Hexagon Pharma


Concise Prescribing Info
Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial & community-acquired pneumonia, complicated & uncomplicated skin & skin structure infections, chronic bacterial prostatitis, complicated UTI & acute pyelonephritis.
Dosage/Direction for Use
Resp infection 500 mg once daily for 5-14 days. Uncomplicated skin infection 500 mg once daily for 7-10 days. Chronic prostate infection 500 mg once daily for 28 days. Pneumonia 750 mg once daily. Complicated skin infection 750 mg once daily for 7-14 days. Kidney & urinary infection 250 mg once daily for 3-10 days.
May be taken with or without food: Take at least 2 hr before or after Fe salts, antacids & sucralfate. Ensure adequate fluid intake.
Hypersensitivity to levofloxacin & quinolones. Childn.
Special Precautions
Known or suspected CNS disorder predisposing to seizure or lower seizure threshold (eg, severe cerebral arteriosclerosis, epilepsy, certain drug therapy, renal dysfunction). Careful monitoring of blood glucose in concomitant use w/ oral hypoglycemics (eg, glyburide/glibenclamide) or insulin. Discontinue immediately & initiate appropriate therapy if hypoglycemic reaction occur. Discontinue use if convulsion, toxic psychoses, increased intracranial pressure or CNS stimulation occurs & at 1st appearance of skin rash or any other sign of hypersensitivity occur. Avoid use in patients w/ known QT interval prolongation, uncorrected hypokalemia & those receiving class Ia (quinidine, procainamide) & III (amiodarone, sotalol) antiarrhythmics. Maintain adequate hydration.
Adverse Reactions
Ascites, allergic reaction, asthenia, edema, fever, headache, hot flashes, flu-like symptoms, leg pain, malaise, rigors, substernal chest pain, syncope, multiple organ failure, changed temperature sensation, w/drawal syndrome; cardiac failure, HTN, aggravated HTN, hypotension, postural hypotension; convulsion, hyperesthenia, hyperkinesia, hypertonia, hypoesthenia, involuntary muscle contraction, migraine, paresthesia, paralysis, speech disorder, stupor, tremor, vertigo, encephalopathy, abnormal gait, leg cramps, intracranial HTN, ataxia; dry mouth, dysphagia, esophagitis, GERD, GI hemorrhage, glossitis, intestinal obstruction, pancreatitis, tongue edema, melena, stomatitis; abnormal hepatic function, cholecystitis, cholelithiasis, increased hepatic enzyme, hepatic failure, jaundice; airways obstruction, aspiration, asthma, bronchitis, bronchospasm, chronic obstructive airway disease, coughing, hemoptysis, epistaxis, hypoxia, laryngitis, pleural effusion, pleurisy, pneumonitis, pneumonia, pneumothorax, pulmonary edema.
Drug Interactions
Reduced absorption w/ Al- & Mg-containing antacids, sucralfate, metal cations eg, Fe & multivit w/ Zn.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Trulev film-coated tab 500 mg
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