MIRAPEX- pramipexole dihydrochloride tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

pramipexole dihydrochloride (UNII: 3D867NP06J) (pramipexole - UNII:83619PEU5T)

Dostopno od:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (mednarodno ime):

pramipexole dihydrochloride

Sestava:

pramipexole dihydrochloride 0.125 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

MIRAPEX tablets are indicated for the treatment of Parkinson's disease. MIRAPEX 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 MIRAPEX 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 pregnant rats during the period of organogen

Povzetek izdelek:

MIRAPEX tablets are available as follows: 0.125 mg: white, round, tablet with “BI” on one side and “83” on the reverse side.                         Bottles of 90                         NDC 0597-0183-90                                                                              0.25 mg: white, oval, scored tablet with “BI BI” on one side and “84 84” on the reverse side.                      Bottles of 90                                     NDC 0597-0184-90                                                                                          Unit dose packages of 100          NDC 0597-0184-61                                                       0.5 mg: white, oval, scored tablet with “BI BI” on one side and “85 85” on the reverse side.                   Bottles of 90                                      NDC 0597-0185-90                                                                                         Unit dose packages of 100           NDC 0597-0185-61                                                        0.75 mg: white, oval, debossed tablet with “BI” on one side and “101” on the reverse side.                      Bottles of 90                                         NDC 0597-0101-90                                                                 1 mg: white, round, scored tablet with “BI BI” on one side and “90 90” on the reverse side.               Bottles of 90                                        NDC 0597-0190-90                                                                                      Unit dose packages of 100              NDC 0597-0190-61                                                           1.5 mg: white, round, scored tablet with “BI BI” on one side and “91 91” on the reverse side.                    Bottles of 90                                        NDC 0597-0191-90                                                                                      Unit dose packages of 100              NDC 0597-0191-61                                                      Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.

Status dovoljenje:

New Drug Application

Lastnosti izdelka

MIRAPEX- PRAMIPEXOLE DIHYDROCHLORIDE TABLET
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIRAPEX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MIRAPEX.
MIRAPEX (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
MIRAPEX is 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 5-7 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 4-7 days (14 days in patients with CrCl 20-60
mL/min)
RESTLESS LEGS SYNDROME (2.3)
TITRATION STEP
DOSE (MG) 2-3 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)
Hallucinations and Psychotic-like Behavior: May occur; risk increases
with age (5.4)
Dyskinesia: Ma