hydroxyamphetamine/tropicamide [Ophthalmic]

Adult Dosing

Mydriasis

1-2 gtt in the conjunctival sac

Note:

Onset of action takes place within 15 minutes; Maximum effect occurs within 60 minutes
Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last for 3 hrs
As time progresses, mydriasis reverses spontaneously, typically in 6 to 8 hrs
Complete recovery may require up to 24 hrs in some patients

Pediatric Dosing

Safety and effectiveness in pediatric patients have not been established

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

For mydriasis in routine diagnostic procedures and in conditions requiring short-term pupil dilation

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Angle-closure glaucoma
Patients with narrow angles in whom pupil dilation may precipitate an attack of angle-closure glaucoma

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

For topical ophthalmic use only. Avoid using as an injection
In patients with open-angle glaucoma, mydriatics may result in a transient elevation of intraocular pressure
This combination rarely may cause CNS disturbances, and may be especially dangerous in infants, children or the elderly
Psychotic reactions, behavioral disturbances, and vasomotor or cardio-respiratory collapse have been reported with this combination
Monitor patients with hypertension, hyperthyroidism, diabetes or cardiac disease (arrhythmias or chronic ischemic heart disease), elderly patients, and those in whom glaucoma or increased intraocular pressure may be encountered

Cautions: Use cautiously in

Open-angle glaucoma
Infants or children
Elderly
Hypertension
Hyperthyroidism
Diabetes mellitus
Cardiac arrhythmias
Coronary artery disease

Supplemental Patient Information

Advise patients to avoid touching the dropper tip to any surface, as this may contaminate the solution
Advise patients to use the medication cautiously when driving or engaging in other hazardous activities while pupils are dilated
Instruct patients to protect eyes in bright illumination during dilation
Instruct parents to prevent accidental ingestion by their child, and to wash their own hands and the child’s hands following instillation

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety unknown; however, single ophthalmic tropicamide dose is not likely to interfere with breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 October 2013). It is unknown whether this drug is excreted in human milk; manufacturer advises caution while administering to nursing women.

Adverse Reactions ⬆ ⬇

EENT: Increased IOP, transient stinging, dryness of the mouth, blurred vision, photophobia, corneal staining
CV: Tachycardia, myocardial infarction, ventricular fibrillation, hypotensive episodes, cardiorespiratory collapse
CNS: Headache, CNS disturbances, vasomotor collapse
GI: Nausea, vomiting
PSCHIATRY: Psychotic reactions, behavioral disturbances
MUSC: Muscle rigidity
HYPERSENSITIVITY: Allergic reactions
MISC: Pallor, death

Clinical Pharmacology ⬆ ⬇

Hydroxyamphetamine

Adrenergic agent; releases norepinephrine from intact adrenergic nerve terminals resulting in mydriasis
Metabolism: Unknown
Excretion: Unknown
Half-life: Unknown

Tropicamide

Anticholinergic; inhibits the responses of the iris sphincter and ciliary muscles to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscles
Metabolism: Unknown
Excretion: Unknown
Half-life: Unknown

Brands and Availability ⬆ ⬇