Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed. Careful observation for digital changes is necessary during treatment with ADHD stimulants.Ĭases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Signs and symptoms are usually intermittent and mild very rare sequelae include digital ulceration and/or soft tissue breakdown. Treatment may need to be interrupted in children not growing or gaining weight as expected.ĬNS stimulants are associated with peripheral vasculopathy, including Raynaud’s phenomenon. If such symptoms occur, consider discontinuing DYANAVEL XR, Quillivant XR, or QuilliChew ER.ĬNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD monitor weight and height during treatment with DYANAVEL XR, Quillivant XR, and QuilliChew ER. At recommended doses, stimulants may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania, in patients without prior history of psychotic illness or mania. Assess for presence of bipolar disorder prior to initiating treatment. They may induce a mixed/manic episode in patients with bipolar disorder. Monitor all patients for tachycardia and hypertension.ĬNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with DYANAVEL XR, Quillivant XR, and QuilliChew ER.ĬNS stimulants cause increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious cardiac problems when taking CNS stimulants at recommended doses for ADHD. Sudden death, stroke, and myocardial infarction have been reported in adults treated with CNS stimulants at recommended doses.

In patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs, because of risk of hypertensive crisis.Īvoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, and other serious cardiac problems. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported. In patients known to be hypersensitive to amphetamine, methylphenidate, or other components of DYANAVEL XR, Quillivant XR, and QuilliChew ER. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.ĭYANAVEL XR (amphetamine), Quillivant XR (methylphenidate HCI), and QuilliChew ER (methylphenidate HCI) are contraindicated: CNS stimulants, including DYANAVEL XR, Quillivant XR, QuilliChew ER, and other amphetamine-containing or methylphenidate-containing products, have a high potential for abuse and dependence.

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