2.1 General Dosing Considerations
MIRAPEX ER tablets are taken orally once daily, with or without food.
MIRAPEX ER tablets must be swallowed whole and must not be chewed, crushed, or divided.
If a significant interruption in therapy with MIRAPEX ER tablets has occurred, re-titration of therapy may be warranted.
2.2 Dosing for Parkinson's Disease
The starting dose is 0.375 mg given once per day. Based on efficacy and tolerability, dosages may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day.
In clinical trials, dosage was initiated at 0.375 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 4.5 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment [see Clinical Studies (14)].
Due to the flexible dose design used in clinical trials, specific dose-response information could not be determined [see Clinical Studies (14)].
MIRAPEX ER tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day.
Dosing in Patients with Renal Impairment
In patients with moderate renal impairment (creatinine clearance between 30 and 50 mL/min), MIRAPEX ER tablets should initially be taken every other day. Caution should be exercised and careful assessment of therapeutic response and tolerability should be made before increasing to daily dosing after one week, and before any additional titration in 0.375 mg increments up to 2.25 mg per day. Dose adjustment should occur no more frequently than at weekly intervals.
MIRAPEX ER tablets have not been studied in patients with severe renal impairment (creatinine clearance <30 mL/min) or patients on hemodialysis, and are not recommended in these patients.
2.3 Switching from Immediate-Release Pramipexole Tablets to MIRAPEX ER
Patients may be switched overnight from immediate-release pramipexole tablets to MIRAPEX ER tablets at the same daily dose. When switching between immediate-release pramipexole tablets and MIRAPEX ER tablets, patients should be monitored to determine if dosage adjustment is necessary.
