Discontinue treatment in case of clinical manifestations of NMS or presence of high fever w/o clinical manifestations of NMS; hepatitis. Monitor regularly for worsening of glucose control in patients w/ established diagnosis of DM; for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, & weakness. Reports of acute symptoms eg, sweating, insomnia, tremor, anxiety, nausea, or vomiting when treatment is stopped abruptly (very rare); hepatitis (rare); cholestatic or mixed liver injury (very rare); seizures (rare). Caution in patients w/ prostatic hypertrophy, or paralytic ileus & related conditions; w/ elevated ALT &/or AST, w/ signs & symptoms of hepatic impairment, w/ preexisting conditions associated w/ limited hepatic functional reserve, & who are being treated w/ potentially hepatotoxic drugs; w/ low leukocyte &/or neutrophil counts for any reason, w/ history of drug-induced bone marrow depression/toxicity, those receiving medicines known to cause neutropenia in patients w/ bone marrow depression caused by concomitant illness, RT or chemotherapy, & w/ hypereosinophilic conditions or w/ myeloproliferative disease; who have history of seizures or are subject to factors which may lower seizure threshold. Not recommended in treatment of dopamine agonist associated psychosis in patients w/ Parkinson's disease. Occasionally, transient, asymptomatic elevations of hepatic transaminases, ALT, AST especially in early treatment. Patients w/ risk factors for DM (eg, obesity, family history of diabetes) who are starting treatment should undergo fasting blood glucose testing at baseline & periodically during treatment. Gradually reduce dose when discontinuing treatment. Consider follow-up & dose reduction in the event of elevated ALT &/or AST during treatment. Limited data on co-medication w/ lithium & valproate. No clinical data on co-therapy w/ carbamazepine. Caution in combination w/ other centrally acting drugs & alcohol. May antagonize effects of direct & indirect dopamine agonists. May affect performance of skilled tasks eg, driving. Should be used in pregnancy only if the potential benefit justifies the potential risk to fetus. Very rare spontaneous reports of tremor, hypertonia, lethargy & sleepiness in infants born to mothers treated during 3rd trimester. Do not breastfeed during treatment. Increased risk of stroke & all-cause mortality in elderly patients w/ dementia-related psychosis; risk should be considered relevant to any patient w/ history of stroke or transient ischemic attack or other risk factors for cerebrovascular disease including HTN, diabetes, current smoking or atrial fibrillation. Periodically measure BP in patients >65 yr.