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Transderm Scop (Scopolamine Transdermal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Motion Sickness

Transderm Scōp® is indicated in adults for prevention of nausea and vomiting associated with motion sickness. [see Clinical Studies]

Post Operative Nausea and Vomiting (PONV)

Transderm Scōp® is indicated in adults for prevention of nausea and vomiting associated with recovery from anesthesia and/or opiate analgesia and surgery. [see Clinical Studies]

DOSAGE AND ADMINISTRATION

Each Transderm Scōp® patch is formulated to deliver in-vivo approximately 1mg of scopolamine over 3 days. Only one patch should be worn at any time. Do not cut the patch.
The patch should be applied only to the skin in the postauricular (hairless area behind one ear) area.

Handling
After the patch is applied on the dry skin behind the ear, the hands should be washed thoroughly with soap and water and dried. Upon removal, the patch should be discarded. To prevent any traces of scopolamine from coming into direct contact with the eyes, after administration of the patch, the hands and the application site should be washed thoroughly with soap and water and dried. [see How Supplied/Storage and Handling and Patient Counseling Information]

Initiation of Therapy

Motion Sickness

  • To prevent the nausea and vomiting associated with motion sickness, one Transderm Scōp® patch (formulated to deliver approximately 1mg of scopolamine over 3 days) should be applied to the hairless area behind one ear at least 4 hours before the antiemetic effect is required.

Post Operative Nausea and Vomiting

  • To prevent post operative nausea and vomiting, one Transderm Scōp® patch should be applied the evening before scheduled surgery, except for caesarian section.
  • For caesarian section surgery, to minimize exposure of the newborn baby to the drug, apply the patch one hour prior to caesarian section

Continuation of Therapy

Should the patch become displaced, it should be discarded, and a fresh one placed on the hairless area behind the other ear.

Motion Sickness
If therapy is required for longer than 3 days, the first patch should be removed and a fresh one placed on the hairless area behind the other ear.

Post Operative Nausea and Vomiting
For perioperative use, the patch should be kept in place for 24 hours following surgery at which time it should be removed and discarded.

DOSAGE FORMS AND STRENGTHS

The Transderm Scōp® system is a tan-colored circular flat patch which contains 1.5 mg of scopolamine base and is formulated to deliver in-vivo approximately 1mg of scopolamine over 3 days.

HOW SUPPLIED/STORAGE AND HANDLING

The 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 10 patches and 24 patches. Each patch is foil wrapped. Patient instructions are included. [see Patient Counseling Information]

  • 1 Package (10 patches) NDC 10019-553-01
  • 1 Package (24 patches) NDC 10019-553-02

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. [see Dosage and Administration (2) , Warnings and Precautions, and Patient Counseling Information]

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