DailyMed Label: Tetracaine Hydrochloride

DailyMed Label: Tetracaine Hydrochloride

2024

DailyMed Prescription

Tetracaine Hydrochloride

Tetracaine Hydrochloride

REMEDYREPACK INC.

NDC: 70518-2741

NDC: 70518-2741

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 fine, white, crystalline, odorless 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). CHEM

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

One drop topically in the eye(s) as needed. One drop topically in the eye(s) as needed. ( 2 )

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 )

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. ( 4 )

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 ) Not for injection or intraocular use. Do not use intracamerally because use of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may lead to damage of the corneal endothelial cells. Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. 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. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for administration under the direct supervision of a healthcare provider. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is not intended for patient self-administration [see Warnings and Precautions ( 5.2 )].

The following serious ocular adverse reactions are described elsewhere in the labeling:

Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. Risk Summary There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution, USP 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, USP 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%. No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% on fertility are available. Safety of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. No overall differences in safety or effectiveness of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% have been observed between elderly and younger patients.

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied as a sterile, aqueous, topical ophthalmic solution in a low-density polyethylene plastic dropper bottle with a low-density polyethylene dropper tip and white polypropylene cap in the following sizes: NDC: NDC: 70518-2741-00 PACKAGING: 1 in 1 CARTON, 15 mL in 1 BOTTLE TYPE 0 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia. The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

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.

Topical administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% 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 Warnings and Precautions ( 5.2 ) and Overdosage ( 10 )] .

DRUG: Tetracaine Hydrochloride GENERIC: Tetracaine Hydrochloride DOSAGE: SOLUTION/ DROPS ADMINSTRATION: OPHTHALMIC NDC: 70518-2741-0 PACKAGING: 15 mL in 1 BOTTLE OUTER PACKAGING: 1 in 1 CARTON ACTIVE INGREDIENT(S): TETRACAINE HYDROCHLORIDE 5mg in 1mL INACTIVE INGREDIENT(S): CHLOROBUTANOL BORIC ACID POTASSIUM CHLORIDE EDETATE DISODIUM WATER SODIUM HYDROXIDE HYDROCHLORIC ACID Remedy_Label