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:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pramipexole dihydrochloride tablets are indicated for the treatment of 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 resorption of embryos at the highest dose tested. Thi

Product summary:

Product: 50090-1331 Product: 50090-1388 NDC: 50090-1388-0 30 TABLET in a BOTTLE Product: 50090-1451 NDC: 50090-1451-0 90 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

A-S Medication Solutions
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PATIENT INFORMATION
Pramipexole Dihydrochloride (PRAM-i-PEX-ole dye-HYE-droe-KLOR-ide)
Tablets
Read this Patient Information before you start taking pramipexole
dihydrochloride and each time you get
a refill. There may be new information. This information does not take
the place of talking with your
doctor about your medical condition or your treatment.
What is pramipexole dihydrochloride?
Pramipexole dihydrochloride is a prescription medicine used to treat:
•
signs and symptoms of Parkinson's disease (PD)
It is not known if pramipexole dihydrochloride is safe and effective
in children.
What should I tell my doctor before taking pramipexole
dihydrochloride?
•
Before taking pramipexole dihydrochloride, tell your doctor if you:
•
feel sleepy during the day from a sleep problem
•
have low blood pressure, or if you feel dizzy or faint, especially
when getting up from sitting or
lying down
•
have trouble controlling your muscles (dyskinesia)
•
have kidney problems
•
drink alcohol. Alcohol can increase the chance that pramipexole
dihydrochloride will make you
feel sleepy or fall asleep when you should be awake.
•
have any other medical conditions
•
are pregnant or plan to become pregnant. It is not known if
pramipexole dihydrochloride will harm
your unborn baby.
•
are breastfeeding or plan to breastfeed. It is not known if
pramipexole dihydrochloride passes into
your breast milk. You and your doctor should decide if you will take
pramipexole dihydrochloride
or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines,
vitamins, and herbal supplements.
The combination of pramipexole dihydrochloride and other medicines may
affect each other and may
cause side effects. Pramipexole dihydrochloride may affect the way
other medicines work, and other
medicines may affect how pramipexole dihydrochloride works.
Especially tell your doctor if you take:
•
medicines called neuroleptics (pheno

Summary of Product characteristics

PRAMIPEXOLE DIHYDROCHLORIDE- PRAMIPEXOLE DIHYDROCHLORIDE TABLET
A-S MEDICATION SOLUTIONS
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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
INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist
indicated for the treatment of:
Parkinson's disease (PD) (1.1)
DOSAGE AND ADMINISTRATION
Doses should not be increased more frequently than every 5 to 7 days.
T itrate to effective dose. If used with levodopa, may
need to reduce levodopa dose
(2)
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, 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)
Events reported with dopaminergic therapy: Include hyperpyrexia and
confusion, fibrotic complications, and melanoma
(5.9)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 5% and greater than
placeb