Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, ophthalmic:
Paremyd: Hydroxyamphetamine hydrobromide 1% and tropicamide 0.25% (15 mL) [contains benzalkonium chloride]
Pharmacology
Mechanism of Action
Hydroxyamphetamine hydrobromide is an indirect acting sympathomimetic agent which causes the release of norepinephrine from adrenergic nerve terminals, resulting in mydriasis. Tropicamide is a parasympatholytic agent which produces mydriasis and paralysis by blocking the sphincter muscle in the iris and the ciliary muscle.
Pharmacokinetics/Pharmacodynamics
Onset of Action
15 minutes
Time to Peak
60 minutes
Duration of Action
3 hours; complete recovery usually occurs in 6-8 hours, but may take up to 24 hours
Use: Labeled Indications
Mydriasis: Short-term pupil dilation for diagnostic procedures
Contraindications
Hypersensitivity to hydroxyamphetamine, tropicamide, or any component of the formulation; angle-closure glaucoma or those with narrow angles where dilation of the pupil may precipitate angle-closure glaucoma
Dosage and Administration
Dosing: Adult
Mydriasis: Ophthalmic: Instill 1 to 2 drops into conjunctival sac(s)
Dosing: Geriatric
Refer to adult dosing.
Administration
For topical ophthalmic use only. To avoid excessive systemic absorption, apply gentle finger pressure to lacrimal sac for 2 to 3 minutes following application. Do not touch dropper tip to eyelids or other surfaces when placing drops in eyes. Wash hands following administration.
Storage
Store between 20°C and 25°C (68°F and 77°F). Protect from light. Protect from light.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
Frequency not defined. Reported with Paremyd or similar medications.
Cardiovascular: Hypotension, myocardial infarction, tachycardia, ventricular fibrillation
Central nervous system: Behavioral problems, headache, psychosis
Dermatologic: Pallor
Gastrointestinal: Nausea, vomiting, xerostomia
Hypersensitivity: Hypersensitivity reaction
Neuromuscular & skeletal: Muscle rigidity
Ophthalmic: Blurred vision, increased intraocular pressure, photophobia, stinging of eyes (transient)
Warnings/Precautions
Concerns related to adverse effects:
- CNS effects: May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
- Increased intraocular pressure: May cause a transient increase in intraocular pressure; use with caution in patients with glaucoma.
Disease-related concerns:
- Cardiovascular disease: Use caution in patients with hypertension, arrhythmias, or ischemic disease; monitor following administration.
- Diabetes: Use caution in patients with diabetes; monitor following administration.
- Thyroid disease: Use caution in patients with hyperthyroidism; monitor following administration.
Special populations:
- Contact lens wearers: May contain benzalkonium chloride, which may be adsorbed by contact lenses; remove contacts prior to administration and wait 15 minutes before reinserting.
- Elderly: Use with caution in the elderly; monitor closely for increased intraocular pressure following use.
- Pediatric: Use with caution in infants and children; may cause potentially dangerous CNS disturbances. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.
Other warnings/precautions:
- Appropriate use: For topical ophthalmic use only. To avoid excessive systemic absorption, apply gentle finger pressure to lacrimal sac for 2 to 3 minutes following application. Do not touch dropper tip to eyelids or any surface.
Monitoring Parameters
Ophthalmic exam, intraocular pressure, CNS reactions (especially in pediatric patients).
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal reproduction studies have not been conducted with this combination. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples, 1988).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
