FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
3 DOSAGE FORMS AND STRENGTHS
Sterile ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.
5 WARNINGS AND PRECAUTIONS
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)].
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.
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% 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.
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.
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 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
12 CLINICAL PHARMACOLOGY
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.
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)].
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 0065-0741-14
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.
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®
Distributed by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
© 2022 Alcon Inc.
300055204-1121
PRINCIPAL DISPLAY PANEL
NDC 0065-0741-14
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%
STERi-UNITS
Single Dose DROP-TAINER® dispensers for topical use.See package insert for directions.
Rx Only
12 x 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 2°C to 25°C (36°F to 77°F). Protect from Light. Do not use if discolored
Printed in USA
300057714-0622
GTIN: 10300650741146
SN:
LOT:
EXP:
PRINCIPAL DISPLAY PANEL
NDC 0065-0741-14
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%
STERi-UNITS
Single Dose DROP-TAINER® dispensers for topical use.See package insert for directions.
Rx Only
12 x 4mL
STERILE
Alcon
Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA
Product of Switzerland
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 2°C to 25°C (36°F to 77°F). Protect from Light. Do not use if discolored
Printed in USA
GTIN: 10300650741146
SN:
LOT:
EXP:
300057715-0622
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% 4mL
STERILE UNTIL OPENED PROTECT FROM LIGHT
Rx Only
NDC 0065-0741-14
300065025-1223
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
Alcon
LOT: EXP.:
