Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Refer to the “Also Known As” section to reference different products that include the same medication as Adderall.
Brand Name: Adderall
Generic Name: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: TABLET
Data Current As Of: 2019-11-18
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
indications & usage
Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
attention deficit hyperactivity disorder (adhd)
A diagnosis of Attention Deficit Hyperactivity Disorder (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 child and not solely on the presence of the required number of DSM-IV® characteristics.
need for comprehensive treatment program
Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)) 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 children with this syndrome. Stimulants are not intended for use in the child 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.
The effectiveness of Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)) for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)) for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
central nervous system
Vision blurred, mydriasis.
Impotence, changes in libido, frequent or prolonged erections.
drug abuse & dependence
Adderall® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)) is a Schedule II controlled substance.
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 include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.
Adderall ® (ADD-ur-all) (CII)
(Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product))
Read the Medication Guide that comes with Adderall® 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®.
What is the most important information I should know about Adderall®?
The following have been reported with use of Adderall® and other stimulant medicines.
1. Heart-Related Problems:
sudden death in patients who have heart problems or heart defects
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®.
Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Adderall®.
2. Mental (Psychiatric) Problems:
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 ® , 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 color 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 signs of unexplained wounds appearing on fingers or toes while taking Adderall®.
What is Adderall®?
Adderall® is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Adderall® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Adderall® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Adderall® is also used in the treatment of a sleep disorder called narcolepsy.
Adderall® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Adderall® in a safe place to prevent misuse and abuse. Selling or giving away Adderall® 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®?
Adderall ® 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.
- are sensitive to, allergic to, or had a reaction to other stimulant medicines
Adderall® is not recommended for use in children less than 3 years old.
Adderall ® may not be right for you or your child. Before starting Adderall ® tell your or your child’s doctor about all health conditions (or a family history of) including:
- heart problems, heart defects, high blood pressure
- mental problems including psychosis, mania, bipolar illness, or depression
- tics or Tourette’s syndrome
- liver or kidney problems
- circulation problems in fingers and toes
- thyroid problems
- seizures or have had an abnormal brain wave test (EEG)
Tell your doctor if you or your child are pregnant, planning to become pregnant, or breastfeeding.
Can Adderall ® be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Adderall® 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®.
Your doctor will decide whether Adderall® can be taken with other medicines.
Especially tell your doctor if you or your child take:
- anti-depression medicines including MAOIs
- blood pressure medicines
- seizure medicines
- blood thinner medicines
- cold or allergy medicines that contain decongestants
- stomach acid medicines
Know the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking Adderall ® without talking to your doctor first.
How should Adderall ® be taken?
- Take Adderall ® exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
- Adderall® tablets are usually taken two to three times a day. The first dose is usually taken when you first wake in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.
- Adderall® can be taken with or without food.
- From time to time, your doctor may stop Adderall® treatment for a while to check ADHD symptoms.
- Your doctor may do regular checks of the blood, heart, and blood pressure while taking Adderall®. Children should have their height and weight checked often while taking Adderall®. Adderall® treatment may be stopped if a problem is found during these check-ups.
- If you or your child take too much Adderall ® or overdose, call your doctor or poison control center right away, or get emergency treatment.
What are possible side effects of Adderall®?
See “What is the most important information I should know about Adderall ® ?” 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
- serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when medicines such as Adderall® are taken with certain other medicines. Symptoms of serotonin syndrome may include:
Common side effects include:
- stomach ache
- decreased appetite
Adderall® may affect your or your child’s ability to drive or do other dangerous activities.
Talk to your doctor if you or your child have 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 ® ?
- Store Adderall® in a safe place at room temperature, 20° to 25°C (68° to 77°F).
- Keep Adderall ® and all medicines out of the reach of children.
General information about Adderall ®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Adderall® for a condition for which it was not prescribed. Do not give Adderall® 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®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Adderall® that was written for healthcare professionals. For more information about Adderall®, please contact Teva Pharmaceuticals at 1-888-838-2872.
What are the ingredients in Adderall®?
Active Ingredient: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate.
Inactive Ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium. The 5 mg is a white to off-white tablet, which contains no color additives. The 7.5 mg and 10 mg also contain FD&C Blue #1 Aluminum Lake as a color additive. The 12.5 mg, 15 mg, 20 mg and 30 mg also contain FD&C Yellow #6 Aluminum Lake as a color additive.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Teva Select Brands, North Wales, PA 19454
Division of Teva Pharmaceuticals USA, Inc.
Rev. G 9/2016
also known as
- Adderall XR (capsule, extended release)
- Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate (tablet)
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (capsule)
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (tablet)
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (capsule, extended release)
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate ( )
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (tablet)
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII (tablet)
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (capsule, extended release)
- Mixed Salts of a Single Entity Amphetamine Product XR (capsule, extended release)
- MYDAYIS (capsule, extended release)