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 (proparacaine hydrochloride ophthalmic solution) (Proparacaine Hydrochloride) Ophthalmic Solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.

DOSAGE AND ADMINISTRATION

Deep anesthesia as in cataract extraction:

Instill 1 drop every 5 to 10 minutes for 5 to 7 doses.

Removal of sutures:

Instill 1 or 2 drops 2 or 3 minutes before removal of stitches.

Removal of foreign bodies:

Instill 1 or 2 drops prior to operating.

Tonometry:

Instill 1 or 2 drops immediately before measurement.

HOW SUPPLIED

ALCAINE (proparacaine hydrochloride ophthalmic solution) (Proparacaine Hydrochloride) Ophthalmic Solution. 0.5% is supplied in 15 mL DROP-TAINER® dispensers.

Storage: Store at 2°-8°C. Keep refrigerated. Do not use the solution if darker than a pale yellow.

ALCON CANADA INC. Mississauga, Canada L5N 8C7. FDA Rev date: 12/23/2002

SIDE EFFECTS

Pupillary dilatation or cycloplegic effects have rarely been observed with proparacaine hydrochloride. The drug appears to be safe for use in patients sensitive to other local anesthetics, but local or systemic sensitivity occasionally occurs. Instillation of proparacaine in the eye at recommended concentration and dosage usually produces little or no initial irritation, stinging, burning, conjunctival redness, lacrimation or increased winking. However, some local irritation and stinging may occur several hours after the instillation. Rarely, a severe immediate-type, apparently hyperallergic corneal reaction may occur which includes 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. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported. Softening and erosion of the corneal epithelium and conjunctival congestion and hemorrhage have been reported.

DRUG INTERACTIONS

No information provided.

WARNINGS

For topical ophthalmic use only. Do not touch dropper tip to any surface as this may contaminate the solution. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification with accompanying loss of vision.

PRECAUTIONS

General

Proparacaine hydrochloride should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity of proparacaine is unknown, prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity (manifested by central nervous system stimulation followed by depression) may occur. Protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should be advised to avoid touching the eye until the anesthesia has worn off.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Pregnancy Category C

Animal reproduction studies have not been conducted with ALCAINE (proparacaine hydrochloride ophthalmic solution) (Proparacaine Hydrochloride) Ophthalmic Solution. 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.

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

Controlled clinical studies have not been performed with ALCAINE (proparacaine hydrochloride ophthalmic solution) (Proparacaine Hydrochloride) Ophthalmic Solution to establish safety and effectiveness in children; however, the literature cites the use of proparacaine hydrochloride as a topical ophthalmic anesthetic agent in children.

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 (proparacaine hydrochloride ophthalmic solution) Solution is a rapid acting local anesthetic suitable for ophthalmic use. The onset of anesthesia usually begins within 30 seconds and lasts a relatively short period of time. The main site of anesthetic action is the nerve cell membrane where proparacaine interferes with the large transient increase in the membrane permeability to sodium ions that is internally produced by a slight depolarization of the membrane. As the anesthetic action progressively develops in a nerve, the threshold for electrical stimulation gradually increases and the safety factor for conduction decreases; when this action is sufficiently well developed, block of conduction is produced. The exact mechanism whereby proparacaine and other local anesthetics influence the permeability of the cell membrane is unknown; however, several studies indicate that local anesthetics may limit sodium ion permeability through the lipid layer of the nerve cell membrane. This limitation prevents the fundamental change necessary for the generation of the action potential.

PATIENT INFORMATION

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