Alcaine

What is Alcaine and how is it used?

Alcaine is a prescription medicine used to treat the symptoms of Foreign Bodies, Suture Removal and Deep Ophthalmic Anesthesia. Alcaine may be used alone or with other medications.

Alcaine belongs to a class of drugs called Anesthetics, Ophthalmic.

What are the possible 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.

The most common side effects of Alcaine include:

• dry skin with cracking,
• grooves or lines in the skin of the fingertips,
• skin rash,
• hives,
• itching, and
• redness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Alcaine. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

USE THIS PRODUCT ONLY ON THE ADVICE OF A PHYSICIAN

DESCRIPTION

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.

INDICATIONS

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 AND ADMINISTRATION

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.

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

Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134. Revised: Jul 2021

SIDE EFFECTS

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

No information provided

WARNINGS

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.

PRECAUTIONS

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

No information provided.

CONTRAINDICATIONS

This preparation is contraindicated in patients with known hypersensitivity to any component of the solution. This product should never be prescribed for the patient's own use.

CLINICAL PHARMACOLOGY

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

PATIENT INFORMATION

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