PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

AvKARE, Inc.

INN (Tarptautinis Pavadinimas):

PRAMIPEXOLE DIHYDROCHLORIDE

Sudėtis:

PRAMIPEXOLE DIHYDROCHLORIDE 0.75 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE- PRAMIPEXOLE TABLET,
EXTENDED
RELEASE
PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE- PRAMIPEXOLE TABLET,
EXTENDED RELEASE
AVKARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAMIPEXOLE DIHYDROCHLORIDE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PRAMIPEXOLE
DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS.
PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Pramipexole dihydrochloride extended-release tablets are a non-ergot
dopamine agonist indicated for the treatment of
Parkinson’s disease (PD) ( 1)
DOSAGE AND ADMINISTRATION
Pramipexole Dihydrochloride Extended-Release 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 pramipexole dihydrochloride
extended-release tablets at the same daily dose. Dose adjustment may
be needed in some patients ( 2.3)
Pramipexole dihydrochloride extended-release 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 escal