Drugplain

Adzenys XR-ODT 3.1 mg/1

Amphetamine · TABLET, ORALLY DISINTEGRATING · Neos Therapeutics Brands, LLC

No Recall HistoryCurrently in Shortage
Plain English

Adzenys XR-ODT is a prescription stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD) that comes as an orally disintegrating tablet for easy swallowing. It contains amphetamine and is designed to provide long-acting effects throughout the day.

Key Facts

Brand Name
Adzenys XR-ODT
Generic Name
Amphetamine
NDC Code (Product)
70165-005
Manufacturer
Neos Therapeutics Brands, LLC
Strength
3.1 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
02/16/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

toxicity to various agents1,522 reports
drug abuse1,225 reports
completed suicide634 reports
overdose379 reports
death340 reports
cardiac arrest278 reports
cardio-respiratory arrest265 reports
drug ineffective224 reports
respiratory arrest216 reports
fatigue189 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. INDICATIONS AND USAGE ADZENYS XR-ODT 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 ADZENYS XR-ODT 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)] . ADZENYS XR-ODT 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 ADZENYS XR-ODT 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 ADZENYS XR-ODT, 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 ADZENYS XR-ODT [see Warnings and Precautions (5.9) ]. 2.2 General Administration Information ADZENYS XR-ODT may be taken orally with or without food. Individualize the dosage according to…

Contraindications

4. CONTRAINDICATIONS ADZENYS XR-ODT is contraindicated: In patients known to be hypersensitive to amphetamine, or other components of ADZENYS XR-ODT. 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 a 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 ADZENYS XR-ODT. ( 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 ADZENYS XR-ODT 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 ADZENYS XR-ODT during or within 14 days following the administration of MAOI [see Contraindications (4) ]. Serotonergic Drugs Clinical Impact The concomitant use of ADZENYS XR-ODT and serotonergic drugs increases the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during A…

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 ADZENYS XR-ODT [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 incidence than on placebo) were loss of appetite, …

Frequently Asked Questions

What is Adzenys XR-ODT used for?

Adzenys XR-ODT is a prescription stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD) that comes as an orally disintegrating tablet for easy swallowing. It contains amphetamine and is designed to provide long-acting effects throughout the day.

Is Adzenys XR-ODT a controlled substance?

Yes, Adzenys XR-ODT is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Adzenys XR-ODT?

The generic name for Adzenys XR-ODT is Amphetamine. There are 9 other brand versions of Amphetamine.

What is the NDC code for Adzenys XR-ODT 3.1 mg/1?

The NDC (National Drug Code) for Adzenys XR-ODT 3.1 mg/1 is 70165-005, listed by Neos Therapeutics Brands, LLC.

Product NDC

70165-005

Package NDC

70165-005-30

Other Amphetamine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)