Cravit

Cravit

levofloxacin

Manufacturer:

Daiichi Sankyo

Distributor:

Zuellig Pharma

Marketer:

Daiichi Sankyo
Concise Prescribing Info
Contents
Levofloxacin
Indications/Uses
Adults (≥16 yr) w/ mild, moderate & severe infections caused by susceptible strains of microorganisms: Acute sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia, nosocomial pneumonia, uncomplicated skin & skin structure infections, complicated skin & skin structure infections, UTI, chronic bacterial prostatitis, mild to moderate pyelonephritis, empirical treatment for community acquired pneumonia. As 3rd-line therapy for patients w/ gastric ulcer caused by H. pylori infection & duodenal ulcer disease in combination w/ other antimicrobials agents & PPI.
Dosage/Direction for Use
Acute sinusitis 500 mg once daily for 10-14 days or 750 mg once daily for 5 days. Acute exacerbation of chronic bronchitis 500 mg once daily for 7 days or 750 mg once daily for 5 days. Community-acquired pneumonia 500 mg once daily for 7-14 days or 750 mg once daily for 5 days. Nosocomial pneumonia 750 mg once daily for 7-14 days. Uncomplicated SSSI 500 mg once daily for 7-10 days. Complicated SSSI 750 mg once daily for 7-14 days. Chronic bacterial prostatitis 500 mg once daily for 28 days. Complicated UTI 250 mg once daily for 10 days or 750 mg once daily for 5 days. Uncomplicated UTI 250 mg once daily for 3 days. Pyelonephritis 250 mg once daily for 10 days. Acute pyelonephritis 750 mg once daily for 5 days. H. pylori infection 500 mg once daily for 10 days. Impaired renal function Acute sinusitis/acute exacerbation of chronic bronchitis/community-acquired pneumonia/uncomplicated SSSI/chronic bacterial prostatitis CrCl 20-49 mL/min: Initially 500 mg once daily, then subsequent doses as 250 mg once daily. CrCl 10-19 mL/min: Initially 500 mg once daily, then subsequent doses as 250 mg every 48 hr. Patients undergoing hemodialyis & chronic ambulatory peritoneal dialysis (CAPD): Initially 500 mg once daily, then subsequent doses as 250 mg every 48 hr. Complicated SSSI/nosocomial pneumonia/community-acquired pneumonia CrCl 20-49 mL/min: Initially 750 mg once daily, then subsequent doses as 750 mg every 48 hr. CrCl 10-19 mL/min: 750 mg once daily, then subsequent doses as 500 mg every 48 hr. Patients undergoing hemodialysis & CAPD: Initially 750 mg once daily, then 500 mg every 48 hr. Complicated UTI/pyelonephritis CrCl 10-19 mL/min: Initially 250 mg once daily then subsequently 250 mg every 48 hr.
Administration
May be taken with or without food: Take at least 2 hr before or after Fe salts, antacids & sucralfate. Ensure adequate fluid intake.
Contraindications
Hypersensitivity to levofloxacin, ofloxacin. Epilepsy, history of tendon disorder related to fluoroquinolones. Childn/adolescents <16 yr. Pregnancy & lactation.
Special Precautions
History of hypersensitivity to quinolones. Severe renal impairment. Patients w/ known or suspected CNS disorders (eg, epilepsy or w/ a history of convulsive disease that may predispose to seizures or lower the seizure threshold). Diabetic patients receiving concomitant treatment w/ an oral hypoglycemic agent (especially sulfonylureas or w/ insulin prep); serious heart disease (eg, arrhythmia & ischemic heart disease), patients w/ uncorrected electrolyte imbalance (eg, hypokalemia, hypomagnesemia) & patients receiving Class IA & III antiarrhythmic agents; patients w/ myasthenia gravis. Maintain adequate hydration of patients. May give false -ve results in diagnosis of TB. Discontinue use if phototoxicity occurs. Avoid excessive exposure to sunlight. Patients complicated w/ aortic aneurysm or aortic dissection or who have a previous history, +ve family history or risk factors (Marfan syndrome) of aortic aneurysm or aortic dissection. May impair ability to drive or operate machinery. Geriatric patients.
Adverse Reactions
Shock or anaphylactoid reaction; TEN or oculomucocutaenous syndrome (SJS); convulsion; prolonged QT & ventricular tachycardia (including Torsades de Pointes); 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 accompanied w/ pyrexia, cough, dyspnea, abnormal chest X-ray or eosinophilia; serious colitis w/ bloody stool eg, Pseudomembranous colitis; rhabdomyolysis; dysglycemia; tendon disorders eg, Achilles tendonitis or tendon rupture; psychiatric symptoms eg, confusion, delirium & depression; hypersensitivity vasculitis; exacerbation of myasthenia gravis; dizziness, headache, nausea or vomiting; aortic aneurysm, aortic dissection.
Drug Interactions
GI absorption interfered w/ Mg- & Al-containing antacids, sucralfate, metal cations & multivit prep w/ zinc. Pronounced lowering of the cerebral seizure threshold may occur w/ theophylline, fenbufen, phenylacetic acid or propionic acid derivatives. Hyperglycemia & hypoglycemia may occur w/ antidiabetic agents. Prolonged prothrombin time of warfarin. QT prolongation may occur w/ drugs known to cause QT prolongation, class IA antiarrhythmics (eg, quinidine sulfate, procainamide HCl), class III antiarrhythmics (eg, amiodarone HCl & sotalol HCl) & delamanid.
MIMS Class
Quinolones
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Cravit FC tab 500 mg
Packing/Price
10's;5's
Form
Cravit FC tab 750 mg
Packing/Price
1 × 5's
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