FDA Label for Tetracaine Hydrochloride

1 Indications And Usage

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring

a rapid and short-acting topical ophthalmic anesthetic.

2 Dosage And Administration

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

3 Dosage Forms And Strengths

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.

4 Contraindications

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should not be used in patients with a

history of hypersensitivity to any component of this preparation.

5.1 Corneal Injury With Intracameral Use

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.

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.

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, USP 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.

8.1 Pregnancy

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.

8.2 Lactation

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%.

8.3 Females And Males Of Reproductive Potential

No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% on

fertility are available.

8.4 Pediatric Use

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.

8.5 Geriatric Use

No overall differences in safety or effectiveness of Tetracaine Hydrochloride Ophthalmic

Solution, USP 0.5% have been observed between elderly and younger patients.

10 Overdosage

Prolonged use of a topical ocular anesthetic including Tetracaine Hydrochloride Ophthalmic

Solution, USP 0.5% may produce permanent corneal opacification and ulceration with

accompanying visual loss.

11 Description

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 C15H24N2O2 •

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).

12.1 Mechanism Of Action

Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal

impulses thereby affecting local anesthesia.

12.3 Pharmacokinetics

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.

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 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)].

16 How Supplied/Storage And Handling

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied as a sterile, aqueous,

topical ophthalmic solution with a fill volume of 15 mL in a 15 mL low-density polyethylene

plastic dropper bottle with a low-density polyethylene dropper tip and white polypropylene cap.

NDC 68682-920-64

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.

17 Patient Counseling Information

Eye Care Precaution

Do not touch the dropper tip to any surface as this may contaminate the solution.

Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive for up to 20

minutes and that care should be taken to avoid accidental injuries.

Distributed by:

Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by:

Bausch & Lomb Incorporated
Tampa, FL 33637

9675200 (Folded)
9675300 (Flat)

Revised: May 2019

Package/Label Principal Display Panel- Carton 15 Ml

NDC 68682-920-64

Rx only

Tetracaine
Hydrochloride

Ophthalmic
Solution, USP
0.05% (Sterile)

15 mL

OCEANSIDE
PHARMACEUTICALS