Tetracaine Hydrochloride

Remedyrepack Inc.
Human Prescription Drug
NDC 70518-2741

Tetracaine Hydrochloride is a human prescription drug labeled by 'Remedyrepack Inc.'. National Drug Code (NDC) number for Tetracaine Hydrochloride is 70518-2741. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Tetracaine Hydrochloride drug includes Tetracaine Hydrochloride - 5 mg/mL . The currest status of Tetracaine Hydrochloride drug is Active.

Drug Information:

Drug NDC:	70518-2741
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:	Tetracaine 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:	Tetracaine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Remedyrepack Inc.
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:	TETRACAINE 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:	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:	12 May, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	26 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:	NDA210821
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:	REMEDYREPACK INC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1547771
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.
UNII:	5NF5D4OPCI
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:	Ester Local Anesthetic [EPC] Esters [CS] Local Anesthesia [PE]
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
70518-2741-0	1 BOTTLE in 1 CARTON (70518-2741-0) / 15 mL in 1 BOTTLE	12 May, 2020	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

Tetracaine

Tetracaine Hydrochloride

Injection
Bryant Ranch Prepack
NDC: 63629-9160

Product Elements:

Tetracaine hydrochloride tetracaine hydrochloride chlorobutanol boric acid potassium chloride edetate disodium water sodium hydroxide hydrochloric acid tetracaine hydrochloride tetracaine

Indications and Usage:

1 indications and usage tetracaine hydrochloride ophthalmic solution, usp 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. tetracaine hydrochloride ophthalmic solution, usp 0.5%, is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )

Warnings and Cautions:

5 warnings and precautions do not use intracamerally since use may damage corneal endothelial cells. ( 5.1 ) prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. ( 5.2 ) patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. ( 5.3 ) for administration by healthcare provider : tetracaine hydrochloride ophthalmic solution, usp 0.5% is not intended for patient self-administration. ( 5.4 ) 5.1 corneal injury with intracameral use not for injection or intraocular use. do not use intracamerally because use of tetracaine hydrochloride ophthalmic solution, usp 0.5% may lead to damage of the corneal endothelial cells. 5.2 corneal toxicity prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. 5.3 corneal injury d Read more...

ue to insensitivity patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. 5.4 for administration by healthcare provider tetracaine hydrochloride ophthalmic solution, usp 0.5% is indicated for administration under the direct supervision of a healthcare provider. tetracaine hydrochloride ophthalmic solution, usp 0.5% is not intended for patient self-administration [see warnings and precautions ( 5.2 )].

Dosage and Administration:

2 dosage and administration one drop topically in the eye(s) as needed. one drop topically in the eye(s) as needed. ( 2 )

Dosage Forms and Strength:

3 dosage forms and strengths tetracaine hydrochloride ophthalmic solution, usp 0.5% is a clear, colorless, ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v. ophthalmic solution containing 0.5% tetracaine hydrochloride. ( 3 )

Contraindications:

4 contraindications tetracaine hydrochloride ophthalmic solution, usp 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. tetracaine hydrochloride ophthalmic solution, usp 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. ( 4 )

Adverse Reactions:

6 adverse reactions the following serious ocular adverse reactions are described elsewhere in the labeling: corneal injury with intracameral use [ see warnings and precautions ( 5.1 )] corneal toxicity [ see warnings and precautions ( 5.2 )] corneal injury due to insensitivity [ see warnings and precautions ( 5.3 )] the following adverse reactions have been identified following use of tetracaine hydrochloride ophthalmic solution, usp 0.5%. because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ocular adverse reactions transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. ocular adverse events: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. ( 6 ) to report suspected adverse reactions, contact oceanside pharmaceuticals at 1-800-321-4576 or fda at 1-8 Read more...

00-fda-1088 or www.fda.gov/medwatch.

Use in Specific Population:

8 use in specific populations 8.1 pregnancy risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution, usp 0.5% in pregnant women. animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. 8.2 lactation risk summary there are no data to assess whether tetracaine hydrochloride ophthalmic solution, usp 0.5% is excreted in human milk or to assess its effects on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the motherâs clinical need for tetracaine hydrochloride ophthalmic solution, usp 0.5% and any potential adverse effects on the breastfed child from tetracaine hydrochloride ophthalmic solution, usp 0.5%. 8.3 females and males of reproductive potential no human data on the effect of tetracaine hydrochloride ophthalmic solution, usp 0.5% on fertility are available. 8.4 pediatric use sa Read more...

fety of tetracaine hydrochloride ophthalmic solution, usp 0.5% in the pediatric population has been demonstrated in clinical trials. efficacy of tetracaine hydrochloride ophthalmic solution, usp 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. 8.5 geriatric use no overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution, usp 0.5% have been observed between elderly and younger patients.

