Lefloxin

Lefloxin

levofloxacin

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Levofloxacin
Indications/Uses
Susceptible bacterial infections eg, community-acquired & nosocomial pneumonia, complicated & uncomplicated skin infections, mild to moderate UTI & pyelonephritis, acute bacterial sinusitis & exacerbation of chronic bronchitis, chronic bacterial prostatitis, 3rd-line therapy for H. pylori infection. Empirical treatment for community-acquired pneumonia.
Dosage/Direction for Use
FC tab Adult w/ normal renal function (CrCl >80 mL/min) All doses to be given once daily. Community-acquired pneumonia 500 mg for 7-14 days or 750 mg for 5 days. Nosocomial pneumonia & complicated skin infections 750 mg for 7-14 days. Skin infections 500 mg for 7-10 days. Complicated UTI 250 mg for 10 days or 750 mg for 5 days. Uncomplicated UTI 250 mg for 3 days. Pyelonephritis 250 mg for 10 days. Acute pyelonephritis 750 mg for 5 days. Acute bacterial sinusitis 500 mg for 10-14 days or 750 mg for 5 days. Acute exacerbation of chronic bronchitis 500 mg for 7 days or 750 mg for 5 days. Chronic bacterial prostatitis 500 mg for 28 days. H. pylori infection 500 mg for 10 days. IV infusion Infuse slowly for 60 or 90 min every 24 hr over at least 60 min for 250 mg or 500 mg dose, or 90 min for 750 mg dose. Patient w/ normal renal function (CrCl >80 mL/min) All doses to be given every 24 hr. Community-acquired pneumonia 500 mg for 7-14 days or 750 mg for 5 days. Nosocomial pneumonia/complicated skin infection 750 mg for 7-14 days. Uncomplicated skin infection 500 mg for 7-10 days. UTI & pyelonephritis 250 mg for 10 days. Complicated UTI & acute pyelonephritis 750 mg for 5 days. Renal impairment FC tab Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia & skin infections CrCl 20-49 mL/min Initially 500 mg, then 250 mg every 24 hr, CrCl 10-19 mL/min & hemodialysis or peritoneal dialysis Initially 500 mg, then 250 mg every 48 hr. Complicated skin infections, nosocomial pneumonia & community-acquired pneumonia CrCl 20-49 mL/min Initial & subsequent dose: 750 mg every 48 hr, CrCl 10-19 mL/min & hemodialysis or peritoneal dialysis Initially 750 mg, then 500 mg every 48 hr. Complicated UTI & pyelonephritis CrCl 10-19 mL/min Initial & subsequent dose: 250 mg every 48 hr. IV infusion Community-acquired pneumonia & skin infections CrCl 20-49 mL/min Initially 500 mg, then 250 mg every 24 hr, CrCl 10-19 mL/min & hemodialysis or peritoneal dialysis Initially 500 mg, then 250 mg every 48 hr. Community-acquired pneumonia, nosocomial pneumonia & complicated skin infections CrCl 20-49 mL/min Initial & subsequent dose: 750 mg every 48 hr, CrCl 10-19 mL/min & hemodialysis or peritoneal dialysis Initially 750 mg, then 500 mg every 48 hr. UTI & pyelonephritis CrCl 10-19 mL/min Initial & subsequent dose: 250 mg every 48 hr.
Administration
May be taken with or without food: Ensure adequate fluid intake.
Contraindications
History of hypersensitivity to levofloxacin & any other quinolones. Epilepsy; history of tendon disorder related to fluoroquinolones. Pregnancy & lactation. Childn & adolescents <16 yr.
Special Precautions
Discontinue if symptoms of hypersensitivity vasculitis eg, pyrexia, abdominal pain, arthralgia, purpura or maculopapules & skin biopsy evidence of leukocytoclastic vasculitis; rash, malaise, myalgia, arthralgia & tendonitis; abdominal pain & frequent diarrhea; pain & edema in peritendinous region; loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of eyes & skin, light colored feces or dark colored urine are observed. Serious colitis w/ bloody stool eg, pseudomembranous colitis. Rhabdomyolysis characterized by myalgia, weakness, elevated creatine kinase (creatine phosphokinase) & increased myoglobin in plasma & urine w/ acute exacerbation of renal function. Tendon disorder eg, Achilles tendonitis or tendon rupture; increased tendonitis & tendon rupture in elderly >60 yr, on concomitant corticosteroid therapy & transplant recipients. Symptoms of pancytopenia & agranulocytosis (eg, pyrexia, pharynx pain, malaise), hemolytic anemia w/ hemoglobinuria