Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Ryzumvi (phentolamine ophthalmic solution) 0.75% is supplied as a sterile, clear, and colorless solution for topical ophthalmic use contained in a translucent, low-density polyethylene, single-patient-use vial with a 0.31 mL fill. One strip of 5 single-patient-use vials is packaged into a foil pouch, with 6 foil pouches in a carton. One single-patient-use vial should be dispensed for each patient, and it can be used to dose both eyes. Carton of 30 single-patient-use vials – NDC-83368-075-30 Storage and Handling: Store refrigerated at 2°C to 8°C (36°F to 46°F), not to exceed the expiration date printed on the carton and pouch. Protect from freezing. After opening the foil pouch, the product may be stored at 25ºC (68°F to 77ºF) and should be used within 14 days, not to exceed the expiration date printed on the vial. The single-patient-use vial once opened should be discarded immediately after use. © 2024 Viatris Inc. RYZUMVI is a trademark of OCUPHIRE PHARMA, INC., licensed to the Viatris Companies. The brands listed are trademarks of their respective owners. Distributed by: Oyster Point Pharma, Inc., a Viatris Company Princeton, NJ 08540 OYP:RZVMI:R1; PRINCIPAL DISPLAY PANEL – 0.75% NDC: 83368-075-30 Rx Only Ryzumvi™ (phentolamine ophthalmic solution) 0.75% FOR TOPICAL USE IN THE EYES Sterile Contents: 6 pouches containing 5 single-patient-use vials each Dosage: See Prescribing Information. Active: Each mL contains phentolamine mesylate 10 mg (equivalent to 7.5 mg phentolamine as the free base); Inactives: mannitol, sodium acetate trihydrate, and water for injection. May contain either hydrochloric acid or sodium hydroxide to adjust pH. Storage: Store refrigerated at 2°c to 8°C (36°F to 46°F), not to exceed the expiration date printed on the carton and pouch. Protect from freezing. After opening the foil pouch, the product may be stored at 25°C (68°F to 77°F) and should be used within 14 days, not to exceed the expiration date printed on the vial. The single-patient-use vial once opened should be discarded immediately after use. Does not contain an anti-microbial preservative. OYP:075:6C:R1 Distributed by: Oyster Point Pharma, Inc., a Viatris company Princeton, NJ 08540 © 2024 Viatris Inc. RYZUMVI and the Ryzumvi Logo are trademarks of OCUPHIRE PHARMA, INC., licensed to the Viatris Companies. 0.75% Box Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING Ryzumvi (phentolamine ophthalmic solution) 0.75% is supplied as a sterile, clear, and colorless solution for topical ophthalmic use contained in a translucent, low-density polyethylene, single-patient-use vial with a 0.31 mL fill. One strip of 5 single-patient-use vials is packaged into a foil pouch, with 6 foil pouches in a carton. One single-patient-use vial should be dispensed for each patient, and it can be used to dose both eyes. Carton of 30 single-patient-use vials – NDC-83368-075-30 Storage and Handling: Store refrigerated at 2°C to 8°C (36°F to 46°F), not to exceed the expiration date printed on the carton and pouch. Protect from freezing. After opening the foil pouch, the product may be stored at 25ºC (68°F to 77ºF) and should be used within 14 days, not to exceed the expiration date printed on the vial. The single-patient-use vial once opened should be discarded immediately after use. © 2024 Viatris Inc. RYZUMVI is a trademark of OCUPHIRE PHARMA, INC., licensed to the Viatris Companies. The brands listed are trademarks of their respective owners. Distributed by: Oyster Point Pharma, Inc., a Viatris Company Princeton, NJ 08540 OYP:RZVMI:R1
- PRINCIPAL DISPLAY PANEL – 0.75% NDC: 83368-075-30 Rx Only Ryzumvi™ (phentolamine ophthalmic solution) 0.75% FOR TOPICAL USE IN THE EYES Sterile Contents: 6 pouches containing 5 single-patient-use vials each Dosage: See Prescribing Information. Active: Each mL contains phentolamine mesylate 10 mg (equivalent to 7.5 mg phentolamine as the free base); Inactives: mannitol, sodium acetate trihydrate, and water for injection. May contain either hydrochloric acid or sodium hydroxide to adjust pH. Storage: Store refrigerated at 2°c to 8°C (36°F to 46°F), not to exceed the expiration date printed on the carton and pouch. Protect from freezing. After opening the foil pouch, the product may be stored at 25°C (68°F to 77°F) and should be used within 14 days, not to exceed the expiration date printed on the vial. The single-patient-use vial once opened should be discarded immediately after use. Does not contain an anti-microbial preservative. OYP:075:6C:R1 Distributed by: Oyster Point Pharma, Inc., a Viatris company Princeton, NJ 08540 © 2024 Viatris Inc. RYZUMVI and the Ryzumvi Logo are trademarks of OCUPHIRE PHARMA, INC., licensed to the Viatris Companies. 0.75% Box Label
Overview
Ryzumvi (phentolamine ophthalmic solution) 0.75% is a sterile, clear and colorless solution for topical ophthalmic use containing 1% phentolamine mesylate (equivalent to 0.75% phentolamine). The product does not contain an anti-microbial preservative. The chemical name of phentolamine mesylate is 3-[[(4,5-dihydro-1H-imidazol-2-yl)methyl](4-methylphenyl)amino]phenol; methanesulfonic acid (parent phentolamine: [3-[[(4,5-dihydro-1H-imidazol-2-yl)methyl](4-methylphenyl)amino]phenol]) and the molecular formula is C 18 H 23 N 3 O 4 S (parent C 17 H 19 N 3 O). The molecular weight of phentolamine mesylate is 377.46 and the chemical structure is: Each mL of Ryzumvi contains phentolamine mesylate 10 mg as the active ingredient (equivalent to 7.5 mg phentolamine as the free base). Inactive ingredients are mannitol, sodium acetate trihydrate, and water for injection. Hydrochloric acid and/or sodium hydroxide are added to adjust pH (4.5 to 5.5), and the solution is overlaid with nitrogen. chemical structure
Indications & Usage
Ryzumvi is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. Ryzumvi is an alpha adrenergic blocker indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. ( 1 )
Dosage & 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 )
Warnings & Precautions
Uveitis: Ryzumvi is not recommended to be used in patients with active ocular inflammation. ( 5.1 ) 5.1 Uveitis Ryzumvi is not recommended when active ocular inflammation (e.g., iritis) is present because adhesions (synechiae) may form between the iris and the lens. 5.2 Potential for Eye Injury or Contamination To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface. 5.3 Use with Contact Lenses Contact lens wearers should be advised to remove their lenses prior to the instillation of Ryzumvi and wait 10 minutes after dosing before reinserting their contact lenses.
Contraindications
None. None. ( 4 )
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%).
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