Exelon (Rivastigmine Tartrate) - Indications and Dosage

INDICATIONS AND USAGE

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).

DOSAGE AND ADMINISTRATION

Dementia of the Alzheimer’s T ype

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 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 A ssociated with Parkinson’s Disease

The dosage of Exelon shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3-12 mg/day, given as twice-a-day dosing (daily doses of 1.5-6 mg BID). In that medical condition, the starting dose of Exelon 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 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 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 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

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

      Unit Dose Blister Card of 30     ………………………………NDC 0078-0323-15

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

      Unit Dose Blister Card of 30     ………………………………NDC 0078-0324-15

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

      Unit Dose Blister Card of 30     ……………………………...NDC 0078-0325-15

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

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

REV: JUNE 2006                     T2006-73