Usual Adult Dose for Alzheimer's Disease

MILD TO MODERATE ALZHEIMER'S DISEASE:
ORAL:

• Initial dose: 1.5 mg orally twice a day
• Maintenance dose: After a minimum of 2 weeks of treatment, if the initial dosage is well tolerated, it can be increased to 3 mg twice a day; subsequent increases to 4.5 mg and 6 mg twice a day should be attempted only after a minimum of 2 weeks at the previous dosage

• Initial Dose: 4.6 mg/24 hour patch applied to the skin once daily
• Maintenance Dose: After a minimum of 4 weeks of treatment at the initial dose, and if well tolerated, the dose can be increased to 9.5 mg/24 hours for as long as this dose is beneficial; the dose can then be increased to 13.3 mg/24 hours
• Maximum Dose: 13.3 mg/24 hour patch applied to skin daily; higher doses confer no appreciable additional benefit, and are associated with significant increase in the incidence of adverse events

• Recommended dose: 13.3 mg/24 hours transdermal patch applied to skin once daily; replace with a new patch every 24 hours

Usual Adult Dose for Parkinson's Disease

MILD TO MODERATE PARKINSON'S DISEASE DEMENTIA:
ORAL:
Initial dose: 1.5 mg orally twice a day with morning and evening meals
Maintenance dose: Subsequently, the dose can be increased to 3 mg orally twice a day and further to 4.5 mg twice a day and 6 mg twice a day (based on tolerability) with a minimum of 4 weeks at each dose

TRANSDERMAL PATCH:
Initial dose: 4.6 mg/24 hours applied to the skin once a day
Maintenance dose: After a minimum of four weeks of treatment and if well tolerated, the dose of the patch can be increased to 9.5 mg/24 hours for as long as this dose is beneficial. The dose can then be increased to 13.3 mg/24 hours.
Maximum dose: 13.3 mg/24 hours. Higher doses confer no appreciable additional benefit, and are associated with significant increase in the incidence of adverse events.

Use: For the treatment of mild to moderate dementia associated with Parkinson's disease

Renal Dose Adjustments

No dosage adjustment recommended, because the dose is individually titrated to tolerability.

Moderate to severe renal impairment (glomerular filtration rate less than 50 mL/min): Patients may only be able to tolerate lower doses

Liver Dose Adjustments

• Mild (Child-Pugh 5 to 6) and moderate (Child-Pugh 7 to 9) hepatic impairment: The dose may need to be lowered
• Severe hepatic impairment: Data not available

Dose Adjustments

Interruption of therapy with transdermal patches:

• If dosing interrupted for 3 days or fewer, restart treatment with the same or lower strength transdermal patch.
• If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours transdermal patch and titrate

• Carefully titrate and monitor patients with low body weight (less than 50 kg) for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.

• A patient who is on a total daily dose of less than 6 mg orally can be switched to patch dose of 4.6 mg/24 hours.
• A patient who is on a total daily dose of 6 to 12 mg orally can be directly switched to a patch dose of 9.5 mg/24 hours.
• It is recommended to apply the first patch on the day following the last oral dose.

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:
ORAL:

• Take with meals in divided doses in the morning and evening.
• The oral solution may be swallowed directly from the syringe or mixed with a small glass of water, cold fruit juice, or soda.

• Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.
• Apply the patch once a day.
• Press down firmly for 30 seconds until edges stick well.
• Use upper or lower back as the site of application.
• Do not apply to skin area where cream, lotion, or powder has been recently applied.
• Do not apply to skin that is red, irritated, or cut.
• Wear one patch at a time.
• Change site of application daily, do not apply a new patch to same location for at least 14 days.
• May wear patch during bathing, but avoid long exposure to external heat sources.

• Keep transdermal patch in the individual sealed pouch until use
• Store oral solution in an upright position and protect from freezing
• Oral solution is stable at room temperature for up to 4 hours when mixed with cold fruit juice or soda.

• The oral formulation is not indicated for severe dementia of the Alzheimer's type.

• Used transdermal patches should be folded, with the adhesive surfaces pressed together and discarded safely.
• Avoid eye contact and wash hands after handling the transdermal patch.