NDC 17478-704 Paremyd
Hydroxyamphetamine Hydrobromide, Tropicamide Solution Ophthalmic

Product Information

Product Code17478-704
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Paremyd
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Hydroxyamphetamine Hydrobromide, Tropicamide
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Ophthalmic - Administration to the external eye.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Akorn
Labeler Code17478
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA019261
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-30-1992
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 17478-704-12

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

Product Details

Paremyd is a human prescription drug product labeled by Akorn. The generic name of Paremyd is hydroxyamphetamine hydrobromide, tropicamide. The product's dosage form is solution and is administered via ophthalmic form.


What are Paremyd Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Paremyd Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



1%/0.25%
Sterile

Rx only

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

PM00N
Rev. 06/16


Description



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.


Clinical Pharmacology



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.


Indications



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.


Contraindications



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.


Warnings



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.


General



Patients with hypertension, hyperthyroidism, diabetes or cardiac disease (i.e., arrhythmias or chronic ischemic heart disease) should be monitored after instillation. The elderly and others in whom glaucoma or increased intraocular pressure may be encountered following administration of PAREMYD® Solution should also be monitored closely. To avoid inducing angle-closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.


Information For Patients



Patients should be advised not to touch the dropper tip to any surface since this may contaminate the solution. Patients should be advised to use caution when driving or engaging in other hazardous activities while pupils are dilated. Patients may experience photophobia and/or blurred vision and should protect their eyes in bright illumination when pupils are dilated. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.


Carcinogenesis, Mutagenesis, Impairment Of Fertility



No studies have been performed to evaluate the carcinogenic, mutagenic or impairment of fertility potential of PAREMYD®.


Pregnancy Category C



Animal reproduction studies have not been conducted with PAREMYD®. It is also not known whether PAREMYD® can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. PAREMYD® should be given to a pregnant woman only if clearly needed.


Nursing Mothers



It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PAREMYD® is administered to a nursing woman.


Pediatric Use



Safety and effectiveness in pediatric patients have not been established. PAREMYD® may rarely cause CNS disturbances which may be dangerous in infants and children. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs. (See WARNINGS). Keep this and all medications out of the reach of children.


Geriatric Use



No overall differences in safety or effectiveness have been observed between elderly and younger patients.


Adverse Reactions



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.


Overdosage



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.


Dosage And Administration



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.


How Supplied



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


Storage



Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Note: Protect from light.


Package Label.Principal Display Panel



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


* Please review the disclaimer below.