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普拉克索普通片说明书FDA
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DOSAGE FORMS AND STRENGTHS
MIRAPEX safely and effectively. See full prescribing information for Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg (3)
MIRAPEX.
CONTRAINDICATIONS
MIRAPEX® (pramipexole dihydrochloride) tablets, for oral use None (4)
Initial U.S. Approval: 1997
WARNINGS AND PRECAUTIONS
RECENT MAJOR CHANGES Falling asleep during activities of daily living: Sudden onset of sleep
Warnings and Precautions, Hallucinations and Psychotic-like may occur without warning; advise patients to report symptoms (5.1)
Behavior (5.4) 3/2015 Symptomatic orthostatic hypotension: Monitor during dose escalation
Warnings and Precautions, Events Reported with Dopaminergic (5.2)
Therapy (5.9) 3/2015
Impulse control/Compulsive behaviors: Patients may experience
compulsive behaviors and other intense urges (5.3)
INDICATIONS AND USAGE
MIRAPEX is a non-ergot dopamine agonist indicated for the treatment of:
Hallucinations and Psychotic-like Behavior: M
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