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Signs and symptoms are usually intermittent and mild very rare sequelae include digital ulceration and/or soft tissue breakdown. Mydayis is not approved in pediatric patients ≤12 years.ĬNS stimulants are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Treatment may need to be interrupted in patients not growing or gaining weight as expected. Discontinue if symptoms occur.ĬNS stimulants are associated with weight loss and slowing of growth rate in pediatric patients (monitor weight and height). New Psychotic or Manic Symptoms : At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). Induction of a Manic Episode in Patients with Bipolar Disorder : May induce a mixed/manic episode in patients with bipolar disorder.

Exacerbation of Pre-existing Psychosis : May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Monitor for tachycardia and hypertension. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Mydayis treatment.ĬNS stimulants cause increased blood pressure (mean increase ~2-4 mm Hg) and heart rate (mean increase ~3-6 bpm). Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses.

Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of last MAOI dose, due to increased risk of hypertensive crisis.Īvoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems.

Angioedema and anaphylactic reactions have been reported with other amphetamines. Known hypersensitivity to amphetamines or other ingredients of Mydayis. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. CNS stimulants, including Mydayis, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence.