Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Tetracaine hydrochloride ophthalmic solution, USP 0.5% is supplied as a sterile, aqueous, topical ophthalmic solution in a white LDPE bottle, plugged with white LDPE nozzle and capped with white HDPE cap in the following sizes: NDC 70069-596-01, 5 mL fill in 5 mL Bottle NDC 70069-597-01, 15 mL fill in 15 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.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 70069-596-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 5 mL Carton Label NDC 70069-596-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 5 mL Container Label NDC 70069-597-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 15 mL Carton Label NDC 70069-597-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 15 mL Image Image Image Image
- 16 HOW SUPPLIED/STORAGE AND HANDLING Tetracaine hydrochloride ophthalmic solution, USP 0.5% is supplied as a sterile, aqueous, topical ophthalmic solution in a white LDPE bottle, plugged with white LDPE nozzle and capped with white HDPE cap in the following sizes: NDC 70069-596-01, 5 mL fill in 5 mL Bottle NDC 70069-597-01, 15 mL fill in 15 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.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 70069-596-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 5 mL Carton Label NDC 70069-596-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 5 mL Container Label NDC 70069-597-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 15 mL Carton Label NDC 70069-597-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 15 mL Image Image Image Image
Overview
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
Indications & 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)
Dosage & Administration
One drop topically in the eye(s) as needed. One drop topically in the eye(s) as needed. (2)
Warnings & 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) For Administration by Healthcare Provider : Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is not intended for patient self- administration. (5.4) 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. 5.4 For Administration by Healthcare Provider Tetracaine hydrochloride ophthalmic solution, 0.5% is indicated for administration under the direct supervision of a healthcare provider. Tetracaine Hydrochloride Ophthalmic Solution, 0.5% is not intended for patient self-administration [see Warnings and Precautions (5.2)] .
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)
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.
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