Levofloxin-Natrapharm

Levofloxin-Natrapharm

levofloxacin

Manufacturer:

Natrapharm

Distributor:

Natrapharm
Concise Prescribing Info
Contents
Levofloxacin
Indications/Uses
Resp tract infections caused by susceptible organisms including acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, community-acquired, & nosocomial pneumonia. Uncomplicated or complicated skin & skin structure infection, mild to moderate uncomplicated UTI & acute pyelonephritis caused by E. coli including cases w/ concurrent bacteremia, chronic prostatitis, uncomplicated gonorrhea, epididymitis caused by sexually transmitted enteric bacteria or when culture or nucleic acid amplification tests are -ve for N. gonorrhoeae, & meningitis. Alternative treatment of native or prosthetic valve endocarditis caused by fastidious gm -ve bacilli.
Dosage/Direction for Use
Acute sinusitis 500 mg every 24 hr for 10-14 days or 750 mg every 24 hr for 5 days. Acute exacerbations of chronic bronchitis 500 mg every 24 hr for 7 days. Community-acquired pneumonia (CAP) 500 mg every 24 hr for 7-14 days. Empiric CAP treatment or AP caused by S. pneumoniae (penicillin-susceptible strains), H. influenzae, H. parainfluenzae, Chlamydophila pneumoniae, Mycoplasma pneumoniae & P. aeruginosa 750 mg every 24 hr for 5 days. Nosocomial pneumonia 750 mg every 24 hr for 7-14 days. UTI & prostatitis 250 mg every 24 hr for 3 days. Complicated UTI or acute pyelonephritis 250 mg every 24 hr for 10 days. Complicated UTI caused by E. coli, K. pneumoniae or P. mirabilis or acute pyelonephritis caused by E. coli 750 mg every 24 hr for 5 days. Chronic prostatitis 500 mg every 24 hr for 28 days. Nongonococcal urethritis 500 mg once daily for 7 days. Pelvic inflammatory disease 500 mg once daily for 14 days w/ or w/o oral metronidazole 500 mg bid for 14 days. Traveler's diarrhea 500 mg once daily for 1-3 days. Chlamydial infection 500 mg once daily for 7 days. Post-exposure prophylaxis following suspected or confirmed inhalational anthrax Adult 500 mg once daily. Childn ≥6 mth weighing >50 kg 500 mg once daily; <50 kg 8 mg/kg every 12 hr (Max: 250 mg/dose). Uncomplicated or disseminated gonorrhea of uncomplicated cervical, urethral, or rectal gonorrhea caused by Neisseria gonorrhoeae Adult & adolescent 250 mg as a single dose. Epididymitis caused by sexually transmitted enteric bacteria or when culture or nucleic acid amplification tests are -ve for N. gonorrhoeae 500 mg once daily for 10 days. Renal impairment CrCl 20-49 mL/min 500 mg dose: Initially 500 mg then 250 mg every 24 hr, 750 mg dose: Initially 750 mg then 750 mg every 48 hr; 10-19 mL/min 250 mg dose: 250 mg every 48 hr. Dosage adjustment is not required for uncomplicated UTIs. 500 mg dose: Initially 500 mg then 250 mg every 48 hr, 750 mg dose: Initially 750 mg then 500 mg every 48 hr. Hemodialysis or CAPD patients 500 mg dose: Initially 500 mg then 250 mg every 48 hr, 750 mg dose: Initially 750 mg then 500 mg every 48 hr.
Administration
May be taken with or without food: Ensure adequate fluid intake.
Contraindications
Hypersensitivity to levofloxacin or other quinolones.
Special Precautions
Hypersensitivity &/or anaphylactic reactions. Increased risk of aortic aneurysm & dissection. Family history of aneurysm disease, or in patients w/ pre-existing aortic aneurysm &/or aortic dissection, other risk factors or conditions predisposing aortic aneurysm & dissection (eg, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, HTN, known atherosclerosis). Consult immediately the doctor if sudden abdominal, chest or back pain occurs. Increased risk of tendinitis & tendon rupture in all age groups, those receiving concomitant corticosteroids, & kidney, heart, or lung transplant recipients. Discontinue use at 1st appearance of rash, jaundice or any other signs of hypersensitivity; pain, swelling inflammation or tendon rupture; symptoms of neuropathy (eg, pain, burning, tingling, numbness, weakness) or other alterations of sensation (eg, light touch, pain, temp, position sense, vibratory sensation); loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin or eyes, light colored bowel movements or dark colored urine; hypoglycemic reaction occurs. Severe hepatotoxicity including acute hepatitis. Known or suspected CNS disorders (eg, severe cerebral arteriosclerosis, epilepsy) or other risk factors predisposing to seizures or lower the seizure threshold (eg, certain drugs, renal impairment). Possible emergence & overgrowth of nonsusceptible bacteria or fungi. Avoid in patients w/ history of prolonged QT interval, uncorrected electrolyte disorders (eg, hypokalemia) & those receiving class IA (eg, quinidine, procainamide) or III (eg, amiodarone, sotalol) antiarrhythmics. Monitor blood glucose conc in diabetic patients receiving insulin or oral hypoglycemic agents. Do not use to treat proven or suspected gonorrhea including infections acquired w/in the US or while traveling abroad. Administer 2 hr before or 2 hr after in concomitant use w/ Al- or Mg-containing antacids, sucralfate, metal cations eg, Fe or Zn including multivit prep containing Zn, or buffered didanosine. Renal impairment. Pregnancy. Discontinue during lactation. Elderly >60 yr. Risk of musculoskeletal disorders in childn.
Adverse Reactions
Symptomatic hyperglycaemia &/or hypoglycaemia usually in diabetics taking hypoglycaemics or insulin.
Drug Interactions
Additive effects on QT interval prolongation w/ class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmics agents; fluoxetine, imipramine. Decreased absorption w/ Al- or Mg-containing antacids; didanosine; ferrous sulfate or dietary supplements containing Zn, Ca, Mg, or Fe; sucralfate. Altered blood glucose conc & symptomatic hyperglycemia or hypoglycemia w/ antidiabetic therapy (eg, insulin, glyburide). Slightly increased AUC & t1/2 w/ cimetidine; probenecid. Increased risk of severe tendon disorders (eg, tendinitis, tendon rupture) w/ corticosteroids especially in elderly >60 yr. Increased AUC of cyclosporine & tacrolimus. May increase risk of CNS stimulation & seizures w/ NSAIDs. Increased t1/2 & risk of adverse effects of theophylline. Increased prothrombin time w/ warfarin.
MIMS Class
Quinolones
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Levofloxin-Natrapharm FC tab 500 mg
Packing/Price
30's (P1,884.9/box)
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