warnings and cautions
5 WARNINGS AND PRECAUTIONS Falling Asleep During Activities of Daily Living and Somnolence: Advise patients prior to treatment; ordinarily discontinue if occurs ( 5.1 ) Suicidality and Depression: Monitor patients for depressed mood, depression, or suicidal ideation or behavior ( 5.2 ) Hallucinations/Psychotic Behavior: Patients with major psychotic disorder should ordinarily not be treated with OSMOLEX ER; observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases ( 5.3 ) Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting OSMOLEX ER or increasing the dose ( 5.4 ) Withdrawal-Emergent Hyperpyrexia and Confusion: Avoid sudden discontinuation ( 5.5 ) Impulse Control/Compulsive Behaviors: Ask patients about increased gambling urges, sexual urges, uncontrolled spending or other urges; consider dose reduction or discontinuation if occurs ( 5.6 ) 5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients treated with amantadine have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. Patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event. Before initiating treatment with OSMOLEX ER, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with OSMOLEX ER, such as concomitant sedating medications, alcohol, or the presence of a sleep disorder. If a patient develops daytime sleepiness or episodes of falling asleep during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), OSMOLEX ER should ordinarily be discontinued. If a decision is made to continue OSMOLEX ER, advise patients not to drive and to avoid other potentially dangerous activities that might result in harm if they become somnolent. There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living or daytime somnolence. 5.2 Suicidality and Depression Suicide, suicide attempts, and suicidal ideation have been reported in patients with and without prior history of psychiatric illness while treated with amantadine. Amantadine can exacerbate psychiatric symptoms in patients with a history of psychiatric disorders or substance abuse. Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with OSMOLEX ER in patients with a history of suicidality or depression. 5.3 Hallucination/Psychotic Behavior Patients with a major psychotic disorder should ordinarily not be treated with OSMOLEX ER because of the risk of exacerbating psychosis. Treatment with amantadine or abrupt withdrawal can cause confusion, psychosis, personality changes, agitation, aggressive behavior, hallucinations, paranoia, other psychotic or paranoia reactions [see Warnings and Precautions ( 5.5 )] . Monitor patients for hallucinations throughout treatment but especially after initiation and after the dose of OSMOLEX ER is increased or decreased. 5.4 Dizziness and Orthostatic Hypotension Dizziness and orthostatic hypotension can occur with OSMOLEX ER. Patients should be monitored for these adverse reactions, especially after starting OSMOLEX ER or increasing the dose. Concomitant use of alcohol when using OSMOLEX ER is not recommended [see Drug Interactions ( 7.4 )]. 5.5 Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex resembling neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in drugs that increase central dopaminergic tone. Abrupt discontinuation of OSMOLEX ER may cause an increase in the symptoms of Parkinson’s disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. It is recommended to avoid sudden discontinuation of OSMOLEX ER [see Dosage and Administration ( 2.4 )]. 5.6 Impulse Control/Compulsive Behaviors Patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, including OSMOLEX ER. In some cases, these urges were reported to have stopped when the dose was reduced or the medication was stopped. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with OSMOLEX ER. Consider dose reduction or stopping the medication if a patient develops such urges while taking OSMOLEX ER.