TETRACAINE HYDROCHLORIDE solution/ drops

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Bausch Health US LLC

Rotta amministrattiva:

OPHTHALMIC

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

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.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

TETRACAINE HYDROCHLORIDE- TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS
BAUSCH HEALTH US LLC
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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
•
•
•
ADVERSE REACTIONS
Ocular adverse events: transient stinging, burning, conjunctival
redness, eye irritation, eye pain, ocular discomfort. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT 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: 4/2020
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 Injury with Intracameral Use
5.2 Corneal Toxicity
5.3 Corneal Injury due to Insensitivity
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
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 w