Zenzedi (dextroamphetamine sulfate tablets, USP) is a prescription medicine for the treatment of Narcolepsy. Zenzedi is also indicated as a treatment for ADHD in pediatric patients ages 3 to 16 years as an integral part of a total treatment program for ADHD that may include counseling or other therapies.
IMPORTANT SAFETY INFORMATION
Zenzedi (dextroamphetamine sulfate tablets, USP) is a federally controlled substance (CII) with a
high risk of abuse or dependence. Prolonged use may lead to drug dependence and must be avoided.
Subjects may obtain Zenzedi for non-therapeutic use or distribution to others, and it should be
prescribed or dispensed sparingly.
Misuse of Zenzedi may cause sudden death and serious cardiovascular adverse events.
Zenzedi is contraindicated in patients:
- with a history of advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma
- that are tense or agitated
- with a history of drug abuse
- taking or who have taken monoamine oxidase inhibitor (MAOI) within 14 days.
Hypertensive crises may result.
Warnings and Precautions
Sudden death has been reported in children and adolescents with structural cardiac abnormalities or other serious heart problems in association with CNS stimulant treatment at usual doses. Sudden death, stroke and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant medications can cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). All patients should be monitored for larger changes in heart rate and blood pressure.
Children, adolescents, or adults being considered for treatment with Zenzedi should have a careful assessment of family history of sudden death or ventricular arrhythmia and a physical exam to assess for the presence of cardiac disease.
Patients developing any signs of heart problems such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease while taking Zenzedi should undergo a prompt evaluation.
Stimulants may exacerbate symptoms in patients with pre-existing psychotic disorder or in patients with new or worsening bipolar disorder. Treatment emergent psychotic or manic symptoms can occur in children or adolescents such as hallucinations, delusional thinking, or mania. Aggressive behavior or hostility is also often observed in children and adolescents taking medications for ADHD and should be monitored for the appearance of, or worsening of aggressive behavior or hostility.
Stimulants have been associated with long-term suppression of growth in pediatric patients. Growth should be monitored during treatment with Zenzedi, and patients not growing or gaining height or weight as expected may need treatment interrupted.
Stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as MAOIs, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort. See DRUG INTERACTIONS in the prescribing information for all Zenzedi interactions. The potential for a pharmacokinetic interaction exists with the co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to Zenzedi. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6.
Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular symptoms, seizures, and/or gastrointestinal symptoms. Concomitant use of Zenzedi with MAOI drugs is contraindicated. Discontinue treatment with Zenzedi and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of Zenzedi with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Zenzedi with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
The most common side effects reported with Zenzedi treatment include palpitations, tachycardia, hypertension, cardiomyopathy (chronic use), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome, dry mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances, anorexia and weight loss, urticaria and impotence, changes in libido, frequent or prolonged erections, and rhabdomyolysis.
For additional safety information, please see accompanying full Prescribing Information for Zenzedi.
You are encouraged to report side effects of prescription drugs to Azurity Pharmaceuticals, Inc.
at 1-800-461-7449 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
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