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Gatifloxacin: Drug information

Gatifloxacin: Drug information
(For additional information see "Gatifloxacin: Patient drug information" and see "Gatifloxacin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Zymaxid
Brand Names: Canada
  • APO-Gatifloxacin;
  • Zymar
Pharmacologic Category
  • Antibiotic, Fluoroquinolone;
  • Antibiotic, Ophthalmic
Dosing: Adult
Bacterial conjunctivitis

Bacterial conjunctivitis: Ophthalmic:

Zymar [Canadian product]:

Days 1 and 2: Instill 1 drop into affected eye(s) every 2 hours while awake (maximum: 8 times/day).

Days 3 to 7: Instill 1 drop into affected eye(s) 4 times/day while awake.

Zymaxid:

Day 1: Instill 1 drop into affected eye(s) every 2 hours while awake (maximum: 8 times/day).

Days 2 to 7: Instill 1 drop into affected eye(s) 2 to 4 times/day while awake.

Bacterial keratitis

Bacterial keratitis (off-label use): Ophthalmic: Instill 1 drop into affected eye(s) every 1 hour around the clock until healing begins (usually 48 to 72 hours); dosing frequency is then gradually reduced until the ulcer is completely healed, at which point, treatment can be discontinued (Parmar 2006; Shah 2010). One suggested tapering regimen is as follows: Days 3 to 6: Instill 1 drop into affected eye(s) every 2 hours around the clock; Days 7 to 9: Instill 1 drop into affected eye(s) every 2 hours while awake; Day 9 and on: Instill 1 drop into affected eye(s) every 6 hours and continue at this frequency until complete healing of ulcer (Shah 2010). Note: For central or severe keratitis, a loading dose of instillation every 5 to 15 minutes for the first 30 to 60 minutes may be considered (AAO 2013).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Gatifloxacin: Pediatric drug information")

Bacterial conjunctivitis

Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: Zymaxid: Day 1: Instill 1 drop into affected eye(s) every 2 hours while awake (maximum: 8 times/day). Days 2 to 7: Instill 1 drop into affected eye(s) 2 to 4 times/day while awake.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Central nervous system: Headache

Endocrine & metabolic: Chemosis

Gastrointestinal: Dysgeusia

Ophthalmic: Conjunctival hemorrhage, conjunctival irritation, conjunctivitis (worsening), decreased visual acuity, dry eye syndrome, eye discharge, eye irritation, eye pain, eye redness, eyelid edema, increased lacrimation, keratitis, papillary conjunctivitis

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema (including facial edema, oral edema, pharyngeal edema), blepharitis, blurred vision, dyspnea, eye pruritus, hypersensitivity reaction (including allergic dermatitis, eye allergy), nausea, pruritus (including skin rash), Stevens-Johnson syndrome, swelling of eye (including corneal edema, conjunctival edema), urticaria

Contraindications

Hypersensitivity to gatifloxacin, other quinolones, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylactic reactions, angioedema (including pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, have been reported (even following a single dose) with topical ophthalmic gatifloxacin. Rare cases of Stevens-Johnson syndrome were also reported. If an allergic reaction occurs, discontinue use.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection is suspected, institute appropriate alternative therapy.

Special populations:

• Contact lens wearers: Contact lenses should not be worn during treatment of ophthalmic infections.

Dosage form specific issues:

• Appropriate use: For topical ophthalmic use only. Do not inject ophthalmic solution subconjunctivally or introduce directly into the anterior chamber of the eye (may cause corneal endothelial cell injury).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Zymaxid: 0.5% (2.5 mL) [contains benzalkonium chloride, edetate (edta) disodium]

Generic: 0.5% (2.5 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Gatifloxacin Ophthalmic)

0.5% (per mL): $47.26

Solution (Zymaxid Ophthalmic)

0.5% (per mL): $88.18

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Zymar: 0.3% (1 mL, 5 mL) [contains benzalkonium chloride, edetate (edta) disodium]

Generic: 0.3% (5 mL)

Administration: Adult

For topical ophthalmic use only; not for injection. Avoid touching tip of applicator to eye, fingers, or other surfaces.

Administration: Pediatric

For topical ophthalmic use only; avoid touching tip of applicator to eye, fingers, or other surfaces. Apply finger pressure to lacrimal sac during and for 1 to 2 minutes after instillation to decrease risk of absorption and systemic effects.

Use: Labeled Indications

Conjunctivitis: Treatment of bacterial conjunctivitis caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, and Haemophilus influenzae.

Use: Off-Label: Adult

Bacterial keratitis

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Systemic concentrations of gatifloxacin following ophthalmic administration are below the limit of quantification. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion for 3 to 5 minutes after application to decrease potential exposure to the fetus (Samples 1988).

