Drug Facts
Composition & Profile
Identifiers & Packaging
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; DRUG: Tetracaine Hydrochloride GENERIC: tetracaine hydrochloride DOSAGE: SOLUTION ADMINSTRATION: OPHTHALMIC NDC: 70518-4183-0 NDC: 70518-4183-1 PACKAGING: 4 mL in 1 BOTTLE, DROPPER OUTER PACKAGING: 12 in 1 CARTON ACTIVE INGREDIENT(S): Tetracaine Hydrochloride 5mg in 1mL INACTIVE INGREDIENT(S): Sodium Chloride Sodium Acetate Acetic Acid Water MM1 MM2
- 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
- DRUG: Tetracaine Hydrochloride GENERIC: tetracaine hydrochloride DOSAGE: SOLUTION ADMINSTRATION: OPHTHALMIC NDC: 70518-4183-0 NDC: 70518-4183-1 PACKAGING: 4 mL in 1 BOTTLE, DROPPER OUTER PACKAGING: 12 in 1 CARTON ACTIVE INGREDIENT(S): Tetracaine Hydrochloride 5mg in 1mL INACTIVE INGREDIENT(S): Sodium Chloride Sodium Acetate Acetic Acid Water MM1 MM2
Overview
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 Chemical Diagram
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. 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.
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 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 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. 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
None. None ( 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: 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.
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