gatifloxacin ophthalmic (Rx)

Frequency Not Defined

Hypersensitivity

Growth of resistant organisms with prolonged use

Corneal endothelial cell Injury

1-10%

Conjunctival irritation (5-10%)

Incr. lacrimation (5-10%)

Keratitis (5-10%)

Papillary conjunctivitis (5-10%)

Conjunctival hemorrhage (1-4%)

Chemosis (1-4%)

Dry eye (1-4%)

Eye discharge (1-4%)

Eye irritation (1-4%)

Eye pain (1-4%)

Eyelid swelling (1-4%)

Red eye (1-4%)

Visual acuity decr (1-4%)

Taste disturbance (1-4%)

Postmarketing reports

Anaphylactic reactions and angioedema including, pharyngeal, oral or facial edema, blepharitis, dyspnea, eye pruritus, eye swelling (including corneal and conjunctival edema)

Hypersensitivity, including signs and symptoms of eye allergy and allergic dermatitis, nausea, pruritus (including pruritus generalized, rash, urticaria)

Vision blurred

Contraindications

Hypersensitivity to quinolones or other components in product

Cautions

Prolonged use may result in overgrowth of nonsusceptible organisms (incl fungi)

Some patients may require slit-lamp biomicroscopy & fluorescein staining

Advice patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis

Solution may harm corneal endothelial cells if introduced directly into anterior chamber

Pregnancy: There are no available data in pregnant women to inform of a drug-associated risk

Lactation: Excretion in milk unknown; consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Fluoroquinolone antibiotic; antibacterial action results from inhibition of DNA gyrase and topoisomerase IV

Pharmacokinetics

Absorption: undetectable systemic