Dosing & Uses
Dosage Forms & Strengths
hydroxyamphetamine/tropicamide
ophthalmic solution
- 1%/0.25%
Mydriasis/Cycloplegia
Indicated for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation is desired
Provides clinically significant mydriasis with partial cycloplegia
Dose: 1-2 gtt in the conjunctival sac
Administration
Onset of action occurs within 15 minutes
Maximum effect within 60 minutes
Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours
Mydriasis will reverse spontaneously with time, typically in 6 to 8 hours
In some cases, complete recovery may take up to 24 hours
Safety and efficacy not established
Adverse Effects
Frequency Not Defined
Tachycardia
Pallor
Headache
Parasympathetic stimulation
Transient stinging
Dry mouth
Nausea
Vomiting
Allergic reactions
Blurred vision
Photophobia with or without corneal staining
Increased IOP
Muscle rigidity
Rare
- Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported with the use of anticholinergic drugs
- Rare but serious cardiovascular events, including death due to myocardial infarction, ventricular fibrillation and significant hypotensive episodes have occurred shortly following instillation
Warnings
Contraindications
Hypersensitivity to product components
Known or suspected angle-closure glaucoma, presence of a shallow anterior chamber unless gonioscopic observation of the chamber angle is possible; presence of narrow angle where pupil dilation may precipitate angle-closure glaucoma
Cautions
Monitor patients with cardiac disorders, diabetes mellitus, hypertension or hyperthyroidism
May cause increased intraocular pressure (use with caution in patients with glaucoma)
Possibility of undiagnosed glaucoma should be considered
The elderly may experience intraocular pressure increase following use; use caution
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Unknown if excreted in breast milk, use caution
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
Indirect acting sympathomimetic agent; causes mydriasis by stimulating the release of norepinephrine from adrenergic nerve terminasl; blocks acetylcholine resulting in relaxation of cholinergically innervated iris sphincter muscle
Adrenergic innervation to radial muscle is therefore unopposed and pupil becomes dilated
Pharmacokinetics
Onset of action: 15 min
Peak effect: 60 min
Duration: 3 hr
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Formulary
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