Regulatory Information
BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED
BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
SOLUTION, STERILE
**3 DOSAGE AND ADMINISTRATION** **Dosing Considerations** - Do not administer VYZULTA™ more than once daily since it has been shown that more frequent administration of prostaglandin analogues may lessen the intraocular pressure lowering effect. - If VYZULTA™ is to be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure, administer each drug product at least 5 minutes apart. **Recommended Dose and Dosage Adjustment** The recommended dosage is one drop in the conjunctival sac of the affected eye(s) once daily in the evening. VYZULTA is not indicated for use in pediatrics (≤ 18 years of age). **Administration** Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Contact lenses should be removed prior to administration of VYZULTA™, because this product contains Benzalkonium Chloride. Lenses may be reinserted 15 minutes following administration of VYZULTA™. **Missed Dose** If a dose is missed, treatment should continue with the next dose as normal.
OPHTHALMIC
Medical Information
**1 INDICATIONS** VYZULTA™ (latanoprostene bunod ophthalmic solution, 0.024%) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. **Pediatrics (≤ 18 years of age):** No data are available in patients below 18 years old; therefore, VYZULTA is not indicated for use in pediatrics. **Geriatrics (≥ 65 years of age):** Evidence from clinical studies and experience suggests that safety and effectiveness is comparable between elderly and other adult patients.
**2 CONTRAINDICATIONS** Latanoprostene bunod is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see **Dosage Forms, Strengths, Composition and Packaging** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
S01EE06
latanoprostene bunod
Manufacturer Information
BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED
Bausch & Lomb, Incorporated.
Active Ingredients
Documents
Package Inserts
Vyzulta Ophthalmic Solution 0.024% wv Approved PI.pdf
Approved: June 1, 2021