Alcaine

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 6/21/2024

Drug Summary

What Is Alcaine?

Alcaine (proparacaine hydrochloride 0.5%) is a topical anesthetic for the eyes used during eye surgeries and procedures. Alcaine is available in generic form.

What Are Side Effects of Alcaine?

Alcaine may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • blurred vision,
  • redness of the eye,
  • sensitivity to light,
  • tearing of the eye,
  • throbbing eye pain,
  • bloody eye,
  • stinging or itching of the eye, and
  • change in vision

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Alcaine include:

  • eye irritation,
  • stinging,
  • burning,
  • redness,
  • tearing, or
  • increased blinking.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Alcaine

The recommended dosage of Alcaine is 1 or 2 drops prior to having surgery or procedure and 1 drop every 5 or 10 minutes for 5 to 7 doses for cataract extraction. Rinse your eyes with sterile distilled water before using Alcaine. Avoid rubbing or touching your eyes until Alcaine has worn off.

What Drugs, Substances, or Supplements Interact with Alcaine?

Alcaine may interact with other drugs. Tell your doctor all medications and supplements you use.

Alcaine During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plant to become pregnant before treatment with Alcaine; it is unknown if it would affect a fetus. It is unknown if Alcaine passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Alcaine (proparacaine hydrochloride 0.5%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Description for Alcaine

ALCAINE® (proparacaine hydrochloride ophthalmic solution) (Proparacaine Hydrochloride) is a topical anesthetic prepared as a sterile aqueous ophthalmic solution. Each mL contains: Active: Proparacaine Hydrochloride 0.5% (5 mg). Preservative: Benzalkonium Chloride 0.01%. Inactive: Glycerin, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), Purified Water.

Uses for Alcaine

ALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of shortduration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.

Dosage for Alcaine

Usual Dosage

Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating.

Short Corneal and Conjunctival Procedures

1 drop in each eye every 5 to 10 minutes for 5 to 7 doses.

NOTE: ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% should be clear to straw-color. If the solution becomes darker, discard the solution.

HOW SUPPLIED

ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is supplied in DROP-TAINER® dispensers as follows:

15 mL - NDC 0998-0016-15

Storage

Bottle must be stored in unit carton to protect contents from light.

After opening, ALCAINE™ can be used until the expiration date on the bottle.

NOTE: ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% should be clear to straw-color. If the solution becomes darker, discard the solution

Store bottles under refrigeration at 2°C to 8°C (36°F-46°F).

Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134. Revised: Sep 2022

Side Effects for Alcaine

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.

Drug Interactions for Alcaine

No information provided

Warnings for Alcaine

NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of a topical ocular anesthetic is not recommended. Itmay produce permanent corneal opacification with accompanying visual loss.

ALCAINE™ ophthalmic solution is indicated for administration under the direct supervision of a healthcare provider. ALCAINE™ ophthalmic solution is not intended for patient self-administration.

Precautions for Alcaine

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment of fertility inmales or females.

Use In Specific Populations

Pregnancy

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

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 exercisedwhen 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 proparacainehydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safetyinformation in neonates and other pediatric patients.

Geriatric Use

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

Overdose Information for Alcaine

No information provided

Contraindications for Alcaine

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

Clinical Pharmacology for Alcaine

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

Patient Information for Alcaine

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.