Proparacaine

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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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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:
- Proparacaine Hydrochloride
- Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride.
- 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.

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

# Images

## Drug Images

## Package and Label Display Panel

# 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