Terlev

Terlev

levofloxacin

Manufacturer:

ADP Pharma

Distributor:

Metro Drug

Marketer:

Seville Pharma
Concise Prescribing Info
Contents
Levofloxacin
Indications/Uses
Adults (>18 yr) w/ mild, moderate, & severe infections caused by susceptible strains of microorganisms in the following conditions: Nosocomial pneumonia, community-acquired pneumonia, acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, complicated/uncomplicated skin & skin structure infections, chronic bacterial prostatitis, complicated/uncomplicated UTI, acute pyelonephritis, inhalational anthrax (post-exposure).
Dosage/Direction for Use
Adult Nosocomial pneumonia 750 mg every 24 hr for 7-14 days. Community acquired pneumonia 500 mg every 24 hr for 7-14 days or 750 mg every 24 hr for 5 days. Acute bacterial sinusitis 500 mg every 24 hr for 10-14 days or 750 mg every 24 hr for 5 days. Acute bacterial exacerbation of chronic bronchitis 500 mg every 24 hr for 7 days. Complicated skin & skin structure infections 750 mg every 24 hr 7-14 days. Uncomplicated skin & skin structure infections 500 mg every 24 hr for 7-10 days. Chronic bacterial prostatitis 500 mg every 24 hr for 28 days. Complicated UTI or acute pyelonephritis 250 mg every 24 hr for 10 days or 750 mg every 24 hr for 5 days. Uncomplicated UTI 250 mg every 24 hr for 3 days. Inhalational anthrax (post-exposure) Adult & childn >50 kg 500 mg every 24 hr. Plague Adult & childn >50 kg 500 mg every 24 hr for 10-14 days. Renal impairment CrCl 20-49 mL/min 500 mg: Initially 500 mg then 250 mg every 24 hr. 750 mg: 750 mg every 48 hr. 10-19 mL/min 250 mg: 250 mg every 48 hr. 500 mg: Initially 500 mg then 250 mg every 48 hr. 750 mg: Initially 750 mg then 500 mg every 48 hr. Hemodialysis or chronic ambulatory peritoneal dialysis 500 mg: Initially 500 mg then 250 mg every 48 hr. 750 mg: Initially 750 mg then 500 mg every 48 hr.
Administration
May be taken with or without food: Ensure adequate fluid intake.
Contraindications
Hypersensitivity. Patients w/ epilepsy, history of tendon disorders related to fluoroquinolone administration. Pregnancy & lactation. Childn or growing adolescents.
Special Precautions
Discontinue immediately at the 1st appearance of skin rash, jaundice, or any other sign of hypersensitivity; patient develops signs & symptoms of hepatitis; patient experiences symptoms of neuropathy. Increased risk of tendinitis & tendon rupture. Patients w/ known or suspected CNS disorder that may predispose them to seizures or lower the seizure threshold (eg, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (eg, certain drug therapy, renal dysfunction). Clostridium difficile-associated diarrhea. Avoid in patients w/ known prolongation of the QT interval, uncorrected hypokalemia, & those receiving class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmic agents. Increased incidence of musculoskeletal disorders in childn. Disturbances of blood glucose including symptomatic hyper- & hypoglycemia. Moderate to severe photosensitivity/phototoxicity reactions.
Adverse Reactions
Nausea, vomiting, dizziness, & headache.
Drug Interactions
May interfere w/ the GI absorption w/ antacids containing Mg or Al, sucralfate, metal cations (eg, Fe), & multivit prep w/ zinc or didanosine. Enhanced effects of warfarin. Disturbances of blood glucose w/ antidiabetic agents. May increase the risk of CNS stimulation & convulsive seizures. Prolonged elimination t1/2, elevated serum levels, & increased risk of related adverse reactions of theophylline. May produce false +ve urine screening results for opiates.
MIMS Class
Quinolones
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Terlev FC tab 500 mg
Packing/Price
50's (P4,000/box)
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