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.
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