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Gatifloxacin
(gatifloxacin) Ophthalmic Solution, 0.5%
Gatifloxacin sterile ophthalmic solution is an 8-methoxyfluoroquinolone anti-infective for the treatment of bacterial conjunctivitis. Its chemical name is (±)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, anhydrous. Its molecular formula is C19H22FN3O4, and its molecular weight is 375.4. Its chemical structure is:
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Gatifloxacin ophthalmic solution, 0.5% is a clear, pale yellow, sterile, preserved aqueous solution with an osmolality of 260-330 mOsm/kg and a pH of 5.1-5.7.
Gatifloxacin ophthalmic solution, 0.5% contains Active: gatifloxacin 0.5% (5 mg/mL); Inactives: benzalkonium chloride 0.005%; edetate disodium; hydrochloric acid; purified water; and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH to approximatelt 6.
TEQUIN®
(gatifloxacin) Tablets
(gatifloxacin) Injection
(gatifloxacin in 5% dextrose) Injection
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 (gatifloxacin removed from us market - may 2006) and other antibacterial drugs, TEQUIN (gatifloxacin removed from us market - may 2006) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
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.
The chemical structure is:
Its empirical formula is C19H22FN3O4·1.5 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 (gatifloxacin removed from us market - may 2006) Tablets
TEQUIN (gatifloxacin removed from us market - may 2006) 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.
TEQUIN (gatifloxacin removed from us market - may 2006) Injection for Intravenous Administration
TEQUIN (gatifloxacin removed from us market - may 2006) Injection is available in 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 (gatifloxacin in 5% dextrose) 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.
Gatifloxacin ophthalmic solution, 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis group*
Streptococcus oralis*
Streptococcus pneumoniae
Haemophilus influenzae
*Efficacy for this organism was studied in fewer than 10 infections.
Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.
Six (6) mL bottle containing 2.5 mL of a 0.5% sterile topical ophthalmic solution.
Gatifloxacin ophthalmic solution, 0.5% is supplied sterile in a white, low density polyethylene (LDPE) bottle with a controlled dropper tip, and a tan cap in the following sizes:
2.5 mL in 6 mL bottle
Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing.
Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, Revised: July 2013
TEQUIN (gatifloxacin) is indicated for the treatment of 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 (including multidrug-resistant strains [MDRSP])*, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila. (See Clinical Studies.)
Uncomplicated skin and skin structure infections (ie, simple abscesses, furuncles, folliculitis, wound infections, and cellulitis) due to Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.
NOTE: An insufficient number of patients with the diagnosis of impetiginous lesions were available for evaluation.
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 (see WARNINGS).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEQUIN (gatifloxacin (removed from us market - may 2006)) and other antibacterial drugs, TEQUIN (gatifloxacin (removed from us market - may 2006)) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
*Multidrug-resistant Streptococcus pneumoniae (MDRSP) includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC 2 µg/mL), 2nd generation cephalosporins (eg, cefuroxime), macrolides, tetracyclines, and trimethoprim/ sulfamethoxazole.
The recommended dosage for TEQUIN (gatifloxacin (removed from us market - may 2006)) Tablets or TEQUIN (gatifloxacin (removed from us market - may 2006)) Injection is described in Table 4. Doses of TEQUIN (gatifloxacin (removed from us market - may 2006)) are administered once every 24 hours. These recommendations apply to all patients with a creatinine clearance ³40 mL/min. For patients with a creatinine clearance
