Adderall XR

Name: Adderall XR

Adderall Side Effects

Common side effects of Adderall include:

  • Nervousness
  • Dizziness
  • Restlessness
  • Headache
  • Stomach ache
  • Decreased appetite
  • Trouble sleeping
  • Dry mouth
  • Nausea
  • Weight loss
  • Constipation or diarrhea
  • Loss of interest in sex

If more serious side effects develop, call a doctor right away. Serious side effects of Adderall may include:

  • Changes in vision
  • Seizures
  • Chest pain
  • Trouble breathing
  • Fainting
  • Severe weakness or numbness
  • Uncontrolled movements or voice sounds
  • Hallucinations or delusions
  • Aggressive behavior
  • Uncontrollable behavior
  • Severe skin rash
  • Swelling of face, lips, or tongue
  • Difficulty swallowing or talking
  • Irregular heartbeat

Is amphetamine and dextroamphetamine safe to take if I'm pregnant or breastfeeding?

Amphetamines should not be used during pregnancy. Infants who are born to mothers dependent on amphetamines exhibit symptoms of withdrawal and have an increased risk of low birth weight.

Mothers taking amphetamines should refrain from nursing their infants because these drugs are excreted in human milk and can have undesirable effects on the child.

Notes

Do not share this medication with others. It is against the law.Laboratory and/or medical tests (such as blood pressure, heart rate, growth monitoring in children) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed dose

If you miss a dose, take it as soon as you remember in the morning hours. If it is after noon or near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Side effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Studies Experience

The premarketing development program for ADDERALL XR included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40). Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse reactions.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed.

Adverse Reactions Leading to Discontinuation of Treatment

In two placebo-controlled studies of up to 5 weeks duration among children with ADHD, 2.4% (10/425) of ADDERALL XR-treated patients discontinued due to adverse reactions (including 3 patients with loss of appetite, one of whom also reported insomnia) compared to 2.7% (7/259) receiving placebo.

The most frequent adverse reactions leading to discontinuation of ADDERALL XR in controlled and uncontrolled, multiple-dose clinical trials of children (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%). Over half of these patients were exposed to ADDERALL XR for 12 months or more.

In a separate placebo-controlled 4-week study in adolescents with ADHD, five patients (2.1%) discontinued treatment due to adverse events among ADDERALL XR-treated patients (N=233) compared to none who received placebo (N=54). The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of ADDERALL XR-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3). In one placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60 mg, 23 patients (12.0% ) discontinued treatment due to adverse events among ADDERALL XR-treated patients (N=191) compared to one patient (1.6%) who received placebo (N=64). The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of ADDERALL XR-treated patients and at a rate at least twice that of placebo) were insomnia (5.2%, n=10), anxiety (2.1%, n=4), nervousness(1.6%, n=3), dry mouth (1.6%, n=3), anorexia (1.6%, n=3), tachycardia (1.6%, n=3), headache (1.6%, n=3), and asthenia (1.0%, n=2).

Adverse Reactions Occurring in Controlled Trials

Adverse reactions reported in a 3-week clinical trial of children and a 4-week clinical trial in adolescents and adults, respectively, treated with ADDERALL XR or placebo are presented in the tables below.

Table 1 : Adverse Reactions Reported by 2% or More of Children (6-12 Years Old) Receiving ADDERALL XR with Higher Incidence Than on Placebo in a 584-Patient Clinical Study

Body System Preferred Term ADDERALL XR
(n=374)
Placebo
(n=210)
General Abdominal Pain (stomachache) 14% 10%
Fever 5% 2%
Infection 4% 2%
Accidental Injury 3% 2%
Asthenia (fatigue) 2% 0%
Digestive System Loss of Appetite 22% 2%
Vomiting 7% 4%
Nausea 5% 3%
Dyspepsia 2% 1%
Nervous System Insomnia 17% 2%
Emotional Lability 9% 2%
Nervousness 6% 2%
Dizziness 2% 0%
Metabolic/ Nutritional Weight Loss 4% 0%

Table 2 : Adverse Reactions Reported by 5% or More of Adolescents (13-17 Years Old) Weighing ≤ 75 kg/165 lbs Receiving ADDERALL XR with Higher Incidence Than Placebo in a 287 Patient Clinical Forced Weekly-Dose Titration Study*

Body System Preferred Term ADDERALL XR
(n=233)
Placebo
(n=54)
General Abdominal Pain (stomachache) 11% 2%
Digestive System Loss of Appetiteb 36% 2%
Nervous System Insomniab 12% 4%
Nervousness 6% 6%a
Metabolic/ Nutritional Weight Lossb 9% 0%
*Included doses up to 40 mg
a Appears the same due to rounding
b Dose-related adverse reactions
Note: The following reactions did notmeet the criterion for inclusion in Table 2 but were reported by 2% to 4% of adolescent patients receiving ADDERALL XR with a higher incidence than patients receiving placebo in this study: accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting.

