Information for Medical Professionals

   
Clinically proven

Studies at sea demonstrated a 75% mean reduction in the incidence of nausea and vomiting associated with motion sickness.

In clinical trials, 5 out of 6 patients did not report drowsiness.1

Easy for Patients to Use

Please read this instruction sheet carefully before opening the system package.

Transderm Scōp® Transdermal System
Generic Name: scopolamine, pronounced skoe-POL-a-meen

  • Elderly patients should be informed that Transderm Scōp® may cause a greater likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome and to seek immediate medical care if they become confused, disoriented or dizzy while wearing the patch or after removing.
  • Patients should be informed that since Transderm Scōp® may cause drowsiness, disorientation and confusion they should avoid engaging in activities that require mental alertness such as driving a motor vehicle or operating dangerous machinery.
  • Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of Transderm Scōp®.
  • Because of the possibility of drowsiness, disorientation and confusion, patients should be informed that they should avoid drinking alcohol. In addition, patients should be informed that the following medications should be used with caution when taking Transderm Scōp®:

    • sedatives or tranquilizers
    • drugs with anticholinergic properties (e.g., other belladonna alkaloids),
    • antihistamines (including meclizine)
    • tricyclic antidepressants
    • muscle relaxants

  • Patients with the following conditions should be informed about the chance of developing serious reactions with Transderm Scōp®:

    • patients with open angle glaucoma (may cause an increase in intraocular pressure)
    • patients with impaired kidney or liver function (increased likelihood of CNS effects)
    • patients with a history of seizures or psychosis (can potentially worsen both disorders)
    • patients with obstruction at the level of the pylorus, which is the outlet of the stomach, or urinary bladder neck obstruction (may cause difficulties in urinating)
    • patients suspected of having intestinal obstruction
    • pregnant or nursing mothers

  • Patients should be informed that if they remove the Transderm Scōp® patch suddenly before treatment is complete, the following withdrawal symptoms may occur: dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, slow heart rate and low blood pressure. Patients should be instructed to seek immediate medical care if they develop any of these symptoms after removing Transderm Scōp®.
  • Patients should be informed that Transderm Scōp® can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Patients should be informed to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, patients should be informed that used patches must be disposed of properly to avoid contact with children or pets.
  • Patients should be informed that skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a Magnetic Resonance Imaging scan (MRI). Because Transderm Scōp® contains aluminum, patients should be advised to remove the system before undergoing an MRI.
  • Patients should be advised to use only one patch at a time.
  • Patients should be advised not to cut the patch.

How Supplied/Storage and Handling

Transderm Scōp® system is a tan-colored circular patch, 2.5 cm2, on a clear, oversized, hexagonal peel strip, which is removed prior to use.

Each Transderm Scōp® system contains 1.5 mg of scopolamine and is formulated to deliver in-vivo approximately 1 mg of scopolamine over 3 days.Transderm Scōp®is available in packages of four patches. Each patch is foil wrapped.Patient instructions are included.

  • 1 Package (4 patches) NDC 0067-4345-04
Storage
The system should be stored at controlled room temperature between 20°C - 25°C (68°F - 77°F).

Handling
Since scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.

1Transderm Scōp® Prescribing Information. Parsippany, NJ: Novartis Consumer Health, Inc.; 2014