Paremyd

Mydriatics and Cycloplegics

Instill in the conjunctival sac.
Do not to touch the dropper tip to any surface.
Advise patients to not get hydroxyamphetamine; tropicamide solution in their child's mouth and to wash their hands and the child's hands after administration.

myocardial infarction / Delayed / Incidence not known
ventricular fibrillation / Early / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known

photophobia / Early / Incidence not known
blurred vision / Early / Incidence not known
psychosis / Early / Incidence not known
hypotension / Rapid / Incidence not known
sinus tachycardia / Rapid / Incidence not known
hypertonia / Delayed / Incidence not known

headache / Early / Incidence not known
xerostomia / Early / Incidence not known
nausea / Early / Incidence not known
pallor / Early / Incidence not known
vomiting / Early / Incidence not known

Paremyd

Rx

Topical ophthalmic combination of an adrenergic agent and an anticholinergic agent
Used for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation desired
Provides diminished pupil responsiveness to light, facilitating ophthalmoscopy

1 to 2 drops in the conjunctival sac as a single dose.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Hydroxyamphetamine; Tropicamide products.

Paremyd Ophthalmic Sol: 1-0.25%

2 drops/procedure per affected eye.

2 drops/procedure per affected eye.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Hydroxyamphetamine is an indirect-acting sympathomimetic agent which, when applied topically to the eye, causes the release of endogenous norepinephrine from intact adrenergic nerve terminals resulting in mydriasis. Since hydroxyamphetamine hydrobromide has little or no direct activity on the receptor site, dilation does not usually occur if there is damage to the presynaptic nerve terminal. Hydroxyamphetamine has minimal cycloplegic action. Tropicamide is a parasympatholytic agent which, when applied topically to the eye, blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle. Tropicamide produces short-duration mydriasis. Although cycloplegia occurs with higher doses of tropicamide, there is evidence with 0.25% tropicamide that full cycloplegia does not occur. Since both of these agents act on different effector sites, their simultaneous use produces an additive mydriatic effect. Hydroxyamphetamine; tropicamide provides diminished pupil responsiveness to light, facilitating ophthalmoscopy. Effectiveness may differ slightly in patients with light and dark irides, with those patients with light irides experiencing a slightly greater mydriasis.

Hydroxyamphetamine; tropicamide is administered topically to the eye.
 
Affected cytochrome P450 isoenzymes and drug transporters: none

Ophthalmic Route
After ocular administration of 1 drop of hydroxyamphetamine; tropicamide, the onset of mydriasis occurs within 15 minutes with maximum effect being reached within 60 minutes. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours, with recovery beginning after approximately 90 minutes and with complete recovery occurring in 6 to 8 hours in most patients; however, in some cases complete recovery may take up to 24 hours.

Use hydroxyamphetamine; tropicamide during pregnancy only if clearly needed. It is not known whether hydroxyamphetamine; tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capability.

Use caution when administering hydroxyamphetamine; tropicamide to a breast-feeding woman. It is not known if hydroxyamphetamine; tropicamide is excreted in human milk.