Recommended Topic Related To:

Exelon

"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.

Alzheimer’"...

Exelon

Indications
Dosage
How Supplied

INDICATIONS

Alzheimer's Disease

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

Parkinson's Disease Dementia

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

DOSAGE AND ADMINISTRATION

Recommended Dosing

Exelon should be taken with meals in divided doses in the morning and evening.

Alzheimer's Disease

The dosage of Exelon shown to be effective in controlled clinical trials in Alzheimer's disease is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.

Initial Dose

Initiate treatment with the 1.5 mg twice a day with Exelon.

Dose Titration

After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).

Parkinson's Disease Dementia

The dosage of Exelon shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson's disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day).

Initial Dose

Initiate treatment with the 1.5 mg twice a day with Exelon.

Dose Titration

After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).

Interruption of Treatment

If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level.

If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of Exelon. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see WARNINGS AND PRECAUTIONS].

Dosing in Specific Populations

Dosing Modifications in Patients with Renal or Hepatic Impairment

Pharmacokinetic studies of oral rivastigmine in patients with moderate to severe renal impairment (glomerular filtration rate [GFR] < 50 mL/min) and mild to moderate hepatic impairment (Child-Pugh score 5 to 9) showed reduced clearance of the drug [see Use In Specific Populations, CLINICAL PHARMACOLOGY]. Accordingly, such patients may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment.

Dosing Modifications in Patients with Low Body Weight

Because rivastigmine blood levels vary with body weight [see Use In Specific Populations, CLINICAL PHARMACOLOGY], careful titration and monitoring should be performed in patients with low body weight. In patients with low body weight (less than 50 kg), monitor closely for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.

Important Administration Instructions

Caregivers should be instructed in the correct procedure for administering Exelon Oral Solution. In addition, they should be directed to the Instruction Sheet (included with the product) describing how the solution is to be administered. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist [see PATIENT INFORMATION].

Patients should be instructed to remove the oral dosing syringe provided in its protective case, and using the provided syringe, withdraw the prescribed amount of Exelon Oral Solution from the container. Each dose of Exelon Oral Solution may be swallowed directly from the syringe or first mixed with a small glass of water, cold fruit juice, or soda. Patients should be instructed to stir and drink the mixture.

Exelon Oral Solution and Exelon Capsules may be interchanged at equal doses.

HOW SUPPLIED

Dosage Forms And Strengths

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.

Storage And Handling

Exelon Capsules

Exelon (rivastigmine tartrate) Capsules 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.

Bottles of 60 NDC 0078-0323-44
Bottles of 500 NDC 0078-0323-08
Unit Dose (blister pack) Box of 100 (strips of 10) NDC 0078-0323-06

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

Bottles of 60 NDC 0078-0324-44
Bottles of 500 NDC 0078-0324-08
Unit Dose (blister pack) Box of 100 (strips of 10) NDC 0078-0324-06

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

Bottles of 60 NDC 0078-0325-44
Bottles of 500 NDC 0078-0325-08
Unit Dose (blister pack) Box of 100 (strips of 10) NDC 0078-0325-06

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

Bottles of 60 NDC 0078-0326-44
Bottles of 500 NDC 0078-0326-08
Unit Dose (blister pack) Box of 100 (strips of 10) NDC 0078-0326-06

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. Store in a tight container.

Exelon Oral Solution

Exelon (rivastigmine tartrate) Oral Solution is supplied as 120 mL of a clear, yellow solution (2 mg/mL base) in a 4-ounce USP Type III amber glass bottle with a child-resistant 19-mm linerless cap, dip tube and self-aligning plug. The oral solution is packaged with a dispenser set which consists of an assembled oral dosing syringe that allows dispensing a maximum volume of 3 mL corresponding to a 6-mg dose, with a plastic tube container.

Bottles of 120 mL NDC 0078-0339-31

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. Store in an upright position and protect from freezing.

When Exelon Oral Solution is combined with cold fruit juice or soda, the mixture is stable at room temperature for up to 4 hours.

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: 9/2013

Last reviewed on RxList: 10/18/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Exelon - User Reviews

Exelon User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Exelon sorted by most helpful. Patient Discussions FAQs

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.


WebMD Daily

Get breaking medical news.