amphetamine ER 5 mg tablet, immediate and extended release 24 hour

Generic name:
Amphetamine extended-release tablet - oral

Pronunciation
(am-FET-a-meen)

Brand name(s)
Dyanavel XR

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.

This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine 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.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for a certain sleeping disorder (narcolepsy). It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.

Read the Medication Guide provided by your pharmacist before you start taking amphetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

There are different brands and forms of this medication available. Not all have the same effects. Do not change brands or forms without consulting your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. The tablet(s) may be chewed or swallowed whole. Taking this medication late in the day may cause trouble sleeping (insomnia).

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. 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 sometimes stop the medication for a short time to see if the medication is still needed.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as severe tiredness, sleep problems, mental/mood changes like depression). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

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.

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). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if you do not get better or if you get worse.

Loss of appetite, weight loss, dry mouth, stomach upset/pain, nausea/vomiting, dizziness, headache, diarrhea, fever, nervousness, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 (such as twitching, shaking)
• outbursts of words/sounds that are hard to control
• vision changes (such as blurred vision)
• change in sexual ability/desire
• frequent/prolonged erections (in males)

Get medical help right away if you have any very serious side effects, including:

• fainting
• seizures
• severe headache
• fast/pounding/irregular heartbeat
• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• symptoms of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion)

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.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as lisdexamfetamine, dextroamphetamine); 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:

• high blood pressure
• stroke
• personal or family history of heart problems (such as irregular heartbeat, heart attack, heart failure, heart valve problem)
• blood circulation problems (such as Raynaud's disease)
• glaucoma
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• personal or family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts)
• personal or family history of uncontrolled muscle movements (such as motor tics, Tourette's syndrome)
• overactive thyroid (hyperthyroidism)
• seizures

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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, metaxalone, 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.

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).

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.

Amphetamine is very similar to dextroamphetamine and lisdexamfetamine. Do not use medications containing dextroamphetamine or lisdexamfetamine while using amphetamine.

This medication may interfere with certain medical/lab tests (such as blood and urine steroid levels, brain scan for Parkinson's disease), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe mental/mood changes, seizures, severe headache, severe restlessness, fast breathing.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as blood pressure, heart rate, growth monitoring in children) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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. Take your next dose at the regular time. Do not double the dose to catch up.

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.

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.