Tetracaine Hydrochloride

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

4 CONTRAINDICATIONS None. None ( 4 )

11 DESCRIPTION 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 • 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

2 DOSAGE AND ADMINISTRATION One drop topically in the eye(s) as needed. Discard unused portion. ( 2.1 ) 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.

1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )

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.

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.

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.

20230509

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3 DOSAGE FORMS AND STRENGTHS Sterile ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v. Sterile ophthalmic solution containing 0.5% tetracaine hydrochloride ( 3 )

Tetracaine Hydrochloride tetracaine hydrochloride Tetracaine Hydrochloride Tetracaine Sodium Chloride Sodium Acetate Acetic Acid Water Chemical Diagram Blister label Carton Label Carton Label

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.

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.

NDA208135

Tetracaine Hydrochloride

tetracaine hydrochloride

0065-0741

HUMAN PRESCRIPTION DRUG

OPHTHALMIC

PRINCIPAL DISPLAY PANEL NDC 0065-0741-14 Tetracaine Hydrochloride Ophthalmic Solution, 0.5% STERi-UNITS Single Dose DROP-TAINER® dispensers for topical use.See package insert for directions. Rx Only 12 x 4mL STERILE Alcon Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA Printed in USA NDC 0065-0741-14 TETRACAINE HYDROCHLORIDE Ophthalmic Solution 0.5% INGREDIENTS: Each mL contains: Active: Tetracaine Hydrochloride 0.5%. (equivalent to tetracaine (0.44%) Inactive: Sodium Chloride, Sodium Acetate Trihydrate, Acetic Acid (to adjust pH), Water for Injection. USUAL DOSAGE: One drop topically in the eye(s) as needed. Discard unused portion. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Protect from Light. Do not use if discolored Printed in USA 300057714-0622 GTIN: 10300650741146 SN: LOT: EXP: PRINCIPAL DISPLAY PANEL NDC 0065-0741-14 Tetracaine Hydrochloride Ophthalmic Solution, 0.5% STERi-UNITS Single Dose DROP-TAINER® dispensers for topical use.See package insert for directions. Rx Only 12 x 4mL STERILE Alcon Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA Product of Switzerland Printed in USA NDC 0065-0741-14 TETRACAINE HYDROCHLORIDE Ophthalmic Solution 0.5% INGREDIENTS: Each mL contains: Active: Tetracaine Hydrochloride 0.5%. (equivalent to tetracaine (0.44%) Inactive: Sodium Chloride, Sodium Acetate Trihydrate, Acetic Acid (to adjust pH), Water for Injection. USUAL DOSAGE: One drop topically in the eye(s) as needed. Discard unused portion. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Protect from Light. Do not use if discolored Printed in USA GTIN: 10300650741146 SN: LOT: EXP: 300057715-0622 NDC 0065-0741-14 TETRACAINE HYDROCHLORIDE Ophthalmic Solution 0.5% 4mL Rx Only SINGLE DOSE UNIT –DISCARD UNUSED PORTION H14660-0916 LOT: EXP : TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.5% 4mL STERILE UNTIL OPENED PROTECT FROM LIGHT Rx Only NDC 0065-0741-14 9013226-0416 Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA Alcon ® © 2016 Novartis LOT: EXP.:

Warnings and Precautions ( 5.4 ) 2/2022

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 ® Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2022 Alcon Inc. 300055204-1121

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) ] .

8.5 Geriatric Use No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.

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.

8.1 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 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.

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.