Tetracaine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Oceanside Pharmaceuticals, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.
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)
One drop topically in the eye(s) as needed. (2)
Sterile, preserved, ophthalmic solution containing 0.5% tetracaine hydrochloride. (3)
Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%, should not be used in patients with a history of hypersensitivity to any component of this preparation. (4)
Ocular adverse events: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2020
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.
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, USP 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.
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.
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%.
No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% on
fertility are available.
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.
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 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 dihydrate, water for injection.
Sodium hydroxide and/or hydrochloric acid may be added to adjust pH (3.7 – 6.0).
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 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)].
Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied as a sterile, aqueous,
topical ophthalmic solution in a low-density polyethylene
plastic dropper bottle with a low-density polyethylene dropper tip and white polypropylene cap in the following sizes:
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.
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.
Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC, Bridgewater, NJ 08807 USA
Manufactured by:
Bausch & Lomb Incorporated
Tampa, FL 33637 USA
© 2020 Bausch Health Companies Inc. or its affiliates
9675201 (Folded)
9675301 (Flat)
TETRACAINE HYDROCHLORIDE
tetracaine hydrochloride solution/ drops |
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Labeler - Oceanside Pharmaceuticals (832011691) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Bausch & Lomb Incorporated | 079587625 | MANUFACTURE(68682-920) , PACK(68682-920) , LABEL(68682-920) |