Dextroamphetamine and Amphetamine (patient information)

IMPORTANT WARNING
The combination of dextroamphetamine and amphetamine can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor. If you take too much dextroamphetamine and amphetamine you may find that the medication no longer controls your symptoms, you may feel a need to take large amounts of the medication, and you may experience symptoms such as rash, difficulty falling asleep or staying asleep, irritability, hyperactivity, and unusual changes in your personality or behavior. Tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.

Do not stop taking dextroamphetamine and amphetamine without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression and extreme tiredness if you suddenly stop taking dextroamphetamine and amphetamine after overusing it.

Do not let anyone else take your medication. Store dextroamphetamine and amphetamine in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules are left so you will know if any are missing.

The combination of dextroamphetamine and amphetamine may cause sudden death or serious heart problems, especially if the medication is misused.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with dextroamphetamine and amphetamine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide.

Why this medication is prescribed
The combination of dextroamphetamine and amphetamine is used as part of a treatment program for attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age). Dextroamphetamine and amphetamine tablets are also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). The combination of dextroamphetamine and amphetamine is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain.

How this medication should be used
The combination of dextroamphetamine and amphetamine comes as a tablet and an extended-release (long acting) capsule to take by mouth. The tablet is usually taken two to three times daily with or without food. The extended-release capsule is usually taken once daily in the morning with or without food. Dextroamphetamine and amphetamine combination should not be taken in the late afternoon or evening because it may cause difficulty falling asleep or staying asleep. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dextroamphetamine and amphetamine exactly as directed.

You may swallow the extended-release capsule whole, or you may open the capsule and sprinkle the entire contents on a teaspoonful of applesauce. Swallow this mixture right away without chewing. Do not store the applesauce/medication mixture for future use, and do not divide the contents of one capsule into more than one dose.

Your doctor will probably start you on a low dose of dextroamphetamine and amphetamine and increase your dose gradually, not more often than once every week.

Your doctor may tell you to stop taking dextroamphetamine and amphetamine from time to time to see if the medication is still needed. Follow these directions carefully.

Other uses for this medicine
The combination of dextroamphetamine and amphetamine should not be used to treat excessive tiredness that is not caused by narcolepsy.

This medication may be prescribed for other conditions; ask your doctor or pharmacist for more information.

Special precautions
Before taking dextroamphetamine and amphetamine:


 * tell your doctor and pharmacist if you are allergic to amphetamine, dextroamphetamine, or any other medications.
 * tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate), or if you have stopped taking them during the past 14 days. Your doctor will probably tell you not to take dextroamphetamine and amphetamine until at least 14 days have passed since you last took an MAO inhibitor.
 * tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and herbal products you are taking. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), and terazosin (Hytrin); antacids; antidepressants ('mood elevators'), antihistamines; ascorbic acid (Vitamin C); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); chlorpromazine (Thorazine); diuretics ('water pills') such as acetazolamide (Diamox); guanethidine (Ismelin); haloperidol (Haldol); lithium (Lithobid, Eskalith); medications for high blood pressure; certain medications for seizures such as ethosuximide (Zarontin), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin); meperidine (Demerol); methenamine (Hiprex, Urex); propoxyphene (Darvon, Darvon-N); reserpine (Serpalan); sodium bicarbonate (Arm and Hammer Baking Soda, Soda Mint); and sodium phosphate. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor what nutritional supplements you are taking, especially glutamic acid (L-glutamine).
 * tell your doctor if you have glaucoma (an eye disease), hyperthyroidism (condition in which there is too much thyroid hormone in the body), or feelings of anxiety, tension, or agitation. *Your doctor may tell you not to take dextroamphetamine and amphetamine.
 * tell your doctor if anyone in your family has or has ever had an irregular heartbeat or has died suddenly. Also tell your doctor if you have recently had a heart attack and if you have or have ever had a heart defect, high blood pressure, an irregular heartbeat, heart or blood vessel disease, or other heart problems. Your doctor will probably examine you to see if your heart and blood vessels are healthy. Your doctor may tell you not to take dextroamphetamine and amphetamine if you have a heart condition or if there is a high risk that you may develop a heart condition.
 * tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), motor tics (repeated uncontrollable movements), verbal tics (repetition of sounds or words that is hard to control), or Tourette's syndrome (a condition characterized by the need to perform repeated motions or to repeat sounds or words), or has thought about or attempted suicide. Also tell your doctor if you have or have ever had mental illness, seizures, or an abnormal electroencephalogram (EEG; a test that measures electrical activity in the brain).
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dextroamphetamine and amphetamine, call your doctor. You should not breastfeed while you are taking this medication.
 * you should know that this medication may make it difficult for you to perform activities that require alertness or physical coordination. Do not drive a car or operate machinery until you know how this medication affects you.
 * you should know that dextroamphetamine and amphetamine should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.

Special dietary instructions
Talk to your doctor about drinking fruit juice while taking this medicine.

What to do if you forget a dose
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Minor side effects
Dextroamphetamine and amphetamine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:


 * nervousness
 * restlessness
 * difficulty falling asleep or staying asleep
 * uncontrollable shaking of a part of the body
 * headache
 * changes in sex drive or ability
 * dry mouth
 * stomach pain
 * nausea
 * vomiting
 * diarrhea
 * constipation
 * loss of appetite
 * weight loss
 * bad taste in mouth

Severe side effects
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:


 * fast or pounding heartbeat
 * shortness of breath
 * chest pain
 * excessive tiredness
 * slow or difficult speech
 * dizziness or faintness
 * weakness or numbness of an arm or leg
 * seizures
 * mood changes
 * motor tics or verbal tics
 * psychosis (loss of contact with reality)
 * hallucinating (seeing things or hearing voices that do not exist)
 * mania (frenzied or abnormally excited mood)
 * aggressive or hostile behavior
 * changes in vision or blurred vision
 * fever
 * blisters or rash
 * hives
 * itching
 * swelling of the eyes, face, tongue, or throat
 * difficulty breathing or swallowing
 * hoarseness

Dextroamphetamine and amphetamine may cause sudden death in children and teenagers who have heart defects or serious heart problems. This medication also may cause sudden death, heart attack or stroke in adults, especially adults with heart defects or serious heart problems. Talk to your doctor about the risks of taking this medication.

Dextroamphetamine and amphetamine may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your child's doctor about the risks of giving dextroamphetamine and amphetamine to your child.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light and excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:


 * restlessness
 * confusion
 * aggressive behavior
 * feelings of panic
 * hallucination (seeing things or hearing voices that do not exist)
 * fast breathing
 * shaking hands that you cannot control
 * fever
 * dark red or cola-colored urine
 * muscle weakness or aching
 * tirednessor weakness
 * depression
 * fast or irregular heartbeat
 * fainting
 * dizziness
 * blurred vision
 * upset stomach
 * vomiting
 * diarrhea
 * seizures
 * coma (loss of consciousness for a period of time)

Other information
Keep all your appointments with your doctor and the laboratory. Your doctor may order certain lab tests to determine your response to dextroamphetamine and amphetamine.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dextroamphetamine and amphetamine.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

Brand names

 * Adderall®