Natrapharm

Regulatory Class: Rx

C: Levofloxacin hemihydrate

I: Treatment of infections caused by susceptible strains of gm +ve & gm -ve microorganisms.

D: Adult Acute sinusitis 500 mg once daily for 10-14 days or 750 mg once daily for 5 days. Acute exacerbations of chronic bronchitis, chlamydial infections & nongonococcal urethritis 500 mg once daily for 7 days. Community-acquired pneumonia (CAP) 500 mg once daily for 7-14 days. Empiric CAP treatment or CAP caused by S. pneumoniae (penicillin-susceptible strains), H. influenzae, H. parainfluenzae, C. pneumoniae, M. pneumoniae & P. aeruginosa 750 mg once daily for 5 days. Nosocomial pneumonia 750 mg once daily for 7-14 days. UTI & prostatitis 250 mg once daily for 3 days. Complicated UTI caused by E. coli, K. pneumoniae or P. mirabilis or acute pyelonephritis caused by E. coli 250 mg once daily for 10 days or 750 mg once daily for 5 days. Chronic prostatitis 500 mg once daily for 28 days. Epididymitis -ve for N. gonorrhea 500 mg once daily for 10 days. Pelvic inflammatory disease 500 mg once daily for 14 days w/ or w/o metronidazole 500 mg bid for 14 days. Traveler's diarrhea 500 mg once daily for 1-3 days. Post-exposure prophylaxis to inhalational anthrax Adult 500 mg once daily. Childn ≥6 mth weighing >50 kg 500 mg once daily; <50 kg 8 mg/kg (Max: 250 mg/dose) 12 hrly. Uncomplicated or disseminated gonorrhea & associated infections Adult & adolescent 250 mg as a single dose.

A:  Ensure adequate fluid intake.

CI: Known hypersensitivity to levofloxacin or other quinolones. Treatment of proven or suspected gonorrhea.

SP: Monitor closely blood glucose conc in patients taking hypoglycemics or insulin. Discontinue use if pain, swelling, inflammation or rupture of tendon; symptoms of neuropathy or other alterations of sensation & hypoglycemic reactions occurs; if patient experiences 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 & at 1st appearance of rash, jaundice or any other signs of hypersensitivity. Known or suspected CNS disorders or other risk factors predisposing to seizures or lower the seizure threshold. Superinfection/Clostridium difficile-associated diarrhea & colitis. Increased risk of tendonitis & tendon rupture, musculoskeletal disorders (childn) & severe hepatotoxicity. History of prolonged QT interval, uncorrected electrolyte disorders eg, hypokalemia & concomitant use w/ class IA or III antiarrhythmics. Renal impairment. Pregnancy & lactation. Elderly >60 yr especially those receiving concomitant corticosteroids. Infant & childn ≥6 mth except in post-exposure prophylaxis against inhalational anthrax.

AR: Hyperglycemia &/or hypoglycemia; hypersensitivity &/or anaphylactic reactions; seizures, toxic psychoses, increased intracranial pressure & CNS stimulation; peripheral neuropathy; prolonged QT interval.

INT: Class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmics; fluoxetine, imipramine; antidiabetic agents (insulin, glyburide); corticosteroids; cyclosporin, tacrolimus; NSAIDs; theophylline; warfarin; Mg- or Al-containing antacids, buffered didanosine, sucralfate, multivit & minerals containing Fe, Ca, Mg or Zn (at least 2 hr apart).

P/P: FC tab 500 mg x 30's.

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