Evekeo

Using this medicine improperly can cause death or serious side effects on the heart.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Amphetamine may be habit-forming. Never share amphetamine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

You may take amphetamine with or without food. It is best to take this medicine first thing in the morning.

If your doctor changes your brand, strength, or type of stimulant medicine, your dosage needs may change. Use only the brand of this medicine your doctor has prescribed.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To take the null (Adzenys XR-ODT):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
• Use dry hands to remove the tablet and place it in your mouth.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

While using this medicine, your doctor will need to check your progress at regular visits. Your heart rate, blood pressure, height and weight may also need to be checked often.

Amphetamine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Keep track of the amount of medicine used from each new bottle. Amphetamine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Throw away unused or expired amphetamine in a sealed container or bag. Ask your pharmacist where to locate a community pharmaceutical take back disposal program.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine could be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Other overdose symptoms include nausea, vomiting, diarrhea, stomach pain, fainting, seizure (convulsions), or coma.

Take the missed dose as soon as you remember, but not late in the day or you could have trouble sleeping. Skip the missed dose if it is almost evening. Do not take extra medicine to make up the missed dose.

You should not use amphetamine if you are allergic to any stimulant medicine, or if you have:

• moderate to severe high blood pressure;

• overactive thyroid;

• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or

• a history of drug or alcohol addiction.

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Some medicines can interact with amphetamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

To make sure amphetamine is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• problems with drug or alcohol abuse;

• motor tics (muscle twitches) or Tourette's syndrome;

• kidney disease;

• a thyroid disorder;

• seizures or epilepsy;

• an abnormal brain wave test (EEG);

• coronary artery disease (clogged arteries); or

• blood circulation problems in the hands or feet.

It is not known whether this medicine will harm an unborn baby. However, taking the medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amphetamine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Amphetamine is not approved for use by anyone younger than 6 years old.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Amphetamine may be habit-forming. Never share amphetamine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take amphetamine with or without food, first thing in the morning.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

If your doctor changes your brand, strength, or type of stimulant medicine, your dosage needs may change. Use only the brand of this medicine your doctor has prescribed.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To take the orally disintegrating tablet (Adzenys XR-ODT):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.

• Use dry hands to remove the tablet and place it in your mouth.

• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

While using this medicine, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Keep track of your medicine. Amphetamine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Amphetamine is used to treat narcolepsy (sleep disorder). It is also used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Amphetamine is also used for weight reduction in obese patients.

Amphetamine works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with a doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine tablets in children with obesity who are younger than 12 years of age, in children with narcolepsy who are younger than 6 years of age, and in children with ADHD who are younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine extended-release oral suspension and extended-release oral disintegrating tablets in children with ADHD who are younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of amphetamine tablets in geriatric patients.

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine extended-release oral suspension and extended-release oral disintegrating tablets in the geriatric population. Safety and efficacy have not been established.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone
• Acetazolamide
• Alfentanil
• Almotriptan
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Benzthiazide
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cinacalcet
• Citalopram
• Clomipramine
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Ethylmorphine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Ketobemidone
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Methadone
• Milnacipran
• Mirabegron
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Polythiazide
• Protriptyline
• Quinidine
• Quinine
• Remifentanil
• Rizatriptan
• Rolapitant
• Sertraline
• Sodium Bicarbonate
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Terbinafine
• Tianeptine
• Tilidine
• Tramadol
• Trazodone
• Trichlormethiazide
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zolmitriptan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Guanethidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Agitation, severe or
• Arteriosclerosis (hardening of the arteries), severe or
• Drug abuse, history of or
• Heart attack, recent or
• Heart failure or
• Heart or blood vessel disease (eg, cardiomyopathy, coronary artery disease) or
• Heart rhythm problems (eg, arrhythmia, ventricular arrhythmia) or
• Hypertension (high blood pressure), moderate to severe or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of—Should not be used in patients with these conditions.

• Bipolar disorder (manic-depressive illness), or a family history of or
• Blood vessel problems (eg, Raynaud disease) or
• Depression, or a family history of or
• Hypertension (high blood pressure), mild or
• Psychosis (mental illness), history of or
• Seizures, history of or
• Tourette syndrome, or family history of—Use with caution. May make these conditions worse.

• If you have an allergy to Evekeo or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you or a family member have any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette's syndrome or tics.
• If you have any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
• If you have ever had any of these health problems: Drug abuse or stroke.
• If you are taking acetazolamide.
• If you are taking sodium bicarbonate.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Evekeo within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Evekeo.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Dry mouth.
• Not hungry.
• Not able to sleep.
• Hard stools (constipation).
• Headache.
• Weight loss.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Bad taste in your mouth.
• Feeling nervous and excitable.
• Restlessness.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Evekeo is a Schedule II controlled substance. Amphetamines have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to many times the recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines include severe dermatosis, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.

Read this Medication Guide before you or your child starts taking Evekeo and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about you or your child's treatment.

What is Evekeo?

