CLINICAL PHARMACOLOGY SECTION.

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.

CLINICAL STUDIES SECTION.

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)].

ADVERSE REACTIONS SECTION.

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 population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. Ocular Adverse ReactionsTransient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. 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)] 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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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.

DESCRIPTION SECTION.

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 fine, white, crystalline, odorless powder and has molecular weight of 300.82. Tetracaine Hydrochloride Ophthalmic Solution 0.5% has 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.

DOSAGE & ADMINISTRATION SECTION.

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(R) dispenser may then be allowed to fall upon sterile surface. The entire outer surface of the DROP-TAINER(R) dispenser and its contents are sterile.

DOSAGE FORMS & STRENGTHS SECTION.

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).

HOW SUPPLIED SECTION.

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

INDICATIONS & USAGE SECTION.

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

INFORMATION FOR PATIENTS SECTION.

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(R) Novartis companyDistributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA (C) 2016 Novartis 9013124-0316.

LACTATION SECTION.

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 mothers 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.

NONCLINICAL TOXICOLOGY SECTION.

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.

OVERDOSAGE SECTION.

10 OVERDOSAGE. Prolonged use of 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 0065-0741-14Tetracaine Hydrochloride Ophthalmic Solution, 0.5% STERi-UNITS Single Dose DROP-TAINER(R) dispensers for topical use.See package insert for directions. Rx Only 12 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 2C to 25C (36F to 77F). Protect from Light. Do not use if discolored Printed in USA 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% 4mLSTERILE UNTIL OPENED PROTECT FROM LIGHTRx OnlyNDC 0065-0741-149013226-0416 Alcon Laboratories, Inc.Fort Worth, Texas 76134 USAAlcon(R) (C) 2016 Novartis LOT: EXP.:.

PEDIATRIC USE SECTION.

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.

PHARMACOKINETICS SECTION.

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.

PREGNANCY SECTION.

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.

USE IN SPECIFIC POPULATIONS SECTION.

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 mothers 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.

WARNINGS AND PRECAUTIONS SECTION.

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). 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). 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.