Cravit

Cravit

levofloxacin

Manufacturer:

Daiichi Sankyo

Distributor:

Ouiheng International Healthcare

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 acquaired pneumonia. As 3rd-line therapy for patients w/ gastric ulcer caused by H. pylori infection & duodenal ulcer disease in combination w/ other antimicrobials agents & proton-pump inhibitor.
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-negative 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, positive 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; toxic epidermal necrolysis or oculomucocutaenous syndrome (Stevens-Johnson syndrome); 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
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Cravit FC tab 750 mg
Packing/Price
1 × 5's
Form
Cravit FC tab 500 mg
Packing/Price
10's;5's
Form
Cravit FC tab 250 mg
Packing/Price
5's
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