Source: Health Products and Food Branch (CA) Revision Year: 2019
ZYMAR (gatifloxacin ophthalmic solution 0.3%) is indicated for the treatment of patients 1 year of age and older with bacterial conjunctivitis caused by susceptible strains of the following bacteria:
Aerobic Gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Aerobic Gram-negative bacteria:
Haemophilus influenzae
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYMAR and other antibacterial drugs, ZYMAR should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ZYMAR in pediatric patients 1 year of age and older has been established; therefore, Health Canada has authorized an indication for pediatric use (see WARNINGS AND PRECAUTIONS, Pediatrics).
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
The recommended dosage regimen for ZYMAR in the treatment of patients 1 year of age and older with bacterial conjunctivitis is:
Days 1 and 2: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times daily.
Days 3 to 7: Instill one drop four times daily in the affected eye(s) while awake. Doses should be evenly spaced throughout the day.
Patients should be instructed to avoid allowing the tip of the bottle to contact the eye or surrounding structures to avoid eye injury and contamination of the eye drops.
Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses prior to administration of ZYMAR and wait at least 15 minutes following administration before reinserting soft contact lenses.
Patients should be instructed to instill the drops as soon as they remember, and then to return to their regular routine.
For management of a suspected drug overdose, including accidental ingestion, contact your regional Poison Control Centre.
A topical overdosage of ZYMAR is considered to be a remote possibility. Discontinue medication when heavy or protracted use is suspected. A topical overdosage may be flushed from the eye(s) with warm tap water.
If a 10 kg child swallowed the contents of a 5 mL bottle of ZYMAR (15 mg of drug) it would be exposed to 1.5 mg/kg of gatifloxacin. This is equivalent to 25% of the recommended adult systemic therapeutic dose of gatifloxacin of 400 mg/day for a 70 kg adult (6.0 mg/kg).
ZYMAR should be stored at 15°C to 25°C. Protect from freezing.
Keep bottle tightly closed in the outer carton (to protect from light) and discard 28 days after opening.
Keep out of the reach and sight of children.
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