Amphetamine Extended-Release 15.7 mg/1
Amphetamine Extended-Release · TABLET, ORALLY DISINTEGRATING · Neos Therapeutics, LP
Amphetamine Extended-Release is a tablet, orally disintegrating containing amphetamine extended-release at 15.7 mg/1, taken oral. Manufactured by Neos Therapeutics, LP.
Key Facts
- Brand Name
- Amphetamine Extended-Release
- Generic Name
- Amphetamine Extended-Release
- NDC Code (Product)
62542-025- Manufacturer
- Neos Therapeutics, LP
- Strength
- 15.7 mg/1
- Dosage Form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA204326
- Drug Class
- Central Nervous System Stimulant [EPC]
- Marketing Start
- 09/01/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ( 14 )]. Limitations of Use The use of amphetamine extended-release orally disintegrating tablets 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) ]. Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. ( 1 ) Limitations of Use The use of amphetamine extended-release orally disintegrating tablets 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. (5.5, 8.4)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION May be taken with or without food. Allow tablet to disintegrate in saliva then swallow. ( 2.2 ) Pediatric patients (ages 6 to 17 years): Starting dose is 6.3 mg once daily in the morning. Maximum dose is 18.8 mg once daily for patients 6 to 12 years, and 12.5 mg once daily for patients 13 to 17 years. ( 2.3 ) Adults: 12.5 mg once daily in the morning. ( 2.4 ) To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles. ( 2.5 , 5.7 ) 2.1 Pre-treatment Screening Prior to treating patients with amphetamine extended-release orally disintegrating tablets, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating amphetamine extended-release orally disintegrating tablets [see Warnings and Precautions ( 5.9 )] . 2.2 General Administration Information Amp…
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 )
Drug Interactions
7 DRUG INTERACTIONS Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents can decrease amphetamine blood levels, while alkalinizing agents can increase amphetamine blood levels. Adjust amphetamine extended-release orally disintegrating tablets dosage accordingly. ( 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Amphetamines Table 5: Drugs having clinically important interactions with amphetamines. MAO Inhibitors (MAOI) Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines 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. Intervention Do not administer amphetamine extended-release orally disintegrating tablets during or within 14 days following the administration of MAOI [see Contraindications ( 4 )]. Serotonergic Drugs Clinical Impact The concomitant use of amphetamine extended-release orally disintegrating tablets and serotonergic drugs increases the risk of serotonin syndr…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), and Drug Abuse and Dependence ( 9.2 , 9.3 )] Hypersensitivity to amphetamine, or other components of amphetamine extended-release orally disintegrating tablets [see Contraindications ( 4 )] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )] 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 ( 5.5 )] Peripheral Vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions ( 5.6 )] Serotonin Syndrome [see Warnings and Precautions ( 5.7 )] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.8 )] Pediatric patients ages 6 to 12 years: Most common adverse reactions (≥5% and with a higher…
Frequently Asked Questions
What is Amphetamine Extended-Release used for?
Amphetamine Extended-Release contains Amphetamine Extended-Release. It is a tablet, orally disintegrating taken oral. Consult your doctor for specific uses.
Is Amphetamine Extended-Release a controlled substance?
Yes, Amphetamine Extended-Release is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Amphetamine Extended-Release?
The generic name for Amphetamine Extended-Release is Amphetamine Extended-Release. There are no other listed brand versions of Amphetamine Extended-Release.
What is the NDC code for Amphetamine Extended-Release 15.7 mg/1?
The NDC (National Drug Code) for Amphetamine Extended-Release 15.7 mg/1 is 62542-025, listed by Neos Therapeutics, LP.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)