Dosing & Uses
Dosage Forms & Strengths
tropicamide/phenylephrine
ophthalmic spray
- 1%/2.5%
- Each metered spray delivers 0.008 mL (0.08mg/0.2mg)
- 2-mL vial enclosed in a dispenser cartridge for use with device
Mydriasis for Ophthalmic Exam
Indicated to induce mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired
Administer 1 metered spray to cornea of each eye to be dilated; repeat after 5 minutes
Dosage Forms & Strengths
tropicamide/phenylephrine
ophthalmic spray
- 1%/2.5%
- Each metered spray delivers 0.008 mL (0.08mg/0.2mg)
Mydriasis for Ophthalmic Exam
Indicated to induce mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired
≥1 year: Administer 1 metered spray to cornea of each eye to be dilated; repeat after 5 minutes
<1 year
- Administer 1 metered spray to cornea of each eye to be dilated; repeat after 5 minutes
- Not to exceed 3 sprays/eye per day
- 2-mL vial enclosed in a dispenser cartridge for use with device
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (3)
- glucagon
glucagon increases toxicity of tropicamide by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .
- glucagon intranasal
glucagon intranasal increases toxicity of tropicamide by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .
- macimorelin
tropicamide, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that may blunt the growth hormone (GH) response to macrimorelin may impact the accuracy of the diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin.
Monitor Closely (17)
- amitriptyline
amitriptyline, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- amoxapine
amoxapine, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- clomipramine
clomipramine, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- desipramine
desipramine, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- doxepin
doxepin, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- imipramine
imipramine, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- isocarboxazid
isocarboxazid increases effects of phenylephrine ophthalmic by pharmacodynamic synergism. Use Caution/Monitor. Some systemic absorption of ophthalmic phenylephrine; reduce dose within 21 days of MAO inhibitors.
- linezolid
linezolid increases effects of phenylephrine ophthalmic by pharmacodynamic synergism. Use Caution/Monitor. Some systemic absorption of ophthalmic phenylephrine; reduce dose within 21 days of MAO inhibitors.
- lofepramine
lofepramine, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- maprotiline
maprotiline, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- nortriptyline
nortriptyline, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- phenelzine
phenelzine increases effects of phenylephrine ophthalmic by pharmacodynamic synergism. Use Caution/Monitor. Some systemic absorption of ophthalmic phenylephrine; reduce dose within 21 days of MAO inhibitors.
- procarbazine
procarbazine increases effects of phenylephrine ophthalmic by pharmacodynamic synergism. Use Caution/Monitor. Some systemic absorption of ophthalmic phenylephrine; reduce dose within 21 days of MAO inhibitors.
- protriptyline
protriptyline, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- tranylcypromine
tranylcypromine increases effects of phenylephrine ophthalmic by pharmacodynamic synergism. Use Caution/Monitor. Some systemic absorption of ophthalmic phenylephrine; reduce dose within 21 days of MAO inhibitors.
- trazodone
trazodone, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
- trimipramine
trimipramine, phenylephrine ophthalmic. Other (see comment). Use Caution/Monitor. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.
Minor (0)
Adverse Effects
Frequency Not Defined
Ocular effects
- Transient blurred vision
- Reduced visual acuity
- Photophobia
- Superficial punctate keratitis
- Mild eye discomfort
- Increased intraocular pressure
Systemic effects
- Xerostomia
- Tachycardia
- Headache
- Allergic reactions
- Nausea
- Vomiting
- Pallor
- Central nervous system (CNS) disturbances and muscle rigidity reported with tropicamide
- Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children
- Increase in blood pressure reported (phenylephrine-related, particularly in, but not limited to, low-weight premature neonates, infants, and hypertensive patients)
Warnings
Contraindications
Known hypersensitivity
Cautions
For ophthalmic use only (not indicated for injection)
Elevated blood pressure may occur; caution in children aged <5 yr and in patients with hyperthyroidism or cardiovascular disease; monitor post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms
CNS disturbances associated with tropicamide, which may be dangerous in pediatric patients; consider possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergics
Mydriatics may transiently elevate intraocular pressure
Rebound miosis reported 1 day after administering; readministration produced a lesser mydriatic effect
Drug interaction overview
-
Agents that may exaggerate vasopressor responses
- Caution, monitor
- Phenylephrine may enhance vasopressor effects of atropine-like drugs and induce tachycardia in some patients
-
Cholinergic agonists and ophthalmic cholinesterase inhibitors
- Caution, monitor
- Tropicamide may interfere with antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors
-
Potent inhalation anesthetic agents
- Caution, monitor
- Phenylephrine may potentiate cardiovascular depressant effects of some inhalation anesthetic agents
Pregnancy & Lactation
Pregnancy
There are no available data regarding use in pregnant females or animals to inform any drug-associated risks
Lactation
Data are not available regarding presence in human milk, effects on breastfed infants, or effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Tropicamide: Anticholinergic that blocks the responses of the sphincter muscle of the iris, dilating the pupil (mydriasis)
Phenylephrine: Alpha-1 adrenergic agonist component that acts as a mydriatic agent by contracting the dilator muscle of the iris
Fixed-dose combination mydriatic ophthalmic product that is administered as a touchless microdose mist application
Absorption
Onset of action
- 15-30 minutes
- 20-90 minutes (maximal mydriasis)
- Darker irides tend to dilate slower than lightly pigmented irides, and achievement of maximal effect may require more doses
Duration
- Mydriasis reverses spontaneously with time, with recovery after 3-8 hr
- Complete recovery may require 24 hr in some individuals
Administration
Ophthalmic Administration
For ophthalmic use only
Touchless, metered spray ophthalmic mist
See prescribing information for complete instructions and diagrams for use
Advise patients to avoid driving, using machinery, or engaging in activities that require clear vision until they are sure they can perform such activities safely
Storage
Store at room temperature 15-25ºC (59-77ºF)
Do not tamper with or attempt to open cartridge, as it may damage the dispenser, causing an incorrect medication discharge volume, and/or the dispenser base may not function properly
Images
Formulary
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