Amphetamine/ dextroamphetamine extended-release capsules
Generic Name: amphetamine and dextroamphetamine (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 are 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 are an amphetamine. Exactly how it works is not known. 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 amphetamine/dextroamphetamine extended-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; an overactive thyroid; glaucoma; or agitation, anxiety, or tension
- you have serious heart problems (eg, heart defect, irregular heartbeat)
- you have a history of alcohol or other substance abuse
- you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
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 heart problems (eg, heart failure, heart defects, fast or irregular heartbeat), a recent heart attack, high blood pressure, hardening of the arteries, or blood vessel problems, or if a family member has a history of any of these problems or sudden death
- if you have a history of liver or kidney problems, growth problems, thyroid problems, uncontrolled muscle movements (eg, tics), Tourette syndrome, anorexia, or the blood disease porphyria
- if you have a history of seizures or abnormal electroencephalograms (EEGs)
- if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems
- if you have circulation problems in your hands or feet (eg, Raynaud phenomenon, thromboangiitis obliterans)
- if you participate in strenuous exercise or activities
- if you take other medicines for ADHD
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:
- Furazolidone or MAOIs (eg, phenelzine) because side effects, such as increased blood pressure, headache, fever, and irregular heartbeat, may occur
- Alkalinizing agents (eg, antacids, sodium bicarbonate, acetazolamide), decongestants (eg, pseudoephedrine), proton pump inhibitors (PPIs) (eg, lansoprazole, omeprazole), propoxyphene, or sympathomimetic medicines (eg, albuterol) because they may increase the risk of amphetamine/dextroamphetamine extended-release capsules's side effects
- 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
- Meperidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), tramadol, or tricyclic antidepressants (eg, desipramine) because the risk of their side effects may be increased by amphetamine/dextroamphetamine extended-release capsules
- Alpha-blockers (eg, prazosin), antihistamines (eg, diphenhydramine), beta-blockers (eg, metoprolol), 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.
- Amphetamine/dextroamphetamine extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get amphetamine/dextroamphetamine extended-release capsules refilled.
- 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 drinking a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
- Take amphetamine/dextroamphetamine extended-release capsules soon after you wake up in the morning. To decrease the possibility of having trouble sleeping at night, avoid taking amphetamine/dextroamphetamine extended-release capsules in the afternoon, unless your doctor tells you differently.
- Do not take antacids (eg, calcium carbonate) or certain alkalinizing agents (eg, sodium bicarbonate) with amphetamine/dextroamphetamine extended-release capsules without first talking with your doctor. They may increase the risk of amphetamine/dextroamphetamine extended-release capsules's side effects.
- If you miss a dose of amphetamine/dextroamphetamine extended-release capsules, take it as soon as possible if you remember that morning. If it is past noon, 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, drowsiness, or blurred vision. 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.
- Amphetamine/dextroamphetamine extended-release capsules should be used as a part of an ADHD treatment program that includes a variety of treatment measures (eg, psychological, educational, social).
- Certain foods and medicines can affect the amount of acid in your stomach and intestine. This can 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 [eg, famotidine, ranitidine], PPIs [eg, omeprazole, lansoprazole]), antacids, methenamine, or acetazolamide.
- Serious effects, including a heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious problem, talk with your doctor about other therapies to treat your condition.
- Amphetamine/dextroamphetamine extended-release capsules may cause circulation problems in the hands and feet. Tell your doctor if you have any numbness, pain, tingling, cold feeling, or skin color change (eg, from pale to blue or red) in your hands or feet. Call your doctor right away if you have any unexplained sores or wounds on your fingers or toes.
- Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).
- Before you start any new medicine, check the label to see if it has a decongestant in it. If it does or if you are not sure, check with your doctor or pharmacist.
- 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 heart function, 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; safety and effectiveness in these children have not been confirmed.
- Amphetamine/dextroamphetamine extended-release capsules may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take amphetamine/dextroamphetamine extended-release capsules.
- 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 taking amphetamine/dextroamphetamine extended-release capsules while you are pregnant. Amphetamine/dextroamphetamine extended-release capsules are 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; dry mouth; headache; loss of appetite; nausea; nervousness; restlessness; stomach pain or upset; trouble sleeping; unpleasant taste; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision problems; change in sexual ability or desire; chest, jaw, or arm pain; confusion; dark urine; decreased urination; erections that happen often or that last a long time; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; muscle pain or weakness; new or worsening mental, mood, or behavior problems (eg, abnormal thoughts, aggression, agitation, anxiety, delusions, depression, hostility); one-sided weakness; painful or frequent urination; red, swollen, peeling, or blistered skin; seizures; severe or persistent headache; severe stomach pain; severe weight loss; shortness of breath; slurred speech; sudden, severe nausea or vomiting; uncontrolled muscle movement; unusual sweating; unusual weakness or tiredness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of amphetamine/dextroamphetamine extended-release capsules:
Store amphetamine/dextroamphetamine extended-release capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep amphetamine/dextroamphetamine extended-release capsules out of the reach of children and away from pets.
- 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 are 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take amphetamine/dextroamphetamine extended-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about amphetamine/dextroamphetamine extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to amphetamine/dextroamphetamine extended-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using amphetamine/dextroamphetamine extended-release capsules.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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- Amphetamine and dextroamphetamine extended-release capsules
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