Dextroamphetamine
Generic Name: dextroamphetamine
Brand Names:
Xelstrym
11 DESCRIPTION XELSTRYM (dextroamphetamine) transdermal system, contains dextroamphetamine, a CNS stimulant. Dextroamphetamine is the dextro isomer of the compound d , l -amphetamine. The chemical name for dextroamphetamine is (2S)-1-phenylpropan-2-amine. It is a clear to slightly amber colored liquid. Molecular weight of dextroamphetamine is 135.21 g/mol and the molecular formula is C 9 H 13 N.
Overview
11 DESCRIPTION XELSTRYM (dextroamphetamine) transdermal system, contains dextroamphetamine, a CNS stimulant. Dextroamphetamine is the dextro isomer of the compound d , l -amphetamine. The chemical name for dextroamphetamine is (2S)-1-phenylpropan-2-amine. It is a clear to slightly amber colored liquid. Molecular weight of dextroamphetamine is 135.21 g/mol and the molecular formula is C 9 H 13 N.
Uses
1 INDICATIONS AND USAGE XELSTRYM ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see CLINICAL STUDIES (14) ] . Limitations of Use The use of XELSTRYM is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5) , Use in Specific Populations (8.4) ].
Dosage
2 DOSAGE AND ADMINISTRATION Pediatric patients (6 to 17 years): Recommended starting dose is 4.5 mg/9 hours. Titrate dosage in weekly increments of 4.5 mg up to a maximum recommended dose of 18 mg/9 hours ( 2.2 ) Adults: Recommended starting dose is 9 mg/9 hours. Maximum recommended dose is 18 mg/9 hours ( 2.2 ) Apply one XELSTRYM transdermal system 2 hours before an effect is needed and remove within 9 hours ( 2.3 ) Apply XELSTRYM to one of the following sites: hip, upper arm, chest, upper back or flank.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling Known hypersensitivity to amphetamine products or other ingredients of XELSTRYM [see CONTRAINDICATIONS (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS (4) and DRUG INTERACTIONS (7.1) ] Abuse, Misuse, and Addiction [see BOXED WARNING, WARNINGS AND PRECAUTIONS (5.1) and DRUG ABUSE AND DEPENDENCE (9.2, 9.3) ] Risks to Patients with Serious Cardiac Disease [see WARNINGS AND PRECAUTIONS (5.2) ] Increased Blood Pressure and Heart Rate [see WARNINGS AND PRECAUTIONS (5.3) ] Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see WARNINGS AND PRECAUTIONS...
Interactions
7 DRUG INTERACTIONS Acidifying and Alkalinizing Agents: Agents that alter GI and urinary pH can alter blood levels of amphetamine. Acidifying agents can decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels ( 2.7 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Amphetamine Table 3: Drugs Having Clinically Important Interactions with Amphetamines MAO Inhibitors (MAOI) Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamine’s effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Warnings
WARNING: ABUSE, MISUSE, AND ADDICTION XELSTRYM 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 XELSTRYM, 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 XELSTRYM, assess each patient’s risk for abuse, misuse, and addiction. 5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse ( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating XELSTRYM, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing XELSTRYM ( 5.4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. 4 CONTRAINDICATIONS XELSTRYM is contraindicated in patients: with known hypersensitivity to amphetamine products or other components of XELSTRYM. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see ADVERSE REACTIONS (6.2) ] taking monoamine oxidase inhibitors (MAOI), or within 14 days of stopping MAOIs (including MAOIs such a...
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including XELSTRYM, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied XELSTRYM (dextroamphetamine) transdermal system is a translucent product with a printed backing on one side and a release liner on the other packaged in an individual pouch supplied as: 4.5 mg/9 hours transdermal system (system size: 4.76 cm 2 ) Carton of 30 transdermal systems, each transdermal system is packaged in an individual pouch NDC 68968-0...
Frequently Asked Questions
What is Dextroamphetamine used for?▼
1 INDICATIONS AND USAGE XELSTRYM ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see CLINICAL STUDIES (14) ] . Limitations of Use The use of XELSTRYM is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5) , Use in Specific Populations (8.4) ].
What are the side effects of Dextroamphetamine?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling Known hypersensitivity to amphetamine products or other ingredients of XELSTRYM [see CONTRAINDICATIONS (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS (4) and DRUG INTERACTIONS (7.1) ] Abuse, Misuse, and Addiction [see BOXED WARNING, WARNINGS AND PRECAUTIONS (5.1) and DRUG ABUSE AND DEPENDENCE (9.2, 9.3) ] Risks to Patients with Serious Cardiac Disease [see WARNINGS AND PRECAUTIONS (5.2) ] Increased Blood Pressure and Heart Rate [see WARNINGS AND PRECAUTIONS (5.3) ] Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see WARNINGS AND PRECAUTIONS...
Can I take Dextroamphetamine during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including XELSTRYM, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/.
What are the important warnings for Dextroamphetamine?▼
WARNING: ABUSE, MISUSE, AND ADDICTION XELSTRYM 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 XELSTRYM, 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 XELSTRYM, assess each patient’s risk for abuse, misuse, and addiction. 5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse ( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating XELSTRYM, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing XELSTRYM ( 5.4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. 4 CONTRAINDICATIONS XELSTRYM is contraindicated in patients: with known hypersensitivity to amphetamine products or other components of XELSTRYM. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see ADVERSE REACTIONS (6.2) ] taking monoamine oxidase inhibitors (MAOI), or within 14 days of stopping MAOIs (including MAOIs such a...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.