Tigeron 500/Tigeron 750

Tigeron 500/Tigeron 750

levofloxacin

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare
Concise Prescribing Info
Contents
Levofloxacin hemihydrate
Indications/Uses
Treatment of acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, community-acquired pneumonia, complicated UTI including pyelonephritis, chronic bacterial prostatitis, skin & soft tissue infections (uncomplicated & complicated), inhalation anthrax.
Dosage/Direction for Use
Adult w/ normal kidney 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 7-10 days or 750 mg once daily for 3-5 days. Community-acquired pneumonia 500 once daily or bid for 7-14 days or 750 mg once daily for 5 days. Chronic bacterial prostatitis 500 mg once daily for 28 days. Complicated UTI including pyelonephritis 500 mg once daily for 7-14 days. Uncomplicated skin & soft tissues infections 500 mg once daily or bid for 7-10 days. Complicated skin & soft tissue infections 750 mg once daily for 7-14 days. Inhalation anthrax 500 mg once daily for 8 wk. Renal impairment CrCl 50-20 mL/min Initially 250 mg then 125 mg every 24 hr. Initially 500 mg then 250 mg every 24 hr. Initially 500 mg then 250 mg every 12 hr, 19-10 mL/min Initially 250 mg then 125 mg every 48 hr. Initially 500 mg then 125 mg every 24 hr. Initially 500 mg then 125 mg every 12 hr, <10 mL/min (also in hemodialysis & CAPD) Initially 250 mg then 125 mg every 48 hr. Initially 500 mg then 125 mg every 24 hr. Initially 500 mg then 125 mg every 24 hr.
Administration
May be taken with or without food: Take during or between meals. Swallow whole w/ sufficient amount of liqd, do not crush. Take at least 2 hr before or after Fe salts, antacids & sucralfate.
Contraindications
Hypersensitivity to levofloxacin or other quinolone. Patients w/ epilepsy, history of tendon disorders related to fluoroquinolone administration. Pregnancy & lactation. Childn or growing adolescents.
Special Precautions
Serious, potentially fatal hypersensitivity reactions (eg, angioedema up to anaphylactic shock). Not recommended for the treatment of known or suspected MRSA infections. Resistance to fluoroquinolones of E. coli. Increased risk of tendinitis & tendon rupture in elderly >60 yr, in patients receiving daily doses of 1,000 mg & those using corticosteroids. Consider diagnosis of C. difficile-associated disease in patients who develop serious diarrhoea during or after treatment; stop immediately if suspected or confirmed. Patients predisposed to seizures or concomitant treatment w/ active substances that lower the cerebral seizure threshold eg, theophylline, psychotic patients or w/ history of psychiatric disease. G6PD patients. Renal impairment. Severe bullous skin reactions eg, Stevens-Johnson syndrome or toxic epidermal necrolysis. Monitor carefully blood glucose. Avoid exposure to strong sunlight or artificial UV rays (eg, sunray lamp, solarium), during treatment & 48 hr following treatment discontinuation. Patients treated w/ vit K antagonists. Monitor coagulation tests. Psychotic patients or in patients w/ history of psychiatric disease; known risk factors for prolongation of the QT interval eg, congenital long QT syndrome concomitant use of drugs that are known to prolong the QT interval (eg, class IA & III antiarrhythmics, TCAs, macrolides, antipsychotics). Uncorrected electrolyte imbalance (eg, hypokalemia, hypomagnesemia) cardiac disease (eg, heart failure, MI, bradycardia). Discontinue if symptoms of neuropathy occur. Fatal hepatic failure in patients w/ severe underlying diseases eg, sepsis. Stop treatment & contact the doctor if signs & symptoms of hepatic disease develop eg, anorexia, jaundice, dark urine, pruritus or tender abdomen. History of myasthenia gravis. Vision disorders. Superinfection may occur in prolonged use. May give false +ve results in determination of opiates in urine.
Adverse Reactions
Insomnia; headache, dizziness; diarrhea, vomiting, nausea; hepatic enzyme increased (ALT/AST, alkaline phosphatase, GGT).
Drug Interactions
Decreased absorption w/ Fe salts & Mg- or Al-containing antacids. Reduced bioavailability w/ sucralfate. Reduced renal clearance w/ cimetidine & probenecid. Increased half-life of ciclosporin. Increased coagulation tests (PT/INR) &/or bleeding w/ vit K antagonists eg, warfarin. Drugs known to prolong QT interval (eg, Class IA & III antiarrhythmics, TCAs, macrolides).
MIMS Class
Quinolones
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Tigeron 500 FC tab 500 mg
Packing/Price
10's;50's;5's
Form
Tigeron 750 FC tab 750 mg
Packing/Price
10's;50's;5's
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