Applies to the following strength(s): 0.125 mg ; 0.25 mg ; 1 mg ; 0.5 mg ; 1.5 mg ; 0.75 mg ; 0.375 mg ; 3 mg ; 4.5 mg ; 2.25 mg ; 3.75 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Parkinson's Disease
Initial dose: 0.125 mg orally three times a day
Titration: Increase gradually in small dose increments no more frequently than ever 5 to 7 days
Maintenance dose: 1.5 to 4.5 mg per day based on efficacy and tolerability
Maximum dose: 4.5 mg per day
Comment: The following dose titration was used in clinical trials:
Week 2, 0.25 mg 3 times a day
Week 3, 0.5 mg 3 times a day
Week 4, 0.75 mg 3 times a day
Week 5, 1 mg 3 times a day
Week 6, 1.25 mg 3 times a day
Week 7, 1.5 mg 3 times a day.
-When used in combination with levodopa, the levodopa dose was reduced by an average of 27% from baseline providing a concomitant dose of approximately 800 mg per day.
Initial dose: 0.375 mg orally once a day
Titration: Increase gradually no more frequently than every 5 to 7 days, first dose increase should be to 0.75 mg once a day followed by incremental increases of 0.75 mg; assess therapeutic response and tolerability at a minimum of 5 days after each dose increase.
Maximum dose: 4.5 mg per day
SWITCHING FROM IMMEDIATE-RELEASE TO EXTENDED-RELEASE:
-Patients may be switched overnight from immediate-release tablets to extended-release tablets at the same daily dose; monitor closely to determine if dose adjustments may be necessary.
-If a significant interruption in therapy occurs, re-titration may be necessary; upon discontinuation, doses should be tapered.
Use: Treatment of Parkinson's disease
Usual Adult Dose for Restless Legs Syndrome
Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime
Titration: If needed, dose may be titrated upwards by increments of 0.125 mg every 4 to 7 days.
Maximum dose: 0.5 mg orally once a day
-Extended-release tablets are not indicated for Restless Legs Syndrome.
-Doses of 0.75 mg once a day were used in clinical trials, but were not found to provide additional benefit as compared to the 0.5 mg dose.
Use: For the treatment of moderate to severe primary Restless Legs Syndrome.
Renal Dose Adjustments
-Very severe renal impairment (CrCl less than 15 mL/min): Not recommended
-Severe renal impairment (CrCl 15 to less than 30 mL/min): Initial dose: 0.125 mg orally once a day; titrate gradually at intervals of no more frequently than every 5 to 7 days to a maximum dose of 1.5 mg once a day; Maximum dose: 1.5 mg once per day
-Moderate renal impairment (CrCl 30 to 50 mL/min): Initial dose: 0.125 mg orally twice a day; titrate gradually at intervals of no more frequently than every 5 to 7 days to a maximum dose of 0.75 mg 3 times a day; Maximum dose: 2.25 mg per day
-Normal to mild renal impairment (CrCl greater than 50 mL/min): No adjustment recommended
Severe renal impairment: Not recommended
Moderate renal impairment (CrCl 30 to 50 mL/min): Initial dose: 0.375 mg orally every other day; after 1 week, may increase to once a day dosing based on therapeutic response and tolerability; subsequent dose titrations should be in increments of 0.375 mg no more frequently every 7 days; Maximum dose: 2.25 mg per day
Mild renal impairment (CrCl greater than 50 mL/min): No adjustment recommended
Restless Legs Syndrome:
Moderate to severe renal impairment (CrCl 20 to 60 mL/min): Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime
Titration: If needed, dose may be titrated upwards by increments of 0.125 mg every 14 days; Maximum dose: 0.5 mg orally once a day
Liver Dose Adjustments
No adjustment recommended.
If the patient is receiving levodopa, a reduction in the dosage of levodopa should be considered.
Patients may be switched overnight from pramipexole immediate-release to pramipexole extended-release at the same daily dose. Dose adjustment may be needed in some patients.
Discontinuation of Treatment:
-Parkinson's Disease: Taper off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg, then reduce by 0.375 mg per day.
-Restless Legs Syndrome: Taper is not needed
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions
Hemodialysis: Not recommended
Peritoneal dialysis: Data not available
-Take orally with or without food
-If a dose is missed, advise patients not to double their next dose
-Take orally with or without food
-Tablets should be swallowed whole; do not chew, crush, or divide
-If a dose is missed, take as soon as possible, but no later than 12 hours after the regularly scheduled time; after 12 hours, the missed dose should be skipped and dosing resumed on regular schedule
-Protect from light and high humidity
-If a significant interruption in therapy occurs during treatment of Parkinson's disease, retitration may be necessary
-In a fixed dose study in early Parkinson's disease patients, no significant benefit was observed with daily doses of 3 mg, 4.5 mg, or 6 mg compared with 1.5 mg/day; however, the following adverse events increased with increasing dose: postural hypotension, nausea, constipation, somnolence, and amnesia.
-Upon discontinuation, this drug should be gradually tapered; during clinical trials, this drug was not tapered when used to treat restless legs syndrome.
-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.
-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 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