PRAMIPEXOLE DIHYDROCHLORIDE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Zydus Pharmaceuticals USA Inc.

INN (Alþjóðlegt nafn):

PRAMIPEXOLE DIHYDROCHLORIDE

Samsetning:

PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Pramipexole dihydrochloride tablets are indicated for the treatment of 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 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, 0.5, or 1.5 mg/kg/day) to pregna

Vörulýsing:

Pramipexole Dihydrochloride Tablets, 0.125 mg are pink color, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with 'P1'on one side and plain on other side and are supplied are as follows: NDC 68382-196-16 in bottle of 90 tablets NDC 68382-196-05 in bottle of 500 tablets NDC 68382-196-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 0.25 mg are pale blue color, round, flat, beveled-edged, uncoated tablets debossed with 'P2'on one side and break line on other side and are supplied as follows: NDC 68382-197-16 in bottle of 90 tablets NDC 68382-197-05 in bottle of 500 tablets NDC 68382-197-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 0.5 mg are lavender, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with 'P' break line '3' on one side and plain on other side and are supplied as follows: NDC 68382-198-16 in bottle of 90 tablets NDC 68382-198-05 in bottle of 500 tablets NDC 68382-198-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 0.75 mg are light peach color capsule shaped, flat, beveled-edged, uncoated tablets debossed with '440' on one side and plain on other side and are supplied as follows: NDC 68382-440-16 in bottle of 90 tablets NDC 68382-440-05 in bottle of 500 tablets NDC 68382-440-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 1 mg are light peach to peach, round, flat, beveled-edged, uncoated tablets debossed with 'P4'on one side and break line on other side and are supplied as follows: NDC 68382-199-16 in bottle of 90 tablets NDC 68382-199-05 in bottle of 500 tablets NDC 68382-199-10 in bottle of 1000 tablets Pramipexole Dihydrochloride Tablets, 1.5 mg are yellow color, round, flat, beveled- edged, uncoated tablets debossed with 'P5'on one side and break line on other side and are supplied as follows: NDC 68382-200-16 in bottle of 90 tablets NDC 68382-200-05 in bottle of 500 tablets NDC 68382-200-10 in bottle of 1000 tablets Storage:                      Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container. Store in a safe place out of the reach of children.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Zydus Pharmaceuticals USA Inc.
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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 tablets 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 tablet?
Pramipexole dihydrochloride tablet is a prescription medicine used to
treat:
•
signs and symptoms of Parkinson's disease (PD)
•
moderate to severe primary Restless Legs Syndrome (RLS)
It is not known if pramipexole dihydrochloride tablets are safe and
effective in children.
What should I tell my doctor before taking pramipexole dihydrochloride
tablets?
•
Before taking pramipexole dihydrochloride tablets, tell your doctor if
you:
•
$$Unorderedlist
•
feel sleepy during the day from a sleep problem other than Restless
Legs Syndrome
•
have low blood pressure, or if you feel dizzy or faint, especially
when getting up from sitting or
lying down
•
have trouble controlling your muscles (dyskinesia)
•
have kidney problems
•
drink alcohol. Alcohol can increase the chance that pramipexole
dihydrochloride tablets will make
you feel sleepy or fall asleep when you should be awake.
•
have any other medical conditions
•
are pregnant or plan to become pregnant. It is not known if
pramipexole dihydrochloride tablets will
harm your unborn baby.
•
are breastfeeding or plan to breastfeed. It is not known if
pramipexole passes into your breast milk.
You and your doctor should decide if you will take pramipexole
dihydrochloride tablets or breastfeed.
You should not do both.
•
$$EndUnorderedlist
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines,
vitamins, and herbal supplements.
The combination of pramipexole dihydrochloride tablets and other
medicines may affect each other and may
cause side effects. Pramipexol

Vara einkenni

PRAMIPEXOLE DIHYDROCHLORIDE - PRAMIPEXOLE DIHYDROCHLORIDE TABLET
ZYDUS PHARMACEUTICALS USA INC.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Withdrawal Symptoms (5.11)
7/2021
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
Doses should not be increased more frequently than every 5 to 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
Dosing interval is 4 days to 7 days (14 days in patients with CrCl 20
mL/min to 60 mL/min
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)
Halluc