The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
1 Indications And Usage
Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiringa rapid and short-acting topical ophthalmic anesthetic.
2 Dosage And Administration
One drop topically in the eye(s) as needed.
3 Dosage Forms And Strengths
Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a clear, colorless, ophthalmicsolution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.
Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should not be used in patients with ahistory of hypersensitivity to any component of this preparation.
5.1 Corneal Injury With Intracameral Use
Not for injection or intraocular use. Do not use intracamerally because use of TetracaineHydrochloride Ophthalmic Solution, USP 0.5% may lead to damage of the corneal endothelialcells.
5.2 Corneal Toxicity
Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelialdefects 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 accidentalinjuries can occur due to insensitivity of the eye.
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, 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 ReactionsTransient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort.
Risk SummaryThere are no adequate and well-controlled studies with Tetracaine Hydrochloride OphthalmicSolution, USP 0.5% in pregnant women. Animal developmental and reproductive toxicity studieswith tetracaine hydrochloride have not been reported in the published literature.
Risk SummaryThere are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% isexcreted in human milk or to assess its effects on milk production/excretion. The developmentaland health benefits of breastfeeding should be considered along with the mother’s clinical needfor Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% and any potential adverse effectson the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%.
8.3 Females And Males Of Reproductive Potential
No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% onfertility are available.
8.4 Pediatric Use
Safety of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in the pediatric populationhas been demonstrated in clinical trials. Efficacy of Tetracaine Hydrochloride OphthalmicSolution, USP 0.5% for use in pediatric patients has been extrapolated from adequate and wellcontrolled clinical trials in the adult population.
8.5 Geriatric Use
No overall differences in safety or effectiveness of Tetracaine Hydrochloride OphthalmicSolution, USP 0.5% have been observed between elderly and younger patients.
Prolonged use of a topical ocular anesthetic including Tetracaine Hydrochloride OphthalmicSolution, USP 0.5% may produce permanent corneal opacification and ulceration withaccompanying visual loss.
Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a sterile, clear, colorless, topicallocal anesthetic for ophthalmic use only containing tetracaine hydrochloride as the activepharmaceutical 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 of300.82Active 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).
12.1 Mechanism Of Action
Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronalimpulses thereby affecting local anesthesia.
The systemic exposure to tetracaine following topical ocular administration of TetracaineHydrochloride Ophthalmic Solution, USP 0.5% has not been studied. Tetracaine hydrochloride ismetabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.
13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility
Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in thepublished literature. Long-term animal studies have not been conducted to evaluate thecarcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects oftetracaine hydrochloride on fertility have not been reported in the published literature.
14 Clinical Studies
Topical administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% results inlocalized temporary anesthesia. The maximum effect is achieved within 10–20 seconds afterinstillation, with efficacy lasting 10–20 minutes. Duration of effect can be extended withrepeated 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 with a fill volume of 15 mL in a 15 mL low-density polyethyleneplastic dropper bottle with a low-density polyethylene dropper tip and white polypropylene cap.NDC 68682-920-64After 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 solutioncontains crystals, cloudy, or discolored.
17 Patient Counseling Information
Eye Care PrecautionDo 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 20minutes and that care should be taken to avoid accidental injuries.Distributed by:Oceanside Pharmaceuticals, a division ofBausch Health US, LLC, Bridgewater, NJ 08807 USAManufactured by:Bausch & Lomb IncorporatedTampa, FL 336379675200 (Folded)9675300 (Flat)Revised: May 2019
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