Description
NDC: 83368-075-30
Ryzumvi (Phentolamine Mesylate 0.75%) Ophthalmic Solution, 30-pack Single-Use Vials — Viatris
| Active ingredient | Phentolamine (as phentolamine mesylate) 0.75% |
| Dosage form | Ophthalmic solution |
| Route | Topical ophthalmic |
| Size | 30-pack single-use vials |
| Manufacturer | Viatris |
| NDC | 83368-075-30 |
Indications and Usage
Indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. It is used to reverse pupil dilation following an ophthalmic examination.
Dosage and Administration
For adults and pediatric patients 12 years and older, instill 1 or 2 drops in each dilated eye following completion of the ophthalmic examination; if a second drop is used, administer it approximately 5 minutes after the first. For pediatric patients 3 to 11 years of age, instill 1 drop in each dilated eye.
Warnings and Precautions
- Not recommended in patients with active ocular inflammation (e.g., uveitis) due to the potential risk of iris-lens adhesions
- To avoid eye injury or contamination, do not touch the vial tip to the eye or any surface
- Remove contact lenses before instillation and wait at least 10 minutes before reinserting them
Contraindications
None.
Adverse Reactions
The most common adverse reactions reported in clinical trials were instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%).
Storage and Handling
Store refrigerated at 2°C to 8°C (36°F to 46°F). After the foil pouch is opened, vials may be stored at up to 25°C (77°F) for up to 14 days.
How Supplied
Supplied as a sterile, single-patient-use ophthalmic solution in low-density polyethylene vials, each packaged in a foil pouch, in a carton of 30 vials.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
