Scopolamine

DESCRIPTION

ISOPTO^® HYOSCINE (Scopolamine Hydrobromide) is an anticholinergic prepared as a sterile topical ophthalmic solution.

Structure

Established name: Scopolamine Hydrobromide

Chemical name: Benzeneacetic acid , a-(hydroxymethyl)- , 9-methyl-3-oxa-9azatricyclo[3 .3. 1 .O2 -4]non-7-yl ester, hydrobromide, trihydrate, [7(S)-(1 a,2b,4b,5a,7b)]-.

Each ml contains:

Active: Scopolamine Hydrobromide 0.25%.
Preservative: Benzalkonium Chloride 0.01%.
Vehicle: Hydroxypropyl Methylcellulose 0.5%.
Inactive: Sodium Chloride, Glacial Acetic Acid, Sodium Acetate (to adjust pH), Purified Water.

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

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

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

In 5 mL and 15 mL plastic DROP-TAINER® dispensers.

5 mL NDC 0998-0331-05
15 mL NDC -15

STORAGE: Store at 46° to 80°F. Protect from light.

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.

WARNINGS

Do not touch dropper tip to any surface, as this may contaminate the solution. For topical use only-not for injection. In infants and small children, use with extreme caution.

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.

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.