(įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: ABUSE AND DEPENDENCE 1 INDICATIONS AND USAGE 1.1 Attention Deficit Hyperactivity Disorder 2 DOSAGE AND ADMINISTRATION 2.1 Important Information Prior to Initiating Treatment 2.2 Dosing Considerations for All Patients 2.3 Children 2.4 Adolescents 2.5 Adults 2.6 Dosage in Patients with Renal Impairment 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Potential for Abuse and Dependence 5.2 Serious Cardiovascular Reactions 5.3 Psychiatric Adverse Events 5.4 Long-Term Suppression of Growth 5.5 Seizures 5.6 Peripheral Vasculopathy, including Raynaud's Phenomenon 5.7 Serotonin Syndrome 5.8 Visual Disturbance 5.9 Tics 5.10 Prescribing and Dispensing 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Evaluate for tics and Tourette’s syndrome prior to stimulant administration. Visual Disturbance: Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. If it occurs, discontinue dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules and initiate supportive treatment. Serotonin Syndrome: Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Peripheral Vasculopathy, including Raynaud’s phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Seizures: May lower the convulsive threshold. Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals. Psychiatric Adverse Events: Stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis. Evaluate for bipolar disorder prior to stimulant use. ![]() Use with caution in patients for whom blood pressure increases may be problematic. Increase in Blood Pressure: Monitor blood pressure and pulse at appropriate intervals. ![]() Stimulant drugs should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. Serious Cardiovascular Reactions: Sudden death has been reported with usual doses of CNS stimulants in children and adolescents with structural cardiac abnormalities or other serious heart problems sudden death, stroke, and myocardial infarction have been reported in adults taking CNS stimulants at usual doses.
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