Proparacaine

Proparacaine
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: Chetan Lokhande, M.B.B.S [2]

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Overview

Proparacaine is a local anesthetic that is FDA approved for the {{{indicationType}}} of anesthesia for procedures on eye.. Common adverse reactions include ophthalmic: conjunctival hemorrhage, corneal erosion, cycloplegia (rare ), passive conjunctival congestion.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Proparacaine FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• Trigeminal neuralgia

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Safety and effectiveness in pediatric patients have not been established; however the use of Proparacaine HCl as a topical ophthalmic anesthetic agent in pediatric patients has been cited in the literature

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Proparacaine ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.

Warnings

• Not For Injection - For Topical Ophthalmic Use Only.
• Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

Adverse Reactions

Clinical Trials Experience

• Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported.
• Allergic contact dermatitis from proparacaine with drying and fissuring of the fingertips has also been reported.

Postmarketing Experience

There is limited information regarding Proparacaine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Proparacaine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Animal reproduction studies have not been conducted with Proparacaine (proparacaine hydrochloride ophthalmic solution, USP) 0.5%. It is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine hydrochloride should be administered to a pregnant woman only if clearly needed.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Proparacaine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Proparacaine 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 proparacaine hydrochloride is administered to a nursing woman

Pediatric Use

• Safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.

Geriatic Use

• No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients

Gender

There is no FDA guidance on the use of Proparacaine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Proparacaine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Proparacaine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Proparacaine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Proparacaine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Proparacaine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Proparacaine Administration in the drug label.

Monitoring

There is limited information regarding Proparacaine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Proparacaine and IV administrations.

Overdosage

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

Pharmacology

Mechanism of Action

• Proparacaine ophthalmic solution is a rapidly-acting topical anesthetic, with induced anesthesia lasting approximately 10-20 minutes.

Structure

• Proparacaine (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is a topical local anesthetic for ophthalmic use. The active ingredient is represented by the structural formula:

Established name

• Proparacaine Hydrochloride

Chemical name

• Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride.

This image is provided by the National Library of Medicine.

• Molecular Weight: 330.85
• Each mL contains: Active: proparacaine hydrochloride 5 mg 0.5%. Preservative: benzalkonium chloride (0.01%). Inactives: glycerin and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide.

Pharmacodynamics

There is limited information regarding Proparacaine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Proparacaine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Proparacaine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Proparacaine Clinical Studies in the drug label.

How Supplied

• Proparacaine (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is supplied in 15 mL DROP-TAINER® dispensers.

NDC 0998-0016-15

Storage

• Bottle must be stored in unit carton to protect contents from light. Store bottles under refrigeration at 2° - 8°C (36° - 46°F).

Rx Only

©2004 Alcon, Inc.

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134 USA

Printed in USA

MedInfo@AlconLabs.com

1-800-757-9195

249039-0609

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Proparacaine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Proparacaine 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 Proparacaine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Proparacaine 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.

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