PRAMIPEXOLE DIHYDROCHLORIDE- 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:

Sandoz Inc

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 of Parkinson's disease. None. Pregnancy: Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Pramipexole dihydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When pramipexole was given to female rats throughout pregnancy, implantation was inhibited at a dose of 2.5 mg/kg/day (5 times the maximum recommended human dose (MRHD) for Parkinson’s disease of 4.5 mg/day on a body surface area (mg/m2 ) basis). Administration of 1.5 mg/kg/day of pramipexole to pregnant rats during the period of organogenesis (gestation days 7 through 16) resulted in a high incidence of total resorption of embryos. The plasma AUC in rats at this dose was 4 times the AUC in humans at the MRHD. These findings are thought to be due to the prolactin-lowering effect of pramipexole, since prolactin is necessary for implantation and maintenance

Product summary:

Pramipexole dihydrochloride tablets are available as follows: 0.125 mg, white to off-white, uncoated, round shaped tablets, one side debossed with ‘SZ’ and other side debossed with ‘173’. NDC 0781-5248-92, bottle of 90 tablets NDC 0781-5248-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 0.25 mg, white to off-white, uncoated, oval shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side debossed with ‘17’& ‘4’ on either side of scoreline. NDC 0781-5249-31, bottle of 30 tablets NDC 0781-5249-60, bottle of 60 tablets NDC 0781-5249-92, bottle of 90 tablets NDC 0781-5249-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 0.5 mg, white to off-white, uncoated, oval shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side debossed with ‘17’ & ‘5’ on either side of scoreline. NDC 0781-5250-31, bottle of 30 tablets NDC 0781-5250-60, bottle of 60 tablets NDC 0781-5250-92, bottle of 90 tablets NDC 0781-5250-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 0.75 mg, white to off-white, uncoated, oval shaped tablets, one side debossed with ‘SZ’ and other side debossed with ‘178’. NDC 0781-5281-31, bottle of 30 tablets NDC 0781-5281-60, bottle of 60 tablets NDC 0781-5281-92, bottle of 90 tablets NDC 0781-5281-13, in unit-of-use pack of 100 tablets (10 blister card, containing 10 tablets) 1 mg, white to off-white, uncoated, round shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side side debossed with ‘17’ & ‘6’ on either side of scoreline. NDC 0781-5251-31, bottle of 30 tablets NDC 0781-5251-60, bottle of 60 tablets NDC 0781-5251-92, bottle of 90 tablets NDC 0781-5251-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 1.5 mg, white of off-white, uncoated, round shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side debossed with ‘17’ & ‘7’ on either side of scoreline. NDC 0781-5252-31, bottle of 30 tablets NDC 0781-5252-60, bottle of 60 tablets NDC 0781-5252-92, bottle of 90 tablets NDC 0781-5252-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) Store at 20º to 25ºC (68º to 77ºF) [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
SANDOZ INC
----------
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
TABLETS .
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Warning and Precautions, Hallucinations and Psychotic-like Behavior
(5.4) 03/2015
Warning and Precautions, Events Reported with Dopaminergic Therapy
(5.9) 03/2015
INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets are non-ergot dopamine agonist
indicated for the treatment of:
•
DOSAGE AND ADMINISTRATION
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-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
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
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence >5% and greater than
placebo):
Parkinson’s disease (PD) (1.1)
*
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.