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

Exelon® (rivastigmine tartrate) is indicated for the treatment of mild to moderate dementia associated with Parkinson's disease.

The dementia of Parkinson's disease is purportedly characterized by impairments in executive function, memory retrieval, and attention, in patients with an established diagnosis of Parkinson's disease. The diagnosis of the dementia of Parkinson's disease, however, can reliably be made in patients in whom a progressive dementia syndrome occurs (without the necessity to document the specific deficits described above) at least 2 years after a diagnosis of Parkinson's disease has been made, and in whom other causes of dementia have been ruled out (see CLINICAL PHARMACOLOGY, Clinical Trial Data).

Dementia of the Alzheimer's type

The dosage of Exelon® (rivastigmine tartrate) shown to be effective in controlled clinical trials in Alzheimer's Disease is 6-12 mg/day, given as twice-a-day dosing (daily doses of 3 to 6 mg BID). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.

The starting dose of Exelon (rivastigmine tartrate) is 1.5 mg twice a day (BID). If this dose is well tolerated, after a minimum of 2 weeks of treatment, the dose may be increased to 3 mg BID. Subsequent increases to 4.5 mg BID and 6 mg BID should be attempted after a minimum of 2 weeks at the previous dose. 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 treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above (see WARNINGS). The maximum dose is 6 mg BID (12 mg/day).

Dementia associated with Parkinson's Disease

The dosage of Exelon® (rivastigmine tartrate) shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson's Disease is 3 to 12 mg/day, given as twice-a-day dosing (daily doses of 1.5 to 6 mg BID). In that medical condition, the starting dose of Exelon® (rivastigmine tartrate) is 1.5 mg BID; subsequently, the dose may be increased to 3 mg BID and further to 4.5 mg BID and 6 mg BID, based on tolerability, with a minimum of 4 weeks at each dose.

Exelon (rivastigmine tartrate) should be taken with meals in divided doses in the morning and evening.

Recommendations for Administration: Caregivers should be instructed in the correct procedure for administering Exelon (rivastigmine tartrate) 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 PRECAUTIONS: Information for Patients and Caregivers).

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 (rivastigmine tartrate) Oral Solution from the container. Each dose of Exelon (rivastigmine tartrate) 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 (rivastigmine tartrate) Oral Solution and Exelon (rivastigmine tartrate) Capsules may be interchanged at equal doses.

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 (rivastigmine tartrate) 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
Unit Dose Blister Card of 30............................................NDC 0078-0323-15

3 mg Capsule - orange, "Exelon (rivastigmine tartrate) 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
Unit Dose Blister Card of 30...................................NDC 0078-0324-15

4.5 mg Capsule - red, "Exelon (rivastigmine tartrate) 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
Unit Dose Blister Card of 30............................................NDC 0078-0325-15

6 mg Capsule - orange and red, "Exelon (rivastigmine tartrate) 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
Unit Dose Blister Card of 30.............................................NDC 0078-0326-15

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

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 28-mm cap, 0.5-mm foam liner, 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 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in an upright position and protect from freezing.

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

Exelon® (rivastigmine tartrate) Oral Solution Instructions for Use

	1. Remove oral dosing syringe from its protective case. Push down and twist child resistant closure to open bottle.
	2. Insert tip of syringe into opening of white stopper.
	3. While holding the syringe, pull the plunger up to the level (see markings on side of syringe) that equals the dose prescribed by your doctor.
	4. Before removing syringe containing prescribed dose from bottle, push out large bubbles by moving plunger up and down a few times. After the large bubbles are gone, pull the plunger again to the level that equals the dose prescribed by your doctor. Do not worry about a few tiny bubbles. This will not affect your dose in any way. Remove the syringe from the bottle.
	5. You may swallow Exelon Oral Solution directly from the syringe or mix with a small glass of water, cold fruit juice or soda. If mixing with water, juice or soda, be sure to stir completely and to drink the entire mixture. DO NOT MIX WITH OTHER LIQUIDS.
	6. After use, wipe outside of syringe with a clean tissue and put it back into its case. Close bottle using child resistant closure.

Store Exelon (rivastigmine tartrate) Oral Solution at room temperature below 25°C (77°F) in an upright position. Do not place in freezer.

Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. REV: June 2006. FDA Rev date: 6/27/2006

Last reviewed on RxList: 4/18/2008
This monograph has been modified to include the generic and brand name in many instances.