Dextroamphetamine Sulfate (Zenzedi) Risks, Warnings, and Complications

POTENTIAL FOR ABUSE AND ADDICTION: Dextroamphetamine sulfate is a federally controlled substance with a high potential for drug abuse, misuse, drug dependence, and addiction. This medication can be habit-forming and carries the risk of developing a substance use disorder and addiction. Some people abuse prescription medicines and may use amphetamines for non-medical uses or sell or distribute these drugs illegally. Misuse and abuse of CNS stimulants such as dextroamphetamine sulfate is associated with a high risk of overdose and death. 

Before prescribing dextroamphetamine sulfate, your doctor will ask about a personal or family history of substance use disorders (abuse, misuse, and addiction to alcohol, prescription medicines, or street drugs). 

Do not take a higher dose or more frequent doses of dextroamphetamine sulfate than prescribed. Never obtain the drug from illegal sources or share your prescribed medication with others. Do not use the drug in unapproved ways, such as snorting or injecting it. Store dextroamphetamine sulfate in a safe place, preferably under lock. 

RISK IN PATIENTS WITH HEART DISEASE: There are reports of sudden death in people with severe heart disease, such as structural cardiac abnormalities, after treatment with CNS stimulants such as dextroamphetamine sulfate at recommended dosages for ADHD treatment.

Tell your doctor if you have a history of heart problems, including structural abnormalities, cardiomyopathy, cardiac arrhythmias, coronary artery disease, or other serious forms of heart disease. 

Seek emergency medical care for symptoms of serious cardiovascular adverse events such as chest pain, chest pressure, or difficulty breathing during dextroamphetamine sulfate treatment.

INCREASED BLOOD PRESSURE AND HEART RATE: Taking stimulant medications, including dextroamphetamine sulfate, can lead to an increase in blood pressure and heart rate. Your doctor will monitor your or your child’s blood pressure and heart rate while on this medication.

ADVERSE PSYCHIATRIC REACTIONS: CNS stimulants can cause worsening mental symptoms in people with pre-existing psychotic disorders. In addition to psychotic symptoms, these drugs can also cause worse bipolar illness. They may trigger manic or mixed episodes in people with bipolar disorder. 

Taking dextroamphetamine sulfate at the recommended doses can cause new psychotic or manic symptoms in some people. These may include delusions, paranoia, hallucinations, or mania. You may need to discontinue treatment with dextroamphetamine sulfate if these mental and behavioral effects occur.

Given that amphetamines produce mental symptoms, it is important that prior to starting dextroamphetamine sulfate treatment, you tell your doctor about any personal or family history of bipolar illness, depression, psychosis, or suicide attempts. 

LONG-TERM SUPPRESSION OF GROWTH IN CHILDREN: Dextroamphetamine sulfate is a stimulant prescription medicine that can cause weight loss and slow growth in children. Your child’s healthcare provider will monitor growth (height and weight) carefully during treatment with this drug. They may advise discontinuing treatment if your child is not gaining weight or height as expected for age.

SEIZURES: Amphetamine CNS stimulation can lower the seizure threshold in people with a history of seizure disorders or abnormal EEG (abnormal brain wave test). Very rarely, this can also happen in people with no prior history of seizures or EEG abnormalities. You will need to stop treatment with dextroamphetamine sulfate if you develop seizures. 

PERIPHERAL VASCULAR DISEASE: Dextroamphetamine sulfate tablets, USP, can cause peripheral vasculopathy (circulation problems), including Raynaud's phenomenon. Call your doctor without delay if you develop pale or blue fingers or toes or unexplained wounds on your fingers or toes. These symptoms usually improve after the dose is reduced or the drug is discontinued. 

SEROTONIN SYNDROME: People receiving dextroamphetamine sulfate can develop a potentially life-threatening condition called serotonin syndrome. Serotonin syndrome occurs due to too much serotonin, a natural chemical in the brain. Risk factors include concomitant serotonergic drug use. Taking certain other drugs such as monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), triptans, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John's Wort can increase the risk of serotonin syndrome. 

Give your doctor a complete list of your medications before starting treatment. Seek emergency medical care if you develop signs and symptoms of serotonin syndrome, such as mental status changes (agitation, confusion, delirium, hallucinations, or loss of consciousness), fast heartbeat, changes in blood pressure, sweating, flushing, dizziness, fever, tremors, muscle rigidity, muscle twitching, incoordination, convulsions, nausea, vomiting, or diarrhea. Discontinuation of dextroamphetamine sulfate and concomitant serotonergic agents immediately is necessary if this serious complication develops.

TICS: Dextroamphetamine sulfate and other CNS stimulants can cause motor and verbal tics and worsening symptoms in people with Tourette's syndrome. Tell your healthcare provider if there is a personal or family history of tics or Tourette's syndrome before starting dextroamphetamine sulfate