Usual Adult Dose for Alzheimer's Disease

IMMEDIATE-RELEASE:
Week 1: 5 mg orally once a day.
Week 2: 10 mg orally/day (Administer 5 mg twice a day.)
Week 3: 15 mg orally/day (Administer 5 mg and 10 mg as separate doses.)
Week 4/Maintenance Dose: 20 mg orally/day (Administer 10 mg twice a day.)

EXTENDED-RELEASE:

• Initial Dose: 7 mg orally once a day.
• Maintenance and Maximum Dose: 28 mg orally once a day; increase the initial dose in 7 mg increments to the recommended maintenance dose.

Renal Dose Adjustments

• Mild and Moderate Renal Impairment (CrCl 30 to 80 mL/min): No adjustment recommended.
• Severe Renal Impairment (CrCl 5 to 29 mL/min): Immediate-Release: 5 mg orally twice a day; Extended-Release (Maintenance and Maximum Dose): 14 mg orally once a day.

Liver Dose Adjustments

• Mild and Moderate Hepatic Impairment (Child-Pugh A and B): No adjustment recommended.
• Severe Hepatic Impairment (Child-Pugh C): Immediate-Release: Use with caution; Extended-Release: Data not available.

Dose Adjustments

SWITCHING FROM IMMEDIATE-RELEASE (IR) TO EXTENDED RELEASE (XR):

• Patient on Regimen of 10 Mg IR Twice a Day: Switch to 28 mg XR once a day on the day following the last dose of the IR drug.
• Patients with Severe Renal Impairment (CrCl 5 to 29 mL/min): Switch to 14 mg XR once a day on the day following the last dose of the IR drug.
• Comments: There is no study data addressing the comparative efficacy of the 10 mg IR twice a day and 28 mg XR once a day regimens.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration Advice:

• Administer this drug with or without food.
• In the event of a missed dose, advise patients to take the next dose as scheduled and not to double up on that dose.
• EXTENDED-RELEASE CAPSULES: May be opened and its contents sprinkled on applesauce; instruct patients to consume the entire contents of each capsule and not to divide the dose.
• EXTENDED-RELEASE CAPSULES: Except when opened and sprinkled on applesauce, advise patients to swallow the capsules whole and not to divide, chew, or crush them.
• ORAL SOLUTION: Consult the manufacturer product information for instructions on use of the dosing device that comes with this drug formulation.

• ORAL SOLUTION: Do not mix with any other liquid; consult the manufacturer product information for preparation/handling instructions.

• Overdosage: No specific antidote is available; use standard clinical procedures such as urine acidification, carbo medicinalis (interruption of potential entero-hepatic recirculation), gastric lavage, and forced diuresis as appropriate.
• ORAL SOLUTION: If using the bottle with the mounted pump, keep and transport the bottle in a vertical position.

• Reassess the clinical benefit, tolerance, and dosing of this drug on a regular basis, preferably within 3 months after treatment initiation and according to current clinical guidelines thereafter.

• Avoid potentially dangerous activities such as driving and operating machinery until you know how this drug affects you.