Transderm Scop

Transderm Scop

Transderm Scop Recall

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Questions & Answers

Side Effects & Adverse Reactions

Glaucoma therapy in patients with chronic open-angle (wide-angle) glaucoma should be monitored and may need to be adjusted during Transderm Scōp use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure.

Transderm Scōp should not be used in children and should be used with caution in the elderly. See PRECAUTIONS.

Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.

Rarely, idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine. The most serious of these that have been reported are: acute toxic psychosis, including confusion, agitation, rambling speech, hallucinations, paranoid behaviors, and delusions.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Transderm Scōp 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.

History

There is currently no drug history available for this drug.

Other Information

The Transderm Scōp (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
a-(hydroxymethyl) benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo [3.3.1.02,4] non-7-yl ester. The empirical formula is C17H21NO4 and its structural formula is

     

Chemical Structure

Scopolamine is a viscous liquid that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scōp system is a film 0.2 mm thick and 2.5 cm2, 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.

Cross section of the system:

     

Patch Cross Section

Transderm Scop Manufacturers


  • Physicians Total Care, Inc.
    Transderm Scop (Scopolamine) Patch, Extended Release [Physicians Total Care, Inc.]
  • Novatris Consumer Health, Inc.
    Transderm Scop (Scopolamine) Patch, Extended Release [Novatris Consumer Health, Inc.]
  • Baxter Healthcare Corporation
    Transderm Scop (Scopalamine) Patch, Extended Release [Baxter Healthcare Corporation]

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