Important Safety Information
Clinical use:
Pediatrics (≤16 years of age): No data are available to Health Canada; therefore, Health Canada
has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age): Evidence from clinical studies and experience suggests that
safety and effectiveness is comparable between elderly and other adult patients.
Relevant warnings and precautions:
- Bacterial keratitis
- Gradual change in the eyelashes and vellus hair in the treated eye. These changes include increased
Xilength, thickness, and the number of lashes or hairs Eyelash changes are usually reversible upon
Xidiscontinuation of treatment.
- Use with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should
Xigenerally not be used in patients with active intraocular inflammation
- Use with caution in patients who do not have an intact posterior capsule or who have known risk
Xifactors for macular edema
- May cause changes to pigmented tissues
- Contact lenses should be removed prior to the administration of VYZULTA™ because this product
contains benzalkonium chloride. Lenses may be reinserted after 15 minutes following administration.
- Use with caution in patients with a history of herpetic keratitis and do not use in cases of active
herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically
associated with prostaglandin analogues
- Use with caution in patients with hepatic and renal impairment
- Use with caution in patients with severe or uncontrolled asthma
- Should not be used in pregnant women unless the benefit to the mother justifies the potential risk
to the fetus
- Caution when administered to nursing women
For more information:
Please consult the Product Monograph at https://pdf.hres.ca/dpd_pm/00048990.PDF for important
information relating to adverse reactions, drug interactions, and dosing information that has not been
discussed in this piece. The Product Monograph is also available by calling 1-800-361-4261.
