Adderall

Name: Adderall

What Is Adderall (Adderall XR)?

Adderall is the brand name of a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in children and adults.

Adderall is a combination of two stimulant drugs, amphetamine and dextroamphetamine.

Adderall XR is an extended-release form of the drug.

Doctors also prescribe Adderall (but not Adderall XR) to treat narcolepsy.

Adderall may help people with ADHD control their activities and increase their attention spans.

The drug may also prevent symptoms of narcolepsy, which include excessive sleepiness and sudden attacks of daytime sleepiness.

The Food and Drug Administration (FDA) approved Adderall in 1960. The agency also has approved the combination of amphetamine and dextroamphetamine as a generic drug.

DSM Pharmaceuticals makes the brand-name drug, and many drug companies make a generic version.

Adderall belongs to a class of drugs called central nervous system stimulants. The drug works by increasing levels of the brain chemical dopamine, which stimulates the brain.

This stimulation has a calming and focusing effect on people with ADHD.

Adderall 'High' and Abuse

Use of Adderall has surged in recent years.

Research shows that the number of ADHD medications prescribed to children increased 45 percent from 2002 to 2010.

Of these drugs, Adderall was the second most-prescribed medication.

Sales of the drug jumped more than 3,000 percent from 2002 to 2006. In 2010 alone, the total number of Adderall prescriptions topped 18 million.

One reason for the surge in Adderall prescriptions is that increasing numbers of children and teenagers are getting an ADHD diagnosis.

However, doctors also prescribe the drug to children and adults who do not have ADHD.

This increased availability of Adderall has led to widespread abuse of the medication.

Because Adderall increases dopamine levels, it can trigger a feeling of euphoria among people who don't have a medical reason to take it.

As a result, it has become a drug of choice among people trying to get "high," who often crush and snort the pills or mix them water and inject them.

Because stimulants like Adderall increase alertness and attention, a growing number of people who do not have an ADHD diagnosis are using the drug to enhance their ability to think and focus.

This off-label use of Adderall is a growing trend, particularly among high school and college students who are trying to study for exams or boost their academic performance.

Stimulants like Adderall, sometimes called “smart pills,” are currently the second most common form of drug use on college campuses.

Despite the widespread belief that Adderall can improve a person's ability to learn, the drug does not enhance thinking ability in people who do not have ADHD.

Young people who do not have ADHD but are taking Adderall to get better grades in school or gain an academic advantage are at risk for potentially deadly side effects.

Adderall and Weight Loss

Adderall also can suppress appetite, and a growing number of people who want to lose weight also abuse the drug as a diet pill.

However, using Adderall or Adderall XR for weight loss can result in severe side effects, including psychosis, addiction, stroke, cardiac arrest, and death.

Adderall Warnings

Adderall can increase your risk for heart problems, high blood pressure, and stroke.

If the person taking Adderall has a history of a heart defect or other heart problems, there is a risk for sudden death.

Doctors need to check children for any heart problems before prescribing Adderall.

Adderall may increase your risk for mental health problems, including depression, bipolar disorder, and unusual behaviors including aggressive or hostile behavior.

Children on Adderall also may develop psychotic symptoms, which include seeing things that are not there (hallucinations) and believing things that are not true (delusions).

Adderall may be habit-forming. This is more likely if you take Adderall in larger doses, more often, or for longer than recommended by your doctor.

You may need to take increasingly greater doses to control symptoms, but taking larger doses increases your risk for heart and mental health problems.

Children younger than 3 should not take Adderall, and children younger than 6 should not take Adderall XR.

Always tell your doctor if you have allergies to any medications. Let your doctor know about any:

  • Reactions you have had to other stimulants
  • Family history of heart problems, high blood pressure, or stroke
  • Family history of mental problems
  • Previous drug or alcohol abuse

Several other conditions your doctor will need to be aware of before prescribing Adderall for you include any history of:

  • Hyperthyroidism
  • Glaucoma or any eye problems
  • Anxiety
  • Tourette’s syndrome or any sudden, uncontrolled movements
  • Seizures
  • Liver disease
  • Kidney disease

If your child is taking Adderall, you should talk to the doctor about the risk for delayed growth.

Some stimulants may delay growth and development in children. A doctor will need to check your child regularly while the child is on Adderall.

It's also important confirm a diagnosis of ADHD before treating a child with Adderall.

Sometimes, poor school performance or behavioral issues are symptoms of other problems that need treatment, such as trauma, dyslexia, or mental illness.

Medical experts do not know whether Adderall is safe for elderly people.

If you are older than 65, ask your doctor whether there are other drug options that might be safer for you.

Adderall Withdrawal

If you suddenly stop taking Adderall, you may have Adderall withdrawal symptoms, also known as an "Adderall crash."

Symptoms of Adderall withdrawal can include depression, insomnia or other sleep disorders, irritability, and extreme fatigue.

You are at higher risk for Adderall addiction if you have abused drugs or alcohol in the past.

Adderall withdrawal can be managed with help from your doctor, who may advise you to slowly taper off your use of the drug.

Adderall and Pregnancy

Adderall might be unsafe to take during pregnancy.

