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Amphetamine Extended-Release

Also known as: Dyanavel

Central Nervous System Stimulant

Route: Oral

Check Amphetamine Extended-Release Interactions →

3 interactions on record⛔ Black Box Warning

Amphetamine Extended-Release has 3 known drug interactions based on U.S. FDA drug labeling data. Of these, 1 are contraindicated combinations that should be avoided entirely. 1 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Mao Inhibitors, Alkalinizing Agents, Acidifying Agents. Patients taking Amphetamine Extended-Release should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Contraindicated: 1
Major: 1
Moderate: 1

Contraindicated (1)

Amphetamine Extended-Release + Mao Inhibitors— MAOI antidepressants slow amphetamine metabolism, increasing norepinephrine release and risk of hypertensive crisis, tox…

Major (1)

Amphetamine Extended-Release + Alkalinizing Agents— Increase blood levels and potentiate the action of amphetamine. Co-administration should be avoided.

Moderate (1)

Amphetamine Extended-Release + Acidifying Agents— Lower blood levels and efficacy of amphetamines. Dose adjustment may be needed based on clinical response.

Amphetamine Extended-Release + Mao Inhibitors⛔Contraindicated

MAOI antidepressants slow amphetamine metabolism, increasing norepinephrine release and risk of hypertensive crisis, toxic neurological effects, and potentially fatal malignant hyperpyrexia.

Amphetamine Extended-Release + Alkalinizing Agents⚠️Major

Increase blood levels and potentiate the action of amphetamine. Co-administration should be avoided.

Amphetamine Extended-Release + Acidifying Agents🟡Moderate

Lower blood levels and efficacy of amphetamines. Dose adjustment may be needed based on clinical response.

⛔ FDA Black Box Warning

WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine extended-release orally disintegrating tablets has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including amphetamine extended-release orally disintegrating tablets, can result in overdose and death [ see Overdosage ( 10 ) ], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine extended-release orally disintegrating tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout amphetamine extended-release orally disintegrating tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 )]. WARNING: ABUSE, MISUSE AND ADDICTION See full prescribing information for complete boxed warning. Amphetamine extended-release orally disintegrating tablets has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including amphetamine extended-release orally disintegrating tablets, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing amphetamine extended-release orally disintegrating tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Contraindications

4 CONTRAINDICATIONS Amphetamine extended-release orally disintegrating tablets is contraindicated: In patients known to be hypersensitive to amphetamine, or other components of amphetamine extended-release orally disintegrating tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions ( 6.2 )] . Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions ( 5.7 ), Drug Interactions 7.1 ] . Known hypersensitivity to amphetamine products or other ingredients in amphetamine extended-release orally disintegrating tablets. ( 4 ) Use of monoamine oxidase inhibitor (MAOI) or within 14 days of the last MAOI dose. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women exposed to ADHD medications, including amphetamine extended-release orally disintegrating tablets, during pregnancy. Healthcare providers are encouraged to advise patients to register by contacting the National Pregnancy Registry for ADHD Medication at 1-866-961-2388 or online at www.womensmentalhealth.org/pregnancyregistry. Risk Summary Available data from epidemiologic studies and postmarketing reports on the use of amphetamine in pregnant women over decades of use have not identified a drug-associated risk of major birth defects or miscarriage. Neonates exposed to amphetamine in utero are at risk for withdrawal symptoms following delivery. Adverse pregnancy outcomes including premature delivery and low birth weight have been seen in infants born to mothers taking amphetamines during pregnancy (see Clinical Considerations). No apparent effects on morphological development were observed in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis. However, in a pre- and post-natal development study, amphetamine (d- to l- ratio of 3:1) administered orally to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine. In addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. Long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverseoutcomes. In the U.S. general population, the estimated background risk of

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.