Pramipexole 0.125 mg Immediate Release Tablets — Generic For Mirapex — Glenmark

These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS.

PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use

Initial U.S. Approval: 1997

Recent Major Changes

Warnings and Precautions, Withdrawal Symptoms (5.11) 7/2021

Indications And Usage

Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of:

Dosage And Administration

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

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

Dosage Forms And Strengths

Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg (3)

Contraindications

None (4)

Warnings And Precautions

• , Withdrawal Symptoms (5.11) 7/2021 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of:
• Parkinson’s disease (PD) (1.1)
• Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2) DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS
• Falling Asleep During Activities of Daily Living: Sudden onset of sleep may occur without warning; advise patients to report symptoms (5.1)
• Symptomatic Orthostatic Hypotension: Monitor during dose escalation (5.2)
• Impulse Control/Compulsive Behaviors: Patients may experience compulsive behaviors and other intense urges (5.3)
• Hallucinations and Psychotic-like Behavior: May occur; risk increases with age (5.4)
• Dyskinesia: May be caused or exacerbated by pramipexole dihydrochloride (5.5)

• , Withdrawal Symptoms (5.11) 7/2021 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of:
• Parkinson’s disease (PD) (1.1)
• Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2) DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS
• Falling Asleep During Activities of Daily Living: Sudden onset of sleep may occur without warning; advise patients to report symptoms (5.1)
• Symptomatic Orthostatic Hypotension: Monitor during dose escalation (5.2)
• Impulse Control/Compulsive Behaviors: Patients may experience compulsive behaviors and other intense urges (5.3)
• Hallucinations and Psychotic-like Behavior: May occur; risk increases with age (5.4)
• Dyskinesia: May be caused or exacerbated by pramipexole dihydrochloride (5.5)

Adverse Reactions

Most common adverse reactions (incidence >5% and greater than placebo):

To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Dopamine antagonists: May diminish the effectiveness of pramipexole (7.1)

Use In Specific Populations

Pregnancy: Based on animal data, may cause fetal harm (8.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2025