Label: TETRACAINE HYDROCHLORIDE solution
- NDC Code(s): 68071-5079-4
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 0065-0741
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 9, 2019
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
INDICATIONS AND USAGE
Tetracaine Hydrochloride Ophthalmic Solution 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. Discard unused portion. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Sterile ophthalmic solution containing 0.5% tetracaine hydrochloride ( 3)
None ( 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)
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.
See 17 for PATIENT COUNSELING INFORMATION.
Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
- Sections or subsections omitted from the full prescribing information are not listed.
- 1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS 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.
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
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.
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.
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.
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
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.
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 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)] .
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.
- 17 PATIENT COUNSELING INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
tetracaine hydrochloride solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-5079(NDC:0065-0741) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM ACETATE (UNII: 4550K0SC9B) ACETIC ACID (UNII: Q40Q9N063P) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-5079-4 4 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 10/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208135 10/26/2016 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-5079)