Transderm Scop® is indicated in adults for prevention of nausea and vomiting associated with motion sickness and recovery from anesthesia and surgery. The patch should be applied only to skin in the postauricular area.

Initiation of Therapy: To prevent the nausea and vomiting associated with motion sickness, one Transderm Scop® patch (programmed to deliver approximately 1.0 mg 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. To prevent post operative nausea and vomiting, the patch should be applied the evening before scheduled surgery. To minimize exposure of the newborn baby to the drug, apply the patch one hour prior to cesarean section. Only one patch should be worn at any time. Do not cut the patch.

Handling: After the patch is applied on 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, the hands and the application site should be washed thoroughly with soap and water and dried. (A patient brochure is available).

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

The Transderm Scop® 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 Scop® system contains 1.5 mg of scopolamine and is programmed to deliver in-vivo approximately 1.0 mg of scopolamine over 3 days. Transderm Scop® is available in packages of four patches. Each patch is foil wrapped. Patient instructions are included. 1 Package (4 patches) NDC 0067-4345-04. The system should be stored at controlled room temperature between 20°C - 25°C (68°F - 77°F).

REFERENCE

6. Clinical safety data on file.

Mfd by: ALZA Corporation Palo Alto, CA 94303-0802. Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 ©2004.
FDA rev date: 1/10/2007

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