Table 3 : Adverse Reactions Reported by 5% or More of Adults Receiving ADDERALL XR with Higher Incidence Than on Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study*

Body System Preferred Term ADDERALL XR
(n=191)
Placebo
(n=64)
General Headache 26% 13%
Asthenia 6% 5%
Digestive System Dry Mouth 35% 5%
Loss of Appetite 33% 3%
Nausea 8% 3%
Diarrhea 6% 0%
Nervous System Insomnia 27% 13%
Agitation 8% 5%
Anxiety 8% 5%
Dizziness 7% 0%
Nervousness 13% 13%a
Cardiovascular System Tachycardia 6% 3%
Metabolic/ Nutritional Weight Loss 10% 0%
Urogenital System Urinary Tract Infection 5% 0%
*Included doses up to 60 mg.
a Appears the same due to rounding
Note: The following reactions did not meet the criterion for inclusion in Table 3 but were reported by 2% to 4% of adult patients receiving ADDERALL XR with a higher incidence than patients receiving placebo in this study: infection, photosensitivity reaction, constipation, tooth disorder (e.g., teeth clenching, tooth infection), emotional lability, libido decreased, somnolence, speech disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea, sweating, dysmenorrhea, and impotence.

Hypertension

[see WARNINGS AND PRECAUTIONS]

In a controlled 4-week outpatient clinical study of adolescents with ADHD, isolated systolic blood pressure elevations ≥ 15 mmHg were observed in 7/64 (11%) placebotreated patients and 7/100 (7%) patients receiving ADDERALL XR 10 or 20 mg. Isolated elevations in diastolic blood pressure ≥ 8 mmHg were observed in 16/64 (25%) placebo-treated patients and 22/100 (22%) ADDERALL XR-treated patients. Similar results were observed at higher doses.

In a single-dose pharmacokinetic study in 23 adolescents with ADHD, isolated increases in systolic blood pressure (above the upper 95% CI for age, gender, and stature) were observed in 2/17 (12%) and 8/23 (35%), subjects administered 10 mg and 20 mg ADDERALL XR, respectively. Higher single doses were associated with a greater increase in systolic blood pressure. All increases were transient, appeared maximal at 2 to 4 hours post dose and not associated with symptoms.

Adverse Reactions Associated With The Use of Amphetamine, ADDERALL XR, Or ADDERALL

The following adverse reactions have been associated with the use of amphetamine, ADDERALL XR, or ADDERALL:

Cardiovascular

Palpitations. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System

Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania, paresthesia (including formication), and bruxism.

Eye Disorders

Vision blurred, mydriasis.

Gastrointestinal

Unpleasant taste, constipation, other gastrointestinal disturbances.

Allergic

Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine

Impotence, changes in libido, frequent or prolonged erections.

Skin

Alopecia.

Vascular Disorders

Raynaud's phenomenon.

Musculoskeletal and Connective Tissue Disorders

Rhabdomyolysis

What do I need to tell my doctor BEFORE I take Adderall XR?

  • If you have an allergy to dextroamphetamine, amphetamine, or any other part of Adderall XR.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you or a family member have any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette's syndrome or tics.
  • If you have any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
  • If you have ever had any of these health problems: Drug abuse or stroke.
  • If you have kidney disease.
  • If you are taking acetazolamide.
  • If you are taking sodium bicarbonate.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are breast-feeding. Do not breast-feed while you take Adderall XR.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Adderall XR with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How do I store and/or throw out Adderall XR?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Indications and Usage for Adderall XR

Attention Deficit Hyperactivity Disorder

Adderall XR® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

The efficacy of Adderall XR in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met DSM-IV® criteria for ADHD [see CLINICAL STUDIES (14)].

A diagnosis of ADHD (DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV® characteristics.

Need for Comprehensive Treatment Program

Adderall XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

Long-Term Use

The effectiveness of Adderall XR for long-term use, i.e., for more than 3 weeks in children and 4 weeks in adolescents and adults, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Adderall XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Patient Counseling Information

Information on Medication Guide

Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Adderall XR and should counsel them in its appropriate use. A patient Medication Guide is available for Adderall XR. Instruct patients, their families, and their caregivers to read the Medication Guide and assist them in understanding its contents. Give patients the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Controlled Substance Status/Potential for Abuse, Misuse, and Dependence

Advise patients that Adderall XR is a federally controlled substance because it can be abused or lead to dependence. Additionally, emphasize that Adderall XR should be stored in a safe place to prevent misuse and/or abuse. Evaluate patient history (including family history) of abuse or dependence on alcohol, prescription medicines, or illicit drugs [see DRUG ABUSE AND DEPENDENCE (9)].

