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
Its empirical formula is C19H22FN3O41.5
H2O and its molecular weight is 402.42. Gatifloxacin is a sesquihydrate
crystalline powder and is white to pale yellow in color. It exists as
a racemate, with no net optical rotation. The solubility of the compound
is pH dependent. The maximum aqueous solubility (40-60 mg/mL) occurs at
a pH range of 2 to 5.
TEQUIN Tablets are available as 200-mg and 400-mg white, film-coated
tablets and contain the following inactive ingredients: hydroxypropyl
methylcellulose, magnesium stearate, methylcellulose, microcrystalline
cellulose, polyethylene glycol, polysorbate 80, simethicone, sodium starch
glycolate, sorbic acid, and titanium dioxide.
TEQUIN Injection is available in 20-mL (200-mg) and 40-mL (400-mg) single-use
vials as a sterile, preservative-free aqueous solution of gatifloxacin
with pH ranging from 3.5 to 5.5. TEQUIN Injection is also available in
ready-to-use 100-mL (200-mg) and 200-mL (400-mg) flexible bags as a sterile,
preservative-free aqueous solution of gatifloxacin with pH ranging from
3.5 to 5.5. The appearance of the intravenous solution may range from
light yellow to greenish-yellow in color. The color does not affect nor
is it indicative of product stability.
The intravenous formulation contains dextrose, anhydrous, USP or dextrose,
monohydrate, USP and Water for Injection, USP, and may contain hydrochloric
acid and/or sodium hydroxide for pH adjustment.