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
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, 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, 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
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
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%.
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.
8.4 Pediatric Use
Safety of tetracaine hydrochloride ophthalmic solution, 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution, 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.
10 OVERDOSAGE
Prolonged use of a topical ocular anesthetic including tetracaine hydrochloride ophthalmic solution, 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 white crystalline 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 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 tetracaine hydrochloride ophthalmic solution, 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 in a white LDPE bottle, plugged with white LDPE nozzle and capped with white HDPE cap in the following sizes:
NDC 70069-596-01, 5 mL fill in 5 mL Bottle
NDC 70069-597-01, 15 mL fill in 15 mL Bottle
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
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.
SPL UNCLASSIFIED
Somerset Therapeutics, LLC
Somerset, NJ 08873
Made in India
Code No.: KR/DRUGS/KTK/28/289/97
ST-TEC/P/00
1200992
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70069-596-01
Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%
Sterile
Rx only
5 mL
NDC 70069-596-01
Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%
Sterile
Rx only
5 mL
NDC 70069-597-01
Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%
Sterile
Rx only
15 mL
NDC 70069-597-01
Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%
Sterile
Rx only
15 mL