Breastfeeding Considerations

It is not known if gatifloxacin is excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of infant exposure, the benefits of breast-feeding to the infant, and benefits of treatment to the mother.

Mechanism of Action

Gatifloxacin is a DNA gyrase inhibitor, and also inhibits topoisomerase IV. DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition; inhibition is bactericidal.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Ophthalmic: Not measurable (<5 ng/mL)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Zymar | Zymaxid;
  • (AR) Argentina: Gatif | Gatif forte | Gatiflax | Gatimicin forte | Zymaran | Zymaxid;
  • (BD) Bangladesh: Gatibac | Gatiflox | Gatipro | Gatsina | Tag | Xegal | Zymar | Zymarin;
  • (BF) Burkina Faso: Gatistar;
  • (BR) Brazil: Zymar;
  • (CI) Côte d'Ivoire: Gatistar;
  • (CL) Chile: Gatif | Zolimin | Zymar;
  • (CO) Colombia: Gasyn | Gatiflox | Gatioftal | Gatipharm | Poengatif | Poengatif forte | Zymaran | Zymaxid;
  • (DO) Dominican Republic: Gatixin | Poengatif | Zymar;
  • (EC) Ecuador: Poengatif | Zymaran | Zymaxid;
  • (EG) Egypt: Gatigrand | Gatilox | Gatipram | Gatistar | Gatyxel | Occubact | Pharmagatin | Tymer | Zymar | Zymaxid;
  • (ID) Indonesia: Gaforin;
  • (IN) India: Arogat | Arogat hs | Autogati | Bell gat | Biogat | Engatt | Floxgat | G flox | G-cebran | Gate | Gatiblu | Gaticin | Gatifax | Gatifect | Gatikind | Gatilab | Gatilox | Gatiquin | Gatiray | Gatitrust | Gatsun | Gatt | Gfc | Gflotas | Go 3 | Gxn | K gat | Microgat | Oxigat | Qugat | Zengat | Zigat | Zymar | Zymaxid;
  • (JO) Jordan: Gatistar | Zymar | Zymaxid;
  • (JP) Japan: Gatiflo senju;
  • (KE) Kenya: Zymaxid;
  • (KR) Korea, Republic of: Gatiflo;
  • (KW) Kuwait: Zymar | Zymaxid;
  • (LB) Lebanon: Tymer | Zymar | Zymaxid;
  • (MA) Morocco: Zymaxid;
  • (MX) Mexico: Micfi | Zymar;
  • (MY) Malaysia: Zymar | Zymaxid;
  • (NG) Nigeria: Zymaxid;
  • (PE) Peru: Poengatif | Zymaran | Zymaxid;
  • (PH) Philippines: Agatiflox | Itiflox | Vendiflox | Zymar;
  • (PK) Pakistan: Gaticin | Loxiget;
  • (PR) Puerto Rico: Zymar | Zymaxid;
  • (PY) Paraguay: Poengatif;
  • (QA) Qatar: Tymer | Zymar | Zymaxid;
  • (RU) Russian Federation: Zimar | Zymar;
  • (SA) Saudi Arabia: Tymer | Zymaxid;
  • (SG) Singapore: Zymar;
  • (TH) Thailand: Zymar;
  • (TR) Turkey: Zymar;
  • (UY) Uruguay: Gatimicin | Poengatif;
  • (VE) Venezuela, Bolivarian Republic of: Poengatif;
  • (ZA) South Africa: Zymar
  1. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern Guidelines. Bacterial Keratitis. San Francisco, CA: American Academy of Ophthalmology; 2013. Available at: www.aao.org/ppp.
  2. Parmar P, Salman A, Kalavathy CM, et al. Comparison of topical gatifloxacin 0.3% and ciprofloxacin 0.3% for the treatment of bacterial keratitis. Am J Ophthalmol. 2006;141(2):282-286. [PubMed 16458681]
  3. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
  4. Shah VM, Tandon R, Satpathy G, et al. Randomized clinical study for comparative evaluation of fourth-generation fluoroquinolones with the combination of fortified antibiotics in the treatment of bacterial corneal ulcers. Cornea. 2010;29(7):751-757. doi:10.1097/ICO.0b013e3181ca2ba3 [PubMed 20489580]
  5. Zymar (gatifloxacin ophthalmic solution) [prescribing information]. Irvine, CA: Allergan; August 2004.
  6. Zymar (gatifloxacin ophthalmic solution) [product information]. St-Laurent, Quebec, Canada: Allergan Inc; August 2022.
  7. Zymaxid (gatifloxacin) [prescribing information]. Irvine, CA: Allergan; September 2016.
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