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.

Last updated on RxList: 12/8/2004

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

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.

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.

Last updated on RxList: 12/8/2004

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.

No Information Provided

Last updated on RxList: 12/8/2004

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.

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.

Last updated on RxList: 12/8/2004

No information provided.

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.

Last updated on RxList: 12/8/2004

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).

Last updated on RxList: 12/8/2004

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.

See WARNINGS, CONTRAINDICATIONS and PRECAUTIONS.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

SCOPOLAMINE SOLUTION - OPHTHALMIC

(sko-PALL-un-meen)

COMMON BRAND NAME(S): Isopto Hyoscine

USES: This medication is used to widen the pupils for eye examination or eye surgery. It is also used to decrease pain and swelling from an inflammation of the eye (iridocyclitis). It belongs to a class of drugs known as anticholinergics. Scopolamine works by blocking the effects of a certain natural chemical (acetylcholine) on certain eye muscles, causing relaxation of these muscles. This effect causes the pupil to widen and the lens to temporarily lose the ability to focus. Scopolamine decreases pain in eye inflammation by relaxing the eye muscles.

HOW TO USE: If you are using this medication for eye inflammation, apply it to the eye up to 3 or 4 times a day or as directed by your doctor. If you are using this medication to widen the pupil, it is usually applied in the eye 1 hour before the procedure/exam or as directed by your doctor. This medication is for use in the eye only. Do not take by mouth or inject.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

If you are wearing contact lenses, remove them before using these eye drops. Ask your doctor when you can start wearing your contact lenses again.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch as directed by your doctor. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure for 2 to 3 minutes. This will prevent the medication from draining away from the eye and will also help reduce side effects. Try not to blink and do not rub your eye. Repeat these steps if your dose is for more than 1 drop or for your other eye if so directed. Wash your hands after applying eye drops.

If you are applying eye drops into a child's eyes, wash your hands and the child's hands afterwards. Be careful not to get any drops in the child's mouth.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), ask your doctor if you should continue to use them with this medication and when you should start them again. Use eye drops before eye ointments to allow the drops to enter the eye.

If you have been directed to use this medicine more than 1 time (e.g., for eye inflammation), use it regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Continue using it for the full time prescribed.

This medication starts to work in minutes, and its effect usually lasts for several days or sometimes longer. Tell your doctor if you continue to have blurred vision, sensitivity to light, or widened pupils 1 week after your exam. If you are treating inflammation, tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Temporary burning/stinging /redness of the eye may occur. Blurred vision, sensitivity to light, drowsiness, or dry mouth may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: eye pain/swelling/severe redness, vision changes (such as seeing colored halos around light sources, sudden loss of vision), mental/mood changes (e.g., confusion, hallucinations, memory problems), nausea/vomiting, difficulty urinating, muscle spasms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using scopolamine, tell your doctor or pharmacist if you are allergic to it; or to atropine, other belladonna-type drugs, or benzalkonium chloride; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle) or higher risk for developing glaucoma.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain damage or spastic paralysis in children, Down's syndrome, certain eye conditions (e.g., thinning cornea also known as keratoconus, or scarring between the cornea, iris, and lens).

After you apply this drug, your vision may become blurred. You may also be sensitive to light and should wear protective eye wear such as dark sunglasses. The effects on your vision may last up to 7 days after use of scopolamine. This drug may also make you drowsy. Use caution while driving, using machinery, or doing any other activity that requires clear vision or alertness. Limit alcoholic beverages.

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially the mental/mood effects.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other anticholinergic medications (e.g., belladonna), antihistamines (e.g., diphenhydramine, meclizine), eye medications for glaucoma/increased pressure in the eye (e.g., carbachol, dorzolamide, pilocarpine), certain drugs for Parkinson's disease (e.g., anticholinergics such as benztropine, trihexyphenidyl).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you are using this drug on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 46-80 degrees F (8-27 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.