Evekeo (Amphetamine Sulfate)

Arbor Pharmaceuticals, Inc.

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CNS Stimulants

ADHD

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 medication is also used to treat a certain sleeping disorder (narcolepsy) to help you stay awake during the day. It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder. Amphetamine may also be used along with a doctor-approved, reduced-calorie diet to help significantly overweight (obese) people lose weight. It should only be used for a short time (a few weeks) in people who have not lost enough weight with other treatments (such as dieting, other drugs, group programs). It may work by decreasing your appetite.

Read the Medication Guide provided by your pharmacist before you start using amphetamine 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 1 to 3 times a day. The first dose is usually taken when you wake up in the morning. If more doses are prescribed, take them as directed by your doctor, usually 4 to 6 hours apart. If you are using this medication for weight loss, take it as directed by your doctor, usually 30 to 60 minutes before each meal. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not take this medication late in the evening because it may cause you to have trouble sleeping (insomnia). 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 (such as extreme tiredness, mental/mood changes such as agitation or 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. 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. Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Nausea, stomach upset, diarrhea, dry mouth, headache, nervousness, dizziness, trouble sleeping, loss of appetite, weight loss, irritability, or restlessness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. 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, thoughts of suicide, hallucinations, abnormal thoughts/behavior), uncontrolled muscle movements (such as twitching, shaking), outbursts of words/sounds, swelling ankles/feet, extreme tiredness, change in sexual ability/interest, frequent/prolonged erections (in males), vision changes (such as blurred vision). Get medical help right away if you have any very serious side effects, including: fainting, severe headache, fast/pounding/irregular heartbeat, seizures, 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). 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.

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, 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, NSAIDs such as ibuprofen/naproxen) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely. Amphetamine is very similar to dextroamphetamine or lisdexamfetamine. Do not use medications containing dextroamphetamine or lisdexamfetamine while using amphetamine. 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.

Symptoms of overdose may include: severe mental/mood changes, seizures, severe/persistent headache, severe restlessness, fast breathing. 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.

If you miss a dose, take it as soon as you remember. If it is late in the afternoon 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.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.