|Dosage Form||Package Information||Links|
|SOLUTION||12 BOTTLE, DROPPER in 1 CARTON (0065-0741-12) > 2 mL in 1 BOTTLE, DROPPER||Label Information|
Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. (1)
One drop topically in the eye(s) as needed. Discard unused portion. (2.1)
Sterile ophthalmic solution containing 0.5% tetracaine hydrochloride (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.
Open package using standard aseptic technique. The DROPâ€‘TAINER® dispenser may then be allowed to fall upon a sterile surface. The entire outer surface of the DROPâ€‘TAINER® dispenser and its contents are sterile.
Not for injection or intraocular use. Do not use intracamerally because use of TetracaineHydrochloride Ophthalmic Solution 0.5% may lead to damage of the corneal endothelial cells.
Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage.
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.
The following serious ocular adverse reactions are described elsewhere in the labeling:
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.
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 motherâ€™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.
No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available.
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.
No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.
Prolonged use of a topical ocular anesthetic including TetracaineHydrochloride 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 C15H24N2O2 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
Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.
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.
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.
Topical administration of tetracainehydrochloride ophthalmic solution results in localized temporary anesthesia. The maximum effect is achieved within 10â€“20 seconds after instillation, with efficacy lasting 10â€“20 minutes. Duration of effect can be extended with repeated dosing. [see Corneal toxicity (5.2) and Overdosage (10)].
Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI-UNITS® is supplied as single patient use, 4 mL filled in 4-mL 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.
Storage: Store 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.
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%
Single Dose DROP-TAINER® dispensers for topical use.
See package insert for directions.
12 x 4mL
© 2016 Novartis
A Novartis Company
Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA
Printed in USA
Ophthalmic Solution 0.5%
INGREDIENTS: Each mL contains: Active: Tetracaine Hydrochloride 0.5%. (equivalent to tetracaine (0.44%))
Inactive: Sodium Chloride, Sodium Acetate Trihydrate, Acetic Acid (to adjust pH), Water for Injection.
USUAL DOSAGE: One drop topically in the eye(s) as needed. Discard unused portion.
STORAGE: Store at 2°C to 25°C (36°F to 77°F). Protect from Light. Do not use if discolored
Printed in USA
SINGLE DOSE UNIT â€“DISCARD UNUSED PORTION
OPHTHALMIC SOLUTION 0.5% 4mL
STERILE UNTIL OPENED PROTECT FROM LIGHT
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
© 2016 Novartis
tetracaine hydrochloride solution
|Labeler - Alcon Laboratories, Inc. (008018525)|
|Albemarle Corporation||788779192||API MANUFACTURE(0065-0741) , ANALYSIS(0065-0741)|