IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DEXTROAMPHETAMINE/AMPHETAMINE EXTENDED-RELEASE - ORAL

(DEX-troe-am-FET-a-meen/am-FET-a-meen)

COMMON BRAND NAME(S): Adderall XR

WARNING : Misuse or abuse of amphetamines may cause serious (possibly fatal) heart and blood pressure problems. Amphetamine-type medications can be habit-forming. Use only as directed. If you use this drug for a long time, you may become dependent on it and may have withdrawal symptoms after stopping the drug. Consult your doctor or pharmacist for more details. (See also How to Use section).

USES: This combination medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine/dextroamphetamine belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.Top

HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking amphetamine/dextroamphetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication after noon may cause trouble sleeping (insomnia). Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. If you have difficulty swallowing this medication whole, you may sprinkle the entire contents of a capsule on a small amount of applesauce just before taking. Swallow the mixture right away. Do not chew the mixture, and do not save it for future use. Drink a glass of liquid after each dose. The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor's instructions carefully. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. During treatment, your doctor may occasionally recommend stopping the medication for a short time to see whether there are any changes in your behavior and whether the medication is still needed. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (including severe tiredness, sleep problems, mental/mood changes such as depression) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. Tell your doctor if your condition does not improve or if it worsens.Top

SIDE EFFECTS: Loss of appetite, weight loss, dry mouth, stomach upset/pain, nausea/vomiting, dizziness, headache, diarrhea, fever, nervousness, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, abnormal thoughts, thoughts of suicide), uncontrolled movements, continuous chewing movements/teeth grinding, outbursts of words/sounds, change in sexual ability/desire, frequent/prolonged erections (in males). Get medical help right away if you have any very serious side effects, including: shortness of breath, chest/jaw/left arm pain, fainting, severe headache, fast/pounding/irregular heartbeat, seizures, weakness on one side of the body, slurred speech, confusion, swelling ankles/feet, extreme tiredness, blurred vision. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.Top

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as lisdexamfetamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud's disease), certain mental/mood conditions (such as agitation, psychosis), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), heart problems (including irregular heartbeat/rhythm, coronary artery disease, heart failure, cardiomyopathy, problems with the heart structure such as valve problems), family history of heart problems (such as sudden death/irregular heartbeat/rhythm), history of stroke, high blood pressure, overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), seizures, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of uncontrolled muscle movements (such as Tourette's syndrome), kidney disease, liver disease. This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to the side effects of this drug, especially weight loss. This medication may slow down a child's growth. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height. Consult your doctor or pharmacist for more details. Older adults may be more sensitive to the side effects of this drug, especially chest pain, trouble sleeping, or weight loss. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor right away if you notice possible mood changes, agitation, or unusual tiredness in your newborn. This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.Top

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication. Check the labels on all your medicines (such as cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using these products safely. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/ "ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Dextroamphetamine is very similar to lisdexamfetamine. Do not use medications containing lisdexamfetamine while using dextroamphetamine. This medication may interfere with certain medical/laboratory tests (including blood and urine steroid levels, brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.Top

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe mental/mood changes, seizures, severe/persistent headache, severe restlessness, fast breathing.Top

NOTES: Do not share this medication with others. It is against the law. Laboratory and/or medical tests (such as blood pressure, heart rate, growth monitoring in children) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Top

MISSED DOSE: If you miss a dose, take it as soon as you remember in the morning hours. If it is after noon or near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.Top

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Top

Information last revised June 2017. Copyright(c) 2017 First Databank, Inc.

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