Tetracaine Hydrochloride

RECENT MAJOR CHANGES Warnings and Precautions (5.4) 2/2022

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)

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.

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. Ophthalmic solution containing 0.5% tetracaine hydrochloride. (3)

4 CONTRAINDICATIONS Tetracaine hydrochloride ophthalmic solution, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. Tetracaine hydrochloride ophthalmic solution, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. (4)

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: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. (6) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at +1 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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%. 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 of tetracaine hydrochloride ophthalmic solution, 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution, 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, 0.5% have been observed between elderly and younger patients.

12.1 Mechanism of Action Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

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 C 15 H 24 N 2 O 2 ● HCl and it is represented by the chemical structure: Tetracaine hydrochloride is a white crystalline 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). Image

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.

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: 70518-4183-00 NDC: 70518-4183-01 PACKAGING: 12 in 2 CARTON PACKAGING: 1-4 mL BOTTLE, DROPPER TYPE 0 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762