--------------------------RECENT MAJOR CHANGES----------------------------
Boxed Warning 10/2023
Indications and Usage (1) 10/2023
Dosage and Administration (2.1, 2.2, 2.7) 10/2023
Contraindications (4) 10/2023
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.7, 5.9) 10/2023
-------------------------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)
---------------------------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 ESRD: Not recommended. (2.6, 8.6)
-----------------------DOSAGE FORMS AND STRENGTHS--------------------
Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg,
30 mg (3)
------------------------------CONTRAINDICATIONS----------------------------
• Known hypersensitivity or idiosyncrasy to amphetamine (4)
• During or within 14 days following the administration of monoamine
oxidase inhibitors (MAOI) (4, 7.1)
--------------------------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 at appropriate intervals. (5.3)
• Psychiatric Adverse Reactions: Prior to initiating ADDERALL XR,
screen patients for risk factors for developing a manic episode. If
new psychotic or manic symptoms occur, consider discontinuing
ADDERALL XR. (5.4)
• Long-Term Suppression of Growth in Pediatric Patients: Closely
monitor growth (height and weight) in pediatric patients. Pediatric
patients not growing or gaining height or weight as expected may
need to have their treatment interrupted. (5.5)
• Seizures: May lower the convulsive threshold. Discontinue in the
presence of seizures. (5.6)
• Peripheral Vasculopathy, Including Raynaud’s Phenomenon:
Careful observation for digital changes is necessary during
ADDERALL XR treatment. Further clinical evaluation (e.g.,
rheumatology referral) may be appropriate for patients who develop
signs or symptoms of peripheral vasculopathy. (5.7)
• Serotonin Syndrome: Increased risk when coadministered with
serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during
overdosage situations. If it occurs, discontinue ADDERALL XR and
initiate supportive treatment. (4, 5.8, 10)
• Motor and Verbal Tics, and Worsening of Tourette’s Syndrome:
Before initiating ADDERALL XR, assess the family history and
clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor patients for the emergence or worsening of tics
or Tourette’s syndrome. Discontinue treatment if clinically
appropriate. (5.9)
--------------------------------ADVERSE REACTIONS-----------------------------
• 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 than on placebo) were loss of
appetite, insomnia, abdominal pain, weight loss, and nervousness.
(6.1)
• Adults: Most common adverse reactions ≥5% and with a higher
incidence than on placebo were dry mouth, loss of appetite,
insomnia, headache, weight loss, nausea, anxiety, agitation,
dizziness, tachycardia, diarrhea, asthenia, and urinary tract
infections. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda
Pharmaceuticals at 1-800-828-2088 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
--------------------------------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)
--------------------------USE IN SPECIFIC POPULATIONS---------------------
• Pregnancy: May cause fetal harm. (8.1)
• Lactation: Breastfeeding not recommended. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 10/2023
Reference ID: 5260286