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, uncomplicated skin & skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections; complicated UTI, chronic bacterial prostatitis; plague eg, pneumonic & septicemic plague, due to Yersinia pestis. Prophylaxis for plague. Reduce the incidence or progression reduction of inhalational following exposure to aerosolized Bacillus anthracis.
Dosage/Direction for Use
Adult Acute bacterial sinusitis, complicated UTI 500 mg once every 24 hr for 10-14 days. Acute bacterial exacerbation of chronic bronchitis 500 mg once every 24 hr for 7 days. Community-acquired pneumonia 500 mg once every 24 hr for 7-14 days. Uncomplicated skin & skin structure infections 500 mg once every 24 hr for 7-10 days. Chronic bacterial prostatitis 500 mg once every 24 hr for 28 days. Adult & childn ≥50 kg (who can swallow whole tab) Inhalational anthrax (post-exposure) 500 mg once every 24 hr for 60 days. Plague 500 mg once every 24 hr for 10-14 days. Renal impairment: CrCl 20-49 mL/min Initially 500 mg, then 250 mg every 24 hr, CrCl 10-19 mL/min, hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) Initially 500 mg, then 250 mg every 48 hr.
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 such as Fe, multivit prep w/ Zn or didanosine.
Contraindications
Hypersensitivity to levofloxacin or other quinolones.
Special Precautions
Tendinitis & tendon rupture, myasthenia gravis, hepatotoxicity, hypersensitivity, fatal reactions, CNS & cardiac disorders, peripheral neuropathy, Clostridium difficile-associated diarrhea (CDAD), musculoskeletal disorders in childn, blood glucose disturbance, G6PD deficiency, photosensitivity/phototoxicity. Concomitant use w/ corticosteroids. Periodic assessment of organ system functions eg, renal, hepatic & hematopoietic. Development of drug-resistant bacteria, overgrowth of nonsusceptible organisms eg, fungi. False +ve urine screening results for opiates; false -ve results in bacteriological diagnosis of TB. May affect ability to drive & use machines. Renal & hepatic impairment. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Nausea, vomiting, diarrhea, constipation, headache, insomnia & dizziness.
Drug Interactions
May interfere GI absorption & lowered systemic levels w/ antacid containing Ca, Mg or Al, as well as sucralfate, didanosine, metal cations eg, Fe & multivit prep w/ Zn or any products containing these components. Additive effects on QT interval prolongation w/ class IA (eg, quinidine, procainamide) or III (eg, amiodarone, sotalol) antiarrhythmic agents; antidepressants (eg, fluoxetine, imipramine); fluconazole. Disturbance of blood glucose eg, hyperglycemia, hypoglycemia w/ antidiabetic agents. Increased AUC of ciclosporin & tacrolimus. Increased risk of tendon rupture w/ corticosteroids particularly in elderly. Increased CNS stimulation & convulsive seizures w/ NSAIDs. Increased AUC & t½ w/ probenecid & cimetidine. Prolonged elimination t½, elevated serum levels & subsequent increased AR 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 (P54/film-coated tab, P5,400/box)
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