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|Amphetamine/Dextroamphetamine Extended-Release Capsules

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Amphetamine/Dextroamphetamine Extended-Release Capsules

Generic Name: Amphetamine/Dextroamphetamine Extended-Release Capsules (am-FET-a-meen/dex-troe-am-FET-a-meen)
Brand Name: Adderall XR

Amphetamine/Dextroamphetamine Extended-Release Capsules has a high potential for abuse and may be habit forming if used for a long period of time. Use Amphetamine/Dextroamphetamine Extended-Release Capsules only as prescribed and do not share it with others. Abuse of Amphetamine/Dextroamphetamine Extended-Release Capsules may cause serious heart problems, blood vessel problems, or sudden death.

Amphetamine/Dextroamphetamine Extended-Release Capsules is used for:

Treating attention-deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.

Amphetamine/Dextroamphetamine Extended-Release Capsules is an amphetamine. The exact way it works is unknown. Amphetamine/Dextroamphetamine Extended-Release Capsules affects certain chemicals in the brain that may affect attention span and behavior.

Do NOT use Amphetamine/Dextroamphetamine Extended-Release Capsules if:

you are allergic to any ingredient in this medicine or to similar medicines
you have severe hardening of the arteries; active heart or blood vessel disease; moderate, severe, or uncontrolled high blood pressure; high blood pressure in the lungs; anorexia; an overactive thyroid; glaucoma; or agitation, anxiety, or tension
you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
you have a history of alcohol or other substance abuse

Contact your doctor or health care provider right away if any of these apply to you.

Before using Amphetamine/Dextroamphetamine Extended-Release Capsules:

Some medical conditions may interact with Amphetamine/Dextroamphetamine Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of mental or mood problems, growth problems, thyroid problems, heart problems or abnormalities, birth defects, high blood pressure, uncontrolled muscle movements (eg, tics), Tourette syndrome, certain blood problems (eg, porphyria), hardening of the arteries, or blood vessel problems

Some MEDICINES MAY INTERACT with Amphetamine/Dextroamphetamine Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Glutamic acid, haloperidol, lithium carbonate, phenothiazines (eg, chlorpromazine), reserpine, urinary acidifiers (eg, methenamine, ammonium chloride), or vitamin C (ascorbic acid) because they may decrease Amphetamine/Dextroamphetamine Extended-Release Capsules"s effectiveness
Alkalinizing agents (eg, daily antacids, sodium bicarbonate, acetazolamide), furazolidone , MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, desipramine, protriptyline) because side effects such as increased blood pressure, headache, fever, and irregular heartbeat may occur
Propoxyphene because it may increase the risk of Amphetamine/Dextroamphetamine Extended-Release Capsules"s side effects
Meperidine, norepinephrine, selective serotonin reuptake inhibitors (eg, fluoxetine), or tramadol because the risk of their side effects may be increased by Amphetamine/Dextroamphetamine Extended-Release Capsules
Alpha blockers (eg, prazosin), antihistamines (eg, diphenhydramine), ethosuximide, guanadrel, guanethidine, medicines for high blood pressure, phenobarbital, or phenytoin because their effectiveness may be decreased by Amphetamine/Dextroamphetamine Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amphetamine/Dextroamphetamine Extended-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Amphetamine/Dextroamphetamine Extended-Release Capsules:

Use Amphetamine/Dextroamphetamine Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Amphetamine/Dextroamphetamine Extended-Release Capsules by mouth with or without food.
Swallow Amphetamine/Dextroamphetamine Extended-Release Capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
Do not take an antacid within 1 hour before or 2 hours after you take Amphetamine/Dextroamphetamine Extended-Release Capsules.
Take Amphetamine/Dextroamphetamine Extended-Release Capsules soon after you wake up in the morning. Avoid taking Amphetamine/Dextroamphetamine Extended-Release Capsules in the afternoon to decrease trouble sleeping at night, unless your doctor tells you differently.
If you miss a dose of Amphetamine/Dextroamphetamine Extended-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Amphetamine/Dextroamphetamine Extended-Release Capsules.

Important safety information:

Amphetamine/Dextroamphetamine Extended-Release Capsules may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Amphetamine/Dextroamphetamine Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Certain foods and medicines can affect the amount of acid in your stomach/intestine and increase or decrease (depending on the medicine) the absorption of Amphetamine/Dextroamphetamine Extended-Release Capsules. Tell your doctor if you take any of these products: fruit juice, ascorbic acid (vitamin C), sodium bicarbonate, ammonium chloride, sodium acid phosphate, ulcer medicines (eg, H₂ blockers such as famotidine and ranitidine, proton pump inhibitors such as omeprazole and lansoprazole), antacids, methenamine, or acetazolamide.
Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
Tell your doctor or dentist that you take Amphetamine/Dextroamphetamine Extended-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
Amphetamine/Dextroamphetamine Extended-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Amphetamine/Dextroamphetamine Extended-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Amphetamine/Dextroamphetamine Extended-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Amphetamine/Dextroamphetamine Extended-Release Capsules.
Lab tests, including blood pressure, pulse, and growth rate, may be performed while you use Amphetamine/Dextroamphetamine Extended-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Amphetamine/Dextroamphetamine Extended-Release Capsules should be used with extreme caution in CHILDREN younger than 6 years old. Amphetamine/Dextroamphetamine Extended-Release Capsules should not be used in CHILDREN younger than 3 years old. Safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Amphetamine/Dextroamphetamine Extended-Release Capsules may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amphetamine/Dextroamphetamine Extended-Release Capsules while you are pregnant. Amphetamine/Dextroamphetamine Extended-Release Capsules is found in breast milk. Do not breast-feed while taking Amphetamine/Dextroamphetamine Extended-Release Capsules.

When used for long periods of time or at high doses, Amphetamine/Dextroamphetamine Extended-Release Capsules may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Amphetamine/Dextroamphetamine Extended-Release Capsules stops working well. Do not take more than prescribed.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Amphetamine/Dextroamphetamine Extended-Release Capsules. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Amphetamine/Dextroamphetamine Extended-Release Capsules. If you do, you may have WITHDRAWAL symptoms. These may include feeling unwell or unhappy, anxious or irritable, dizzy, confused, or sluggish. You may also have nausea, unusual skin sensations, mood swings, headache, trouble sleeping, or sweating. If you need to stop Amphetamine/Dextroamphetamine Extended-Release Capsules, your doctor will lower your dose over time.

Possible side effects of Amphetamine/Dextroamphetamine Extended-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; difficulty sleeping; dizziness; dry mouth; headache; loss of appetite; nausea; nervousness; restlessness; stomach pain or upset; unpleasant taste; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; change in sexual ability or desire; chest pain; confusion; depression; fast or irregular heartbeat; fever; growth suppression; mental/mood changes; numbness or tingling in an arm or leg; one-sided weakness; painful or frequent urination; seizures; severe headache; severe stomach pain; severe weight loss; sudden severe dizziness, fainting, or vomiting; uncontrolled muscle movement; unusual weakness or tiredness; vision or speech changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; fast breathing; fever; hallucinations; irregular heartbeat; muscle pain or tenderness; severe mental/mood changes; severe or persistent headache; severe restlessness.

Proper storage of Amphetamine/Dextroamphetamine Extended-Release Capsules:

Store Amphetamine/Dextroamphetamine Extended-Release Capsules at room temperature, 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, light, and moisture. Keep Amphetamine/Dextroamphetamine Extended-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Amphetamine/Dextroamphetamine Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Amphetamine/Dextroamphetamine Extended-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Amphetamine/Dextroamphetamine Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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