May 24, 2016
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Transderm Scop

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Transderm Scop




Transderm Scop Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/25/2015

Transderm Scop (transdermal scopolamine) is an anticholinergic drug patch applied to the skin used to prevent nausea and vomiting caused by motion sickness or from anesthesia given during surgery. Side effects of Transderm Scop include dry mouth, dry or itchy eyes, drowsiness, dizziness, feeling restless, memory problems, or itching or skin rash.

There are no adequate and well-controlled studies about the use of Transderm scop in pregnant women. Other than in the adjunctive use for delivery by cesarean section, Transderm Scop should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Because scopolamine is excreted in human milk, caution should be exercised when Transderm Scop (scopolamine) is administered to a nursing woman.

Our Transderm scop Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Transderm Scop in Detail - Patient Information: Side Effects

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

Read the entire detailed patient monograph for Transderm Scop (Scopolamine)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Transderm Scop Overview - Patient Information: Side Effects

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, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (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 right away if you have any serious side effects, including: mental/mood changes (such as confusion, agitation), difficulty urinating, fast/irregular heartbeat.

Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.

Read the entire patient information overview for Transderm Scop (Scopolamine)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Transderm Scop FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Motion Sickness

In motion sickness clinical studies of Transderm Scop, the most frequent adverse reaction was dry mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed.

Post-Operative Nausea and Vomiting

In a total of five clinical studies in which Transderm Scop was administered perioperatively to a total of 461 patients where safety was assessed, dry mouth was the most frequently reported adverse drug reaction, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug. Other adverse drug reactions reported from these studies, with a frequency of ≥ 3% of patients treated with Transderm Scop and with a frequency higher than placebo were, in descending order: somnolence, urinary retention, agitation/restlessness, visual impairment, confusion, mydriasis and pharyngitis (see Table 6.1).

Table 6.1 PONV: Adverse Drug Reactions in ≥ 3% of Patients

  Transderm Scop
(N=461)
Placebo
(N=457)
n % n %
Adverse Drug Reactions 303 65.7 259 56.7
Dry mouth 133 28.9 72 15.8
Dizziness 57 12.4 33 7.2
Somnolence 36 7.8 16 3.5
Urinary Retention 33 7.2 30 6.6
Agitation 28 6.1 20 4.4
Visual Impairment. 23 5.0 12 2.6
Confusion 18 3.9 14 3.1
Mydriasis 16 3.5 2 0.4
Pharyngitis 15 3.3 10 2.2

Postmarketing Experience

The following adverse drug reactions, further to those reported from clinical trials, have been identified during postapproval use of Transderm Scop. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to confirm a definite causal relationship.

In worldwide marketing with Transderm Scop, the following adverse drug reactions were reported by body system.

Psychiatric disorders: acute psychosis including: hallucinations disorientation, and paranoia.

Nervous system disorders: headache, amnesia, coordination abnormalities, speech disorder, disturbance in attention, restlessness.

General disorders and administration site conditions: application site burning.

Eye disorders: dry eyes, eye pruritis, angle closure glaucoma, amblyopia, eyelid irritation.

Skin and subcutaneous tissue disorders: rash generalized, skin irritation, erythema.

Renal and urinary disorders: dysuria.

Ear and Labyrinth Disorders: vertigo.

Drug Withdrawal/Post-Removal Symptoms

Symptoms such as dizziness, nausea, vomiting, abdominal cramps, sweating, headache mental confusion, muscle weakness, bradycardia and hypotension may occur following abrupt discontinuation of anticholinergic drugs such as Transderm Scop. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scop system. These symptoms usually do not appear until 24 hours or more after the patch has been removed. These symptoms can be severe and may require medical intervention. Some symptoms may be related to adaptation from a motion environment to a motion-free environment.

These symptoms can be severe and may require medical intervention.

Read the entire FDA prescribing information for Transderm Scop (Scopolamine)

Transderm Scop - User Reviews

Transderm Scop User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Transderm Scop sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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