Label: TETRACAINE HYDROCHLORIDE solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 9, 2019

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI‑UNIT ® safely and effectively. See full prescribing information for Tetracaine Hydrochloride Ophthalmic Solution.



    Tetracaine Hydrochloride Ophthalmic Solution 0.5%

    STERI‑UNIT ®, topical ophthalmic Initial U.S. Approval: 1965

    INDICATIONS AND USAGE

    Tetracaine Hydrochloride Ophthalmic Solution 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. Discard unused portion. ( 2.1)

    DOSAGE FORMS AND STRENGTHS

    Sterile ophthalmic solution containing 0.5% tetracaine hydrochloride ( 3)

    CONTRAINDICATIONS

    None ( 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: stinging, burning, conjunctival redness ( 6)


    To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

     

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 10/2016

  • Table of Contents
  • 1 INDICATIONS AND USAGE

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

  • 2 DOSAGE AND ADMINISTRATION

    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 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 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:

    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 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 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 Tetracaine Hydrochloride 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 C 15H 24N 2O 2 • HCl and it is represented by the chemical structure:

    Chemical Diagram

    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 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 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 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 4mL 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.

    68071-5079-4 bottle of 4mL StorageStore 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 Precaution
    Advise 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 company

    Distributed by:
    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA
    © 2016 Novartis

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    TETRACAINE HYDROCHLORIDE 
    tetracaine hydrochloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68071-5079(NDC:0065-0741)
    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
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-5079-44 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20813510/26/2016
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-5079)