Serious Cardiovascular Risks

Advise patients of serious cardiovascular risk (including sudden death, myocardial infarction, stroke, and hypertension) with Adderall XR. Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during treatment should undergo a prompt cardiac evaluation [see WARNINGS AND PRECAUTIONS (5.1)].

Psychiatric Risks

Prior to initiating treatment with Adderall XR, adequately screen patients with comorbid depressive symptoms to determine if they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and/or depression. Additionally, Adderall XR therapy at usual doses may cause treatment-emergent psychotic or manic symptoms in patients without prior history of psychotic symptoms or mania [see WARNINGS AND PRECAUTIONS (5.2)].

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]

Instruct patients beginning treatment with Adderall XR about the risk of peripheral vasculopathy, including Raynaud's Phenomenon, and in associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.  Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.  Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Adderall XR.  Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see WARNINGS AND PRECAUTIONS (5.5)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with concomitant use of Adderall XR and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.6) and DRUG INTERACTIONS (7.1)]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.

Concomitant Medications

Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see DRUG INTERACTIONS (7.1)].

Growth

Monitor growth in children during treatment with Adderall XR, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see WARNINGS AND PRECAUTIONS (5.3)].

Pregnancy

Advise patients to notify their physicians if they become pregnant or intend to become pregnant during treatment [see USE IN SPECIFIC POPULATIONS (8.1)].

Nursing

Advise patients not to breast feed if they are taking Adderall XR [see USE IN SPECIFIC POPULATIONS (8.3)].

Impairment in Ability to Operate Machinery or Vehicles

Adderall XR may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.

Manufactured for Shire US Inc., 300 Shire Way, Lexington, MA 02421, Made in USA.

For more information call 1-800-828-2088

Pharmacist: Medication Guide to be dispensed to patients

Adderall XR® is a registered trademark of Shire LLC

ADDERALL® is a registered trademark of Shire LLC, under license to Duramed Pharmaceuticals, Inc.

Copyright© 2017 Shire US Inc.

Rev. 01/2017

MEDICATION GUIDE Adderall XR® (ADD-ur-all X-R) CII

Read the Medication Guide that comes with Adderall XR before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child's treatment with Adderall XR.

What is the most important information I should know about Adderall XR?

Adderall XR is a stimulant medicine. The following have been reported with use of stimulant medicines.

1. Heart-related problems:

• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Adderall XR.

Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with Adderall XR.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Adderall XR.

2. Mental (Psychiatric) problems:

All Patients

• new or worse behavior and thought problems
• new or worse bipolar illness
• new or worse aggressive behavior or hostility

Children and Teenagers

• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Adderall XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]:

• Fingers or toes may feel numb, cool, painful
• Fingers or toes may change from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have or your child has any unexplained wounds appearing on fingers or toes while taking Adderall XR.

What Is Adderall XR?

Adderall XR is a once daily central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Adderall XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Adderall XR should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Adderall XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Adderall XR in a safe place to prevent misuse and abuse. Selling or giving away Adderall XR may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Adderall XR?

Adderall XR should not be taken if you or your child:

  • have heart disease or hardening of the arteries
  • have moderate to severe high blood pressure
  • have hyperthyroidism
  • have an eye problem called glaucoma
  • are very anxious, tense, or agitated
  • have a history of drug abuse
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • is sensitive to, allergic to, or had a reaction to other stimulant medicines

Adderall XR has not been studied in children less than 6 years old.

Adderall XR may not be right for you or your child. Before starting Adderall XR tell you or your child's doctor about all health conditions (or a family history of) including:

  • heart problems, heart defects, or high blood pressure
  • mental problems including psychosis, mania, bipolar illness, or depression
  • tics or Tourette's syndrome
  • liver or kidney problems
  • thyroid problems
  • seizures or have had an abnormal brain wave test (EEG)
  • circulation problems in fingers and toes

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can Adderall XR be taken with other medicines?

Tell your doctor about all of the medicines that you or your child takes including prescription and non-prescription medicines, vitamins, and herbal supplements. Adderall XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Adderall XR.

