Drugplain

Adderall XR 6.25 mg/1

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate · CAPSULE, EXTENDED RELEASE · Takeda Pharmaceuticals America, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Adderall XR is a capsule, extended release containing dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate at 6.25 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..

Key Facts

Brand Name
Adderall XR
Generic Name
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
NDC Code (Product)
54092-389
Manufacturer
Takeda Pharmaceuticals America, Inc.
Strength
6.25 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
NDA021303
Marketing Start
05/22/2002

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective4,659 reports
fatigue3,171 reports
nausea2,862 reports
headache2,637 reports
anxiety2,479 reports
depression2,111 reports
feeling abnormal1,990 reports
pain1,744 reports
dizziness1,735 reports
somnolence1,691 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ADDERALL XR, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. ( 1 ) Limitations of Use The use of ADDERALL XR 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 ) 1.1 Attention Deficit Hyperactivity Disorder ADDERALL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of Use The use of ADDERALL XR 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 & Administration

2 DOSAGE AND ADMINISTRATION Pediatric patients (ages 6 to 17): 10 mg once daily in the morning. Maximum dose for children 6 to 12 years of age is 30 mg once daily. ( 2.2 , 2.3 , 2.4 ) Adults: 20 mg once daily in the morning. ( 2.5 ) Pediatric patients (ages 6 to 17) with severe renal impairment: 5 mg once daily in the morning. Maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily. ( 2.6 , 8.6 ) Adults with severe renal impairment: 15 mg once daily in the morning. ( 2.6 , 8.6 ) Patients with end stage renal disease (ESRD): Not recommended. ( 2.6 , 8.6 ) 2.1 Pretreatment Screening Prior to treating patients with ADDERALL XR, 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 ADDERALL XR [see Warnings and Precautions ( 5.9 )] . 2.2 General Administration Information Individualize the dosage according to the therapeutic needs and response of the patient. Administer ADDERALL XR at the lo…

Contraindications

4 CONTRAINDICATIONS ADDERALL XR administration is contraindicated in patients: known to be hypersensitive to amphetamine, or other components of ADDERALL XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions ( 6.2 )] . 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 ( 5.8 ), Drug Interactions ( 7.1 )]. Known hypersensitivity or idiosyncrasy to amphetamine. ( 4 ) During or within 14 days following the administration of monoamine oxidase inhibitors (MAOI). ( 4 , 7.1 )

Drug Interactions

7 DRUG INTERACTIONS Alkalinizing agents (GI antacids and urinary): These agents increase blood levels of amphetamine. ( 2.7 , 7.1 ) Acidifying agents (GI and urinary): These agents reduce blood levels of amphetamine. ( 7.1 ) 7.1 Clinically Important Interactions with Amphetamines Table 4: Drugs Having Clinically Important Interactions with Amphetamines Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Intervention Do not administer ADDERALL XR concomitantly or within 14 days after discontinuing MAOI [see Contraindications ( 4 )] . Serotonergic Drugs Clinical Impact The concomitant use of ADDERALL XR 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 ADDERALL XR initiation or dosage increase. If serotonin syndrome occurs, discontinue ADDERALL XR and the concomitant serotonergic drug(s) [see Warnings and Preca…

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 ), 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 ( 5.5 )] Seizures [see Warnings and Precautions ( 5.6 )] Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions ( 5.7 )] Serotonin Syndrome [see Warnings and Precautions ( 5.8 )] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.9 )] Pediatric patients ages 6 to 12: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. ( 6.1 ) Pediatric patients ages 13 to 17: Most common adverse reactions (≥5% and with a higher incidence …

Frequently Asked Questions

What is Adderall XR used for?

Adderall XR contains Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Adderall XR a controlled substance?

Yes, Adderall XR is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Adderall XR?

The generic name for Adderall XR is Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate. There are 7 other brand versions of Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate.

What is the NDC code for Adderall XR 6.25 mg/1?

The NDC (National Drug Code) for Adderall XR 6.25 mg/1 is 54092-389, listed by Takeda Pharmaceuticals America, Inc..

Product NDC

54092-389

Package NDC

54092-389-01

Other Dextroamphetamine Brands

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

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