Exelon

DRUG DESCRIPTION

Exelon® (rivastigmine tartrate) is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2•C4H6O6 (hydrogen tartrate salt - hta salt) and a molecular weight of 400.43 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n- octanol/phosphate buffer solution pH 7 is 3.0.

Exelon® (rivastigmine tartrate) structural formula illustration

Exelon Capsules contain rivastigmine tartrate, equivalent to 1.5, 3, 4.5 and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides.

Exelon (rivastigmine tartrate) Oral Solution is supplied as a solution containing rivastigmine tartrate, equivalent to 2 mg/mL of rivastigmine base for oral administration. Inactive ingredients are citric acid, D&C yellow #10, purified water, sodium benzoate and sodium citrate.

What are the possible side effects of rivastigmine (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 and call your doctor at once if you have any of these serious side effects:

  • stomach pain, nausea and vomiting, loss of appetite;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like blood or coffee grounds;
  • feeling light-headed, fainting;
  • chest pain;
  • confusion,...

Read All Potential Side Effects and See Pictures of Exelon »

What are the precautions when taking rivastigmine tartrate (Exelon)?

Before taking 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 disease (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 »


Exelon Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, loss of appetite/weight loss, diarrhea, weakness, dizziness, drowsiness, and shakiness (tremor) may occur as your body adjusts to the drug. These effects usually occur when you start the medication or increase the dose and then lessen. 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 taking 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 disease (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.

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 Patient Information Including Side Effects

Brand Names: Exelon

Generic Name: rivastigmine (Pronunciation: ri va STIG meen)

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

What is rivastigmine (Exelon)?

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 is used to treat mild to moderate dementia caused by Alzheimer's or Parkinson's disease.

Rivastigmine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of rivastigmine (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 and call your doctor at once if you have any of these serious side effects:

  • stomach pain, nausea and vomiting, loss of appetite;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like blood or coffee grounds;
  • feeling light-headed, fainting;
  • chest pain;
  • confusion, agitation, extreme fear; or
  • pain or burning when you urinate.

Less serious side effects may include:

  • upset stomach, diarrhea;
  • weight loss;
  • weakness, dizziness;
  • swelling in your hands or feet;
  • joint pain;
  • cough, runny or stuffy nose;
  • increased sweating;
  • sleep problems (insomnia); or
  • headache.

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 (Exelon)?

Before taking rivastigmine, 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 and call your doctor at once if the medicine causes you to have stomach pain, nausea and vomiting, and loss of appetite.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

It is important to use rivastigmine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you stop taking rivastigmine 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 taking rivastigmine.

Rivastigmine 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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