Isopto Hyoscine Ophthalmic Solution
Generic Name: scopolamine hydrobromide
Dosage Form: ophthalmic solution
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
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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.
CLINICAL PHARMACOLOGY SECTION
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 & USAGE SECTION
For mydriasis and cycloplegia in diagnostic procedures. For some pre- and postoperative states when a mydriatic and cycloplegic is needed in treatment of iridocyclitis.
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.
Do not touch dropper tip to any surface, as this may contaminate the solution.
FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION.
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.
Patient should be advised not to drive or engage in other hazardous activities when drowsy or while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child’s mouth and to wash their own hands and the child’s hands following administration.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
ADVERSE REACTIONS SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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 SUPPLIED SECTION
In 5 mL plastic DROP-TAINER® dispensers.
5 mL NDC 0998-0331-05
Store at 8°-27°C (46°-80°F). Protect from light.
Revised: June 2007
ALCON LABORATORIES, INC.
Ft. Worth, Texas 76134 USA
Printed in USA
© 2003, 2007 Alcon, Inc.
PRINCIPAL DISPLAY PANEL
Isopto® Hyoscine 0.25%
(scopolamine hydrobromide ophthalmic solution)
5 mL Sterile
scopolamine hydrobromide solution
|Labeler - Alcon Laboratories, Inc. (008018525)|
|Registrant - Alcon Laboratories, Inc. (008018525)|
|Alcon Laboratories, Inc.||008018525||MANUFACTURE(0998-0331)|