TETRACAINE HYDROCHLORIDE- tetracaine hydrochloride solution/ drops 
Paragon BioTeck, Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% safely and effectively. See full prescribing information for Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%.
Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%, for topical
ophthalmic use
Initial U.S. Approval: 1965

INDICATIONS AND USAGE

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)

DOSAGE AND ADMINISTRATION

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

DOSAGE FORMS AND STRENGTHS

Sterile, preserved, ophthalmic solution containing 0.5% tetracaine hydrochloride. (3)

CONTRAINDICATIONS

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

WARNINGS AND 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)

ADVERSE REACTIONS

Ocular adverse events: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb, a Division of Valeant Pharmaceuticals North America LLC,. at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2019

FULL PRESCRIBING INFORMATION

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 WARNINGS AND PRECAUTIONS

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 reliable 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 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 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:

chemstructure.jpg

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, water for injection USP.

Sodium hydroxide and/or hydrochloric acid may be added to adjust pH (3.7 – 6.0)

12 CLINICAL PHARMACOLOGY

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 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 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 42702-170-15

After opening, this product can be used until the expiration date stamped on the bottle.

Storage: Store at 15°C to 25°C (59°F 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.

Manufactured for:

Paragon BioTeck, Inc.

4640 SW Macadam Ave, Ste 80

Portland, OR 97239

Manufactured and Distributed by:

Bausch & Lomb

8500 Hidden River Pkwy

Tampa, FL 33637

Revised: March 2019

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- Carton 15 mL

NDC 42702-170-15

Paragon
BioTeck, Inc.

Tetracaine
Hydrochloride

Ophthalmic
Solution, USP
0.05%
(Sterile)

Rx Only

15 mL

carton.jpg
TETRACAINE HYDROCHLORIDE 
tetracaine hydrochloride solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42702-170
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CHLOROBUTANOL (UNII: HM4YQM8WRC)  
BORIC ACID (UNII: R57ZHV85D4)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42702-170-151 in 1 CARTON03/12/2019
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21082103/12/2019
Labeler - Paragon BioTeck, Inc. (078279037)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(42702-170)

Revised: 3/2019
Document Id: 0a988ff2-88a8-4929-b524-4c8efef9c601
Set id: 0a988ff2-88a8-4929-b524-4c8efef9c601
Version: 1
Effective Time: 20190312
 
Paragon BioTeck, Inc.