Adderall XR

Name: Adderall XR

Precautions While Using Adderall XR

Your doctor should check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Do not take amphetamine and dextroamphetamine combination with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking this medicine during the 2 weeks after you stop an MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, headaches, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter (OTC)) medicines, herbal supplements (eg, St. John's wort), and especially those for appetite control, asthma, colds, cough, hay fever, allergies, or sinus problems.

This medicine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, trouble breathing, fainting, or a fast, irregular heartbeat while taking this medicine.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. It may also cause blurred vision or other vision problems. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence may be:

  • A strong desire or need to continue taking the medicine.
  • A need to increase the dose to receive the same effects.
  • Withdrawal effects after stopping the medicine such as mental depression, nausea or vomiting, stomach cramps or pain, trembling, or unusual tiredness or weakness.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

This medicine may cause Raynaud phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

This medicine may increase your risk of having seizures. This is more likely to occur in patients with a history of seizures or heart rhythm problems. Check with your doctor right away if this happens.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition, called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Uses of Adderall XR

  • It is used to treat attention deficit problems with hyperactivity.
  • It may be given to you for other reasons. Talk with the doctor.

What are some things I need to know or do while I take Adderall XR?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Adderall XR affects you.
  • If you have been taking this medicine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if Adderall XR stops working well. Do not take more than ordered.
  • This medicine may be habit-forming with long-term use.
  • If you have been taking this medicine for many weeks, talk with your doctor before stopping. You may want to slowly stop Adderall XR.
  • You may have some heart tests before starting this medicine. Talk with your doctor.
  • This medicine may cause high blood pressure.
  • Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Adderall XR (dextroamphetamine and amphetamine extended-release capsules (adderall XR)).
  • Do not take antacids with this medicine.
  • Do not switch between this product and other products that have the same drugs in them without checking with the doctor.
  • New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with Adderall XR. Tell your doctor if you or a family member have any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Different brands of Adderall XR may be for use in different ages of children. Talk with the doctor before giving this medicine to a child.
  • Talk with your doctor before you drink alcohol.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Adderall XR while you are pregnant.

How is this medicine (Adderall XR) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Take in the morning.
  • Swallow whole. Do not chew, break, or crush.
  • You may sprinkle contents of capsule on applesauce. Do not chew.
  • After mixing, take your dose right away. Do not store for future use.
  • To gain the most benefit, do not miss doses.
  • Keep taking Adderall XR as you have been told by your doctor or other health care provider, even if you feel well.
  • Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.

What do I do if I miss a dose?

  • Do not take it later in the day.
  • Do not take 2 doses at the same time or extra doses.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Adderall XR is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Adderall XR or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Adderall XR (dextroamphetamine and amphetamine extended-release capsules (adderall XR)). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Dosage Forms and Strengths

Adderall XR 5 mg capsules: Clear/blue (imprinted Adderall XR 5 mg)

Adderall XR 10 mg capsules: Blue/blue (imprinted Adderall XR 10 mg)

Adderall XR 15 mg capsules: Blue/white (imprinted Adderall XR 15 mg)

Adderall XR 20 mg capsules: Orange/orange (imprinted Adderall XR 20 mg)

Adderall XR 25 mg capsules: Orange/white (imprinted Adderall XR 25 mg)

Adderall XR 30 mg capsules: Natural/orange (imprinted Adderall XR 30 mg)

Drug Abuse and Dependence

Controlled Substance

Adderall XR is a Schedule II controlled substance.

Abuse and Dependence

Amphetamines have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to levels many times higher than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines may include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

PRINCIPAL DISPLAY PANEL - 15 mg Capsule Bottle Label

NDC 54092-385-01

Adderall XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

15 mg

CII
100 Capsules

Rx only

Shire

015926

LOT
EXP

For the Consumer

Applies to amphetamine / dextroamphetamine: oral capsule extended release, oral tablet

Along with its needed effects, amphetamine / dextroamphetamine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amphetamine / dextroamphetamine:

More common
  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • lower back or side pain
Less common
  • Cold or flu-like symptoms
  • cough or hoarseness
  • fever or chills
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chest pain or discomfort
  • confusion
  • dark-colored urine
  • diarrhea
  • difficulty breathing
  • difficulty with speaking
  • difficulty with swallowing
  • dizziness
  • double vision
  • faintness
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching, skin rash
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of bladder control
  • muscle cramps or spasms
  • muscle pain or stiffness
  • muscle spasm or jerking of all extremities
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seeing, hearing, or feeling things that are not there
  • seizures
  • slow speech
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of consciousness
  • sweating
  • swelling of the feet or lower legs
  • tightness in the chest
  • uncontrolled repeated movements (tics)
  • uncontrolled vocal outbursts
  • unusual tiredness or weakness
  • vomiting

