Tetracaine Hydrochloride
These highlights do not include all the information needed to use Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI‑UNIT safely and effectively. See full prescribing information for Tetracaine Hydrochloride Ophthalmic Solution. Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI‑UNIT , topical ophthalmic Initial U.S. Approval: 1965
947d7944-afe9-5361-e053-2995a90a05e9
HUMAN PRESCRIPTION DRUG LABEL
Feb 19, 2021
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tetracaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
1 INDICATIONS AND USAGE
Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1)
CONTRAINDICATIONS SECTION
4 CONTRAINDICATIONS SECTION
None.
None ( 4)
WARNINGS AND PRECAUTIONS SECTION
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.
- 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 SECTION
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.
Ocular adverse events: stinging, burning, conjunctival redness ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE FORMS & STRENGTHS SECTION
3 DOSAGE FORMS AND STRENGTHS
Sterile ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.
Sterile ophthalmic solution containing 0.5% tetracaine hydrochloride ( 3)
DOSAGE & ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
2.1 Topical Administration
One drop topically in the eye as needed. Discard unused portion.
2.2 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.
One drop topically in the eye(s) as needed. Discard unused portion. ( 2.1)
USE IN SPECIFIC POPULATIONS SECTION
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.
8.4 Pediatric Use
Safety in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution 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 have been observed between elderly and younger patients.
OVERDOSAGE SECTION
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. Symptoms related to systemic toxicity consist mainly of effects on the neurologic and cardiovascular systems.
DESCRIPTION SECTION
11 DESCRIPTION
Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C 15H 24N 2O 2 • 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
CLINICAL PHARMACOLOGY SECTION
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 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.
NONCLINICAL TOXICOLOGY SECTION
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.
CLINICAL STUDIES SECTION
14 CLINICAL STUDIES
Topical administration of tetracaine hydrochloride 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)] .
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI UNITS is supplied as single patient use 4 mL filled in 4mL 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.
68071-5079-4 bottle of 4mL StorageStore 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.
INFORMATION FOR PATIENTS SECTION
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**®**
a Novartis company
Distributed by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
© 2016 Novartis