Use in Pregnancy:

8.1 pregnancy risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution, usp 0.5% in pregnant women. animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.

Pediatric Use:

8.4 pediatric use safety of tetracaine hydrochloride ophthalmic solution, usp 0.5% in the pediatric population has been demonstrated in clinical trials. efficacy of tetracaine hydrochloride ophthalmic solution, usp 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

Geriatric Use:

8.5 geriatric use no overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution, usp 0.5% have been observed between elderly and younger patients.

Overdosage:

10 overdosage prolonged use of a topical ocular anesthetic including tetracaine hydrochloride ophthalmic solution, usp 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.

Description:

11 description tetracaine hydrochloride ophthalmic solution, usp 0.5% is a sterile, clear, colorless, topical local anesthetic for ophthalmic use only containing tetracaine hydrochloride as the active pharmaceutical ingredient. tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-, 2-(dimethylamino) ethyl ester, monohydrochloride. its chemical formula is c 15 h 24 n 2 o 2 â hcl and it is represented by the chemical structure: tetracaine hydrochloride is a fine, white, crystalline, odorless powder with a molecular weight of 300.82 active ingredient: tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine) preservative: chlorobutanol 0.4% inactive ingredients: boric acid, potassium chloride, edetate disodium dihydrate, water for injection. sodium hydroxide and/or hydrochloric acid may be added to adjust ph (3.7 â 6.0). chem

Clinical Pharmacology:

12 clinical pharmacology 12.1 mechanism of action tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia. 12.3 pharmacokinetics the systemic exposure to tetracaine following topical ocular administration of tetracaine hydrochloride ophthalmic solution, usp 0.5% has not been studied. tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

Mechanism of Action:

12.1 mechanism of action tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

Pharmacokinetics:

12.3 pharmacokinetics the systemic exposure to tetracaine following topical ocular administration of tetracaine hydrochloride ophthalmic solution, usp 0.5% has not been studied. tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

Nonclinical Toxicology:

13 nonclinical toxicology 13.1 carcinogenesis, mutagenesis, impairment of fertility studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

13.1 carcinogenesis, mutagenesis, impairment of fertility studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.

Clinical Studies:

14 clinical studies topical administration of tetracaine hydrochloride ophthalmic solution, usp 0.5% results in localized temporary anesthesia. the maximum effect is achieved within 10â20 seconds after instillation, with efficacy lasting 10â20 minutes. duration of effect can be extended with repeated dosing [ see warnings and precautions ( 5.2 ) and overdosage ( 10 )] .

How Supplied:

16 how supplied/storage and handling tetracaine hydrochloride ophthalmic solution, usp 0.5% is supplied as a sterile, aqueous, topical ophthalmic solution in a low-density polyethylene plastic dropper bottle with a low-density polyethylene dropper tip and white polypropylene cap in the following sizes: ndc: ndc: 70518-2741-00 packaging: 1 in 1 carton, 15 ml in 1 bottle type 0 after opening, this product can be used until the expiration date stamped on the bottle. storage: store at 15Â° to 25Â°c (59Â° to 77Â°f). protect from light. do not use if solution contains crystals, cloudy, or discolored. repackaged and distributed by: remedy repack, inc. 625 kolter dr. suite #4 indiana, pa 1-724-465-8762

Information for Patients:

17 patient counseling information eye care precaution do not touch the dropper tip to any surface as this may contaminate the solution. advise patients that, due to the effect of the anesthetic, their eyes will be insensitive for up to 20 minutes and that care should be taken to avoid accidental injuries. repackaged by / distributed by: remedyrepack inc. 625 kolter drive, indiana, pa 15701 (724) 465-8762

Package Label Principal Display Panel:

Drug: tetracaine hydrochloride generic: tetracaine hydrochloride dosage: solution/ drops adminstration: ophthalmic ndc: 70518-2741-0 packaging: 15 ml in 1 bottle outer packaging: 1 in 1 carton active ingredient(s): tetracaine hydrochloride 5mg in 1ml inactive ingredient(s): chlorobutanol boric acid potassium chloride edetate disodium water sodium hydroxide hydrochloric acid remedy_label

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