PROPARACAINE HYDROCHLORIDE solution/ drops

Proparacaine Hydrochloride by

Drug Labeling and Warnings

Proparacaine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION

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%). Inactives: glycerin and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Preservative: benzalkonium chloride (0.01%).

CLINICAL PHARMACOLOGY

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

INDICATIONS AND USAGE

Proparacaine hydrochloride 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.

CONTRAINDICATIONS

Proparacaine hydrochloride ophthalmic solution is contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.

WARNINGS

NOT FOR INJECTION INTO THE EYE - FOR TOPICAL OPHTHALMIC USE ONLY

Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Pregnancy

Pregnancy Category C Animal reproduction studies have not been conducted with 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.

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

Safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.

Geriatric Use

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

ADVERSE REACTIONS

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 been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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: Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% should be clear, colorless to faint yellow color. If the solution becomes darker, discard the solution.

FOR TOPICAL OPHTHALMIC USE ONLY

HOW SUPPLIED

Product: 50090-1923

NDC: 50090-1923-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Storage

Refrigerate at 2°-8°C (36°- 46°F). Protect from light. Keep tightly closed.

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Revised: July 2016

Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

9114403 (Folded)
9114503 (Flat)

Proparacaine Hydrochloride

INGREDIENTS AND APPEARANCE

PROPARACAINE HYDROCHLORIDE 
proparacaine hydrochloride solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 50090-1923(NDC:24208-730)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPARACAINE HYDROCHLORIDE (UNII: U96OL57GOY) (PROPARACAINE - UNII:B4OB0JHI1X)	PROPARACAINE HYDROCHLORIDE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-1923-0	1 in 1 CARTON	07/15/2015
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040074	09/29/1995

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-1923)