Product Information / Press Release

TEQUIN is available as TEQUIN (gatifloxacin) Tablets for oral administration and TEQUIN (gatifloxacin) Injection and TEQUIN (gatifloxacin in 5% dextrose) Injection for intravenous administration.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEQUIN and other antibacterial drugs, TEQUIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION
TEQUIN contains gatifloxacin, a synthetic broad-spectrum 8-methoxyfluoroquinolone antibacterial agent for oral or intravenous administration. Chemically, gatifloxacin is (±) -1- cyclopropyl-6-fluoro-1, 4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3- quinolinecarboxylic acid sesquihydrate.

TEQUIN Tablets
TEQUIN Tablets are available as 200-mg and 400-mg white, film-coated tablets and contain the following inactive ingredients: hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, simethicone, sodium starch glycolate, sorbic acid, and titanium dioxide.

INDICATIONS AND USAGE

Tequin® (gatifloxacin) is indicated for the treatment of patients 18 years and older for infections due to susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION.)

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 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. 

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to gatifloxacin. Therapy with Tequin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Available only by prescription.