Each tablet contains Gatifloxacin INN 400 mg.
• Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus.
• Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae.
• Community-acquired pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila.
• Uncomplicated skin and skin structure infections (i.e., simple abscesses, furuncles, folliculitis, wound infections, and cellulitis) due to Staphylococcus aureus or Streptococcus pyogenes.
• Uncomplicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
• Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
• Pyelonephritis due to Escherichia coli.
• Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.
• Acute, uncomplicated rectal infections in women due to Neisseria gonorrhoeae.
Infection Daily dose Duration:
• Acute Bacterial Exacerbation of Chronic Bronchitis 400 mg 5 days
• Acute Sinusitis 400 mg 10 days
• Community-acquired Pneumonia 400 mg 7-14 days
• Uncomplicated Skin and Skin Structure Infections 400 mg 7-10 days
• Uncomplicated Urinary Tract Infections 400 mg Single Dose or 200 mg 3 days
• Complicated Urinary Tract Infections 400 mg 7-10 days
• Acute Pyelonephritis 400 mg 7-10 days
• Uncomplicated Urethral Gonnorrhea in Men; 400 mg Single dose
• Endocervical and Rectal Gonorrhea in Women
• Doses in impaired renal function
• Since gatifloxacin is eliminated primarily by renal excretion, a dosage modification of Gatifloxacin is recommended for patients with creatinine clearance <40 mL/min, including patients on hemodialysis and on CAPD.
• Recommended Dosage of Gatifloxacin in Adult Patients with Renal Impairment: Creatinine Clearance Initial Dose Subsequent Dose: 40 mL/min 400 mg 400 mg every day. < 40 mL/min 400 mg 200 mg every day. Hemodialysis 400 mg 200 mg every day. Continuous peritoneal dialysis 400 mg 200 mg every day.
Pediatric use: The safety and effectiveness of gatifloxacin in pediatric populations (<18 years of age) have not been established.
Lactation: It is not known whether Gatifloxacin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when gatifloxacin is administered to a nursing woman.