PRAMIPEXOLE DIHYDROCHLORIDE- pramipexole dihydrochloride tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

American Health Packaging

DCI (Denominação Comum Internacional):

PRAMIPEXOLE DIHYDROCHLORIDE

Composição:

PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 2-4% 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) t

Resumo do produto:

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: Unit dose packages of 30 (5 x 6) NDC 68084-793-25 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: Unit dose packages of 100 (10 x 10) NDC 68084-440-01 Pramipexole Dihydrochloride Tablets, 0.5 mg are lavender, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with 'P' breakline '3' on one side and plain on other side and are supplied as follows: Unit dose packages of 30 (5 x 6) NDC 68084-974-25 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: Unit dose packages of 30 (5 x 6) NDC 68084-982-25 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Store in a safe place out of the reach of children.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PRAMIPEXOLE DIHYDROCHLORIDE- PRAMIPEXOLE DIHYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
----------
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, Postural Deformity ( 5.6)
5/2018
Warnings and Precautions, Rhabdomyolysis ( 5.8)
5/2018
Warnings and Precautions, Events Reported with Dopaminergic Therapy (
5.10);
Melanoma Removed
5/2018
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
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 LEG 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, 1 mg, and 1.5 mg ( 3).
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
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.
*
Dosing interval is 4 days to 7 days (14 days in patients with CrCl 20
mL/min to 60 mL/min
*
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)
Symptom