Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)
REMEDYREPACK INC.
OPHTHALMIC
PRESCRIPTION DRUG
Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. 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. No overall differences in safety or effectiveness of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% have been observed between elderly and younger patients.
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: NDC: NDC: 70518-2741-00 PACKAGING: 1 in 1 CARTON, 15 mL in 1 BOTTLE TYPE 0 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
New Drug Application
TETRACAINE HYDROCHLORIDE- TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5%. TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5%, FOR TOPICAL OPHTHALMIC USE INITIAL U.S. APPROVAL: 1965 RECENT MAJOR CHANGES 1. Warnings and Precautions (5.4) 2/2022 INDICATIONS AND USAGE 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) DOSAGE AND ADMINISTRATION One drop topically in the eye(s) as needed. ( 2) DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing 0.5% tetracaine hydrochloride. ( 3) CONTRAINDICATIONS 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) 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) For Administration by Healthcare Provider: Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is not intended for patient self-administration. ( 5.4) ADVERSE REACTIONS 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: 7/2022 FULL PRESCRIBING INFORMATION: CO Citiți documentul complet