Proparacaine Hydrochloride
Akorn
Human Prescription Drug
NDC 17478-263Proparacaine Hydrochloride is a human prescription drug labeled by 'Akorn'. National Drug Code (NDC) number for Proparacaine Hydrochloride is 17478-263. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Proparacaine Hydrochloride drug includes Proparacaine Hydrochloride - 5 mg/mL . The currest status of Proparacaine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 17478-263 |
| 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: | Proparacaine Hydrochloride |
| 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: | Proparacaine Hydrochloride |
| 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/ Drops |
| 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: | PROPARACAINE HYDROCHLORIDE - 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: | ANDA |
| 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: | 16 Mar, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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: | ANDA040277 |
| 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: | 1191013
|
| 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: | 0317478263128
|
| UPC stands for Universal Product Code. |
| UNII: | U96OL57GOY
|
| 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: | Local Anesthesia [PE]
Local Anesthetic [EPC]
|
| 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 |
|---|
| 17478-263-12 | 1 BOTTLE, DROPPER in 1 CARTON (17478-263-12) / 15 mL in 1 BOTTLE, DROPPER | 16 Mar, 2000 | 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. |
Product Elements:
Proparacaine hydrochloride proparacaine hydrochloride proparacaine hydrochloride proparacaine glycerin hydrochloric acid sodium hydroxide water benzalkonium chloride
Indications and Usage:
Indications and usage proparacaine hydrochloride ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.
Warnings:
Warnings not for injection. for topical ophthalmic use only. prolonged use of a topical ocular anesthetic may produce permanent corneal opacification with accompanying loss of vision.
General Precautions:
General proparacaine should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. the long-term toxicity of proparacaine is unknown; prolonged use may possibly delay wound healing. although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity (manifested by central nervous system stimulation followed by depression) may occur. protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of anesthesia is very important. tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. patients should be advised to avoid touching the eye until the anesthesia has worn off. do not touch dropper tip to any surface as this may contaminate the solution.
Dosage and Administration:
Dosage and administration deep anesthesia as in cataract extraction: instill 1 drop to the eye every 5 to 10 minutes for 5 to 7 doses. removal of sutures: instill 1 or 2 drops to the eye 2 or 3 minutes before removal of stitches. removal of foreign bodies: instill 1 or 2 drops to the eye prior to operating. tonometry: instill 1 or 2 drops to the eye immediately before measurement.
Contraindications:
Contraindications this preparation is contraindicated in patients with known hypersensitivity to any component of the solution.
Adverse Reactions:
Adverse reactions pupillary dilatation or cycloplegic effects have rarely been observed with proparacaine hydrochloride. the drug appears to be safe for use in patients sensitive to other local anesthetics, but local or systemic sensitivity occasionally occurs. instillation of proparacaine in the eye at recommended concentration and dosage usually produces little or no initial irritation, stinging, burning, conjunctival redness, lacrimation or increased winking. however, some local irritation and stinging may occur several hours after the instillation. rarely, a severe, immediate-type, apparently hyperallergic corneal reaction may occur which includes acute, intense and diffuse epithelial keratitis; a gray, ground-glass appearance; sloughing of large areas of necrotic epithelium; corneal filaments and, sometimes, iritis with descemetitis. allergic contact dermatitis with drying and fissuring of the fingertips has been reported. softening and erosion of the corneal epithelium and conjun
Read more...ctival congestion and hemorrhage have been reported.
Use in Pregnancy:
Pregnancy teratogenic effects category c animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution. it is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. proparacaine hydrochloride should be administered to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use controlled clinical studies have not been performed with proparacaine hydrochloride ophthalmic solution to establish safety and effectiveness in pediatric patients; however, the literature cites the use of proparacaine hydrochloride as a topical ophthalmic anesthetic agent in pediatric patients.
Description:
Description proparacaine hydrochloride ophthalmic solution usp, 0.5% is a local anesthetic for ophthalmic instillation. each ml of sterile, aqueous solution contains: active: proparacaine hydrochloride 5 mg (0.5%). preservative: benzalkonium chloride 0.1 mg (0.01%). inactives: glycerin as a stabilizer, hydrochloric acid and/or sodium hydroxide may be added to adjust ph (3.5 to 6.0), and water for injection usp. proparacaine hydrochloride is designed chemically as 2-(diethylamino)ethyl 3-amino-4-propoxybenzoate monohydrochloride. the active ingredient is represented by the structural formula: chemical structure
Clinical Pharmacology:
Clinical pharmacology proparacaine hydrochloride ophthalmic solution is a rapid acting local anesthetic suitable for ophthalmic use. with a single drop, the onset of anesthesia begins within 30 seconds and persists for 15 minutes or longer. the main site of anesthetic action is the nerve cell membrane where proparacaine interferes with the large transient increase in the membrane permeability to sodium ions that is normally produced by a slight depolarization of the membrane. as the anesthetic action progressively develops in a nerve, the threshold for electrical stimulation gradually increases and the safety factor for conduction decreases; when this action is sufficiently well developed, block of conduction is produced. the exact mechanism whereby proparacaine and other local anesthetics influence the permeability of the cell membrane is unknown; however, several studies indicate that local anesthetics may limit sodium ion permeability by closing the pores through which the ions migr
Read more...ate in the lipid layer of the nerve cell membrane. this limitation prevents the fundamental change necessary for the generation of the action potential.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment of fertility in males or females.
How Supplied:
How supplied proparacaine hydrochloride ophthalmic solution usp, 0.5% is supplied as a sterile solution in 15 ml plastic dropper bottles â ndc 17478-263-12 storage refrigerate at 2° to 8°c (36° to 46°f). keep bottle tightly closed. store in carton until empty to protect from light. if solution shows more than a faint yellow color, it should not be used. warning â keep this and all drugs out of the reach of children.
Package Label Principal Display Panel:
Principal display panel text for container label: ndc 17478-263-12 proparacaine hydrochloride ophthalmic solution, usp 0.5% 15 ml rx only principal display panel text for container label
Principal display panel text for carton label: ndc 17478-263-12 proparacaine hydrochloride ophthalmic solution, usp 0.5% for topical ophthalmic use only not for injection 15 ml sterile rx only akorn logo principal display panel text for carton label