Cravit IV

Cravit IV

levofloxacin

Manufacturer:

Daiichi Sankyo

Distributor:

Ouiheng International Healthcare
Concise Prescribing Info
Contents
Levofloxacin
Indications/Uses
Adults ≥16 yr w/ mild, moderate & severe infections caused by susceptible strains of the designated microorganisms in the conditions as follows: Community-acquired pneumonia due to Staph aureus, Strep pneumoniae (including penicillin-resistant strains), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae. Nosocomial pneumonia due to methicillin-susceptible Staph aureus, Pseudomonas aeruginosa, Serratia marcescens, E. coli, Klebsiella pneumoniae, Haemophilus influenzae or Strep pneumoniae. Adjunctive therapy should be used as clinically indicated. Uncomplicated skin & skin structure infections (mild or moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections due to Staph aureus or Strep pyogenes. Complicated skin & skin structure infections due to methicillin-susceptible Staph aureus, Enterococcus faecalis, Strep pyogenes or Proteus mirabilis. UTI (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, E. coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa or Staph saprophyticus. Pyelonephritis (mild to moderate) caused by E. coli.
Dosage/Direction for Use
IV infusion 500 mg by slow IV infusion over 60 min every 24 hr or 750 mg by slow IV infusion over 90 min every 24 hr. Community-acquired pneumonia 500 mg daily for 7-14 days or 750 mg daily for 5 days. Nosocomial pneumonia, complicated skin & soft tissue infection (SSTI) 750 mg daily for 7-14 days. Uncomplicated SSTI 500 mg daily for 7-10 days. UTI, pyelonephritis 250 mg daily for 10 days. Complicated UTI, acute pyelonephritis 750 mg for 5 days. Impaired renal function Community-acquired pneumonia/uncomplicated skin & skin structure infections (SSSI) CrCl 20-49 mL/min: Initially 500 mg. Subsequent dose: 250 mg every 24 hr, CrCl 10-19 mL/min, hemodialysis & chronic ambulatory peritoneal dialysis (CAPD): Initially 500 mg. Subsequent dose: 250 mg every 48 hr. Community acquired pneumonia/nosocomial pneumonia/complicated SSSI CrCl 20-49 mL/min: Initially 750 mg. Subsequent dose: 750 mg every 48 hr, CrCl 10-19 mL/min, hemodialysis, CAPD: Initially 750 mg. Subsequent dose: 500 mg every 48 hr. Complicated UTI/pyelonephritis CrCl 10-19 mL/min: Initially 250 mg. Subsequent dose: 250 mg every 48 hr.
Contraindications
Hypersensitivity to levofloxacin or ofloxacin. Epilepsy, history of tendon disorder related to fluoroquinolones. Childn/adolescents <16 yr. Pregnancy & lactation.
Special Precautions
Do not administer by rapid or bolus IV inj. Patients w/ severe renal impairment. History of hypersensitivity to quinolone antibiotics. Severe renal impairment. Known or suspected CNS disorder eg, epilepsy or history of convulsive diseases. Diabetics receiving concomitant treatment w/ an oral hypoglycemic agent (especially sulfonylureas) or w/ insulin prep. Serious heart diseases (eg, arrhythmia & ischemic heart disease), uncorrected electrolyte imbalance (eg, hypokalemia, hypomagnesemia) & receiving Class IA & III antiarrhythmic agents; QT prolongation may occur. Myasthenia gravis. Ensure adequate hydration during therapy. False-negative results in bacteriological diagnosis of TB. Avoid excessive exposure to sunlight. Patients complicated w/ aortic aneurysm or aortic dissection or who have previous history, positive family history, or risk factors (Marfan syndromre) of aortic aneurysm or dissection. May impair ability to concentrate & react, (eg, driving or operating machinery). Geriatric patients. Ped patients.
Adverse Reactions
Shock or anaphylactoid reaction; toxic epidermal necrolysis or oculomucocutaneous syndrome; convulsion; QT prolongation & ventricular tachycardia; acute renal failure or interstitial nephritis; hepatitis fulminant, hepatic function disorder or jaundice; pancytopenia, agranulocytosis, hemolytic anemia w/ hemoglobinuria or thrombocytopenia; interstitial pneumonia or eosinophilic pneumonia w/ pyrexia, cough, dyspnea, abnormal chest X-ray or eosinophilia; serious colitis w/ bloody stool eg, pseudomembranous colitis; rhabdomyolysis; dysglycemia, hypoglycemia; tendon disorders eg, Achilles tendonitis or tendon rupture; psychiatric symptoms eg, confusion, delirium & depression; hypersensitivity vasculitis; exacerbation of myasthenia gravis; aortic aneurysm, aortic dissection. Infusion site reaction (erythema, pruritus, swelling, pain, induration, warmth, discomfort, phlebitis, vasculitis, angiopathy, puncture site pain). Anemia; sleep loss; dizziness, vertigo, headache; nausea, vomiting, diarrhea, abdominal discomfort; increased AST/ALT, LDH, eosinophil count, decreased WBC count.
Drug Interactions
Lowered cerebral seizure threshold w/ theophylline, fenbufen, or similar NSAIDs. Hyperglycemia & hypoglycemia w/ anti-diabetic agents. May potentiate effect of warfarin. QT prolongation may occur w/ drugs known to prolong QT, class IA antiarrhythmics (eg, quinidine sulfate & procainamide HCl), class III antiarrhythmics (eg, amiodarone HCl & sotalol HCl).
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Cravit IV infusion 250 mg/50 mL
Packing/Price
1's
Form
Cravit IV infusion 750 mg/150 mL
Packing/Price
1's
Form
Cravit IV infusion 500 mg/100 mL
Packing/Price
1's
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