" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
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(scopolamine) Transdermal System
The Transderm Scop® (scopolamine) transdermal 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 α -(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:
Scopolamine is a viscous liquid that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scop 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:
What are the possible side effects of scopolamine transdermal (Transderm-Scop)?
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.
What are the precautions when taking scopolamine (Transderm Scop)?
Before using scopolamine, tell your doctor or pharmacist if you are allergic to it; or to other belladonna alkaloids (such as atropine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, emphysema), personal or family history of glaucoma (angle-closure type), heart disease, high blood pressure, seizures, stomach/intestine/esophagus problems (such as ulcers, blockage, GERD), overactive thyroid (hyperthyroidism), difficulty urinating (for example, due to enlarged prostate), mental/mood disorders (such as psychosis,...
Last reviewed on RxList: 1/25/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Transderm Scop Information
Transderm Scop - User Reviews
Transderm Scop User Reviews
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Report Problems to the Food and Drug Administration
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