Exelon

• Exelon^®

GENERIC AVAILABLE: Yes

• Exelon and Exelon Patch usually is taken twice daily with meals. Due to gastrointestinal side effects that can be seen early in therapy, rivastigmine therapy is generally started at a low dose.

Exelon and Exelon Patch for treating dementia associated with Alzheimer's disease

• For treating dementia associated with Alzheimer's the starting dose is 1.5 mg twice daily.
• It is gradually increased no more than once every two weeks.
• The goal usually is 3 to 6 mg twice daily.
• If a patient develops severe gastrointestinal side effects such as upset stomach and vomiting, he or she may need to stop taking rivastigmine for a few doses and then start taking it again at the same dose or a lower dose.

Exelon and Exelon Patch for treating dementia associated with Parkinson's disease

• The starting dose for treating dementia associated with Parkinson's disease is 1.5 mg orally twice daily.
• The dose may be increased every four weeks to 3 to 6 mg twice daily.
• When using the patch the recommended starting dose is 4.6 mg/24 hours patch once daily.
• The patch should be replaced with a new one every day.
• The maximum dose is one 9.5 mg/24 hour patch. At least four weeks should elapse before increasing the dose.

Exelon is a prescription medicine used to treat dementia in people with Alzheimer's disease or Parkinson's disease.

Exelon is part of the drug class:

• Anticholinesterases

It is not known if Exelon crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Exelon.

Capsule:

• Store Exelon capsules at controlled room temperature in a tight container.

Patch:

• Store Exelon patches between 59-86°F (15-30°C)
• Keep Exelon patches in the sealed pouch until ready to use.
• Do not use Exelon Patch after the expiration date shown on the carton and pouch.
• Keep this and all medicines out of the reach of children.

A centrally active, reversible cholinesterase inhibitor.1 3 4 5 6 7 8 9 10 11 12 17

Rivastigmine is used to treat mild to moderate dementia (memory loss and mental changes) associated with Alzheimer's disease or Parkinson's disease. Rivastigmine will not cure or stop Alzheimer's disease or Parkinson's disease from getting worse, however, rivastigmine can improve the thinking ability in some patients.

In Alzheimer's disease, many chemical changes take place in the brain. One of the earliest and biggest changes is that there is less of a chemical called acetylcholine (ACh). ACh helps the brain to work properly. Rivastigmine slows the breakdown of ACh, so it can build up and have a greater effect. However, as Alzheimer's disease gets worse, there will be less and less ACh, so rivastigmine may not work as well.

This medicine is available only with your doctor's prescription.

     Alzheimer’s Disease

Exelon is indicated for the treatment of mild to moderate dementia of the Alzheimer's type (AD).

      Parkinson’s Disease Dementia

Exelon is indicated for the treatment of mild to moderate dementia associated with Parkinson’s disease.

      Exelon Capsules

Capsules, containing rivastigmine tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg, or 6 mg of rivastigmine base, are available as follows:

      1.5 mg capsule – yellow, “Exelon 1,5 mg” is printed in red on the body of the capsule.

      3 mg capsule – orange, “Exelon 3 mg” is printed in red on the body of the capsule.

      4.5 mg capsule – red, “Exelon 4,5 mg” is printed in white on the body of the capsule.

      6 mg capsule – orange and red, “Exelon 6 mg” is printed in red on the body of the capsule.

      Exelon Oral Solution

Oral Solution is a clear yellow, solution containing rivastigmine tartrate equivalent to 2 mg/mL of rivastigmine base. 

For a full list of excipients, see Description (11).

Exelon may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

You should not take oral Exelon if you have ever had severe redness, itching, or skin irritation caused by wearing a Exelon transdermal skin patch.

Call your doctor at once if you have severe or ongoing vomiting or diarrhea, loss of appetite, weight loss, heavy sweating or hot and dry skin, black or bloody stools, coughing up blood, tremors (uncontrolled shaking), or restless muscle movements in your eyes, tongue, jaw, or neck.

Before using Exelon, tell your doctor if you have liver disease, a heart rhythm disorder such as "sick sinus syndrome" (slow heartbeats), recent weight loss or lack of appetite, an enlarged prostate, urination problems, a seizure disorder, asthma or allergies, tremors or uncontrolled muscle movements, or a history of stomach ulcer.

Always remove an old patch before putting on a new one. Do not wear more than one Exelon skin patch at a time.

Applies to rivastigmine: oral capsule, oral solution, transdermal film extended release

Dermatologic

Common (1% to 10%): Hyperhidrosis
Rare (less than 0.1%): Rash
Frequency not reported: Pruritus
Postmarketing reports: Stevens-Johnson syndrome disseminated allergic dermatitis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, bradycardia
Uncommon (0.1% to 1%): Hypotension
Rare (0.01% to 0.1%): Angina pectoris
Very rare (less than 0.01%): Cardiac arrhythmia (e.g., bradycardia, atrioventricular block, atrial fibrillation, tachycardia)
Frequency not reported: Sick sinus syndrome[Ref]

Gastrointestinal

Very common (10% or more): Nausea (47%), vomiting (31%)diarrhea (19%), abdominal pain (13%)
Common (1% to 10%): Dyspepsia, salivary hypersecretion, upper abdominal pain, flatulence, eructation
Rare (0.01% to 0.1%): Gastric and duodenal ulcers
Very rare (less than 0.01%): GI hemorrhage, pancreatitis
Frequency not reported: Some cases of severe vomiting were associated with esophageal rupture[Ref]

Genitourinary

Common (1% to 10%): Urinary incontinence
Very rare (less than 0.01%): Urinary tract infection[Ref]

Hepatic

Frequency not reported: Elevated liver function tests, hepatitis[Ref]

Nervous system

Very common (10% or more): Tremor (23%), dizziness (21%)
Common (1% to 10%): Somnolence, bradykinesia, dyskinesia, cogwheel rigidity, hypokinesia, vertigo, psychomotor hyperactivity, gait disturbance, Parkinson gait, headache
Uncommon (0.1% to 1%): Syncope, dystonia
Rare (0.01% to 0.1%): Seizures[Ref]

Psychiatric

Common (1% to 10%): Insomnia, confusion, depression, anxiety, hallucination, agitation, restlessness, nightmares[Ref]

Local

Common (1% to 10%): Application site erythema, application site irritation (e.g., pruritus, rash)
Postmarketing reports: Application site hypersensitivity, urticaria, blister, allergic dermatitis[Ref]

Metabolic

Very common (10% or more): Anorexia (17%)
Common (1% to 10%): Decreased appetite
Frequency not reported: Dehydration[Ref]

Other

Common (1% to 10%): Asthenia, weight loss, fatigue, malaise, fall[Ref]

Respiratory

Common (1% to 10%): Rhinitis[Ref]

Some side effects of Exelon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.