Your doctor will decide whether Adderall XR can be taken with other medicines.
Especially tell your doctor if you or your child takes:

  • anti-depression medicines including MAOIs
  • anti-psychotic medicines
  • lithium
  • narcotic pain medicines
  • seizure medicines
  • blood thinner medicines
  • blood pressure medicines
  • stomach acid medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Adderall XR without talking to your doctor first.

How should Adderall XR be taken?

  • Take Adderall XR exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Take Adderall XR once a day in the morning when you first wake up. Adderall XR is an extended release capsule. It releases medicine into your body throughout the day.
  • Swallow Adderall XR capsules whole with water or other liquids. If you or your child cannot swallow the capsule, open it and sprinkle the medicine over a spoonful of applesauce. Swallow all of the applesauce and medicine mixture without chewing immediately. Follow with a drink of water or other liquid. Never chew or crush the capsule or the medicine inside the capsule.
  • Adderall XR can be taken with or without food.
  • From time to time, your doctor may stop Adderall XR treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking Adderall XR. Children should have their height and weight checked often while taking Adderall XR. Adderall XR treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much Adderall XR or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Adderall XR?

See "What is the most important information I should know about Adderall XR?" for information on reported heart and mental problems.

Other serious side effects include:

  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision

Common side effects include:

  • headache
  • decreased appetite
  • stomach ache
  • nervousness
  • trouble sleeping
  • mood swings
  • weight loss
  • dizziness
  • dry mouth
  • fast heart beat

Adderall XR may affect you or your child's ability to drive or do other dangerous activities.

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Adderall XR?

  • Store Adderall XR in a safe place at room temperature, 59 to 86° F (15 to 30° C).
  • Keep Adderall XR and all medicines out of the reach of children.

General information about Adderall XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Adderall XR for a condition for which it was not prescribed. Do not give Adderall XR to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Adderall XR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Adderall XR that was written for healthcare professionals. For more information, you may also contact Shire Pharmaceuticals (the maker of Adderall XR) at 1-800-828-2088 or visit the website at http://www.adderallxr.com.

What are the ingredients in Adderall XR?

Active Ingredients: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, USP, amphetamine sulfate USP

Inactive Ingredients: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide

Manufactured for Shire US Inc., 300 Shire Way,
Lexington, MA 02421.
Adderall XR® is a registered trademark of Shire LLC
© 2015 Shire US Inc
Rev. 12/2015
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Headache, dry mouth, loss of appetite, insomnia, nervousness, and nausea are the most common side effects.
  • High potential for dependence especially when administered for long periods of time.
  • High potential for abuse. May be sought after by drug abusers or people with addiction disorders. Misuse may cause sudden death or cardiovascular events.
  • May not be suitable for people with certain heart conditions, as risk of sudden death increased even with usual dosages.
  • May exacerbate preexisting psychiatric disorders such as bipolar disorder, psychotic disorder or mania; and increase anxiety, tension, and agitation.
  • May impair judgment or reaction skills; exercise caution before driving or operating machinery until full effects of Adderall XR are known.
  • Reports indicate some temporary slowing of growth may occur when Adderall XR is given regularly to children aged 7 through 10 years. Doctors should monitor height and weight and consider treatment interruption if growth suppression suspected.
  • May increase risk of seizures and peripheral circulatory problems and cause visual problems. May not be suitable for people with heart disease, thyroid problems, glaucoma, agitation, or a history of drug abuse.
  • May cause heart palpitations, dry mouth, constipation and other GI disturbances, headache, weight loss, changes in libido, alopecia (hair loss), elevate blood pressure and affect the muscles.
  • May precipitate depression during withdrawal from Adderall XR, particularly in those who have been overusing it.
  • May interact with other medicines, particularly those that also increase serotonin such as tramadol, fentanyl, lithium, and antidepressants.
  • Rare cases of priapism (painful erections more than 6 hours in duration) have been reported.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine and dextroamphetamine could be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, panic, aggressiveness, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Other overdose symptoms include nausea, vomiting, diarrhea, stomach pain, uneven heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

