PRAMIPEXOLE DIHYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)

Available from:

Macleods Pharmaceuticals Limited

INN (International Name):

PRAMIPEXOLE DIHYDROCHLORIDE

Composition:

PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pramipexole dihydrochloride tablets are indicated for the treatment Parkinson's disease. Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).  None. Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride in pregnant women. No adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. Effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see Data]. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of pramipexole (0.1,

Product summary:

Pramipexole dihydrochloride tablets are available as follows: 0.125 mg: White coloured, circular, flat, beveled edged uncoated tablet debossed 'CL' on one side of the tablet and '2' on the other side. Bottles of 90's                               NDC 33342-031-10 Bottles of 500's                             NDC 33342-031-15 Unit dose blister Pack of 30's         NDC 33342-031-06 Unit dose blister pack of 100's       NDC 33342-031-12 0.25 mg: White coloured, oval shaped, uncoated tablet with 'CL' and '3' debossed on one side of the tablet with breakline separating 'CL' and '3' and having a breakline on the other side. Bottles of 90's                                NDC 33342-032-10 Bottles of 500's                              NDC 33342-032-15 Unit dose blister pack of 30's          NDC 33342-032-06 Unit dose blister pack of 100's        NDC 33342-032-12 0.5 mg: White coloured, oval shaped, uncoated tablet with 'CL' and '4' debossed on one side of the tablet with breakline separating 'CL' and '4' and having a breakline on the other side. Bottles of 90's                             NDC 33342-033-10 Bottles of 500's                           NDC 33342-033-15 Unit dose blister pack of 30's       NDC 33342-033-06 Unit dose blister pack 100's         NDC 33342-033-12 1 mg: White coloured, flat, circular, beveled edged uncoated tablet with 'CL' and '5' debossed on one side of the tablet with breakline separating 'CL' and '5' and having a breakline on the other side. Bottles of 90's                               NDC 33342-034-10 Bottles of 500's                             NDC 33342-034-15 Unit dose blister pack of 30's         NDC 33342-034-06 Unit dose blister pack of 100s        NDC 33342-034-12 1.5 mg: White coloured, flat, circular, beveled edged uncoated tablet with 'CL' and '6' debossed on one side of the tablet with breakline separating 'CL' and '6' and having a breakline on the other side. Bottles of 90's                               NDC 33342-035-10 Bottles of 500's                             NDC 33342-035-15 Unit dose blister pack of 30's         NDC 33342-035-06 Unit dose blister pack of 100's       NDC 33342-035-12 Store pramipexole dihydrochloride tablet at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAMIPEXOLE DIHYDROCHLORIDE - PRAMIPEXOLE DIHYDROCHLORIDE TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAMIPEXOLE DIHYDROCHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PRAMIPEXOLE DIHYDROCHLORIDE.
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Warnings and Precautions,
Impulse Control/Compulsive Behaviors (5.3) 4/2020
Warnings and Precautions,
Hallucinations and Psychotic-like Behavior (5.4) 4/2020
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 5-7 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) 2-3 HOURS BEFORE BEDTIME
1
0.125
2 (if needed)
0.25
3 (if needed)
0.5
* Dosing interval is 4-7 days (14 days in patients with CrCl 20-60
mL/min)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.125 mg, 0.25 mg, 0.5 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 B