Preparation
Orlev® 500 Tablet: Each tablet contains Levofloxacin INN 500 mg (as Levofloxacin Hemihydrate).
Therapeutic Class
Fluroquinolone Antibiotic
Indication
Levofloxacin (Orlev®) is indicated for the infections caused by susceptible organisms such as:
Respiratory tract infections: Acute maxillary sinusitis, caused by susceptible Haemophilus influenzae, Moraxella (Branhamella) catarrhalis or Streptococcus pneumoniae. Acute exacerbation of chronic bronchitis, caused by susceptible H. influenzae, H. parainfluenzae, M. catarrhalis, Staphylococcus aureus. Community-acquired pneumonia, caused by susceptible S. pneumoniae, (including penicillin resistant strains), S. aureus, H. influenzae, H. parainfluenzae, K. pneumoniae, Legionella pneumoniae, M. catarrhalis and M. pneumoniae.
Skin and skin structure infections: Levofloxacin (Orlev®) is used in adult for the treatment of both uncomplicated and complicated skin and skin structure infections caused by susceptible S. aureus, Enterococcus faecalis, S. pyogenes or Proteus mirabilis.
Urinary tract infections: Levofloxacin (Orlev®) can be used for the treatment of both uncomplicated and complicated urinary tract infections caused by susceptible E. coli, K. pneumoniae, S. saprophyticus, Enterobacter cloacae or Enterococcus faecalis.
Contraindication
Levofloxacin (Orlev®) is contraindicated in patients with known hypersensitivity to Levofloxacin or quinolone group of antibiotics
Dosage & Administration
In acute sinusitis: 500 mg daily for 10-14 days.
In exacerbation of chronic bronchitis: 250-500 mg daily 7-10 days.
In community-acquired pneumonia: 500 mg once or twice daily 7-14 days.
In complicated urinary tract infections: 250 mg daily 7-10 days.
In skin and skin structure infections: 250 mg daily or 500 mg once or twice daily for 7-14 days
Side Effect
Levofloxacin is generally well tolerated, but side effects like GI disturbance includes nausea, vomiting, diarrhea, abdominal pain and dyspepsia, skin rash, headache, dizziness, restlessness, insomnia, nightmares and more rarely hallucination, convulsion, depression, psychotic reaction may occur.
Precaution
Dosage adjustment of Levofloxacin is required in patients with renal insufficiency. Levofloxacin should not be used in children, adolescent, pregnant women or breast feeding mothers.
Drug Interaction
Antacids containing magnesium or aluminium, sucralfate, metal cations such as iron or zinc may interfere with oral absorption of Levofloxacin.
Presentation
Orlev 500 Tablet: Box containing 2 x 10's tablets in blister pack.
Use Children
Levofloxacin can be used in children aged as low as 6 months. The usual dose for children in community acquired pneumonia (CAP) is Children aged 6 months to less than 5 years: 10 mg/kg b.i.d. (up to 500 mg per day) for 10 days. Children aged 5 years to 16 years: 10 mg/kg q.d. (up to 500 mg per day) for 10 days. The usual dose for children in recurrent or persistent Acute Otitis Media (AOM) is Children aged 6 months to less than 5 years: 10 mg/kg per day (maximum dose: 500 mg/day) given twice daily for 10 days.
Use Pregnancy Lactation
Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. Pregnancy Category C.
