Adderall

Absorption

Bioavailability

Plasma concentration-time profiles similar for single 20-mg extended-release dose versus two 10-mg immediate-release doses given 4 hours apart.c

Peak plasma concentration and AUC decrease with increasing body weight.c

Rapidly absorbed from the GI tract.PDH

Duration

Therapeutic effects persist for 4–24 hours.PDH

Food

Food does not affect the extent of absorption of the extended-release preparation (Adderall XR), but prolongs Tmax by 2.5 hours (for d-amphetamine) and 2.1 hours (for l-amphetamine).c Opening the capsule and sprinkling the contents on applesauce results in comparable absorption to the intact capsule taken in the fasted state.c

Plasma Concentrations

Tmax, immediate-release: About 3 hours.a c

Tmax, extended-release: About 7 hours.c

Therapeutic plasma concentrations are 5–10 mcg/dL.PDH

Distribution

Extent

Distributed widely throughout body, with high levels in the brain.PDH

Apparently crosses the placenta since withdrawal manifestations have occurred in neonates.a c f

Distributed into milk in concentrations 3–7 times maternal blood concentrations.f

Volume of distribution increases with increasing body weight.c

Elimination

Metabolism

Metabolized to several active metabolites.a c

Enzymes involved in metabolism not clearly defined; however, CYP2D6 is involved with formation of at least one metabolite.a c Because CYP2D6 is genetically polymorphic, potential variability in metabolism among patients exists.a c

Elimination Route

With normal urinary pH, excreted in urine as unchanged drug (approximately 30–40%) and metabolites (approximately 50%).a c Changes in urinary pH may alter excretion; urinary recovery of unchanged drug reported to range from 1–75%, depending on urinary pH.a c (See Specific Drugs and Laboratory Tests under Interactions.)

Clearance increases with increasing body weight.c On a mg/kg basis, however, children have higher clearance than adolescents or adults.c

Half-life

Children 6–12 years of age: 9 hours (for d-amphetamine) or 11 hours (for l-amphetamine).c

Adolescents 13–17 years of age: 11 hours (for d-amphetamine) or 13–14 hours (for l-amphetamine).c

Adults: 10 hours (for d-amphetamine) or 13 hours (for l-amphetamine).c

Elimination half-life increases with increasing body weight.c

• Provide patient or caregiver with a copy of the manufacturer’s patient information (medication guide); discuss and answer questions about its contents as needed.c Instruct patient or caregiver to read and understand contents of medication guide before initiating therapy and each time the prescription is refilled.c

• Advise parents with concerns about long-term effects (e.g., effects on weight) and the need for continued therapy that drug holidays can be considered in consultation with the patient’s clinician.e PDH However, the benefits versus risks of such interruptions in therapy have not been established.e

• Advise to take drug, particularly extended-release capsules, early in the day to minimize insomnia.b PDH

• Advise not to chew or crush the pellets contained in the capsules and not to store the sprinkle/food mixture for later use.b

• Advise not to increase dosage unless instructed by their clinician.b PDH

• Advise that appetite suppression may occur.a c d e

  Giving the morning dose with a meal and providing a high-caloric drink or snack late in the evening when the stimulant effects have subsided may be helpful.e

• Question about possible substance abuse,c including in family members (since they may abuse the patient’s medication supply).e

• Advise to inform clinician immediately if adverse cardiovascular (e.g., chest pain, shortness of breath, fainting) or psychiatric effects (e.g., hallucinations, delusional thinking, mania) occur.c

• Instruct about the potential for amphetamine to impair patient’s ability to perform potentially hazardous activities, such as driving or operating heavy machinery.a c

• Advise narcoleptic patients with severe sleepiness as a manifestation of their disease to avoid potentially dangerous activities at home and work and to not operate a motor vehicle until sleepiness is appropriately controlled by stimulant drug therapy.f

• Advise narcoleptic patients about occupational and social accommodation for disabilities associated with their disease (e.g., advise about legal guidance provided by the Americans with Disabilities Act).f

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and herbal products, as well as any concomitant illnesses/conditions (e.g., cardiac/cardiovascular disease, thyroid disease, glaucoma, suicidal ideation or behaviors, mental/psychiatric disorder, seizures, hepatic or renal disease).a b c

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

• Importance of informing patients of other important precautionary information. (See Cautions.)a b

In the U.S.

