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Dextroamphetamine Sustained-Release Capsules is used for:

Treating attention deficit disorders with hyperactivity in children. It is also used to treat a type of sleep disorder (narcolepsy). It may also be used for other conditions as determined by your doctor.

Dextroamphetamine Sustained-Release Capsules is an amphetamine. Exactly how Dextroamphetamine Sustained-Release Capsules works is not known. It affects certain chemicals in the brain that may help improve attention span, behavior, and certain sleep disorders.

Do NOT use Dextroamphetamine Sustained-Release Capsules if:

• you are allergic to any ingredient in Dextroamphetamine Sustained-Release Capsules 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 take guanethidine or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (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 Dextroamphetamine Sustained-Release Capsules:

Some medical conditions may interact with Dextroamphetamine Sustained-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 or a family member have a history of mental or mood problems (eg, bipolar disorder, depression, psychosis), uncontrolled muscle movements (eg, tics), Tourette syndrome, or suicidal thoughts or attempts
• if you have a history of seizures, growth problems, thyroid problems, heart problems (eg, heart failure, heart rhythm problems), birth defects, high blood pressure, certain blood problems (eg, porphyria), hardening of the arteries, or blood vessel problems, or you have had a recent heart attack
• if you have a family history of sudden death or heart rhythm problems

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

• Furazolidone, MAOIs (eg, phenelzine), or propoxyphene because the risk of high blood pressure, dizziness, and decreased heart rate may be increased
• Ammonium chloride, ascorbic acid (vitamin C), chlorpromazine, glutamic acid, haloperidol, lithium carbonate, methenamine, reserpine, or sodium acid phosphate because they may decrease Dextroamphetamine Sustained-Release Capsules's effectiveness
• Acetazolamide, sodium bicarbonate, or thiazide diuretics (eg, hydrochlorothiazide) because they may increase the risk of Dextroamphetamine Sustained-Release Capsules's side effects
• Meperidine, norepinephrine, phenobarbital, phenytoin, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), tramadol, or tricyclic antidepressants (eg, desipramine) because the risk of their side effects may be increased by Dextroamphetamine Sustained-Release Capsules
• Antihistamines (eg, diphenhydramine), beta-blockers (eg, atenolol), certain blood pressure medicines, ethosuximide, or guanethidine because their effectiveness may be decreased by Dextroamphetamine Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dextroamphetamine Sustained-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 Dextroamphetamine Sustained-Release Capsules:

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

• Dextroamphetamine Sustained-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dextroamphetamine Sustained-Release Capsules refilled.
• Take Dextroamphetamine Sustained-Release Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Dextroamphetamine Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
• Do not drink fruit juice at the same time that you take Dextroamphetamine Sustained-Release Capsules. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Dextroamphetamine Sustained-Release Capsules's effectiveness.
• If you miss a dose of Dextroamphetamine Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Dextroamphetamine Sustained-Release Capsules.

Important safety information:

• Dextroamphetamine Sustained-Release Capsules may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Dextroamphetamine Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose or take for longer than prescribed without checking with your doctor.
• Dextroamphetamine Sustained-Release Capsules may cause sleeplessness. Do not take Dextroamphetamine Sustained-Release Capsules near your bedtime unless your doctor tells you otherwise.
• Avoid large amounts of caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate. Caffeine may increase the side effects of Dextroamphetamine Sustained-Release Capsules.
• Tell your doctor or dentist that you take Dextroamphetamine Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
• Dextroamphetamine Sustained-Release Capsules may interfere with certain lab tests, including corticosteroid levels. Be sure your doctor and lab personnel know you are taking Dextroamphetamine Sustained-Release Capsules.
• Dextroamphetamine Sustained-Release Capsules should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
• Dextroamphetamine Sustained-Release Capsules may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Dextroamphetamine Sustained-Release Capsules.
• PREGNANCY and BREAST-FEEDING: It is not known if Dextroamphetamine Sustained-Release Capsules can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dextroamphetamine Sustained-Release Capsules while you are pregnant. Dextroamphetamine Sustained-Release Capsules is found in breast milk. Do not breast-feed while taking Dextroamphetamine Sustained-Release Capsules.

Some people who use Dextroamphetamine Sustained-Release Capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Dextroamphetamine Sustained-Release Capsules, you may experience WITHDRAWAL symptoms. These may include severe or unusual sadness, agitation, or fatigue.

Possible side effects of Dextroamphetamine Sustained-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; trouble sleeping; unpleasant taste; upset stomach; weight loss.

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; fainting; fast or irregular heartbeat; fever; mental or mood changes; severe headache; stomach pain; tremor; uncontrolled speech or muscle movements (eg, tics); unusual weakness or tiredness; vomiting.

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 aggressiveness; coma; confusion; depression; fast breathing; fatigue; fever; hallucinations; increased reflexes; irregular heartbeat; muscle pain; panic; restlessness; seizures; severe dizziness; severe or persistent nausea, vomiting, or diarrhea; stomach pain; tremor.

Store Dextroamphetamine Sustained-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep in a tightly closed container. Do not store in the bathroom. Keep Dextroamphetamine Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Dextroamphetamine Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Dextroamphetamine Sustained-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 Dextroamphetamine Sustained-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.