Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
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 polyethylene plastic dropper bottle with a low-density polyethylene dropper tip and white polypropylene cap.
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.
Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%, is a clear, colorless, sterile, preserved, ophthalmic solution containing 0.5% w/v tetracaine hydrochloride, equivalent to tetracaine 0.44% w/v. Preservative: chlorobutanol 0.4%. Inactive ingredients: boric acid, potassium chloride, edetate disodium, and water for injection USP.
STORAGE AND HANDLING
Store at 15°C to 25°C (59°F to 77°F). Protect from light. Do not use if solution contains crystals, cloudy, or discolored. After opening, this product can be used until the expiration date stamped on the bottle. Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. One drop topically in the eye(s) as needed. Do not touch the dropper tip to any surface as this may contaminate the solution.
USE IN SPECIFIC POPULATIONS
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. No overall differences in safety or effectiveness of Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% have been observed between elderly and younger patients. 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.
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