Isopto Hyoscine

(Generic versions may still be available.)

DRUG 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.

What are the possible side effects of scopolamine ophthalmic (Isopto Hyoscine)?

If you experience any of the following serious side effects, stop using scopolamine ophthalmic and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • an irregular or fast heart rate;
  • hallucinations or unusual behavior (especially in children); or
  • a swollen or distended stomach (in infants).

Other, less serious side effects may be more likely to occur. Continue to...

Read All Potential Side Effects and See Pictures of Isopto Hyoscine »

What are the precautions when taking scopolamine (Isopto Hyoscine)?

Before using scopolamine, tell your doctor or pharmacist if you are allergic to it; or to atropine, other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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...

Read All Potential Precautions of Isopto Hyoscine »


Isopto Hyoscine Consumer (continued)

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 (especially of the face/tongue/throat), 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to 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 if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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).

This drug may cause blurred vision. Your eyes may also become sensitive to light. Wearing dark sunglasses may help with the light sensitivity. These vision changes may last up to 7 days after use of scopolamine. This drug may also make you drowsy. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. 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.


Isopto Hyoscine Patient Information Including Side Effects

Brand Names: Isopto Hyoscine

Generic Name: scopolamine ophthalmic (Pronunciation: skoe POL a meen)

  • What is scopolamine ophthalmic (Isopto Hyoscine)?
  • What are the possible side effects of scopolamine ophthalmic (Isopto Hyoscine)?
  • What is the most important information I should know about scopolamine ophthalmic (Isopto Hyoscine)?
  • Who should not use scopolamine ophthalmic (Isopto Hyoscine)?
  • How should I use scopolamine ophthalmic (Isopto Hyoscine)?
  • What happens if I miss a dose (Isopto Hyoscine)?
  • What happens if I overdose (Isopto Hyoscine)?
  • What should I avoid while using scopolamine ophthalmic (Isopto Hyoscine)?
  • What other drugs will affect scopolamine ophthalmic (Isopto Hyoscine)?
  • Where can I get more information?

What is scopolamine ophthalmic (Isopto Hyoscine)?

Scopolamine ophthalmic causes the muscles in your eye to become relaxed. This widens your pupil. Your pupil will remain wide and will not respond to light.

Scopolamine ophthalmic is used to dilate (widen) your pupil when you have an inflammatory condition or in diagnostic or postsurgery situations in which this effect may be helpful.

Scopolamine ophthalmic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of scopolamine ophthalmic (Isopto Hyoscine)?

If you experience any of the following serious side effects, stop using scopolamine ophthalmic and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • an irregular or fast heart rate;
  • hallucinations or unusual behavior (especially in children); or
  • a swollen or distended stomach (in infants).

Other, less serious side effects may be more likely to occur. Continue to use scopolamine ophthalmic and talk to your doctor if you experience

  • blurred vision,
  • sensitivity to sunlight,
  • stinging and burning, or
  • swelling of the eyelids.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about scopolamine ophthalmic (Isopto Hyoscine)?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) for 1 to 3 minutes after each drop to prevent the medicine from draining down your tear duct.

Use caution when driving, operating machinery, or performing other hazardous activities. Scopolamine ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities. The effects of even one drop of this medication can last for up to 3 days. Be sure that your vision is clear before attempting any activity that could be dangerous.

Scopolamine ophthalmic may make your eyes more sensitive to light. Protect your eyes when you are going to be in bright light.

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