Paremyd

Hydroxyamphetamine Hydrobromide, Tropicamide

Akorn
Human Prescription Drug
NDC 17478-704

Paremyd also known as Hydroxyamphetamine Hydrobromide, Tropicamide is a human prescription drug labeled by 'Akorn'. National Drug Code (NDC) number for Paremyd is 17478-704. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Paremyd drug includes Hydroxyamphetamine Hydrobromide - 10 mg/mL Tropicamide - 2.5 mg/mL . The currest status of Paremyd drug is Active.

Drug Information:

Drug NDC:	17478-704
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Paremyd
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Hydroxyamphetamine Hydrobromide, Tropicamide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Akorn
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	HYDROXYAMPHETAMINE HYDROBROMIDE - 10 mg/mL TROPICAMIDE - 2.5 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	OPHTHALMIC
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	30 Jan, 1992
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	16 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA019261
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Akorn
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	204426 206629
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0317478704126
UPC stands for Universal Product Code.
NUI:	N0000175574 N0000175370
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	59IG47SZ0E N0A3Z5XTC6
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	Cholinergic Antagonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Anticholinergic [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:	Adrenergic Agonists [MoA] Adrenergic Receptor Agonist [EPC] Anticholinergic [EPC] Cholinergic Antagonists [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
17478-704-12	1 BOTTLE, DROPPER in 1 CARTON (17478-704-12) / 15 mL in 1 BOTTLE, DROPPER	30 Jan, 1992	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Paremyd

Hydroxyamphetamine Hydrobromide, Tropicamide

Solution
Akorn
NDC: 17478-704

Product Elements:

Paremyd hydroxyamphetamine hydrobromide, tropicamide hydroxyamphetamine hydrobromide hydroxyamphetamine tropicamide tropicamide edetate disodium sodium chloride hydrochloric acid sodium hydroxide water benzalkonium chloride

Indications and Usage:

Indications paremyd Â® solution is indicated for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation is desired. paremyd Â® provides clinically significant mydriasis with partial cycloplegia.

Warnings:

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 Precautions:

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 Â® 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.

Dosage and Administration:

Dosage and administration one to two drops in the conjunctival sac. the onset of action with paremyd Â® 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.

Contraindications:

Contraindications paremyd Â® 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.

Adverse Reactions:

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 Â® 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 Â® instillation.

Use in Pregnancy:

Pregnancy pregnancy category c animal reproduction studies have not been conducted with paremyd Â® . it is also not known whether paremyd Â® can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. paremyd Â® should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use safety and effectiveness in pediatric patients have not been established. paremyd Â® 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:

Geriatric use no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Overdosage:

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.

Description:

Description paremyd Â® 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-Î±-(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 Â® is approximately 307 mosm/l. chemical structure

Clinical Pharmacology:

Clinical pharmacology paremyd Â® 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 Â® . 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, pro Read more...

ducing 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 Â® provides diminished pupil responsiveness to light, facilitating ophthalmoscopy. the onset of action with paremyd Â® 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.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility no studies have been performed to evaluate the carcinogenic, mutagenic or impairment of fertility potential of paremyd Â® .

How Supplied:

How supplied paremyd Â® (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 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. note: protect from light.

Information for Patients:

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.

Package Label Principal Display Panel:

Container label principal display panel ndc 17478-704-12 paremyd Â® (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25% 15 ml sterile rx only container label principal display panel

Carton principal display panel ndc 17478-704-12 [akorn logo] paremyd Â® (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25% 15 ml sterile rx only carton principal display panel

Comments/ Reviews:

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