Floxagat 400 mg – Film-Coated Tablets

Description

Floxagat (gatifloxacin) is a synthetic broad-spectrum 8-methoxyflouroquinolone antibacterial agent for oral and intravenous administration.

Composition

Each film-coated tablet of Floxagat 400 mg contains :

• Gatifloxacin: 400 mg.
• Excipients: S.Q. for one film-coated tablet.

Indications

Floxagat is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.

• 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-acquirede pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzea, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila.
• Uncomplicated urinary tract infections (cystitis) 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.

Dosage & Administration

When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with Floxagat injection may be switched to Floxagat tablets when clinically indicated at the discretion of the physician.

Floxagat injection should be administered by Intravenous infusion only, over a period of 60 minutes.

Rapid or bolus intravenous infusion should be avoided.

The suggested doses for either the oral and intravenous routes of administration for Floxagat are:

Acute bacterial exacerbation of chronic bronchitis:

400 mg daily, for 7-10 days.

Acute sinusitis:

400 mg daily, for 10 days.

Community-acquired pneumonia:

400 mg daily, for 7-14 days.

Uncomplicated urinary tract infections (cystitis):

400 mg as a single dose and then 200 mg daily for 3 days.

Complicated urinary tract infections:

400 mg daily, for 7-10 days.

Acute pyelonephritis:

400 mg daily, for 7-10 days.

Uncomplicated urethral gonorrhea in men; endocervical and rectal gonorrhea in women:

single dose of 400 mg.

Acute, uncomplicated rectal infections in women:

400 mg daily, for 7-10 days.

Impaired renal function:

Creatinine clearance < 40 ml/min, Hemodialysis, continuous peritoneal dialysis: the initial dose is 400 mg and then 200 mg every day.

Floxagat regimen for the treatment of uncomplicated urinary tract infections and gonorrhea requires no dosage adjustment in patients with impaired renal function.