• Adderall
• Adderall XR
• Mydayis

In Canada

• Adderall XR - 10mg
• Adderall XR - 15mg
• Adderall XR - 20mg
• Adderall XR - 25mg
• Adderall XR - 30mg
• Adderall XR - 5mg

Available Dosage Forms:

• Tablet
• Capsule, Extended Release

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine

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.

• 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 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 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.
• 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 (dextroamphetamine and amphetamine tablets).
• 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. 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 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 while you are pregnant.

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.

Long-Term Use

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.

Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs Adderall, and may increase side effects.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• lithium or other medicine to treat depression or mental illness;

• blood pressure medicine;

• a blood thinner such as warfarin, Coumadin, Jantoven;

• cold or allergy medicine that contains a decongestant;

• opioid (narcotic) medicine; or

• seizure medicine.

This list is not complete and many other drugs can interact with amphetamine and dextroamphetamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

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:

• Insomnia (inability to sleep), headache, dry mouth, loss of appetite, nervousness, and nausea are the most common side effects.
• May also cause heart palpitations, constipation and other GI disturbances, weight loss, changes in libido, alopecia (hair loss), elevated blood pressure and muscle twitching, stiffness, or tightness.
• 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. Overdosage has resulted in psychosis which is indistinguishable from schizophrenia.
• May exacerbate pre-existing 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 the full effects of Adderall are known.
• Reports indicate some temporary slowing of growth may occur when regular Adderall is given to children aged 7 through 10 years. Doctors should monitor height and weight and consider treatment interruption if growth suppression suspected.
• May increase the risk of seizures and peripheral circulatory problems and cause visual problems.
• May not be suitable for people with certain heart conditions, as the risk of sudden death is increased even with usual dosages. May also not be suitable for people with thyroid disease, glaucoma, psychiatric disease, a history of drug abuse, a tic disorder, seizures, or liver or kidney disease or circulation problems.
• May interact with a number of other drugs including other antidepressants, medications used to treat heart disease, blood thinners, decongestants, tramadol, and proton pump inhibitors.
• Extreme fatigue and depression have been reported when Adderall has been stopped suddenly, particularly in those who have been taking more than the recommended dose.
• 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.

Adderall is a combination of four different amphetamine salts and is used for the treatment of ADHD or narcolepsy. Adderall is potentially addictive and can cause insomnia.

Breastfeeding is not recommended during treatment. Excreted into human milk: Yes Comments: -The effect of amphetamine and dextroamphetamine in milk on the neurological development of a breastfed infant has not been well studied. -Large dosages of amphetamine and/or dextroamphetamine might interfere with milk production, especially in women whose lactation is not well established. Level 2: -The urinary excretion in 2 breastfed infants whose mothers took amphetamine 20 to 35 mg/day ranged from 0.1% to 2.1% of the mothers' excretion; these infants showed no signs of abnormal development. -Dextroamphetamine blood levels in 3 breastfed infants were up to 14% of the maternal plasma level. -Four breastfed infants whose mothers took an average dose of 18 mg/day dextroamphetamine had normal progress, no adverse effects, and weights between the 10th and 75th percentiles. -In a study of 20 postpartum women, dextroamphetamine reduced serum prolactin by 25% to 32% (7.5 mg IV dose) and 30% to 37% (15 mg IV dose). Another study showed a 20 mg oral dose of dextroamphetamine produced a sustained suppression of serum prolactin by 40%.

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.

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.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine and dextroamphetamine. These can make your body absorb less of the medicine.