DOSAGE AND ADMINISTRATION
Dementia of the Alzheimer’s
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).
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
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
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