"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
(rivastigmine) Transdermal System
Exelon Patch (rivastigmine transdermal system) contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)- 3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate.
The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27.
Exelon Patch is for transdermal administration. The patch is a four-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use.
Figure 1: Cross Section of the Exelon Patch
Layer 1: Backing Film
Layer 2: Drug Product (Acrylic) Matrix
Layer 3: Adhesive (Silicone) Matrix
Layer 4: Release Liner (removed at time of use)
Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E.
What are the possible side effects of rivastigmine transdermal (Exelon)?
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.
Call your doctor at once if you have a serious side effect such as:
- feeling like you might pass out;
- severe or ongoing vomiting or diarrhea, loss of appetite, weight loss;
- feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
- black or bloody stools, coughing up blood or vomit that looks like blood or coffee grounds;
- restless muscle...
What are the precautions when taking rivastigmine transdermal system (Exelon Patch)?
Before using rivastigmine, tell your doctor or pharmacist if you are allergic to it (including any serious allergic skin reaction with past use of the patch); 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/lung problems (such as asthma, COPD-chronic obstructive pulmonary disease), stomach/intestinal problems (such as ulcers, bleeding), heart problems (such as sick sinus syndrome, other conduction disorders), fainting, seizures, problems urinating (such as due to enlarged prostate), liver disease.
This drug may make you dizzy or drowsy....
Last reviewed on RxList: 7/30/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Exelon Patch Information
Exelon Patch - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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