Some side effects of amphetamine / dextroamphetamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Anxiety
  • dry mouth
  • lack or loss of strength
  • stomach pain
  • weight loss
Incidence not known
  • Constipation
  • decreased interest in sexual intercourse
  • false or unusual sense of well-being
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

For Healthcare Professionals

Applies to amphetamine / dextroamphetamine: oral capsule extended release, oral tablet

Metabolic

Very common (10% or more): Appetite loss (up to 36%), weight loss (up to 10%)
Frequency not reported: Anorexia[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 35%), abdominal pain (up to 14%)
Common (1% to 10%): Nausea, vomiting, diarrhea, dyspepsia
Frequency not reported: Unpleasant taste, constipation, other GI disturbances[Ref]

Cardiovascular

Very common (10% or more): Transient blood pressure elevations (up to 35%)
Common (1% to 10%): Tachycardia, palpitation
Frequency not reported: Cardiomyopathy, myocardial infarction, Raynaud's phenomenon[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 27%), nervousness (up to 13%)
Common (1% to 10%): Emotional lability, agitation, anxiety
Frequency not reported: Psychotic episodes, irritability, euphoria, dysphoria, restlessness, depression, aggression, anger, logorrhea, dermatillomania[Ref]

Nervous system

Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Somnolence, dizziness, twitching, speech disorder (e.g., stuttering, excessive speech)
Frequency not reported: Overstimulation, paresthesia/formication, dyskinesia, tremor, exacerbation of motor/phonic tics and Tourette's syndrome[Ref]

Dermatologic

Common (1% to 10%): Photosensitivity reaction, sweating
Frequency not reported: Urticaria, rash, alopecia, serious skin rashes (e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis)[Ref]

Endocrine

Common (1% to 10%): Decreased libido, dysmenorrhea, impotence
Frequency not reported: Frequent or prolonged erections[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Other

Common (1% to 10%): Fever, infection, accidental injury, asthenia/fatigue, tooth disorder (e.g., teeth clenching, tooth infection)
Frequency not reported: Sudden death, bruxism[Ref]

Respiratory

Common (1% to 10%): Dyspnea[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (e.g., angioedema, anaphylaxis)[Ref]

Ocular

Frequency not reported: Blurred vision, mydriasis[Ref]

Musculoskeletal

Postmarketing reports: Rhabdomyolysis[Ref]

Some side effects of Adderall XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. Do not take extra medicine to make up the missed dose.

Adverse Effects

>10% (Extended Release)

Loss of appetite (22-36%)

Headache (<26%)

Insomnia (12-27%)

Abdominal pain (11-14%)

Weight loss (4-11%)

1-10% (Extended Release)

Anxiety (8%)

Vomiting (7%)

Nervousness (6%)

Tachycardia (6%)

Fever (5%)

Nausea (5-8%)

Infection (4%)

Emotional lability (2-9%)

Dizziness (2-7%)

Diarrhea (2-6%)

Fatigue (2-4%)

Dry mouth (2-4%)

Dyspepsia (2-4%)

Postmarketing Reports

Cardiovascular: Palpitations; isolated reports of cardiomyopathy associated with chronic amphetamine use

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

Eye disorders: Blurred vision, 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)

Endocrine: Impotence, changes in libido, frequent/prolonged erections

Skin: Alopecia

Vascular disorders: Raynaud phenomenon

Musculoskeletal: Rhabdomyolysis

Pharmacology

Mechanism of Action

Sympathomimetic amine that promotes release of dopamine and norepinephrine from their storage sites in the presynaptic nerve terminals; may also block reuptake of catecholamines by competitive inhibition

Absorption

Well absorbed

Onset of action: 30-60 min

Duration: 4-6 hr

Vd: 3.5-4.6 L/kg (distributes into CNS; mean CSF concentrations are 80% of plasma)

Peak plasma time: 3 hr (Adderall); 7 hr (Adderall XR)

Metabolism

Hepatic via glucuronidation and CYP450 mono-oxygenase

Elimination

Half-life elimination (children)

  • 6-12 years: 9 hr (d-amphetamine); 11 hr (l-amphetamine)
  • 12-18 years: 11 hr (d-amphetamine); 13-14 hr (l-amphetamine)

Half-life elimination (adults)

  • d-amphetamine: 10 hr
  • l-amphetamine: 13 hr

Excretion

  • Urine; dependent on urinary pH

Administration

Oral Administration

Tablet

  • May take with or without food
  • Give first dose on awakening; give additional doses (1 or 2) at intervals of 4-6 hr
  • Avoid late evening doses owing to potential insomnia

Extended-release capsule

  • May take with or without food
  • Take in morning upon awakening; avoid afternoon doses owing to potential insomnia
  • Swallow capsule whole, OR
  • Open capsule and sprinkle the entire content over a spoonful of applesauce and consume immediately without chewing (do not store)
  • Do not divide content of a single capsule

Patient Handout

Print without Office InfoPrint with Office Info
(web3)