Exelon
Description
Clinical
Indications
Side Effects
Warnings
OverDosage
Patient Info


INDICATIONS

AND USAGE

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

DOSAGE AND ADMINISTRATION

The dosage of Exelon® (rivastigmine tartrate) shown to be effective in controlled clinical trials 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 two 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).

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

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 0078-0323-28
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 0078-0324-28
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 0078-0325-28
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 0078-0326-28
Unit Dose (blister pack)
Box of 100 (strips of 10)
  NDC 0078-0326-06

Store below 77°F (25°C) in a tight container.

Jun 2001

Printed in U.S.A.

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

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