Because of this, talk with your doctor before starting Adderall if you are pregnant or may become pregnant, and call your doctor right away if you get pregnant while on Adderall.

Also, do not take Adderall while breastfeeding because the drug can pass through breast milk to a breastfeeding baby.

Interactions for Adderall

Inhibits MAO.a c

Amphetamine or metabolites modestly inhibit CYP2D6, 1A2, and 3A4 in vitro.a c In vivo effects on metabolism of drugs metabolized by CYP isoenzymes not known.a c

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Acidifying agents, GI (ascorbic acid, glutamic acid hydrochloride, reserpine)

Decreases absorption, serum concentrations, and efficacy of amphetaminesa c

Acidifying agents, urinary (ammonium chloride, sodium acid phosphate)

Increases urinary excretion and decreases serum concentrations and efficacy of amphetaminesa c

Adrenergic blockers

Potential inhibition of adrenergic blockadea c

Alkalinizing agents, GI (antacids, sodium bicarbonate)

Increases absorption and serum concentrations and potentiates the effects of amphetaminesa c

Avoid concomitant usea c

Alkalinizing agents, urinary (acetazolamide and some thiazides)

Decreases urinary excretion and increases serum concentrations and potentiates the effects of amphetaminesa c

Antidepressants, tricyclic (desipramine, protriptyline)

Enhanced activity of tricyclic antidepressants; desipramine or protriptyline cause striking and sustained increases in the concentration of dextroamphetamine in the brain; cardiovascular effects can be potentiateda c

Antihistamines

May counteract the sedative effects of antihistaminesa c

Antihypertensives

May antagonize the hypotensive effects of antihypertensivesa c

Chlorpromazine

Inhibits the central stimulant effects of amphetamines by blocking dopamine and norepinephrine receptorsa c

Can be used to treat amphetamine poisoninga d

Ethosuximide

Intestinal absorption may be delayed by amphetaminesa c

Haloperidol

Inhibits the central stimulant effects of amphetamines by blocking dopamine receptorsa c

Lithium carbonate

May inhibit the anorectic and stimulatory effects of amphetaminea c

MAO inhibitors

Slow the metabolism of amphetamines, increasing their effect on the release of norepinephrine and other monoamines leading to headaches and other signs of hypertensive crisisa c

Toxic neurologic effects, hypertensive crisis, and malignant hyperpyrexia can occur, sometimes with fatal resultsa c

Amphetamines contraindicated in patients currently or recently (within 14 days) receiving MAO inhibitora c d e

Meperidine

Amphetamines potentiate the analgesic effect of meperidinea c

Methenamine

Acidifying agents used with methenamine increase urinary excretion and decrease efficacy of amphetaminesa c

Norepinephrine

Amphetamines enhance the adrenergic effects of norepinephrinea c

Phenobarbital

Amphetamines may delay absorption of phenobarbital; concomitant use may produce a synergistic anticonvulsant actiona c

Phenytoin

Amphetamines may delay absorption of phenytoin; concomitant use may produce a synergistic anticonvulsant actiona c

Propoxyphene

In propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occura c

Sympathomimetic agents

Enhanced activity of sympathomimetic agentsa c

Test, plasma corticosteroids

Can elevate plasma corticosteroid concentrations; this increase is greatest in the eveninga c

Test, urinary steroids

May interfere with urinary steroid determinationsa c

Veratrum alkaloids

Amphetamines inhibit the hypotensive effect of veratruma c

Proper Use of dextroamphetamine and amphetamine

This section provides information on the proper use of a number of products that contain dextroamphetamine and amphetamine. It may not be specific to Adderall. Please read with care.

Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much, the medicine may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Talk to your doctor or pharmacist if you have any questions.

If you think this medicine is not working properly after you have taken it for several weeks, do not increase the dose and check with your doctor.

Take the regular tablet in the morning and early afternoon. If you take the tablet in the evening, you may have trouble falling asleep at night.

If you are using the extended-release capsule:

  • Swallow the capsule whole with water or other liquids. Do not crush, break, or chew it.
  • Take the capsule in the morning right after you wake up. If you take it in the afternoon or evening, you may have trouble falling asleep at night.
  • You may take the capsule with or without food, but make sure to take it the same way each time.
  • If you cannot swallow the capsule, carefully open it and sprinkle the small beads over a spoonful of applesauce. Swallow the mixture right away without chewing. Do not store the mixture for future use. Do not crush or chew the beads from the capsule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For attention deficit hyperactivity disorder (ADHD):
    • For oral dosage form (Adderall XR® extended-release capsules):
      • Adults—20 milligrams (mg) once a day in the morning. Your doctor may adjust your dose if needed.
      • Children 13 to 17 years of age—At first, 10 mg once a day in the morning. Your doctor may adjust your dose if needed.
      • Children 6 to 12 years of age—At first, 10 mg once a day in the morning. Your doctor may adjust your dose if needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (Mydayis™ extended-release capsules):
      • Adults—At first, 12.5 milligrams (mg) once a day in the morning right after you wake up. Your doctor may adjust your dose if needed. However, the dose is usually not more than 50 mg per day.
      • Children 13 to 17 years of age—At first, 12.5 mg once a day in the morning. Your doctor may adjust your dose if needed. However, the dose is usually not more than 25 mg per day.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (Adderall® tablets):
      • Adults and children 6 years of age and older—At first, 5 milligrams (mg) given 1 or 2 times a day. Your doctor may adjust your dose if needed.
      • Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may adjust your dose if needed.
      • Children younger than 3 years of age—Use is not recommended.
  • For narcolepsy:
    • For oral dosage form (Adderall® tablets):
      • Adults and children 12 years of age and older—At first, 10 milligrams (mg) per day, divided and given into 2 doses. Your doctor may adjust your dose if needed.
      • Children 6 to 12 years of age—At first, 5 mg per day. Your doctor may adjust your dose if needed.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Uses of Adderall

