Ryzumvi (phentolamine mesylate/PF)

One single-patient-use vial can be used to dose each dilated eye. Discard the single-patient-use vial immediately after use.

For topical ophthalmic use only.

To avoid eye injury or contamination, avoid touching vial tip to the eye or to any other surface.

Remove contact lenses prior to instillation of the ophthalmic solution and wait 10 minutes after dosing to reinsert the lenses.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

• Uveitis

There are no moderate contraindications for this drug.

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%).

There are no severe adverse reactions for this drug.

More Frequent

• Conjunctival hyperemia
• Dysgeusia
• Ocular irritation
• Ocular pain

No enhanced messaging available.

The safety and effectiveness of phentolamine ophthalmic solution have been established in pediatric patients 3 to 17 years of age. No overall differences have been observed between pediatric and adult subjects.

There are no available data with phentolamine ophthalmic solution administration in pregnant women to inform a drug-associated risk. In animal toxicology studies, when phentolamine was administered orally to pregnant mice and rats during the period of organogenesis, skeletal immaturity and decreased growth were observed in the offspring at doses at least 24-times the recommended clinical dose. Additionally, a lower rate of implantation was seen in pregnant rats treated with phentolamine administered at least 60-times the recommended clinical dose. No malformations or embryofetal deaths were observed in the offspring of pregnant mice, rats, and rabbits administered phentolamine during the period of organogenesis at doses of at least 24-, 60-, and 20-times, respectively, the recommended clinical dose. Phentolamine ophthalmic solution should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Oral administration of phentolamine to pregnant rats and mice at doses at least 24-times the recommended clinical dose (based on a body weight per surface area (mg/m2) comparison with a 60-kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses. Immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral phentolamine doses at least 60-times the recommended clinical dose (based on a mg/m2 comparison with a 60-kg human), a slightly lower rate of implantation was found in rats. Phentolamine did not affect embryonic or fetal development in rabbits at oral doses at least 20-times the recommended dose (based on a mg/m2 comparison with a 60-kg human). No malformations or embryofetal deaths were observed in the rat, mouse, or rabbit studies.

There is no information regarding the presence of phentolamine in human milk, the effects on the breastfed infants, or the effects on milk production during lactation to inform risk of phentolamine ophthalmic solution to an infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for phentolamine ophthalmic solution and any potential adverse effects on the breastfed child from the drug.

No overall differences in safety and effectiveness have been observed between elderly and younger adult subjects.