Amphetamine Sulfate (AMPHETAMINE SULFATE) Warn…

Amphetamine Sulfate (AMPHETAMINE SULFATE)

Warnings

Abuse, Misuse, and Addiction

Amphetamine sulfate tablets have a high potential for abuse and misuse. The use of amphetamine sulfate tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Amphetamine sulfate can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including amphetamine sulfate tablets, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing amphetamine sulfate tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give amphetamine sulfate tablets to anyone else. Throughout amphetamine sulfate tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Risks to Patients with Serious Cardiac Disease

Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who are treated with CNS stimulants at the recommended ADHD dosages. Avoid amphetamine sulfate tablets use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

Increased Blood Pressure and Heart Rate

CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.

Psychiatric Adverse Reactions

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

Induction of a Manic Episode in Patients with Bipolar Disorder: CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating amphetamine sulfate tablets, screen patients for risk factors for developing a manic episode.

New Psychotic or Manic Symptoms: CNS stimulants, at recommended doses, may cause psychotic or manic symptoms in patients without a prior history of psychotic illness or mania.

Long-Term Suppression of Growth in Pediatric Patients

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in amphetamine sulfate tablets-treated pediatric patients treated with CNS stimulants.

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures. In the presence of seizures, the drug should be discontinued.

Peripheral Vasculopathy, Including Raynaud’s Phenomenon

Stimulants, including amphetamine sulfate tablets, 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.

Serotonin Syndrome

Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems. Concomitant use of amphetamine sulfate tablets with MAOI drugs is contraindicated. Discontinue treatment with amphetamine sulfate tablets and any concomitant serotonergic agents immediately if symptoms of serotonin syndrome occur.

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

CNS stimulants, including amphetamine sulfate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported.

FAQs

Q: What are the risks associated with amphetamine sulfate tablets?

A: Amphetamine sulfate tablets have a high potential for abuse and misuse, can cause exacerbation of pre-existing psychosis, induce a manic episode in patients with bipolar disorder, and may lower the convulsive threshold in patients with prior history of seizures. They are also associated with peripheral vasculopathy, including Raynaud’s phenomenon, and may lead to the onset or exacerbation of motor and verbal tics.

Q: How should amphetamine sulfate tablets be stored?

A: Patients should store amphetamine sulfate tablets in a safe place, preferably locked, and should not give the tablets to anyone else. Proper disposal of any unused drug is also advised.

Q: What should patients do if they experience symptoms of serotonin syndrome while taking amphetamine sulfate tablets?

A: Patients should discontinue treatment with amphetamine sulfate tablets and any concomitant serotonergic agents immediately if symptoms of serotonin syndrome occur, and seek medical attention.

Disclaimer: This content is for informational purposes only and should not be considered medical advice. Always consult with a healthcare professional before making any decisions about your health or medication.