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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. For further information about unapproved drugs, click here.

Isopto® Hyoscine
(scopolamine hydrobromide ophthalmic solution)
Sterile

DESCRIPTION SECTION

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.

CONTRAINDICATIONS SECTION

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 SECTION

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

FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION.

PRECAUTIONS SECTION

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 Warning

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

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

STORAGE SECTION

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

ISOPTO HYOSCINE  
scopolamine hydrobromide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0998-0331
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Scopolamine Hydrobromide (Scopolamine) Scopolamine Hydrobromide 2.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride  
Hypromelloses  
Sodium Chloride  
Acetic Acid  
Sodium Acetate  
Water  
Packaging
# Item Code Package Description
1 NDC:0998-0331-05 5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/19/1981
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Laboratories, Inc. 008018525 MANUFACTURE(0998-0331)
Revised: 06/2007
 
Alcon Laboratories, Inc.



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