PRAMIPEXOLE - pramipexole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

INN (International Name):

PRAMIPEXOLE DIHYDROCHLORIDE

Composition:

PRAMIPEXOLE DIHYDROCHLORIDE 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. None. Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole 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 2-4% and 15-20%, 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, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total

Product summary:

Product: 50090-3009 NDC: 50090-3009-0 30 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAMIPEXOLE - PRAMIPEXOLE TABLET
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS
RX ONLY
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
TABLE TS.
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
PRAMIPEXOLE DIHYDROCHLORIDE tablets is a non-ergot dopamine agonist
indicated for the treatment of
• the signs and symptoms of idiopathic Parkinson's disease (PD)
(1.1)
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 CLEARANCESTARTING 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 (functional scored tablets), 0.5 mg
(functional scored tablets), 0.75 mg, 1 mg (functional scored
tablets), and 1.5 mg (functional scored tablets) (3).
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
• Falling asleep during activities of daily living: Sudden onset of
sleep may occur without warning. Advise patients to report
symptoms to the prescriber. (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: May occur. Risk increases with age. (5.4)
• Dyskinesia: May be caused or exacerbated by PRAMIPEXOLE
DIHYDROCHLORIDE