Proparacaine
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
ALCAINE® 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 ALCAINE® (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
There is no FDA guidance on the use of Proparacaine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Proparacaine in geriatric settings.
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
There is limited information regarding Proparacaine Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Proparacaine Mechanism of Action in the drug label.
Structure
There is limited information regarding Proparacaine Structure in the drug label.
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
There is limited information regarding Proparacaine How Supplied in the drug label.
Storage
There is limited information regarding Proparacaine Storage in the drug label.
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.