Chemical Name: (±-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinoline- carboxylic acid sesquihydrate
Molecular Formula: C19H22FN3O4
CAS Number: 112811-59-3
Antibacterial; 8-methoxy fluoroquinolone.1 4
Uses for Gatifloxacin
Bacterial Ophthalmic Infections
Treatment of conjunctivitis caused by susceptible Corynebacterium propinquum, Staphylococcus aureus, S. epidermidis, Streptococcus mitis, S. pneumoniae, or Haemophilus influenzae.1
Role of topical fluoroquinolones in management of uncomplicated bacterial conjunctivitis not fully elucidated; some clinicians suggest that the drugs be reserved principally for severe bacterial conjunctivitis because of potential development of quinolone resistance, and possibly, cost considerations.8 10 11 12
Gatifloxacin Dosage and Administration
For topical use only.1 Not for injection.1 Not for subconjunctival injection or introduction directly into anterior chamber of the eye.1
Apply topically to the eye as an ophthalmic solution.1
Avoid contamination of applicator tip.1
Bacterial Ophthalmic Infections
Children ≥1 year of age: 1 drop of 0.3% solution in the affected eye(s) every 2 hours while awake (up to 8 times daily) for 2 days, then 1 drop up to 4 times daily while awake for the next 5 days.1
Bacterial Ophthalmic Infections
1 drop of 0.3% solution in the affected eye(s) every 2 hours while awake (up to 8 times daily) for 2 days, then 1 drop up to 4 times daily while awake for the next 5 days.1
Cautions for Gatifloxacin
Hypersensitivity to gatifloxacin, other quinolones, or any ingredient in the formulation.1
Serious, potentially fatal hypersensitivity reactions reported following systemic administration of fluoroquinolones; has occurred with the initial dose.1
If allergic reaction occurs, discontinue use and institute appropriate therapy if indicated.1
Possible overgrowth of nonsusceptible organisms (e.g., fungi) with prolonged use; if superinfection occurs, discontinue gatifloxacin and institute other appropriate therapy.1
Careful monitoring, including slit-lamp biomicroscopy and fluorescein staining when appropriate, may be necessary in some patients.1
Distributed into milk in rats after systemic administration; not known whether distributed into human milk.1 Use gatifloxacin ophthalmic preparations with caution.1
Safety and efficacy not established in children <1 year of age.1
No substantial differences in safety and efficacy relative to younger adults.1
Common Adverse Effects
Conjunctival irritation, increased lacrimation, keratitis, papillary conjunctivitis, chemosis, conjunctival hemorrhage, ocular dryness, ocular discharge/irritation/pain, eyelid edema, headache, ocular redness, reduced visual acuity, taste disturbance.1
Serum gatifloxacin concentrations were undetectable (<5 ng/mL) after topical application to one eye of gatifloxacin 0.3 or 0.5% ophthalmic solution in an escalated dosage regimen (2 drops initially, then 2 drops 4 times daily for 7 days, and then 2 drops 8 times daily for 3 days).1
15–25°C; protect from freezing.1
Actions and Spectrum
Like other fluoroquinolones, gatifloxacin inhibits bacterial DNA gyrase and topoisomerase IV.1 4 6
Spectrum of activity includes gram-positive aerobic bacteria and some gram-negative aerobic bacteria.1
Active against C. propinquum, S. aureus, S. epidermidis, S. mitis, S. pneumoniae, and H. influenzae.1
Advice to Patients
Importance of discontinuing drug and informing clinician at first sign of rash or other sign of hypersensitivity.1
Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1
Importance of not wearing contact lenses in the presence of signs and symptoms of bacterial conjunctivitis.1 Contains benzalkonium chloride,1 which may be absorbed by soft contact lenses.13
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Zymar (with benzalkonium chloride)
AHFS DI Essentials. © Copyright 2017, Selected Revisions July 1, 2006. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
1. Allergan, Inc. Zymar (gatifloxacin) ophthalmic solution 0.3% prescribing information. Irvine, CA; 2004 Aug.
2. Allergan, Inc. Zymar (gatifloxacin) ophthalmic solution 0.3% formulary kit: summary of efficacy and safety. Irvine, CA; 2003.
3. Tepedino ME, Jensen HG. Efficacy and safety of gatifloxacin 0.3% ophthalmic solution compared with ofloxacin 0.3% for treatment of acute bacterial conjunctivitis. Poster presented at the annual meeting of the American Academy of Ophthalmology (AAO) Orlando, FL: 2002 Oct 20-3. Poster No. 165
4. Mah FS. New antibiotics for bacterial infections. Ophthalmol Clin North Am. 2003; 16:11-27. [PubMed 12683245]
5. Zhanel GC, Ennis K, Vercaigne L et al. A critical review of the fluoroquinolones: focus on respiratory tract infections. Drugs. 2002; 62:13-59. [PubMed 11790155]
6. O’Brien T. Conjunctivitis. In: Mandell GL, Bennett JE, Dolin R eds. Principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:1251-6.
7. Limberg MB. A review of bacterial keratitis and bacterial conjunctivitis. Am J Ophthalmol. 1991; 112:2-9S.
8. Thielen TL, Castle SS, Terry JE. Anterior ocular infections: an overview of pathophysiology and treatment. Ann Pharmacother. 2000; 34:235-46. [PubMed 10676832]
9. Bearden DT, Danziger LH. Mechanism of action of and resistance to quinolones. Pharmacotherapy. 2001; 21:224S-32S. [PubMed 11642689]
10. Yolton DP. New antibacterial drugs for topical ophthalmic use. Optom Clin. 1992; 2:59-72.
11. Gwon A for the Ofloxacin Study Group II. Ofloxacin vs tobramycin for the treatment of external ocular infection. Arch Ophthalmol. 1992; 110:1234-7. [PubMed 1520109]
12. Robert PY, Adenis JP. Comparative review of topical ophthalmic antibacterial preparations. Drugs. 2001; 61:175-85. [PubMed 11270936]
13. Allergan, Inc, Irvine, CA: Personal communication.
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