From the FDA Drug Label
The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Table 4: Pramipexole Dosage in Parkinson’s Disease Patients With Renal Impairment Renal Status Starting Dose (mg) Maximum Dose (mg) ... Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients)
The safe dose for mirapex (pramipexole) in dialysis patients is not established, as the use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients 1.
From the Research
Mirapex (pramipexole) dosing should be reduced in dialysis patients due to decreased drug clearance, with a recommended starting dose of 0.125 mg once daily, as evidenced by the most recent study in 2019 2.
Key Considerations
- The dose reduction is necessary because approximately 90% of pramipexole is normally eliminated by the kidneys, and patients with end-stage renal disease have significantly reduced clearance of the medication, leading to higher blood levels and increased risk of adverse effects if standard doses are used.
- Pramipexole is not significantly removed by dialysis, so supplemental doses after dialysis are not necessary, as shown in a study published in 2019 2.
- Close monitoring for side effects is essential, particularly orthostatic hypotension, somnolence, hallucinations, and impulse control disorders.
- Dose increases should be made cautiously, no more frequently than every 5-7 days, based on clinical response and tolerability.
Additional Guidance
- The maximum recommended dose for dialysis patients is generally 1.5 mg per day, divided into three doses, though many patients may require lower doses.
- A study published in 2016 3 emphasizes the importance of careful consideration of drug clearance and dosing design in patients with renal impairment, including those on dialysis.
- Another study from 2021 4 highlights the complexity of pharmacokinetics in hemodialysis patients and the need for individualized dosing regimens.
Summary of Evidence
- The most recent and highest-quality study, published in 2019 2, provides direct evidence for the pharmacokinetics of pramipexole in hemodialysis patients.
- Earlier studies, such as those published in 2012 5 and 2016 3, provide general guidance on drug dosing in patients with renal impairment and on dialysis.
- Other studies, including those from 2004 6 and 2021 4, offer additional insights into the management of restless legs syndrome and the use of antipsychotics in hemodialysis patients, but are not directly relevant to the dosing of mirapex in dialysis patients.