DailyMed Label: Proparacaine Hydrochloride

DailyMed Label: proparacaine hydrochloride

2024

DailyMed Prescription

proparacaine hydrochloride

proparacaine hydrochloride

NuCare Pharmaceuticals,Inc.

NDC: 68071-5139

NDC: 68071-5139

NDC: 68071-5139

ALCAINE ® (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is a topical local anesthetic for ophthalmic use. The active ingredient is represented by the structural formula: Established name: Proparacaine Hydrochloride Chemical name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride. Molecular Weight: 330.85 Each mL contains: Active: proparacaine hydrochloride 5 mg 0.5%. Preservative: benzalkonium chloride (0.01%). Inactives: glycerin and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide. chemical

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

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.

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

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

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.

ALCAINE ® (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is supplied in 15 mL DROP-TAINER ® dispensers. NDC68071-5139-5 Storage: Bottle must be stored in unit carton to protect contents from light. Store bottles under refrigeration at 2° - 8°C (36° - 46°F). Rx Only ©2004 Alcon, Inc. ALCON LABORATORIES, INC. 6201 South Freeway Fort Worth, Texas 76134 USA Printed in USA MedInfo@AlconLabs.com 1-800-757-9195 249039-0609

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

pdp