Preview FDA label, Torrent Pharmaceuticals Limited, oral, effective 2026-03-31. Full label on DailyMed
Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.
Dosing in kidney impairment
Renal Impairment The elimination of pramipexole is dependent on renal function. Pramipexole clearance is extremely low in dialysis patients, as a negligible amount of pramipexole is removed by dialysis. Caution should be exercised when administering pramipexole dihydrochloride tablets to patients with renal disease [see Dosage and Administration, Warnings and Precautions, and Clinical Pharmacology] .
Parkinson's Disease-Normal Renal Function* (2.2)
Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.5
4
0.75 TID
2.25
5
1 TID
3
6
1.25 TID
3.75
7
1.5 TID
4.5
* Doses should not be increased more frequently than every 5 to 7 days. Titrate to effective dose. If used with levodopa, may need to reduce levodopa dose.
Parkinson's Disease-Impaired Renal Function (2.2)
Creatinine Clearance
Starting Dose (mg)
Maximum Dose (mg)
> 50 mL/min
0.125 TID
1.5 TID
30 to 50 mL/min
0.125 BID
0.75 TID
15 to 30 mL/min
0.125 QD
1.5 QD
< 15 mL/min and hemodialysis patients
Data not available
Restless Legs Syndrome* (2.3)
Titration Step
Dose (mg) 2 to 3 hours before bedtime
1
0.125
2 (if needed)
0.25
3 (if needed)
0.5
* Dosing interval is 4 to 7 days (14 days in patients with CrCl 20 to 60 mL/min)
Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson's Disease Patients with Renal Impairment
Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment (creatinine Cl > 50 mL/min)
0.125 three times a day
1.5 three times a day
Moderate impairment (creatinine Cl = 30 to 50 mL/min)
0.125 twice a day
0.75 three times a day
Severe impairment (creatinine Cl = 15 to <30 mL/min)
0.125 once a day
1.5 once a day
Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
