Version May 2024
Mydriasis, pharmacologically induced; treatment:
Note: Not recommended for use when active ocular inflammation is present.
Children ≥3 to <12 years: Ophthalmic: Instill 1 drop in dilated eye(s) once following completion of ophthalmic examination or procedure.
Children ≥12 years and Adolescents: Ophthalmic: Instill 1 to 2 drop(s) in dilated eye(s) once following completion of ophthalmic examination or procedure. If 2 drops are to be instilled, wait 5 minutes between each drop.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Phentolamine (ophthalmic): Drug information")
Mydriasis, pharmacologically induced: Ophthalmic: Instill 1 or 2 drops into each dilated eye following the completion of the eye exam or procedure; when using 2 drops, instill second drop 5 minutes after the first drop.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Ophthalmic: Conjunctival hyperemia (12%), eye discomfort (instillation site: 16%; including burning sensation of eyes, eye pain, and stinging of eyes)
1% to 10%: Gastrointestinal: Dysgeusia (6%)
There are no contraindications listed in the manufacturer's labeling.
Disease-related concerns:
• Ocular inflammation: Use is not recommended when iritis is present; adhesions may form between the iris and the lens.
Special populations:
• Contact lens wearers: Remove contacts prior to administration and wait at least 10 minutes before reinserting.
Other warnings/precautions:
• Appropriate use: For ophthalmic use only. To avoid contamination, do not touch tip of container to any surface.
Ryzumvi: FDA approved September 2023; availability anticipated in 2024.
Ophthalmic: For topical ophthalmic use only; not for injection. Single-use vial may be used for both eyes if necessary. Remove contact lenses prior to instillation. Wash hands before and after application. To avoid contamination, do not touch vial tip to eye or other surfaces. If 2 drops are necessary for dose, wait 5 minutes before administering second drop. Wait at least 10 minutes after administration before reinserting contact lenses. Discard vial immediately after use.
Ophthalmic: For ophthalmic use only. Administer into dilated eye(s) after the completion of eye exam or procedure. Single-patient use vial may be used to dose both dilated eyes; discard immediately after use. Remove contact lenses prior to instillation and wait 10 minutes before reinserting. Do not touch the tip of the dropper to the eye, fingertips, or other surface.
Store refrigerated at 2°C to 8°C (36°F to 46°F); protect from freezing. Upon opening the foil pouch, may store at 20°C to 25°C (68°F to 77ºF) for up to 14 days. Discard opened single-dose vials immediately after use.
Treatment of pharmacologically induced mydriasis produced by adrenergic agonists (eg, phenylephrine) or parasympatholytic (eg, tropicamide) agents (FDA approved in ages ≥3 years and adults).
None known.
There are no known significant interactions.
Animal reproduction studies were not conducted following ophthalmic application.
If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctual occlusion to decrease potential exposure to the fetus (Samples 1988).
Phentolamine is a relatively nonselective alpha-1 and alpha-2 adrenergic antagonist. Phentolamine reversibly binds to alpha-1 adrenergic receptors on the iris dilator muscle, thereby reducing pupil diameter. Phentolamine directly antagonizes the mydriatic effect of an alpha-1 adrenergic agonist, and indirectly reverses mydriasis induced by muscarinic antagonist effects on the iris sphincter muscle.
Onset: Within 30 minutes; maximum effect: 60 to 90 minutes.
Duration: 24 hours.
Time to peak: 15 to 60 minutes.
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