Tava-Floxacin  (Film Coated Tablets)

Broad Spectrum antibacterial


COMPOSITION:
Each film coated tablet contains 250, or 500mg Levofloxacin.

MECHANISM OF ACTION:
Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class.
Tava-Floxacin is antibacterial agent with activity against wide range of gram-negative and gram-positive organisms. The bactericidal action of Tava-Floxacin results from interference with the activity of the bacterial enzyme DNA gyres, which is needed for the transcription and replication of bacterial DNA.

INDICATIONS:
Tava-Floxacin is indicated for infections of mild to moderate severity, it is indicated for treatment of the following infections when due to levofloxacin susceptible micro-organisms:

  • Acute sinusitis.
  • Acute exacerbation of chronic bronchitis, pneumonia.
  • Complicated urinary tract infections including pyelonephritis.
  • Skin and soft tissue infections.

DOSAGE:
The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen.

  • Acute sinusitis: 500mg once daily, for 10 – 14 days.
  • Acute exacerbation of chronic bronchitis: 250 - 500mg once daily, for 7 days.
  • Pneumonia: 500mg once daily, for 7 – 14 days
  • Complicated urinary tract infections including pyelonephritis: 250mg once daily, for 7 - 10 days.
  • Skin and soft tissue infections: 250 - 500mg once or twice daily, for 7 – 14 days.

Dosage in patient with impaired renal function must be adjusted. No adjustment of dosage is required in patient with impaired liver functions, or elderly.

SIDE EFFECTS:
It may cause: Nausea, diarrhea, increases in liver enzymes. Tendon rupture.
Less frequency: urticaria, bronchospasm, anorexia, vomiting, abdominal pain, headache, dizziness, drowsiness and increase in bilirubin and serum creatinine.
Very rare: Confusion, psychotic reactions, angio-oedema, hypotension, tachycardia, tremor, anxiety, agitation, and confusion.

CONTRAINDICATIONS:
Hypersensitivity to levofloxacin or other quinolones, epilepsy, in patients with history of tendon disorders related to fluoroquinolone administration, children or growing adolescents.

DRUG INTERACTIONS:
The drug absorption is significantly reduced when iron salt, magnesium or aluminum containing antacids are administrated concomitantly with Tava-Floxacin. It is recommended that those preparations should not be taken two hours before or after Tava-Floxacin administration. A pronounced lowering of the cerebral seizure threshold may occur when the product is given concurrently with theophilline, non steroidal anti-inflammatory drugs, or other agents, which lower the seizure threshold. The half life of cyclosporin is increased by 33% when co-administrated with the drug.

PRECAUTIONS:

  • The drug (as other quinolones) should be used with extreme caution in patients predisposed to seizures.
  • Diarrhea, particularly if severe, during or after treatment. The drug must be stopped immediately and patients must consult a doctor.
  • Caution should be exercised when the drug is co-administrated with drugs that affect the tubular renal secretion (such as probenecid and cimetidine), especially in renally impaired patient.

USE IN PREGNANCY OR LACTATION:
It should not be used in pregnancy or lactation.

PRESENTATION:
Carton pack contains blister of 10 tablets with concentration of 250 or 500mg, with leaflet.

 
 
 

© 2010 Domina Pharmaceuticals