Usual Adult Dose for Parkinson's Disease

200 mg orally concomitantly with each dose of levodopa-carbidopa up to a maximum of 8 times a day
Maximum dose: 1600 mg per day

Comments:

• Upon initiation, a majority of patients required levodopa dose reductions or an extension of the interval between their levodopa doses, especially those receiving levodopa doses of 800 mg/day or greater, and patients with baseline moderate or severe dyskinesia.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Dose adjustment may be required; however, no specific guidelines have been suggested. Caution is recommended.

Dose Adjustments

When discontinuing therapy, monitor patients closely and adjust other dopaminergic treatments as needed; no specific dose reduction is recommended, although tapering seems prudent.

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:

• May be taken with or without food
• This drug should be taken at least 2 to 3 hours apart from iron; taken together, they may form chelates in the gastrointestinal tract

• This drug has no antiparkinsonian effect of its own and it must be administered with levodopa-carbidopa.
• May be combined with both the immediate and sustained-release formulations of levodopa and carbidopa.

• Cardiovascular: Monitor for signs and symptoms of orthostatic hypotension, particularly during dose escalation..
• Nervous System: Monitor for somnolence and drowsiness
• Dermatologic: Monitor for melanomas; consider periodic skin examinations by dermatologists.
• Psychiatric: Question patients about new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges.

• Tell patients that this drug may cause a brownish orange discoloration of their urine that is of no concern.
• This drug frequently causes drowsiness; patients should not drive a car or operate machinery or other potentially dangerous activities until it is determined how this drug affects their mental and/or motor performance.
• Patients should be instructed to report episodes of sudden onset of sleep, new or worsening dyskinesia, new or worsening compulsive behaviors and/or unusual urges.
• Patients should be instructed to report changes in the size, shape, or color of moles on their skin and should have their skin checked on a regular basis for melanomas.
• Patients should be aware that this drug may cause orthostatic blood pressure changes including fainting and dizziness and patients are advised to avoid standing rapidly after sitting or lying down.
• Patients should speak to their physician or health care provider if they become pregnant, intend to become pregnant, or are breastfeeding.