
Concise Prescribing Info
Contents
Levofloxacin hemihydrate
Indications/Uses
Mild, moderate or severe infections: Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, health-care associated pneumonia; complicated skin & skin structure infections (SSSI), uncomplicated SSSI including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections; complicated/uncomplicated UTI, acute pyelonephritis, chronic bacterial prostatitis for adults ≥18 yr. Reduce the incidence or progression of inhalational anthrax in adults & childn ≥6 mth. Treatment of plague including pneumonic & septicemic plague. Prophylaxis for plague in adults & childn ≥6 mth.
Dosage/Direction for Use
Adult Tab 250-500 mg once daily. Inj 500 mg by slow infusion over 60 min every 24 hr or 750 mg administered by slow infusion over 90 min every 24 hr. Adult w/ normal renal function (CrCl ≥50 mL/min) PO/IV 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 or 750 mg once daily for 5 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 SSSI 750 mg once daily for 7-14 days. Uncomplicated SSSI 500 mg for 7-10 days. Complicated UTI 250 mg once daily for 10 days or 750 mg once daily 5 days. Acute pyelonephritis 250 mg 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) Adult 500 mg once daily for 60 days. Childn ≥50 kg 500 mg every 24 hr for 60 days, <50 kg & ≥6 mth 8 mg/kg (not to exceed 250 mg/dose) every 12 hr for 60 days. Plague Adult 500 mg once daily for 10-14 days. Childn ≥50 kg 500 mg every 24 hr for 60 days, <50 kg & ≥6 mth 8 mg/kg (not to exceed 250 mg/dose) every 12 hr for 10-14 days. Renal impairment CrCl 20-49 mL/min 750 mg 750 mg every 48 hr. 500 mg Initially 500 mg, then 250 mg every 24 hr, 10-29 mL min 750 mg Initially 750 mg then 500 mg every 48 hr. 500 mg Initially 500 mg then 250 mg every 48 hr. 250 mg 250 mg every 48 hr. Hemodialysis or chronic ambulatory peritoneal dialysis 750 mg Initially 750 mg then 500 mg every 48 hr. 500 mg Initially 500 mg then 250 mg every 48 hr.
Administration
May be taken with or without food: Ensure adequate fluid intake.
Special Precautions
Hypersensitivity in levofloxacin & fluoroquinolones. Risk of tendinitis & tendon rupture in all ages especially patients taking corticosteroids, patients w/ kidney, heart or lung transplants. Discontinue treatment if pain, swelling, inflammation, or rupture of a tendon occurs & 1st appearance of skin rash or any other sign of hypersensitivity; patient experiences symptoms of neuropathy; hypoglycemia. Myasthenia gravis. Severe hepatotoxicity. May cause CNS stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, anxiety & rarely, suicidal thoughts or acts. Patients w/ unstable known or suspected CNS disorders, other risk factors that may predispose to seizures or lower the seizure threshold or unstable psychiatric illness; known prolongation of the QT interval, uncorrected hypokalemia, significant bradycardia, cardiomyopathy, or MI; latent or actual defects in G6PD activity. C. difficile-associated diarrhea. Musculoskeletal disorders in childn. Blood glucose disturbances usually in diabetic patients receiving concomitant treatment w/ an oral hypoglycemic agent (eg, glibenclamide) or w/ insulin. Overgrowth of non-susceptible organisms (long-term or repeated use). Monitor blood glucose in patients receiving concomitant treatment w/ oral hypoglycemic agent or w/ insulin. Avoid direct exposure to excessive sunlight or UV radiation during treatment. Periodic assessment of organ system functions, including renal, hepatic & hematopoietic. False +ve urine screening results for opiates. False -ve results in bacteriological diagnosis of TB. Adequate hydration during therapy to prevent the formation of a highly conc urine. Discontinue treatment if phototoxicity occurs. Rapid or bolus IV infusion may result in hypotension; administer over a period of not less than 60 min. Avoid performing tasks which require complete mental alertness eg, driving & operating machinery. Pregnancy & lactation. Childn <6 mth. Elderly.
Adverse Reactions
Nausea, vomiting, diarrhea, constipation, headache, insomnia, & dizziness.
Drug Interactions
May interfere w/ the absorption w/ antacids containing Ca, Mg, or Al; sucralfate, didanosine, metal cations (eg, Fe), multivit prep w/ Zn. Potential pharmacologic interaction w/ class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol); fluoxetine or imipramine. May cause disturbances of blood glucose w/ antidiabetic agents. Increased AUC of ciclosporin or tacrolimus. Increased risk of tendon rupture w/ corticosteroids. Prolonged QT interval w/ fluconazole. Increased risk of CNS stimulation & convulsive seizures w/ NSAIDs. Prolonged elimination t½, elevated serum theophylline levels & increased risk of theophylline-related adverse reactions w/ theophylline. Enhanced effect of warfarin. False -ve results in bacteriological diagnosis of TB. Tab: May interfere w/ the GI absorption w/ antacids, sucralfate, metal cations & Zn-containing multivit prep. Infusion: Do not co-administer w/ any soln containing multivalent cations eg, Mg through the same IV line.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Levox infusion 250 mg/50 mL
Packing/Price
50 mL x 1's (P806.76/vial)
Form
Levox infusion 500 mg/100 mL
Packing/Price
100 mL x 1's (P1,427.4/vial)
Form
Levox FC tab 500 mg
Packing/Price
40's (P7,194.6/pack)
Form
Levox FC tab 750 mg
Packing/Price
20's (P4,704.76/pack)
Form
Levox infusion 750 mg/150 mL
Packing/Price
150 mL x 1's
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