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Mydriatics and Cycloplegics
Topical ophthalmic combination of an adrenergic agent and an anticholinergic agentUsed for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation desiredProvides diminished pupil responsiveness to light, facilitating ophthalmoscopy
Paremyd Ophthalmic Sol: 1-0.25%
1 to 2 drops in the conjunctival sac as a single dose.
2 drops/procedure per affected eye.
Safety and efficacy have not been established.
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.
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.
Paremyd:- Protect from light- Store between 59 to 77 degrees F
Hydroxyamphetamine; tropicamide is contraindicated in patients who are hypersensitive to any of its components.
Hydroxyamphetamine; tropicamide is contraindicated in patients with closed-angle glaucoma or in those with narrow angles in whom dilation of the pupil may precipitate an attack of closed-angle glaucoma. An estimation of the depth of the angle of the anterior chamber should be made to avoid inducing closed-angle glaucoma. In some patients with open-angle glaucoma, the use of mydriatic agents like hydroxyamphetamine; tropicamide may produce a transient elevation of intraocular pressure.
Monitor patients with hypertension or cardiac disease (i.e., cardiac arrhythmias or chronic ischemic heart disease) after hydroxyamphetamine; tropicamide instillation.
Monitor patients with hyperthyroidism after hydroxyamphetamine; tropicamide instillation.
Monitor patients with diabetes mellitus after hydroxyamphetamine; tropicamide instillation.
Monitor geriatric patients for increased intraocular pressure or glaucoma as well as CNS disturbances after hydroxyamphetamine; tropicamide instillation.
The safety and efficacy of hydroxyamphetamine; tropicamide have not been established in neonates, infants, children, or adolescents. Hydroxyamphetamine; tropicamide may rarely cause CNS disturbances which may be particularly dangerous in pediatric patients. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs.
Advise patients to use caution when driving or operating machinery while pupils are dilated. Patients may experience photophobia and/or blurred vision; advise patients to protect their eyes in bright illumination when pupils are dilated.
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.
myocardial infarction / Delayed / Incidence not knownventricular fibrillation / Early / Incidence not knownanaphylactoid reactions / Rapid / Incidence not known
photophobia / Early / Incidence not knownblurred vision / Early / Incidence not knownpsychosis / Early / Incidence not knownhypotension / Rapid / Incidence not knownsinus tachycardia / Rapid / Incidence not knownhypertonia / Delayed / Incidence not known
headache / Early / Incidence not knownxerostomia / Early / Incidence not knownnausea / Early / Incidence not knownpallor / Early / Incidence not knownvomiting / Early / Incidence not known
There are no drug interactions associated with Hydroxyamphetamine; Tropicamide products.
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 RouteAfter 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.