TETRACAINE HYDROCHLORIDE- tetracaine hydrochloride solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)

Available from:

NuCare Pharmaceuticals,Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Hydroc

Product summary:

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. NDC 68071-5069-5 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.

Authorization status:

New Drug Application

Summary of Product characteristics

TETRACAINE HYDROCHLORIDE- TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS
NUCARE PHARMACEUTICALS,INC.
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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
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
Sterile, preserved, 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)
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, A DIVISION OF BAUSCH
HEALTH US, LLC, AT 1-800-321-4576 OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Corneal