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Zymar eent

Generic Name: Gatifloxacin eent
Class: Antibacterials
VA Class: OP210
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

Introduction

Antibacterial; 8-methoxy fluoroquinolone.1 2 4 5 20

Uses for Zymar

Bacterial Ophthalmic Infections

Topical treatment of bacterial conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis, Streptococcus mitis group, S. oralis, S. pneumoniae, or Haemophilus influenzae.1 2 3

Many cases of mild, acute bacterial conjunctivitis resolve spontaneously without anti-infective therapy.6 17 18 19 Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications,6 8 17 18 19 avoid indiscriminate use of topical anti-infectives.6 17

Treatment of acute bacterial conjunctivitis generally is empiric;6 17 18 use of a broad-spectrum topical ophthalmic antibacterial usually recommended.6 17 18 In vitro staining and/or cultures of conjunctival material may be indicated in diagnosis and management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.6 17 18

Zymar Dosage and Administration

Administration

Ophthalmic Administration

Apply 0.5% ophthalmic solution topically to the eye.1 2

For topical ophthalmic use only;1 2 do not inject directly into anterior chamber of the eye.1 2 (See Administration Precautions under Cautions.)

Avoid contaminating applicator tip with material from eye, fingers, or other source.1 2

Dosage

Pediatric Patients

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

Children ≥1 year of age: Instill 1 drop of 0.5% solution in the affected eye(s) every 2 hours while awake (up to 8 times daily) on day 1, then 1 drop 2–4 times daily while awake on days 2 through 7.1 2

Adults

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

Instill 1 drop of 0.5% solution in the affected eye(s) every 2 hours while awake (up to 8 times daily) on day 1, then 1 drop 2–4 times daily while awake on days 2 through 7.1 2

Cautions for Zymar

Contraindications

  • Hypersensitivity to gatifloxacin, other quinolones, or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Hypersensitivity reactions, including anaphylactic reactions, angioedema (e.g., pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, reported in patients receiving gatifloxacin ophthalmic solution.1 Stevens-Johnson syndrome reported rarely.1

Hypersensitivity reactions have occurred following a single dose.1

Immediately discontinue at first sign of rash or hypersensitivity reaction.1

Administration Precautions

For topical ophthalmic use only.1 2

Corneal endothelial cell injury may occur if gatifloxacin ophthalmic solution is introduced directly into anterior chamber of the eye.1

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.1 2

If superinfection occurs, discontinue gatifloxacin ophthalmic solution and institute appropriate therapy.1 2

Patient Monitoring

Whenever clinical judgment dictates, examine patient with the aid of magnification (e.g., slit lamp biomicroscopy) and, if appropriate, fluorescein staining.1 2

Contact Lenses

Do not wear contact lenses during treatment with gatifloxacin ophthalmic solution or if any signs or symptoms of bacterial conjunctivitis are present.2

Specific Populations

Pregnancy

Data not available regarding use of gatifloxacin 0.5% ophthalmic solution in pregnant women.1 2

Lactation

Distributed into milk in rats after oral administration;1 2 not known whether distributed into human milk following topical application to the eye.1 2

Consider benefits of breast-feeding and importance of the drug to the woman;1 also consider potential adverse effects on the breast-fed child from the drug or underlying maternal condition.1

Pediatric Use

Safety and efficacy not established in children <1 year of age.1 2

Geriatric Use

No overall differences in safety and efficacy relative to younger adults.1 2

Common Adverse Effects

Worsening of conjunctivitis, eye irritation, dysgeusia, eye pain.1 2

Interactions for Zymar

No formal drug interaction studies using gatifloxacin 0.5% ophthalmic solution.2

Zymar Pharmacokinetics

Absorption

Bioavailability

Serum concentrations of gatifloxacin were undetectable (<5 ng/mL) after topical application to one eye of gatifloxacin 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 2

Stability

Storage

Ophthalmic

Solution

15–25°C (may be exposed to 15–30°C).1 2 Protect from freezing.1 2

Contains benzalkonium chloride as a preservative.1 2

Actions and Spectrum

  • Fluoroquinolone anti-infective.1 2 4 5 20

  • Like other fluoroquinolones, inhibits DNA synthesis in susceptible bacteria via inhibition of type II DNA topoisomerases (DNA gyrase, topoisomerase IV).1 2 4 6 9 20

  • Spectrum of activity includes gram-positive aerobic bacteria and some gram-negative aerobic bacteria.1

  • Active in vitro and in vivo in conjunctival infections against Staphylococcus aureus, S. epidermidis, S. mitis group, S. oralis, Streptococcus pneumoniae, and Haemophilus influenzae.1 2

  • Cross-resistance between gatifloxacin and some other fluoroquinolones reported.1 2

Advice to Patients

  • Advise patients to avoid contaminating applicator tip with material from the eye, fingers, or other source.1 2

  • Advise patients not to wear contact lenses during treatment with gatifloxacin ophthalmic solution or if any signs or symptoms of bacterial conjunctivitis are present.2

  • Advise patients to immediately discontinue gatifloxacin ophthalmic solution and contact a clinician at first sign of rash or hypersensitivity reaction.1

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as other concomitant illnesses.1 2

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

  • Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

Preparations

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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Gatifloxacin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.5%*

Gatifloxacin 0.5% Ophthalmic Solution

Zymaxid

Allergan

AHFS DI Essentials. © Copyright 2017, Selected Revisions May 22, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Allergan, Inc. Zymaxid (gatifloxacin) ophthalmic solution 0.5% prescribing information. Irvine, CA; 2016 Sep.

2. Lupin Pharmaceuticals, Inc. Gatifloxacin ophthalmic solution 0.5% prescribing information. Baltimore, MD; 2016 May.

3. Heller W, Cruz M, Bhagat YR et al. Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older. J Ocul Pharmacol Ther. 2014; 30:815-22. [PubMed 25244402]

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. Barnes SD, Kumar NM, Pavin-Langston D et al. Microbial Conjunctivitis. In: Bennett JE, Dolin R, and Blaser MJ, eds. Mandell, Douglas, and Bennett's principles and practices of infectious diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015:1392-1401.

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]

12. Robert PY, Adenis JP. Comparative review of topical ophthalmic antibacterial preparations. Drugs. 2001; 61:175-85. [PubMed 11270936]

17. American Academy of Ophthalmology. Preferred practice pattern (PPP) guidelines: conjunctivitis PPP - 2013. From American Academy of Ophthalmology website. Accessed 17 Oct 2016.

18. Azari AA, Barney NP. Conjunctivitis: a systematic review of diagnosis and treatment. JAMA. 2013; 310:1721-9. [PubMed 24150468]

19. Sheikh A, Hurwitz B, van Schayck CP et al. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database Syst Rev. 2012; :CD001211. [PubMed 22972049]

20. Hooper DC, Strahilevitz J. Quinolones. In: Bennett JE, Dolin R, and Blaser MJ, eds. Mandell, Douglas, and Bennett's principles and practices of infectious diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015:419-39.

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