Label: TETRACAINE HYDROCHLORIDE solution/ drops

  • NDC Code(s): 68682-920-05, 68682-920-64
  • Packager: Oceanside Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 6, 2020

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% safely and effectively. See full prescribing information for Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%.
    Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%, for topical
    ophthalmic use.
    Initial U.S. Approval: 1965

    INDICATIONS AND USAGE

    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)

    DOSAGE AND ADMINISTRATION

    One drop topically in the eye(s) as needed. (2)

    DOSAGE FORMS AND STRENGTHS

    Sterile, preserved, ophthalmic solution containing 0.5% tetracaine hydrochloride. (3)

    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. (4)

    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)

    ADVERSE REACTIONS

    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 1-800-FDA-1088 or www.fda.gov/medwatch.

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 4/2020

  • Table of Contents
  • 1 INDICATIONS AND USAGE

    Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring

    a rapid and short-acting topical ophthalmic anesthetic.

  • 2 DOSAGE AND ADMINISTRATION

    One drop topically in the eye(s) as needed.

  • 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.

  • 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.

  • 5 WARNINGS AND PRECAUTIONS

    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 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, 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.

  • 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 mother’s 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

    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.

    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.

  • 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.

  • 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 C15H24N2O2 •

    HCl and it is represented by the chemical structure:

    chemstructure.jpg

    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 – 6.0).

  • 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.

  • 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.

  • 14 CLINICAL STUDIES

    Topical administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% 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 Warnings and Precautions (5.2) and Overdosage (10)].

  • 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 68682-920-64 15 mL in a 15 mL Bottle
    NDC 68682-920-05 5 mL in a 7.5 mL Bottle

    After opening, this product can be used until the expiration date stamped on the bottle.

    Storage: Store at 15° to 25°C (59° to 77°F). Protect from light. Do not use if solution

    contains crystals, cloudy, or discolored.

  • 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.

    Distributed by:

    Oceanside Pharmaceuticals, a division of
    Bausch Health US, LLC, Bridgewater, NJ 08807 USA

    Manufactured by:

    Bausch & Lomb Incorporated
    Tampa, FL 33637 USA

    © 2020 Bausch Health Companies Inc. or its affiliates

    9675201 (Folded)
    9675301 (Flat)

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- Carton 15 mL

    NDC 68682-920-64

    Rx only

    Tetracaine
    Hydrochloride

    Ophthalmic
    Solution, USP
    0.05% (Sterile)

    15 mL

    OCEANSIDE
    PHARMACEUTICALS

    carton.jpg
  • INGREDIENTS AND APPEARANCE
    TETRACAINE HYDROCHLORIDE 
    tetracaine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68682-920
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    BORIC ACID (UNII: R57ZHV85D4)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68682-920-641 in 1 CARTON06/27/2019
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68682-920-051 in 1 CARTON04/05/2020
    25 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21082106/27/2019
    Labeler - Oceanside Pharmaceuticals (832011691)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(68682-920) , PACK(68682-920) , LABEL(68682-920)