Dosing and uses of Paremyd (hydroxyamphetamine/tropicamide)
Adult dosage forms and strengths
hydroxyamphetamine/tropicamide
ophthalmic solution
- 1%/0.25%
Mydriasis
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
Other Information
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
Pediatric dosage forms and strengths
<18 safety and efficacy not established
Paremyd (hydroxyamphetamine/tropicamide) adverse (side) 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 either component
Known or suspected angle-closure glaucoma, presence of a shallow anterior chamber unless gonioscopic observation of the chamber angle is possible
Cautions
Cardiac disorders
Diabetes mellitus
Hypertension
Hyperthyroidism
May cause increased intraocular pressure
Possibility of undiagnosed glaucoma should be considered
Pregnancy and 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 of Paremyd (hydroxyamphetamine/tropicamide)
Onset: 15 min
Maximum effect: 60 min
Duration: 3 hr
Recovery (usual): spontaneous 6-8 hr
Mechanism of action
Blocks acetylcholine resulting in relaxation of cholinergically innervated iris sphincter muscle
Adrenergic innervation to radial muscle is therefore unopposed and pupil becomes dilated