Dosing & Uses

Dosage Forms & Strengths

Each tab/cap contains equal portions of the following: amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate

tablet: Schedule II

  • 5mg (1.25mg/1.25mg/1.25mg/1.25mg)
  • 10mg (2.5mg/2.5mg/2.5mg/2.5mg)
  • 20mg (5mg/5mg/5mg/5mg)
  • 30mg (7.5mg/7.5mg/7.5mg/7.5mg)

capsule, extended-release: Schedule II

  • 5mg (1.25mg/1.25mg/1.25mg/1.25mg) (Adderall XR)
  • 10mg (2.5mg/2.5mg/2.5mg/2.5mg) (Adderall XR)
  • 12.5mg (3.125mg/3.125mg/3.125mg/3.125mg) (Mydayis)
  • 15mg (3.75mg/3.75mg/3.75mg/3.75mg) (Adderall XR)
  • 20mg (5mg/5mg/5mg/5mg) (Adderall XR)
  • 25mg (6.25mg/6.25mg/6.25mg/6.25mg) (Adderall XR, Mydayis)
  • 30mg (7.5mg/7.5mg/7.5mg/7.5mg) (Adderall XR)
  • 37.5mg (9.375mg/9.375mg/9.375mg/9.375mg) (Mydayis)
  • 50mg (12.5mg/12.5mg/12.5mg/12.5mg) (Mydayis)

Attention Deficit Hyperactivity Disorder (ADHD)

Tablet: 5 mg PO qDay initially; may increase by 5-10 mg/day qWeek; administer daily dose in 2-3 doses; not to exceed 40 mg/day

Extended-release capsule

  • Adderall XR
    • 20 mg PO qAM initially or switching from another medication
    • May increase by increments of 5-10 mg/week; not to exceed 60 mg/day
  • Mydayis
    • 18-55 years: 12.5 mg qAM initially
    • May increase by increments of 12.5 mg/week; not to exceed 50 mg/day
    • Note: 25 mg qAM may be considered as an initial dose for some patients

Narcolepsy

Amphetamine/dextroamphetamine

  • 5-60 mg PO qDay; may increase by 10 mg/day qWeek
  • No more than 60 mg given qDay or divided doses with intervals of 4-6 hr between doses

Dosage Forms & Strengths

Each tab/cap contains equal portions of the following: amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate

tablet: Schedule II

  • 5mg (1.25mg/1.25mg/1.25mg/1.25mg)
  • 10mg (2.5mg/2.5mg/2.5mg/2.5mg)
  • 20mg (5mg/5mg/5mg/5mg)
  • 30mg (7.5mg/7.5mg/7.5mg/7.5mg)

capsule, extended-release: Schedule II

  • 5mg (1.25mg/1.25mg/1.25mg/1.25mg) (Adderall XR)
  • 10mg (2.5mg/2.5mg/2.5mg/2.5mg) (Adderall XR)
  • 12.5mg (3.125mg/3.125mg/3.125mg/3.125mg) (Mydayis)
  • 15mg (3.75mg/3.75mg/3.75mg/3.75mg) (Adderall XR)
  • 20mg (5mg/5mg/5mg/5mg) (Adderall XR)
  • 25mg (6.25mg/6.25mg/6.25mg/6.25mg) (Adderall XR, Mydayis)
  • 30mg (7.5mg/7.5mg/7.5mg/7.5mg) (Adderall XR)
  • 37.5mg (9.375mg/9.375mg/9.375mg/9.375mg) (Mydayis)
  • 50mg (12.5mg/12.5mg/12.5mg/12.5mg) (Mydayis)

Attention Deficit Hyperactivity Disorder (ADHD)

Tablet

  • <3 years: Safety and efficacy not established
  • Age 3-6 years: 2.5 mg/day; may increase by 2.5 mg qWeek; not to exceed 40 mg qDay or divided q8hr; use intervals of 4-6 hr between additional doses
  • >6 years: 5 mg PO qDay or q12hr; may increase by 5 mg qWeek; not to exceed 40 mg qDay or divided q8hr; use intervals of 4-6 hr between additional doses

Capsule, extended-release

  • (Adderall XR)
    • <6 years: Safety and efficacy not established
    • ≥6 years to <13 years: 5-10 mg PO qAM initially; may increase by 5-10 mg/day qWeek; not to exceed 30 mg/day
    • 13-17 years: 10 mg PO qAM initially; may increase to 20 mg/day after 1 week if symptoms not controlled; doses up to 60 mg/day have been used, but there is no evidence that higher doses increase effectiveness
  • Mydayis
    • <13 years: Safety and efficacy not established; younger children experienced higher plasma exposure than those aged ≥13 yr at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite
    • ≥13-17 years: 12.5 mg qAM initially
    • May increase by increments of 12.5 mg/week; not to exceed 50 mg/day

Narcolepsy

<6 years: Safety and efficacy not established

6-12 years: 5mg/day PO initially in divided doses; may increase by 5 mg/day qWeek; not to exceed 60 mg qDay or divided doses with intervals of 4-6 hr between doses

>12 years: 10 mg/day PO initially; may increase by 10 mg/day qWeek; not to exceed 60 mg given qDay or divided doses with intervals of 4-6 hr between doses

(web3)