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  • CLASSES

    Fluoroquinolone Antibiotics
    Ophthalmological Anti-infectives

    DEA CLASS

    Rx

    DESCRIPTION

    Ophthalmic fluoroquinolone antibiotic
    Indicated for bacterial conjunctivitis
    Minimal systemic absorption

    COMMON BRAND NAMES

    Zymaxid

    HOW SUPPLIED

    Gatifloxacin/Zymaxid Ophthalmic Sol: 0.5%

    DOSAGE & INDICATIONS

    For the treatment of bacterial conjunctivitis.
    Ophthalmic dosage (0.5% solution)
    Adults

    On day 1, instill 1 drop in each affected eye every 2 hours while awake, up to 8 times daily. On days 2 to 7, instill 1 drop in each affected eye 2 to 4 times daily while awake.

    Children and Adolescents

    On day 1, instill 1 drop in each affected eye every 2 hours while awake, up to 8 times daily. On days 2 to 7, instill 1 drop in each affected eye 2 to 4 times daily while awake.

    Ophthalmic dosage (0.3% solution)
    Adults

    On days 1 and 2, instill 1 drop in each affected eye every 2 hours while awake, up to 8 times daily. On days 3 to 7, instill 1 drop in each affected eye up to 4 times daily while awake.

    Neonates, Infants, Children, and Adolescents

    On days 1 and 2, instill 1 drop in each affected eye every 2 hours while awake, up to 8 times daily. On days 3 to 7, instill 1 drop in each affected eye up to 4 times daily while awake.

    For ophthalmic surgical infection prophylaxis†.
    Ophthalmic dosage
    Adults

    1 drop to the affected eye(s) every 5 to 15 minutes for 5 doses within 1 hour before the start of the procedure. Perioperative antisepsis with povidone-iodine is recommended. Subconjunctival or intracameral antibiotics at the end of the procedure is optional. The necessity of continuing topical antimicrobials postoperatively has not been established.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    8 drops/day in affected eye(s).

    Geriatric

    8 drops/day in affected eye(s).

    Adolescents

    8 drops/day in affected eye(s).

    Children

    8 drops/day in affected eye(s).

    Infants

    8 drops/day in affected eye(s) of 0.3% solution only.

    Neonates

    8 drops/day in affected eye(s) of 0.3% solution only.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustments are needed.

    Renal Impairment

    No dosage adjustments are needed.

    ADMINISTRATION

    Ophthalmic Administration

    Apply topically to the eye. For topical ophthalmic use only.
    Instruct patient on proper instillation of eye solution.
    Avoid contamination of the eye solution; do not to touch the tip of the eye dropper to the eye, fingertips, or other surface.

    STORAGE

    Tequin:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Zymar:
    - Protect from freezing
    - Store between 59 to 77 degrees F
    Zymaxid :
    - Protect from freezing
    - Store between 59 to 77 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Gatifloxacin is for topical ophthalmic use only. Corneal endothelial cell injury may occur if gatifloxacin ophthalmic solution is introduced directly into the chamber of the eye.

    Fungal infection

    Prolonged use of gatifloxacin ophthalmic preparations may result in overgrowth of nonsusceptible organisms. If superinfection, including fungal infection, occurs with gatifloxacin use, discontinue therapy and institute an alternative.

    Quinolone hypersensitivity

    Gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, a history of quinolone hypersensitivity, or hypersensitivity to any components of the medication. Serious hypersensitivity reactions, including anaphylactoid reactions, angioedema (including pharyngeal, laryngeal, or facial edema), and dyspnea, have been reported with ophthalmic gatifloxacin, even following a single dose. Gatifloxacin should be discontinued if an allergic reaction or any other sign of hypersensitivity appears.
     

    Pregnancy

    There are no data available on gatifloxacin ophthalmic use in pregnancy to inform a drug-associated risk. However, animal data have shown that administration of oral gatifloxacin throughout organogenesis and during late gestation through lactation did not produce adverse maternal, fetal, or neonatal effects at clinically relevant doses.
     

    Breast-feeding

    There are no data available regarding the presence of gatifloxacin in human milk, the effect of gatifloxacin on breast-feeding infants, or the effect of gatifloxacin on milk production. Animal data have shown that gatifloxacin is excreted in breast milk following oral administration; however, systemic levels of gatifloxacin following topical ocular administration are low and it is unknown whether gatifloxacin would be present in maternal milk at measurable levels following topical ocular administration. Two other fluoroquinolones, ciprofloxacin and ofloxacin, are considered to be compatible with breast-feeding by the American Academy of Pediatrics. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition prior to using ophthalmic gatifloxacin.
     

    ADVERSE REACTIONS

    Severe

    keratitis / Delayed / 5.0-10.0
    ocular hemorrhage / Delayed / 1.0-4.0
    visual impairment / Early / 1.0-4.0
    Stevens-Johnson syndrome / Delayed / 0-1.0
    anaphylactoid reactions / Rapid / Incidence not known
    laryngeal edema / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known

    Moderate

    conjunctivitis / Delayed / 5.0-10.0
    dyspnea / Early / Incidence not known
    blurred vision / Early / Incidence not known
    blepharitis / Early / Incidence not known
    corneal edema / Early / Incidence not known

    Mild

    lacrimation / Early / 5.0-10.0
    ocular irritation / Rapid / 5.0-10.0
    ocular discharge / Delayed / 1.0-4.0
    ocular pain / Early / 1.0-4.0
    xerophthalmia / Early / 1.0-4.0
    dysgeusia / Early / 1.0
    pruritus / Rapid / Incidence not known
    rash / Early / Incidence not known
    urticaria / Rapid / Incidence not known
    ocular pruritus / Rapid / Incidence not known
    headache / Early / Incidence not known
    nausea / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Gatifloxacin products.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no data available on gatifloxacin ophthalmic use in pregnancy to inform a drug-associated risk. However, animal data have shown that administration of oral gatifloxacin throughout organogenesis and during late gestation through lactation did not produce adverse maternal, fetal, or neonatal effects at clinically relevant doses.
     

    There are no data available regarding the presence of gatifloxacin in human milk, the effect of gatifloxacin on breast-feeding infants, or the effect of gatifloxacin on milk production. Animal data have shown that gatifloxacin is excreted in breast milk following oral administration; however, systemic levels of gatifloxacin following topical ocular administration are low and it is unknown whether gatifloxacin would be present in maternal milk at measurable levels following topical ocular administration. Two other fluoroquinolones, ciprofloxacin and ofloxacin, are considered to be compatible with breast-feeding by the American Academy of Pediatrics. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition prior to using ophthalmic gatifloxacin.
     

    MECHANISM OF ACTION

    Gatifloxacin is bactericidal via inhibition of DNA gyrase (topoisomerase II), an enzyme responsible for counteracting the excessive supercoiling of DNA during replication or transcription and topoisomerase IV, an enzyme that helps separate the daughter DNA molecules. In gram-negative bacteria, the primary target is the DNA gyrase A subunit, while the primary target in gram-positive bacteria is generally topoisomerase IV.

    PHARMACOKINETICS

    Gatifloxacin is administered topically to the eye. Systemic absorption is minimal.

    Other Route(s)

    Ophthalmic Route
    Following ophthalmic administration, serum concentrations of gatifloxacin are below detectable limits.