Discontinue use if patient develops signs & symptoms indicative of neuroleptic malignant syndrome (NMS) or presents w/ unexplained high fever w/o additional clinical manifestations of NMS; has been diagnosed w/ hepatitis (including hepatocellular, cholestatic or mixed liver injury). Not approved for dementia-related psychosis &/or behavioral disturbances. Not recommended in dopamine agonist-associated psychosis in patients w/ Parkinson's disease. Tardive dyskinesia. Risk of sudden cardiac death. Patients w/ prostatic hypertrophy or paralytic ileus & related conditions; low leucocyte &/or neutrophil counts for any reason, receiving medicines causing neutropenia, history of drug-induced bone marrow depression/toxicity, bone marrow depression caused by concomitant illness, RT or chemotherapy, hypereosinophilic conditions or myeloproliferative disease; prescribed w/ medicines increasing QTc interval, w/ congenital long QT syndrome, CHF, heart hypertrophy, hypokalemia or hypomagnesemia; history of seizures or those subject to factors which may lower seizure threshold. Observe for signs & symptoms of hyperglycemia (eg, polydipsia, polyuria, polyphagia & weakness) during treatment. Regularly monitor for worsening of glucose control & wt in patients w/ DM or w/ risk factors for diabetes; for lipids in accordance w/ utilized antipsychotic guidelines during treatment. Identify all possible risk factors of VTE (eg, immobilization of patients) & undertake preventive measures. Combination w/ other centrally acting medicines & alcohol. Contains aspartame which may be harmful for people w/ phenylketonuria. Gradually taper dose when discontinuing use. Patients w/ elevated ALT &/or AST, signs & symptoms of hepatic impairment, preexisting conditions associated w/ limited hepatic functional reserve & those treated w/ potentially hepatotoxic medicines. Pregnancy. Do not use during lactation. Not indicated in childn & adolescents. Not indicated for use in childn & adolescents. Periodically measure BP in elderly >65 yr.
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