Pramipexole 1 mg Immediate Release Tablets — Generic For Mirapex — Rising Pharma

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

Indications And Usage

Pramipexole dihydrochloride is 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

Parkinson’s Disease-Impaired Renal Function (2.2)

Creatinine ClearanceStarting Dose (mg)Maximum Dose (mg)

<15 mL/min and hemodialysis patients

Data not available

>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

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

• 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)
• Postural Deformity: Consider reducing the dose or discontinuing pramipexole dihydrochloride if postural deformity occurs (5.6)

• 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)
• Postural Deformity: Consider reducing the dose or discontinuing pramipexole dihydrochloride if postural deformity occurs (5.6)

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)

Postural Deformity: Consider reducing the dose or discontinuing pramipexole dihydrochloride if postural deformity occurs (5.6)

Adverse Reactions

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

Early PD without levodopa: nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations (6.1)

Advanced PD with levodopa: postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation, asthenia, somnolence, dystonia, gait abnormality, hypertonia, dry mouth, amnesia, and urinary frequency (6.1)

RLS: nausea, somnolence, fatigue, and headache (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 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: 12/2025