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Hydroxyamphetamine and tropicamide: Drug information

Hydroxyamphetamine and tropicamide: Drug information
(For additional information see "Hydroxyamphetamine and tropicamide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Paremyd
Pharmacologic Category
  • Adrenergic Agonist Agent, Ophthalmic
Dosing: Adult
Mydriasis

Mydriasis: Ophthalmic: Instill 1 to 2 drops into conjunctival sac(s).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified. Also see tropicamide.

Postmarketing:

Cardiovascular: Acute myocardial infarction (Gaynes 1998), bradycardia (Gaynes 1998), hypotension, syncope (Gaynes 1998), ventricular fibrillation (Gaynes 1998)

Ophthalmic: Burning sensation of eyes (Anicho 1999), stinging of eyes (Anicho 1999)

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

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.

• Older adult: 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.

Dosage Forms: US

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]

Generic Equivalent Available: US

No

Pricing: US

Solution (Paremyd Ophthalmic)

1-0.25% (per mL): $5.66

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Use: Labeled Indications

Mydriasis: Short-term pupil dilation for diagnostic procedures

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Carbachol: Tropicamide may diminish the therapeutic effect of Carbachol. Risk C: Monitor therapy

Echothiophate Iodide: Tropicamide may diminish the therapeutic effect of Echothiophate Iodide. Risk C: Monitor therapy

Pilocarpine (Ophthalmic): Tropicamide may diminish the therapeutic effect of Pilocarpine (Ophthalmic). Risk C: Monitor therapy

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).

Breastfeeding Considerations

It is not known if hydroxyamphetamine or tropicamide is excreted in breast milk. The manufacturer recommends that caution be exercised when administering hydroxyamphetamine/tropicamide to nursing women.

Monitoring Parameters

Ophthalmic exam, intraocular pressure, CNS reactions (especially in pediatric patients).

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 (Adult Data Unless Noted)

Onset of action: 15 minutes

Duration: 3 hours; complete recovery usually occurs in 6-8 hours, but may take up to 24 hours

Time to peak: 60 minutes

  1. Anicho UM, Cooper J, Feldman J, Jaanus SD, Dignam K. The clinical efficacy of paremyd with and without dapiprazole in subjects with light and dark brown irides. Optom Vis Sci. 1999;76(2):94-101. doi:10.1097/00006324-199902000-00016 [PubMed 10082055]
  2. Gaynes BI. Monitoring drug safety; cardiac events in routine mydriasis. Optom Vis Sci. 1998;75(4):245-246. doi:10.1097/00006324-199804000-00019 [PubMed 9586747]
  3. Paremyd (hydroxyamphetamine and tropicamide) [prescribing information]. Lake Forest, IL: Akorn Inc; June 2016.
  4. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
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