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

Adderall - Clinical Pharmacology

Pharmacodynamics

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Pharmacokinetics

Adderall® tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of Adderall® to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine. The mean elimination half-life (t1/2) for d-amphetamine was shorter than the t1/2 of the l-isomer (9.77 to 11 hours vs. 11.5 to 13.8 hours). The PK parameters (Cmax, AUC0-inf) of d-and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics.

The effect of food on the bioavailability of Adderall® has not been studied.

Metabolism and Excretion

Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain α or β carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility.

Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made.

With normal urine pHs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine and approximately another 30% to 40% of the dose is recoverable in urine as amphetamine itself. Since amphetamine has a pKa of 9.9, urinary recovery of amphetamine is highly dependent on pH and urine flow rates. Alkaline urine pHs result in less ionization and reduced renal elimination, and acidic pHs and high flow rates result in increased renal elimination with clearances greater than glomerular filtration rates, indicating the involvement of active secretion. Urinary recovery of amphetamine has been reported to range from 1% to 75%, depending on urinary pH, with the remaining fraction of the dose hepatically metabolized. Consequently, both hepatic and renal dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. In addition, drugs that affect urinary pH are known to alter the elimination of amphetamine, and any decrease in amphetamine’s metabolism that might occur due to drug interactions or genetic polymorphisms is more likely to be clinically significant when renal elimination is decreased (see PRECAUTIONS).

Contraindications

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

Adderall Dosage and Administration

Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.

Attention Deficit Hyperactivity Disorder

Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Narcolepsy

Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

What is Adderall?

Adderall contains a combination of amphetamine and dextroamphetamine. Amphetamine and dextroamphetamine are central nervous system stimulants that affect chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Adderall is used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD).

Adderall may also be used for purposes not listed in this medication guide.

Before taking this medicine

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You may not be able to use Adderall if you are allergic to any stimulant medicine. You may not be able to use Adderall if you have:

  • high blood pressure, heart disease, coronary artery disease (hardened arteries);

  • overactive thyroid;

  • glaucoma;

  • severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or

  • a history of drug or alcohol addiction.

Some medicines can interact with amphetamine and dextroamphetamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

  • heart problems or a congenital heart defect;

  • high blood pressure; or

  • a family history of heart disease or sudden death.

To make sure Adderall is safe for you, tell your doctor if you or anyone in your family has ever had:

  • depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

  • motor tics (muscle twitches) or Tourette's syndrome;

  • seizures or epilepsy;

  • an abnormal brain wave test (EEG); or

  • blood circulation problems in the hands or feet.

Taking Adderall during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amphetamine and dextroamphetamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medicine.

Adderall is not approved for use by anyone younger than 6 years old.

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.

What should I avoid while taking Adderall?

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 Adderall. These can make your body absorb less of the medicine.

Tips

  • Take in the morning if using once daily. If using twice daily, avoid late evening dosages to reduce the risk of insomnia.
  • May be taken with or without food.
  • Take exactly as directed by your doctor and never increase the dosage without his or her advice.
  • Ensure your child partakes in other psychological, educational, or social treatment measures as recommended by your doctor as these are also an important part of ADHD treatment.
  • Do not suddenly stop taking Adderall, unless it is an emergency. Sudden discontinuation may precipitate a withdrawal reaction. Symptoms include extreme tiredness, depression, or agitation.
  • Seek medical advice if symptoms persist or worsen despite treatment, or if psychotic symptoms (such as hearing voices or signs of paranoia) or hallucinations develop.
  • Seek urgent medical help if you experience chest pain, shortness of breath or fainting while taking Adderall or other worrying symptoms such as unexplained nausea or vomiting or a fast heartbeat.
  • Do not drive or operate machinery if Adderall impairs your judgment or reaction skills. Alcohol may contribute to these effects and should be avoided.
  • Seek medical advice if any new numbness, pain, skin color change, sensitivity or unexplained wounds occur in your fingers or toes.

Amphetamine and dextroamphetamine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;

  • signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;

  • signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;

  • a seizure (convulsions);

  • muscle twitches (tics); or

  • changes in your vision.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Amphetamine and dextroamphetamine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • stomach pain, loss of appetite;

  • weight loss;

  • mood changes, feeling nervous;

  • fast heart rate;

  • headache, dizziness;

  • sleep problems (insomnia); or

  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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