Ryzumvi 10 mg/mL
phentolamine mesylate · SOLUTION/ DROPS · Oyster Point Pharma, Inc.
Ryzumvi is a solution/ drops containing phentolamine mesylate at 10 mg/mL, taken ophthalmic. Manufactured by Oyster Point Pharma, Inc..
Key Facts
- Brand Name
- Ryzumvi
- Generic Name
- phentolamine mesylate
- NDC Code (Product)
83368-075- Manufacturer
- Oyster Point Pharma, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA217064
- Marketing Start
- 03/25/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RYZUMVI is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). RYZUMVI is an alpha-adrenergic blocker indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients Aged 12 Years or Older: Instill 1 or 2 drops in each dilated eye following the completion of the ophthalmic examination or procedure. If 2 drops are instilled, the second drop should be administered 5 minutes after the first drop. Pediatric Patients Aged 3 to 11 Years: Instill 1 drop in each dilated eye following the completion of the ophthalmic examination or procedure. One single-patient-use vial can be used to dose each dilated eye. Discard the single-patient-use vial immediately after use. • Adults and Pediatric Patients Aged 12 Years and Older: Instill 1 to 2 drops in each dilated eye following the completion of the ophthalmic examination or procedure to reverse mydriasis. ( 2 ) • Pediatric Patients Aged 3 to 11 Years: Instill 1 drop in each dilated eye following the completion of the ophthalmic examination or procedure to reverse mydriasis. ( 2 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. RYZUMVI was evaluated in 642 subjects in clinical trials across various subject populations. The most common ocular adverse reactions reported in > 5% of subjects were instillation site discomfort including pain, stinging, and burning (16%) and conjunctival hyperemia (12%). The only non-ocular adverse reaction reported in > 5% of subjects was dysgeusia (6%).
Frequently Asked Questions
What is Ryzumvi used for?
Ryzumvi contains phentolamine mesylate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Ryzumvi a controlled substance?
Ryzumvi is not classified as a controlled substance by the DEA.
What is the generic name for Ryzumvi?
The generic name for Ryzumvi is phentolamine mesylate. There are 3 other brand versions of phentolamine mesylate.
What is the NDC code for Ryzumvi 10 mg/mL?
The NDC (National Drug Code) for Ryzumvi 10 mg/mL is 83368-075, listed by Oyster Point Pharma, Inc..