MIRAPEX ER- pramipexole dihydrochloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (International Name):

PRAMIPEXOLE DIHYDROCHLORIDE

Composition:

PRAMIPEXOLE DIHYDROCHLORIDE 0.375 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MIRAPEX ER® 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 MIRAPEX ER 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 organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. This incre

Product summary:

MIRAPEX ER tablets are available as follows: 0.375 mg: white to off-white, round, bevel-edged, extended-release tablets debossed with "ER" on one side and "0.375" on the other side. 0.75 mg: white to off-white, round, bevel-edged, extended-release tablets debossed with "ER" on one side and "0.75" on the other side. 1.5 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "1.5" on the other side. 2.25 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "2.25" on the other side. 3 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "3.0" on the other side. 3.75 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "3.75" on the other side. 4.5 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "4.5" on the other side. 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 exposure to high humidity. Store in a safe place out of the reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

MIRAPEX ER- PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIRAPEX ER SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MIRAPEX ER.
MIRAPEX ER® (PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS),
FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Warnings and Precautions,
Impulse Control/Compulsive Behaviors (5.3)
7/2021
Hallucinations and Psychotic-Like Behavior (5.4)
7/2021
Withdrawal Symptoms (5.11)
7/2021
INDICATIONS AND USAGE
MIRAPEX ER is a non-ergot dopamine agonist indicated for the treatment
of Parkinson's disease (PD) (1)
DOSAGE AND ADMINISTRATION
MIRAPEX ER tablets are taken once daily, with or without food (2.1)
Tablets must be swallowed whole and must not be chewed, crushed, or
divided (2.1)
Starting dose is 0.375 mg given once daily (2.2)
Dose may be increased gradually, not more frequently than every 5 to 7
days, first to 0.75 mg per day
and then by 0.75 mg increments up to a maximum recommended dose of 4.5
mg per day. Assess
therapeutic response and tolerability at a minimal interval of 5 days
or longer after each dose
increment (2.2)
Patients may be switched overnight from immediate-release pramipexole
tablets to MIRAPEX ER tablets
at the same daily dose. Dose adjustment may be needed in some patients
(2.3)
MIRAPEX ER tablets should be discontinued gradually (2.2)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg,
3.75 mg, and 4.5 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 closely especially during
dose escalation (5.2)
Impulse Control/Compulsive Behaviors: Patients may experience
compulsive behaviors and other
intense urges (5.3)
Hallucinations and Psychotic-like Beha