TETRACAINE HYDROCHLORIDE solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)

Tilgjengelig fra:

Alcon Laboratories, Inc.

INN (International Name):

Tetracaine Hydrochloride

Sammensetning:

Tetracaine Hydrochloride 5 mg in 1 mL

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. None. Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 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 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 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution 0.5% or from the underlying maternal condition. No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available. Safety in the pediatric population has been demonstrated in clinical trials.  Efficacy of tetracaine hydrochloride ophthalmic solution 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 have been observed between elderly and younger patients.

Produkt oppsummering:

Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI-UNITS® is supplied as single patient use, 4 mL filled in 4-mL natural medium- or low-density polyethylene plastic DROP-TAINER® dispensers and natural low-density polyethylene tips with white polypropylene caps in a carton of 12.  Each sterilized DROP-TAINER® dispenser is packaged in a clear PVC and Tyvek blister.  This product does not contain a preservative; discard unused portion. NDC 0065-0741-14 Storage: Store at 2°C to 25°C (36°F to 77°F). Protect from light. Do not use if solution contains crystals, is cloudy, or discolored.

Autorisasjon status:

New Drug Application

Preparatomtale

TETRACAINE HYDROCHLORIDE- TETRACAINE HYDROCHLORIDE SOLUTION
ALCON LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TETRACAINE HYDROCHLORIDE
OPHTHALMIC SOLUTION 0.5% STERI‑UNIT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION.
TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.5% STERI‑UNIT ,
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1965
RECENT MAJOR CHANGES
Warnings and Precautions (5.4)
2/2022
INDICATIONS AND USAGE
Tetracaine Hydrochloride Ophthalmic Solution 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. Discard unused portion.
(2.1)
DOSAGE FORMS AND STRENGTHS
Sterile ophthalmic solution containing 0.5% tetracaine hydrochloride
(3)
CONTRAINDICATIONS
None (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 0.5% is not
intended for patient self-administration. (5.4)
ADVERSE REACTIONS
Ocular adverse events: stinging, burning, conjunctival redness (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALCON LABORATORIES,
INC., AT 1-800-757-
9195 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Topical Administration
2.2 Sterile Field Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTION