NDC 0065-0741 Tetracaine Hydrochloride

Tetracaine Hydrochloride

NDC Product Code 0065-0741

NDC 0065-0741-14

Package Description: 12 BLISTER PACK in 1 CARTON > 1 BOTTLE, DROPPER in 1 BLISTER PACK > 4 mL in 1 BOTTLE, DROPPER

NDC Product Information

Tetracaine Hydrochloride with NDC 0065-0741 is a a human prescription drug product labeled by Alcon Laboratories, Inc.. The generic name of Tetracaine Hydrochloride is tetracaine hydrochloride. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug 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.

Tetracaine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TETRACAINE HYDROCHLORIDE 5 mg/mL

Inactive Ingredient(s)

About the 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.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM ACETATE (UNII: 4550K0SC9B)
  • ACETIC ACID (UNII: Q40Q9N063P)
  • WATER (UNII: 059QF0KO0R)

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.
  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Esters - [CS]
  • Local Anesthesia - [PE] (Physiologic Effect)
  • Ester Local Anesthetic - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: NDA208135 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 10-26-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Tetracaine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.

2.1 Topical Administration

One drop topically in the eye as needed.  Discard unused portion.

2.2 Sterile Field Administration

Open package using standard aseptic technique.  The DROP‑TAINER® dispenser may then be allowed to fall upon a sterile surface.  The entire outer surface of the DROP‑TAINER® dispenser and its contents are sterile.

3 Dosage Forms And Strengths

Sterile ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.

4 Contraindications Section

None.

5.1 Corneal Injury With Intracameral Use

Not for injection or intraocular use. Do not use intracamerally because use of TetracaineHydrochloride Ophthalmic Solution 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 Due 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.

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 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 ReactionsTransient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort.

8.1 Pregnancy

Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 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 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 mother’s clinical need for Tetracaine Hydrochloride Ophthalmic Solution 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution 0.5% or from the underlying maternal condition.

8.3 Females And Males Of Reproductive Potential

No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available.

8.4 Pediatric Use

Safety in the pediatric population has been demonstrated in clinical trials.  Efficacy of tetracaine hydrochloride ophthalmic solution 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 have been observed between elderly and younger patients.

10 Overdosage

Prolonged use of a topical ocular anesthetic including TetracaineHydrochloride Ophthalmic Solution 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.  Symptoms related to systemic toxicity consist mainly of effects on the neurologic and cardiovascular systems.

11 Description

Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride.  Its chemical formula is C15H24N2O2 • HCl and it is represented by the chemical structure:Tetracaine hydrochloride is a fine, white, crystalline, odorless powder and has a molecular weight of 300.82.  Tetracaine Hydrochloride Ophthalmic Solution 0.5% has a pH of 3.7 to 5.5.Active ingredient: tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine) Inactive ingredients: sodium chloride, sodium acetate trihydrate, acetic acid (to adjust pH approximately 4.5), Water for Injection, USP

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 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

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.

14 Clinical Studies

Topical administration of tetracainehydrochloride ophthalmic solution results in localized temporary anesthesia.  The maximum effect is achieved within 10–20 seconds after instillation, with efficacy lasting 10–20 minutes.  Duration of effect can be extended with repeated dosing. [see Corneal toxicity (5.2) and Overdosage (10)].

16 How Supplied/Storage And Handling

Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI-UNITS® is supplied as single patient use, 4 mL filled in 4-mL natural medium- or low-density polyethylene plastic DROP-TAINER® dispensers and natural low-density polyethylene tips with white polypropylene caps in a carton of 12.  Each sterilized DROP-TAINER® dispenser is packaged in a clear PVC and Tyvek blister.  This product does not contain a preservative; discard unused portion.NDC 0065-0741-14 Storage: Store at 2°C to 25°C (36°F to 77°F). Protect from light. Do not use if solution contains crystals, is cloudy, or discolored.

17 Patient Counseling Information

Eye Care PrecautionAdvise patients that, due to the effect of the anesthetic, their eyes will be insensitive up to 20 minutes and that care should be taken to avoid accidental injuries. ALCON®a Novartis companyDistributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2016 Novartis

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