Full Prescribing Info
Levofloxacin hemihydrate.
Each Film-coated Tablets contains: Levofloxacin (as Hemihydrate) 500 mg and 750 mg.
Levofloxacin is the S-(-)-isomer of the fluoroquinolone antibacterial ofloxacin. It is active against a number of gram-positive and gram-negative bacteria. Because of its broad spectrum of action, levofloxacin is frequently prescribed empirically for a wide range of infections like pneumonia and urinary tract infection before the specific casual organism is known. If the casual organism is identified, levofloxacin is sometimes discontinued and the patient may be switched to an antibiotic with a narrower spectrum.
Pharmacology: Pharmacokinetics: Levofloxacin is rapidly and almost completely absorbed following oral administration with peak plasma concentrations achieved within an hour of a dose. It is distributed into body tissues including the bronchial mucosa and lungs, but penetration into CSF is relatively poor. Levofloxacin is approximately 30 to 40% bound to plasma proteins. It is only metabolized to a small degree to inactive metabolites. The elimination half-life of levofloxacin is 6 to 8 hours, although this may be prolonged in patients with renal impairment. Levofloxacin is excreted largely unchanged, primarily in the urine. It is not removed by hemodialysis or peritoneal dialysis.
Levofloxacin is used for the treatment of susceptible infections including uncomplicated urinary-tract infections, chronic bacterial prostatitis, complicated skin infections, hospital acquired pneumonia, community-acquired pneumonia or for acute bacterial sinusitis.
Dosage/Direction for Use
Uncomplicated urinary-tract infections: 250 mg once daily for 3 days. Chronic bacterial prostatitis: 500 mg once daily for 28 days. Complicated skin infections and for hospital-acquired pneumonia: 750 mg once daily for 7 to 14 days. Community-acquired pneumonia and for acute bacterial sinusitis: 750 mg once daily for 5 days. For most other susceptible infections: 250 mg or 500 mg once or twice daily for 10 to 14 days.
Special Precautions
Levofloxacin should be used with caution in patients with epilepsy or a history of CNS disorders. Since levofloxacin and related fluoroquinolones have, like nalidixic acid, been shown to cause degenerative changes in weight-bearing joints of young animals, it has been suggested that these compounds should not be used in children, adolescent, pregnant women or breast-feeding mothers. Tendon damage may occur rarely with fluoroquinolones and treatment should be discontinued if patients experience tendon pain, inflammation, or rupture.
Care is necessary in patients with impaired hepatic or renal function, glucose-6-phosphate dehydrogenase deficiency or myasthenia gravis. An adequate fluid intake should be maintained during treatment with levofloxacin and excessive alkalinity of the urine avoided because of crystalluria. Exposure to strong sunlight or sunlamps should also be avoided. The ability to drive or operate machinery may be impaired by levofloxacin, especially when alcohol is also taken. Levofloxacin should be avoided in methicillin-resistant Staphylococcus aureus infections because of the high level of resistance.
Adverse Reactions
Levofloxacin is generally well-tolerated. Gastrointestinal disturbances include nausea, vomiting, diarrhea, abdominal pain and dyspepsia are the adverse effects. Pseudomembranous colitis has been reported rarely. Headache, dizziness, restlessness are among the most common effects on the CNS. Others include tremor, drowsiness, insomnia, nightmares and visual and other sensory disturbances and, more rarely, hallucinations, psychotic reactions, depression and convulsion. Paraesthesia and peripheral neuropathy have occurred occasionally.
Drug Interactions
Fluoroquinolones are known to inhibit hepatic drug metabolism and may interfere with the clearance of drugs, such as theophylline, that are metabolized by the liver. Cations like aluminum, magnesium or iron reduce the absorption of levofloxacin when given concomitantly.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
FC tab 500 mg x 30's. 750 mg x 30's.
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