Levotab

Levotab

levofloxacin

Manufacturer:

Pacific Pharma (Korea)

Distributor:

AA Medical
Full Prescribing Info
Contents
Levofloxacin.
Description
Each 250 mg film coated caplet contains: Levofloxacin Hemihydrate equivalent to 250 mg Levofloxacin.
Each 500 mg film coated caplet contains: Levofloxacin Hemihydrate equivalent to 500 mg Levofloxacin.
Indications/Uses
Levofloxacin can be used in adults, in the treatment of the following bacterial infections: Acute exacerbations of chronic bronchitis: caused by H. influenzae, K. pneumoniae, S. aureus, M. catarrhalis, E. coli, H. parainfluenzae or S. pneumoniae.
Pneumonia (community acquired): caused by H. influenzae, S. pneumoniae, S. aureus, M. catarrhalis, H. parainfluenzae, K. pneumoniae, E. coli, Mycoplasma pneumoniae, Chlamydia pneumoniae or Legionella pneumophila.
Sinusitis: caused by H. influenzae, S. pneumoniae, S. aureus, M. catarrhalis or H. parainfluenzae.
Urinary tract infections (complicated) and acute pyelonephritis: caused by E. coli, K. pneumoniae, S. faecalis, P. mirabilis, Enterobacter cloacae and P. aeruginosa.
Uncomplicated urinary tract infections in women: caused by E. coli, K. pneumoniae.
Skin and soft tissue infections (uncomplicated): caused by S. aureus, S. pyogenes, Acinetobacter calcoaceticus, E. cloacae, P. mirabilis, P. aeruginosa, E. coli, K. pneumoniae or S. faecalis.
Skin and soft tissue infections (complicated): caused by S. aureus, S. pyogenes, P. mirabilis, E.coli, K. pneumoniae, S. faecalis, E. cloacae, K. oxytoca.
Intra-abdominal infections: caused by E. coli and anaerobic micro-organisms.
Dosage/Direction for Use
Levofloxacin caplets should be swallowed whole, without crushing. Levofloxacin may be taken on an empty stomach or with meals.
Levofloxacin is to be taken once or twice daily in a usual dose of 250 or 500 mg. The dosage will depend on the type of pathogen and the severity of the infection. The use of Levofloxacin should be continued to a minimum of 48 to 72 hours after commencement of therapy. The duration of therapy varies according to the course of the disease.
The following daily doses are recommended for Levofloxacin: Daily dosage recommended in patients with normal renal function: Bronchitis, bacterial exacerbations: 500 mg once daily for 5-10 days.
Pneumonia, community acquired: 500 mg once or twice daily for 10-14 days. (The higher dosage should be chosen in the presence of complicating factors e.g. co-morbidity, advanced age).
Sinusitis: 500 mg once daily for 10 to 14 days.
Urinary tract infections (complicated) and acute pyelonephritis: 250 mg once daily for 10 days.
Urinary tract infections (uncomplicated) in women: 250 mg once daily for 3 days.
Uncomplicated skin and soft tissue infections: 250 to 500 mg once daily for 7-10 days.
Complicated skin and soft tissue infections: 500 mg once daily for 10-14 days.
Intra-abdominal infections: 500 mg once daily in combination with an antibiotic with anaerobic coverage for 10-14 days.
Above infections when bacteraemia or septicaemia is present: 500 mg twice daily for 10- 14 days.
Daily dosage recommended in patients with impaired renal function: Dosage must be adjusted in patients with impaired renal function according to the degree of impairment (creatinine clearance <50 mL/min): Patients with a creatinine clearance between 20 and 50 mL/min: Patients meant to be taking 250 or 500 mg once daily: a normal single dose should be given initially and then reduced by half this dose once daily.
Patients meant to be taking 500 mg twice daily: the initial dose should be 500 mg and then 250 mg should be taken twelve hourly.
Patients with a creatinine clearance between 10 and 19 mL/min: Patients to be taking 250 mg once daily: a normal single dose should be given initially and then reduced to 125 mg every 48 hours.
Patients to be taking 500 mg once daily: should be given a normal single dose initially and then this dose should be reduced to 125 mg every 24 hours.
Patients to be taking 500 mg twice daily: should be given 500 mg initially and then this dose should be reduced to 125 mg every 12 hours.
Patients with a creatinine clearance of less than 10 mL/min or in patients on haemodialysis or CAPD (Continuous Ambulatory Peritoneal Dialysis): In patients where the prescribed dosage is 250 mg once daily: a normal single dose should be given initially and then this dose should be reduced to 125 mg every 48 hours.
Patients to be taking 500 mg once daily: should be given a normal single dose initially and this dose should be reduced to 125 mg every 24 hours.
Patients to be taking 500 mg twice daily: should be given 500 mg initially and then this dose should be reduced to 125 mg every 24 hours.
No adjustment of dosage is required in the elderly or in patients with impaired liver function.
Overdosage
The symptoms that can be expected from an acute overdosage of levofloxacin are central nervous system symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures.
The treatment of an overdosage is symptomatic and supportive.
Levofloxacin is not effectively removed by hemodialysis or peritoneal dialysis.
Contraindications
The use of levofloxacin is contra-indicated in: Previous hypersensitivity reactions to levofloxacin, other quinolones, or any other ingredient. Epilepsy. Patients with a history of tendon disorders associated with fluoroquinolone administration. Children or adolescents (under 18 years of age). During pregnancy and lactation.
Warnings
LEVOFLOXACIN SHOULD NOT BE GIVEN TO PATIENTS UNDER 18 YEARS OF AGE.
Caution should be exercised when using levofloxacin in patients: Prone to seizures, such as patients with pre-existing central nervous system lesions; being treated with fenbufen or nonsteroidal anti-inflammatory medicines; or using medicines which lower the cerebral seizure threshold, such as theophylline; driving or operating machinery as the use of levofloxacin may alter the ability to drive or operate machinery; being tested for tuberculosis as levofloxacin inhibits the growth of Mycobacterium tuberculosis and therefore may give false-negative results in the bacteriological diagnosis of tuberculosis; exposed to ultraviolet light such as sunlight through window glass or longer wavelength ultraviolet (UVA) from sun beds in order to prevent photosensitisation.
Use In Pregnancy & Lactation
The use of levofloxacin during pregnancy and lactation is contra-indicated.
Drug Interactions
The absorption of levofloxacin is significantly reduced when administered with iron salts, antacids and sucralfate. It is recommended that preparations containing iron salts, sucralfate, magnesium- or aluminium-containing antacids should not be taken two hours before or after levofloxacin tablet administration. Levofloxacin is known to inhibit hepatic medicine metabolism and may interfere with the clearance of medicines, such as theophylline, fenbufen or similar non-steroidal anti-inflammatory medicines that lower seizure threshold.
Storage
Store below 25°C in a dry place. Protect from light.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
FC caplet 250 mg x 1's. 500 mg x 1's.
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