Tetracaine Ophthalmic Solution

Topical Administration

One drop topically in the eye as needed.  Discard unused portion.

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.

None.

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.

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

Mechanism of Action

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

Pharmacokinetics

The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

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

© 2016 Novartis

Alcon®
A Novartis Company

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

GTIN: 10300650741146

SN:

LOT:

EXP.:

9013123-0316

NDC 0065-0741-14

TETRACAINE HYDROCHLORIDE
Ophthalmic Solution
0.5% 4mL

Rx Only

SINGLE DOSE UNIT –DISCARD UNUSED PORTION

H14511-0616

LOT:             EXP.:

TETRACAINE HYDROCHLORIDE
OPHTHALMIC SOLUTION 0.5% 4mL
STERILE UNTIL OPENED PROTECT FROM LIGHT
Rx Only

NDC 0065-0741-14
9013226-0416

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA

Alcon®

© 2016 Novartis

LOT:                 EXP.: