Paremyd

1%/0.25%
Sterile

Rx only

PAREMYD^® sterile ophthalmic solution is a topical mydriatic combination product for ophthalmic use.

STRUCTURAL FORMULAE

CHEMICAL NAME
Hydroxyamphetamine hydrobromide: Phenol, 4-(2-aminopropyl)-, hydrobromide
Tropicamide: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)-

CONTAINS
Actives: Hydroxyamphetamine hydrobromide, USP.......................1.0%
        Tropicamide, USP.................................................................0.25%
Preservative: Benzalkonium Chloride 0.005%
Inactives: Edetate Disodium 0.015%, Sodium Chloride; Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.2 to 5.8 during its shelf life), and Water for Injecton. The osmolality of PAREMYD^® is approximately 307 mOsm/l.

PAREMYD^® Solution combines the effects of the adrenergic agent, hydroxyamphetamine hydrobromide, and the anticholinergic agent, tropicamide.

Hydroxyamphetamine hydrobromide is an indirectly-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, e.g., Horner's Syndrome. However, it is not known whether damage to the presynaptic nerve terminal will influence the extent of mydriasis produced by PAREMYD^®. Hydroxyamphetamine hydrobromide 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 these agents act on different effector sites, their simultaneous use produces an additive mydriatic effect. PAREMYD^® provides diminished pupil responsiveness to light, facilitating ophthalmoscopy. The onset of action with PAREMYD^® occurs within 15 minutes, followed by maximum effect within 60 minutes after instillation of one drop. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours, with recovery beginning at approximately 90 minutes and with complete recovery occurring in most patients in 6 to 8 hours. However, in some cases complete recovery may take up to 24 hours. Effectiveness may differ slightly in patients with light and dark irides, with those patients with light irides experiencing a slightly greater mydriasis.

PAREMYD^® Solution is indicated for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation is desired. PAREMYD^® provides clinically significant mydriasis with partial cycloplegia.

PAREMYD^® Solution should not be used in patients with angle-closure glaucoma or in those with narrow angles in whom dilation of the pupil may precipitate an attack of angle-closure glaucoma. This product is also contraindicated in patients who are hypersensitive to any of its components.

For topical ophthalmic use only; not for injection.

There is evidence that mydriatics may produce a transient elevation of intraocular pressure in patients with open-angle glaucoma.

This preparation rarely may cause CNS disturbances which may be particularly dangerous in infants, children or the aged. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse have been reported with the use of anticholinergic drugs.

Increased intraocular pressure has been reported following use of mydriatics. Transient stinging, dryness of the mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headache, allergic reactions, nausea, vomiting, pallor and muscle rigidity have been reported with the use of tropicamide and/or hydroxyamphetamine hydrobromide, and thus may occur with PAREMYD^® Solution. Central nervous system disturbances have also been reported. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported with the use of anticholinergic drugs.

Rare but serious cardiovascular events, including death due to myocardial infarction, ventricular fibrillation and significant hypotensive episodes have occurred shortly following PAREMYD^® instillation.

Ocular overdosage will cause dilation of the pupils. Systemic overdosage or ingestion of large doses may result in hypertension, cardiac arrhythmias, sub-sternal discomfort, headache, sweating, nausea, vomiting and gastrointestinal irritation. Patients with systemic overdosage should be carefully monitored and treated symptomatically.

One to two drops in the conjunctival sac. The onset of action with PAREMYD^® Solution occurs within 15 minutes followed by maximum effect within 60 minutes. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours.

Mydriasis will reverse spontaneously with time, typically in 6 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.

PAREMYD^® (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25% as a 15 mL solution in a 15 mL opaque white, low density polyethylene bottle with a natural low density polyethylene dropper tip and a red polypropylene cap.

15 mL - NDC 17478-704-12

Manufactured by:
Akorn, Inc.
Lake Forest, IL 60045

PM00N
Rev. 06/16

Container Label Principal Display Panel

NDC 17478-704-12

PAREMYD^®

(hydroxyamphetamine

hydrobromide/tropicamide

ophthalmic solution) 1%/0.25%

15 mL Sterile Rx only

Carton Principal Display Panel

NDC 17478-704-12

[Akorn logo]

PAREMYD^®

(hydroxyamphetamine

hydrobromide/tropicamide

ophthalmic solution)

1%/0.25%

15 mL

Sterile Rx only