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Withdrawn from the market (safety)

Gatifloxacin

TEQUIN

What it isDNA-gyrase-inhibiting fluoroquinolone eye drop; bacterial conjunctivitis.

Why this oneIts current role is topical ocular therapy because the systemic product's dysglycemia risk outweighed its advantages.

What limits itLocal irritation and hypersensitivity can occur; the withdrawn systemic formulation caused severe hypo- and hyperglycemia.

FDA label

FDA dosingPopulationStartTargetMax
Bacterial conjunctivitisAdults and peds >=1 yearDay 1: 1 drop ophthalmic in affected eye(s) Q2H while awake, up to 8 dosesDays 2-7: 1 drop 2-4x/day while awake8 drops/day (Day 1)

Renal Undefined

Hepatic Undefined

Instructions

Contraindications

Cautions

Adverse reactions

Pregnancy No human data; no adverse developmental outcomes in animals at clinically relevant doses (teratogenic only at >=600x human ophthalmic dose)

Lactation Unknown if present in human milk; systemic levels after ocular dosing are low; weigh benefits vs risk

NO BOXED WARNINGS

Principal riskNo FDA boxed warning; systemic gatifloxacin (Tequin) was withdrawn from the U.S. market in 2006 for serious dysglycemia.

Cost, est. cash$10–$400/month

Generic entry2011

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4
Overdose danger0 / 4
Weight-gain liability0 / 4
Sedation liability0 / 4
QT / Torsades0 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk0 / 4

Legacy pregnancy categoryC

Defining liabilityLocal irritation or hypersensitivity; systemic toxicity is minimal with correct local use.

Mechanism of action: Gatifloxacin ballicule

Gatifloxacin ballicule: receptor binding, kinetics and half-life diagram

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