Reports of somnolence & episodes of sudden onset of sleep while engaging in daily living activities. Consider dose reduction or treatment discontinuation if patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (eg, driving, conversation, eating); if treatment is continued, patients should avoid driving & other potentially dangerous activities. Caution in patients w/ history or evidence of significant CV disease [eg, MI, unstable angina, cardiac decompensation & arrhythmias, vaso-occlusive disease (including cerebral) or cardiomyopathy] or those w/ severe CV disease. Carefully monitor for signs & symptoms of orthostatic hypotension, especially during dose initiation/escalation & in patients at risk of hypotension, those receiving antihypertensives & antiarrhythmics, those who poorly tolerate transient hypotensive episodes, & those w/ severe CV disease, particularly coronary insufficiency. Reports of syncope, sometimes associated w/ bradycardia. Increased incidence of elevations of systolic &/or diastolic BP &/or change in pulse. Reports of possible fibrotic complications (ie, pleural effusion & fibrosis, ILD, & cardiac valvulopathy); closely monitor for signs & symptoms of fibrosis. Reports of a symptom complex resembling NMS w/ no other obvious etiology w/ significant reduction in, or abrupt w/drawal after long-term use. May cause or exacerbate pre-existing dyskinesia. Regularly monitor for development of impulse control disorders & consider dose reduction or tapered discontinuation if patient develops such compulsive behaviors. New or worsening mental status & behavioral changes, which may be severe, including psychotic-like behavior, during initiation of treatment or after increasing dose. May exacerbate psychosis. Only use in patients w/ a history or presence of major psychotic disorder if potential benefits outweigh risks. Hallucinations may occur during treatment. Frequently & regularly monitor for melanomas during treatment; periodically perform skin exam. Do not abruptly discontinue treatment. Concomitant use w/ neuroleptics (eg, phenothiazines, butyrophenones, thioxanthenes) or other centrally-active dopamine antagonists (eg, metoclopramide, sulpiride) is not recommended. May affect ability to drive & use machines. Not recommended in childn <18 yr. Caution in the elderly.
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