Transderm Scop

DRUG DESCRIPTION

The Transderm Scop (transdermal scopolamine) system is a circular flat patch designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is (alpha)-(hydroxymethyl) benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo [3.3.1.0 2,4 ] non-7-yl ester. The empirical formula is C 17 H 21 NO 4. and its structural formula is:

Scopolamine is a viscous liquid that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scop (scopolamine) system is a film 0.2 mm thick and 2.5 cm 2 , with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of tan-colored, aluminized, polyester film; (2) a drug reservoir of scopolamine, light mineral oil, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) an adhesive formulation of mineral oil, polyisobutylene, and scopolamine. A protective peel strip of siliconized polyester, which covers the adhesive layer, is removed before the system is used. The inactive components, light mineral oil (12.4 mg) and polyisobutylene (11.4 mg), are not released from the system.

What are the possible side effects of scopolamine transdermal (Transderm-Scop)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the scopolamine transdermal patch and call your doctor at once if you have any of these serious side effects:

  • eye pain or redness, seeing halos around lights;
  • blurred vision and increased sensitivity to light;
  • confusion, agitation, extreme fear, hallucinations, unusual thoughts or behavior; or
  • urinating less...

Read All Potential Side Effects and See Pictures of Transderm Scop

What are the precautions when taking scopolamine (Transderm Scop)?

Before using scopolamine, tell your doctor or pharmacist if you are allergic to it; or to other belladonna alkaloids (e.g., atropine); or if you have any other allergies. This product may contain inactive ingredients (such as adhesives), 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: a certain type of glaucoma (narrow-angle).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain type of glaucoma (wide-angle), seizures, mental/mood disorders (e.g., psychosis, anxiety), uncontrolled pain, breathing problems (e.g., asthma,...

Read All Potential Precautions of Transderm Scop


Transderm Scop Consumer (continued)

SIDE EFFECTS: Blurred vision and widened pupils may occur as your body adjusts to the medication. Dry mouth, drowsiness, dizziness, decreased sweating, constipation, and mild itching/redness on application site may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

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.

Remove the patch and tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, difficulty urinating, eye problems (e.g., pain/pressure/reddening of the eyes along with widened pupils), fast/irregular heartbeat, severe drowsiness, voice changes (e.g., hoarseness).

After stopping this medication, you may experience dizziness, loss of balance, nausea/vomiting, headache, muscle weakness, or slow heartbeat. If these effects occur, they usually appear 24 hours or more after you stop this medication. This is a result of your body adjusting to being off the medication. Report any such reactions to your doctor immediately.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 other belladonna alkaloids (e.g., atropine); or if you have any other allergies. This product may contain inactive ingredients (such as adhesives), 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: a certain type of glaucoma (narrow-angle).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain type of glaucoma (wide-angle), seizures, mental/mood disorders (e.g., psychosis, anxiety), uncontrolled pain, breathing problems (e.g., asthma, emphysema), trouble urinating (e.g., due to enlarged prostate), bowel disease (e.g., paralytic ileus, pyloric obstruction, diarrhea), stomach/esophagus problems (e.g., ulcers, GERD), heart/blood vessel disease (e.g., fast heartbeat, congestive heart failure, coronary artery disease), overactive thyroid (hyperthyroidism), high blood pressure, myasthenia gravis, kidney disease, liver disease.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, participate in underwater activities, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication can decrease sweating. To prevent heatstroke, avoid becoming overheated in hot weather, in saunas, and during exercise/other strenuous activities.

Before having surgery, tell your doctor or dentist that you are using this medication.

If you are going to have an MRI test, notify testing personnel that you are using this patch. Serious burns may occur during MRI tests because of the aluminum contained in these patches. It should be removed just before the MRI test or consult your doctor for specific instructions.

The elderly may be more sensitive to the effects of this drug, especially dizziness/drowsiness.

Children are very sensitive to the effects of this medication. This medication is not recommended for use in children.

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

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.


Transderm Scop Patient Information Including Side Effects

Brand Names: Transderm-Scop

Generic Name: scopolamine transdermal (Pronunciation: skoe PAL a meen)

  • What is scopolamine transdermal (Transderm Scop)?
  • What are the possible side effects of scopolamine transdermal (Transderm Scop)?
  • What is the most important information I should know about scopolamine transdermal (Transderm Scop)?
  • What should I discuss with my healthcare provider before using scopolamine transdermal (Transderm Scop)?
  • How should I use scopolamine transdermal (Transderm Scop)?
  • What happens if I miss a dose (Transderm Scop)?
  • What happens if I overdose (Transderm Scop)?
  • What should I avoid while using scopolamine transdermal (Transderm Scop)?
  • What other drugs will affect scopolamine transdermal (Transderm Scop)?
  • Where can I get more information?

What is scopolamine transdermal (Transderm Scop)?

Scopolamine reduces the secretions of certain organs in the body, such as the stomach.

Scopolamine transdermal is used to prevent nausea and vomiting caused by motion sickness or from anesthesia given during surgery.

Scopolamine transdermal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of scopolamine transdermal (Transderm Scop)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the scopolamine transdermal patch and call your doctor at once if you have any of these serious side effects:

  • eye pain or redness, seeing halos around lights;
  • blurred vision and increased sensitivity to light;
  • confusion, agitation, extreme fear, hallucinations, unusual thoughts or behavior; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • drowsiness, dizziness;
  • dry mouth;
  • dry or itchy eyes;
  • feeling restless;
  • memory problems; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about scopolamine transdermal (Transderm Scop)?

You should not use this medication if you are allergic to scopolamine or similar medications such as methscopolamine (Pamine) or hyoscyamine (Hyospaz, Levsin, Symax), or if you have narrow-angle glaucoma.

Before using scopolamine transdermal, tell your doctor if you have glaucoma, kidney or liver disease, epilepsy or other seizure disorder, a blockage in your intestines, or if you have a bladder obstruction or are unable to urinate.

Before using scopolamine transdermal, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by scopolamine.

Scopolamine slows the digestive tract, which can make it harder for your body to absorb any medicines you take by mouth. Tell your doctor if any of your oral medications do not seem to work as well while you are using scopolamine transdermal.

Scopolamine transdermal can cause side effects that may impair your vision, thinking, or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Call your doctor at once if you have a serious side effect such as eye pain or redness, seeing halos around lights, blurred vision and increased sensitivity to light, hallucinations, unusual thoughts or behavior; or urinating less than usual.

The scopolamine transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

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