or thrombocytopenia. Interstitial pneumonia or eosinophilic pneumonia accompanied w/ pyrexia, cough, dyspnea, abnormal chest X-ray, or eosinophilia. Confusion, delirium, depression. Dizziness, headache, nausea or vomiting on 750 mg dose than 500 mg dose. May exacerbate symptoms of myasthenia gravis. Clostridium difficile-associated diarrhea & colitis. May cause QT prolongation; phototoxicity reaction including TEN, SJS & erythema multiforme; dysglycemia in diabetic patients. Patients w/ CNS disorder predisposing to seizure dosing dependent; risks of QT prolongation including geriatric, cardiac disease especially arrhythmia, HTN & hypokalemia; serious heart disease eg, arrhythmia & ischemic heart disease; uncorrected electrolyte imbalance eg, hypokalemia, hypomagnesemia. Patient exposed to direct sunlight. Perform culture & sensitivity test to determine causative microorganism & to prevent development of drug resistance. Maintain adequate hydration to prevent formation of highly concentrated urine. Avoid concomitant use w/ QT prolonging drugs including antiarrhythmic class IA (quinidine, procainamide), class III (amiodarone), cisapride, erythromycin, antipsychotics & TCAs. Concomitant use w/ warfarin; oral hypoglycemic agent or insulin prep in diabetic patients. False -ve results in bacteriological diagnosis of TB. May impair ability to drive or operate machines. Hepatic fulminant & function disorder or jaundice; severe hepatotoxicity, including acute hepatitis especially in geriatric patients. Renal impairment. Avoid use in pregnancy & lactation. Discontinue lactation if drug is necessary to breastfeeding women. Not to be used in ped patients. Elderly. IV infusion: Not to be admixed w/ other drugs or infused simultaneously through same tubing w/ other drugs; infused through same tubing w/ any soln containing multivalent cations eg, Mg.
Adverse Reactions
Nausea, vomiting, abdominal pain, loss of appetite, abdominal distension, colitis, bloody stool, hypo-/hyperglycemia, headache, dizziness, somnolence, insomnia, numbness, tremor, restlessness, palpitation, confusion, delirium, depression, seizure, disturbed consciousness, abnormal vision, hearing loss, ageusia, anosmia, hallucination, arthralgia, myalgia, tendinopathy, tendinitis, tendon rupture (Achilles tendon rupture), weakness, exacerbation of myasthenia gravis, rhabdomyolysis, abnormal gait, rash, pruritus, urticaria, bronchospasm, dyspnea, interstitial pneumonia, eosinophilic pneumonia, angioedema, hypotension, hypersensitivity reaction, anaphylactic reaction, photosensitivity, SJS, TEN or Lyell's syndrome, erythema multiforme, hypersensitivity vasculitis, increased liver enzymes (ALT, AST), bilirubin & creatinine, hepatitis, fulminant hepatitis, jaundice, acute renal failure, interstitial nephritis, hematologic effects (eg, eosinophilia, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia), tiredness, overgrowth of fungi, development of drug-resistant bacteria, allergic pneumonitis, fever, arrhythmia, cardiac arrest, tachycardia, torsades de pointes, prolonged QT interval, edema, pancreatitis, face & tongue edema, phlebitis.
Drug Interactions
Decreased absorption w/ antacid, sucralfate, metal cation medications or multivit composed of Mg, Al, ferrous sulfate, Zn, Ca or Fe. Increased risk of CNS stimulation w/ theophylline, NSAIDs (eg, fenbufen). Increased prothrombin time w/ warfarin. May alter blood glucose conc & symptomatic hyper-/hypoglycemia w/ antidiabetics. Additive effect on QT prolongation w/ antidepressants (eg, fluoxetine, imipramine) & antiarrhythmics.
MIMS Class
Quinolones
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
100-mg/500-mg FC tab/IV infusion: D; 750-mg FC tab: S
Presentation/Packing
Form
Lefloxin FC tab 100 mg
Packing/Price
10's
Form
Lefloxin FC tab 500 mg
Packing/Price
10 × 10's;10's
Form
Lefloxin FC tab 750 mg
Packing/Price
5's
Form
Lefloxin infusion 250 mg/50 mL
Packing/Price
1's
Form
Lefloxin infusion 500 mg/100 mL
Packing/Price
1's
Form
Lefloxin infusion 750 mg/150 mL
Packing/Price
1's
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