OSMOLEX ERTM is indicated for the treatment of Parkinson's disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.
OSMOLEX ER (amantadine) extended-release tablets, is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2.
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. 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.
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. 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.
Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with OSMOLEX ER because of the risk of exacerbating psychosis. Monitor patients for hallucinations throughout treatment but especially after initiation and after the dose of OSMOLEX ER is increased or decreased.
Dizziness and Orthostatic Hypotension: Patients should be monitored for these adverse reactions, especially after starting OSMOLEX ER or increasing the dose.
Withdrawal-Emergent Hyperpyrexia and Confusion: 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.
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. It is important for prescribers to specifically ask patients or their caregivers about the development of new or increased urges while being treated with OSMOLEX ER. Consider dose reduction or stopping the medication if a patient develops such urges while taking OSMOLEX ER.
The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.
Other Anticholinergic Drugs: The dose of anticholinergic drugs or of OSMOLEX ER should be reduced if atropine-like effects appear when these drugs are used concurrently
Drugs Affecting Urinary pH: The pH of the urine has been reported to influence the excretion rate of amantadine. Alterations of urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse reactions. Monitor for efficacy or adverse reactions under conditions that alter the urine pH to more acidic or alkaline, respectively.
Live Attenuated Influenza Vaccines: Amantadine may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live vaccines are not recommended during treatment with OSMOLEX ER. Inactivated influenza vaccines may be used, as appropriate.
Alcohol: Concomitant use with alcohol is not recommended, as it may increase the potential for central nervous system effects such as somnolence, dizziness, confusion, lightheadedness, and orthostatic hypotension.
Please click here for Full Prescribing Information.