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ZYMAXID

Last Updated: July 01, 2010

Manufacturer:

Allergan

Pharmacological Class:

Antibiotic (quinolone)

Active Ingredient(s):

Gatifloxacin 0.5%; oph soln; contains benzalkonium chloride.

Indication(s):

Susceptible bacterial conjunctivitis.

Pharmacology:

Zymaxid is an ophthalmic solution formulation of the fluoroquinolone antibiotic, gatifloxacin, which is effective against a wide range of gram positive and gram negative bacteria. It is indicated for treating bacterial conjunctivitis caused by susceptible strains of Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, or Haemophilus influenzae.

Gatifloxacin is also available in a 0.3% strength ophthalmic solution for the treatment of susceptible bacterial conjunctival infections (Zymar, also from Allergan).

Clinical Trials:

The efficacy of gatifloxacin 0.5% ophthalmic solution was evaluated in two randomized, double-masked, dual-arm comparison clinical trials involving 1,437 patients aged 1–89 years of age. Dosing with either gatifloxacin ophthalmic solution 0.5% or vehicle was continued for five days. The study drug was shown to be clinically superior to vehicle on day 6 in patients with conjunctivitis and positive conjunctival cultures. Clinical success was evidenced by resolution of conjunctival hyperemia and discharge. In the group given the study drug, 58% of patients had clinical success compared to 45% for those given the vehicle. Ninety percent of the patients using the study drug had microbiological eradication of the causative pathogens compared to 70% for placebo.

Legal Classification:

Adults & Children:

<1year: not recommended. ≥1year: one drop every 2 hrs in affected eye(s) (max 8 doses) on day 1, then 1 drop in affected eye(s) 2–4 times daily while awake on days 2–7.