Tetracaine (ophthalmic)

Tetracaine (ophthalmic)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Overview

Tetracaine (ophthalmic) is a local anesthesic that is FDA approved for the {{{indicationType}}} of tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea or conjunctiva, other short corneal and conjunctival procedures. Common adverse reactions include nausea, vomiting and burning sensation in eye.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

For Tonometry and Other Procedures of Short Duration

Instill one or two drops just prior to evaluation.

For Minor Surgical Procedures such as Foreign Body or Suture Removal

Instill one or two drops every five to ten minutes for one to three doses.

For Prolonged Anesthesia as in Cataract Extraction

Instill one or two drops in the eye(s) every five to ten minutes for three to five doses.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tetracaine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tetracaine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Tetracaine (ophthalmic) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tetracaine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tetracaine in pediatric patients.

Contraindications

Should not be used by the patient without physician supervision, or in those persons showing hypersensitivity to any component of this preparation.

Warnings

For topical ophthalmic use only. Not for parenteral use. Not for injection. Do not use solution if it contains crystals or if it is cloudy or discolored. Prolonged use results in diminished duration of anesthesia and retarded healing. This may cause the drug to be used more frequently, creating a “vicious circle”. Subsequent corneal infection and/or corneal opacification with accompanying permanent visual loss or corneal perforation may occur. Prolonged use may also produce severe keratitis.

Adverse Reactions

Clinical Trials Experience

Transient symptoms (signs) such as stinging, burning and conjunctival redness may occur. A rare, severe, immediate type allergic corneal reaction has been reported characterized by acute diffuse epithelial keratitis with filament formation and/or sloughing of large areas of necrotic epithelium, diffuse stromal edema, descemetitis and iritis.

TO REPORT SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Postmarketing Experience

There is limited information regarding Tetracaine (ophthalmic) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Tetracaine (ophthalmic) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Animal reproduction studies have not been performed with Tetracaine Hydrochloride. It is also not known whether Tetracaine Hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should be given to pregnant women only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tetracaine (ophthalmic) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tetracaine (ophthalmic) during labor and delivery.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatic Use

There is no FDA guidance on the use of Tetracaine (ophthalmic) in geriatric settings.

Gender

There is no FDA guidance on the use of Tetracaine (ophthalmic) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tetracaine (ophthalmic) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tetracaine (ophthalmic) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tetracaine (ophthalmic) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tetracaine (ophthalmic) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tetracaine (ophthalmic) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Tetracaine (ophthalmic) Administration in the drug label.

Monitoring

There is limited information regarding Tetracaine (ophthalmic) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Tetracaine (ophthalmic) and IV administrations.

Overdosage

There is limited information regarding Tetracaine (ophthalmic) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mechanism of Action

There is limited information regarding Tetracaine (ophthalmic) Mechanism of Action in the drug label.

Structure

Chemical Name: Benzoic acid, 4-(butylamino)-,2-(dimethylamino)ethyl ester, monohydrochloride

Pharmacodynamics

etracaine Hydrochloride Ophthalmic Solution, USP 0.5% acts by decreasing the permeability of the neuronal membrane, thereby decreasing the flux of sodium, potassium and other ions associated with propagation of the nerve impulse. The onset of anesthesia usually begins within 30 seconds and lasts a relatively short period of time.

Pharmacokinetics

There is limited information regarding Tetracaine (ophthalmic) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Tetracaine (ophthalmic) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Tetracaine (ophthalmic) Clinical Studies in the drug label.

How Supplied

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied in 15 mL and 30 mL single drop plastic containers.

Storage

Store at room temperature, 15°-30°C (59°-86°F). Keep container tightly closed. Protect from light.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Tetracaine (ophthalmic) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Tetracaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Tetracaine (ophthalmic) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Tetracaine (ophthalmic) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Tetracaine (ophthalmic)

File:Tetracaine2DCSD.svg
Clinical data
AHFS/Drugs.com	Monograph
MedlinePlus	a682640
Routes of administration	Topical, Epidural, Spinal
ATC code	C05AD02 (WHO) D04AB06 (WHO) N01BA03 (WHO) S01HA03 (WHO)
Legal status
Legal status	In general: ℞ (Prescription only)
Pharmacokinetic data
Protein binding	75.6
Identifiers
IUPAC name 2-(dimethylamino)ethyl 4-(butylamino)benzoate
CAS Number	94-24-6 Y 136-47-0 (hydrochloride)
PubChem CID	5411
ChemSpider	5218 Y
UNII	0619F35CGV
KEGG	D00551 Y
ChEBI	CHEBI:9468 Y
ChEMBL	ChEMBL698 Y
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C15H24N2O2
Molar mass	264.363 g/mol
3D model (JSmol)	Interactive image
SMILES O=C(OCCN(C)C)c1ccc(NCCCC)cc1
InChI InChI=1S/C15H24N2O2/c1-4-5-10-16-14-8-6-13(7-9-14)15(18)19-12-11-17(2)3/h6-9,16H,4-5,10-12H2,1-3H3 Y Key:GKCBAIGFKIBETG-UHFFFAOYSA-N Y
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