Isopto Hyoscine Ophthalmic Solution Prescribing Information

Isopto Hyoscine Ophthalmic Solution Description

ISOPTO® Hyoscine (scopolamine hydrobromide ophthalmic solution) is an anticholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:

Established name: scopolamine hydrobromide
Chemical name: benzeneacetic acid, α-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl ester, hydrobromide, trihydrate, [7(S)-(1α,2β,4β,5α,7β)]-.

Each mL contains: Active: scopolamine hydrobromide 0.25%. Preservative: benzalkonium chloride 0.01%. Vehicle: hypromellose 0.5%. Inactives: sodium chloride, glacial acetic acid, sodium acetate (to adjust pH), purified water.

Isopto Hyoscine Ophthalmic Solution - Clinical Pharmacology

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).

Indications and Usage for Isopto Hyoscine Ophthalmic Solution

For mydriasis and cycloplegia in diagnostic procedures. For some pre- and postoperative states when a mydriatic and cycloplegic is needed in treatment of iridocyclitis.

Contraindications

Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g., narrow anterior chamber angle; and in those showing hypersensitivity to any component of this preparation.

Warnings

Do not touch dropper tip to any surface, as this may contaminate the solution.

FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION.

Precautions

To avoid excessive absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after instillation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.

Adverse Reactions/Side Effects

Prolonged use may produce local irritation, characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Somnolence, dryness of the mouth, or visual hallucinations may occur.

Isopto Hyoscine Ophthalmic Solution Dosage and Administration

For refraction, administer one or two drops in the eye(s) one hour before refracting. For uveitis, administer one or two drops in the eye(s) up to four times daily.

How is Isopto Hyoscine Ophthalmic Solution supplied

In 5 mL plastic DROP-TAINER® dispensers.
5 mL NDC 0998-0331-05

Storage and Handling

Store at 8°-27°C (46°-80°F). Protect from light.

Rx Only

Revised: June 2007

9002667-0607

ALCON LABORATORIES, INC.
Ft. Worth, Texas 76134 USA
Printed in USA
© 2003, 2007 Alcon, Inc.

PRINCIPAL DISPLAY PANEL

NDC 0998-0331-05

Alcon®

Isopto® Hyoscine 0.25%
(scopolamine hydrobromide ophthalmic solution)

5 mL Sterile