Exelon Patch

DRUG DESCRIPTION

Exelon Patch (rivastigmine transdermal system) is a reversible cholinesterase inhibitor and is 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 (rivastigmine) Structural Formula Illustration

Exelon Patch (rivastigmine transdermal system) is for transdermal administration. The patch comprises a four-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner. The release liner is removed and discarded prior to use. See Figure 1 for a detailed illustration.

Figure 1: Cross Section of the Patch

Cross Section of the Patch - Illustration

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.

Stop using rivastigmine transdermal and call your doctor at once if you have any of these serious side effects:

  • nausea and vomiting, loss of appetite, weight loss;
  • black or bloody stools, coughing up blood or vomit that looks like blood or coffee grounds;
  • restless muscle movements in your eyes, tongue, jaw, or neck, tremor...

Read All Potential Side Effects and See Pictures of Exelon Patch »

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; 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).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure...

Read All Potential Precautions of Exelon Patch »


Exelon Patch Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, loss of appetite/weight loss, diarrhea, weakness, dizziness, drowsiness, shakiness (tremors), and skin irritation at the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: slow/irregular heartbeat, fainting, black stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, seizures, trouble urinating.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using rivastigmine, tell your doctor or pharmacist if you are allergic to it; 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).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

While wearing your patch, avoid exposing it to direct heat (such as prolonged direct sunlight, heating pads, electric blankets, heat lamps, saunas, hot tubs). Heat may cause more drug to be released into your body, increasing the chance of side effects.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Exelon Patch Patient Information Including Side Effects

Brand Names: Exelon

Generic Name: rivastigmine transdermal (Pronunciation: riv a STIG meen)

  • What is rivastigmine transdermal (Exelon Patch)?
  • What are the possible side effects of rivastigmine transdermal (Exelon Patch)?
  • What is the most important information I should know about rivastigmine transdermal (Exelon Patch)?
  • What should I discuss with my healthcare provider before using rivastigmine transdermal (Exelon Patch)?
  • How should I use rivastigmine transdermal (Exelon Patch)?
  • What happens if I miss a dose (Exelon Patch)?
  • What happens if I overdose (Exelon Patch)?
  • What should I avoid while using rivastigmine transdermal (Exelon Patch)?
  • What other drugs will affect rivastigmine transdermal (Exelon Patch)?
  • Where can I get more information?

What is rivastigmine transdermal (Exelon Patch)?

Rivastigmine improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine (ah see til KO leen). People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning.

Rivastigmine transdermal (skin patch) is used to treat mild to moderate dementia caused by Alzheimer's or Parkinson's disease.

Rivastigmine transdermal may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of rivastigmine transdermal (Exelon Patch)?

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.

Stop using rivastigmine transdermal and call your doctor at once if you have any of these serious side effects:

  • nausea and vomiting, loss of appetite, weight loss;
  • black or bloody stools, coughing up blood or vomit that looks like blood or coffee grounds;
  • restless muscle movements in your eyes, tongue, jaw, or neck, tremor (uncontrolled shaking);
  • sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance;
  • pale skin, easy bruising or bleeding;
  • confusion, hallucinations; or
  • pain or burning when you urinate.

Less serious side effects may include:

  • diarrhea;
  • headache, tired feeling;
  • redness, itching, or swelling where the patch was worn;
  • dizziness, spinning feeling; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rivastigmine transdermal (Exelon Patch)?

Before using rivastigmine transdermal, tell your doctor if you have a heart rhythm disorder such as "sick sinus syndrome" (slow heartbeats), an enlarged prostate, urination problems, asthma, obstructive pulmonary disease, or a seizure disorder such as epilepsy.

Stop using rivastigmine transdermal and call your doctor at once if the medicine causes you to have nausea and vomiting, loss of appetite, or weight loss.

If you stop using rivastigmine transdermal for any reason, do not restart the medication without talking to your doctor first. You may need to restart treatment with a lower dose.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using rivastigmine transdermal.

Rivastigmine transdermal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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