VyvanseÂ® (lisdexamfetamine Dimesylate) Capsules, (CII) Now Approved In The US For Maintenance Treatment In Children And Adolescents With ADHD
Vyvanse is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of Vyvanse in the treatment of ADHD was established on the basis of three short-term controlled trials in children ages 6 to 12 years, one short-term controlled trial in adolescents ages 13 to 17 years, one short-term trial in children and adolescents ages 6-17 years, one maintenance trial in children and adolescents ages 6-17 years, two short-term controlled trials in adults, and one maintenance trial in adults.
IMPORTANT SAFETY INFORMATION
- Known hypersensitivity to amphetamines or other ingredients in Vyvanse. Anaphylactic reactions, Stevens - Johnson syndrome, angioedema, and urticaria have been observed in postmarketing reports.
- Concurrent administration of monoamine oxidase inhibitors (MAOI) or administration of Vyvanse within 14 days of the last MAOI dose. Hypertensive crisis can occur.
- Educate patients about abuse and periodically re-evaluate the need for Vyvanse.
- Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Prior to treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Vyvanse treatment.
- CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
- Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychosis. Clinical evaluation for bipolar disorder is recommended prior to stimulant use.
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor weight and height in children during treatment with Vyvanse. Treatment may need to be interrupted in children not growing as expected.
- The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials were:
- Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth and dizziness;
- Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
- Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety and anorexia.
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