• Evekeo is a central nervous system stimulant prescription medicine used for the treatment of:
  • a sleep disorder called narcolepsy.
  • Attention-Deficit Hyperactivity Disorder (ADHD).

    Evekeo may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Evekeo should be used as part of a total treatment program for ADHD that may include counseling or other therapies.

  • exogenous obesity. Evekeo may be used as part of a short-term, weight reduction program for obesity.
• Evekeo is not for use as an anorectic agent for exogenous obesity in children less than 12 years of age.
• Evekeo is not for use for ADHD in children less than 3 years old.
• The effects of long term use of Evekeo in children are not known.

Evekeo is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Evekeo in a safe place to protect it from theft. Never give your Evekeo to anyone else, because it may cause death or harm them. Selling or giving away Evekeo is against the law.

Tell your doctor if you or your child has (or has a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Evekeo?

Do not take Evekeo if you or your child:

• have heart problems or hardening of the arteries
• have moderate to severe high blood pressure
• have hyperthyroidism
• are very anxious, tense, or agitated
• have a history of drug abuse
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI
• are sensitive to, allergic to, or had a reaction to other stimulant medicines

What should I tell my doctor before taking Evekeo?

Before you or your child takes Evekeo, tell your doctor if you or your child has or if there is a family history of:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette's syndrome
• thyroid problems
• seizures or have had an abnormal brain wave test ( EEG )
• circulation problems in fingers and toes

Tell your doctor if:

• you or your child are pregnant or planning to become pregnant. It is not known if Evekeo will harm your unborn baby.
• you or your child are breastfeeding or plan to breastfeed. Evekeo can pass into your milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take Evekeo. Do not breastfeed while taking Evekeo.

Tell your doctor about all the medicines that you or your child takes, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Evekeo and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Evekeo.

Your doctor will decide whether Evekeo can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• stomach acid medicines
• anti-depression medicines including MAOIs
• anti-psychotic medicines
• lithium
• cold or allergy medicines that contain decongestants
• blood pressure medicines
• narcotic pain medicines
• seizure medicines
• blood thinner medicines

Know the medicines that you or your child takes.

Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

Do not start any new medicine while taking Evekeo without talking to your doctor first.

How should I take Evekeo?

• Take Evekeo exactly as your doctor tells you to take it.
• Your doctor may change the dose until it is right for you or your child.
• The first dose of the day is usually taken when you first wake in the morning.
• Evekeo may cause problems sleeping if taken late at night.
• Evekeo can be taken with or without food.
• From time to time, your doctor may stop Evekeo treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Evekeo.
• Children should have their height and weight checked often while taking Evekeo. Evekeo treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much Evekeo, call your doctor right away, or go to the nearest hospital emergency room.

What should I avoid while taking Evekeo?

Do not drive, operate machinery, or do other dangerous activities until you know how Evekeo affects you.

What are possible side effects of Evekeo?

Evekeo may cause serious side effects, including:

See "What is the most important information I should know about Evekeo?" for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in people with a history of seizures
• eyesight changes or blurred vision
• Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when medicines such as Evekeo are taken with certain other medicines. Symptoms of serotonin syndrome may include:
  • agitation, hallucinations, coma or other changes in mental status
  • problems controlling your movements or muscle twitching
  • fast heartbeat
  • high or low blood pressure
  • sweating or fever
  • nausea or vomiting
  • diarrhea
  • muscle stiffness or tightness

The most common side effects of Evekeo include:

• headache
• stomach ache
• trouble sleeping
• decreased appetite
• unpleasant taste
• nervousness
• dizziness
• sexual problems (impotence in males)
• vomiting
• itching
• diarrhea or constipation
• dry mouth
• weight loss
• mood swings

Talk to your doctor if you or your child have side effects that are bothersome or do not go away.

These are not all the possible side effects of Evekeo. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Arbor Pharmaceuticals, LLC, Medical Information at 1-866-516-4950 or FDA at 1-800-FDA-1088.

How should I store Evekeo?

• Store Evekeo at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Evekeo and all medicines out of the reach of children.

General information about the safe and effective use of Evekeo.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Evekeo for a condition for which it was not prescribed. Do not give Evekeo to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Evekeo. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Evekeo that was written for healthcare professionals.

For more information about Evekeo, please contact Arbor Pharmaceuticals, LLC at 1-866-516-4950.

What are the ingredients in Evekeo?

Active Ingredient: amphetamine sulfate

Inactive Ingredients: crospovidone, silicifed microcrystalline cellulose, and stearic acid. The 10 mg tablets also contain FD&C Blue #1.

This Medication Guide has been approved by the U .S. Food and Drug Administration.

Manufactured by:
Mikart, Inc.
Atlanta, GA 30318

Manufactured for:
Arbor Pharmaceuticals, LLC
Atlanta, GA 30328

AM-MG-06

Rev. 09/16

Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet extended release disintegrating

Along with its needed effects, amphetamine (the active ingredient contained in Evekeo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amphetamine:

• Seeing, hearing, or feeling things that are not there
• severe mental changes

• Agitation
• blurred vision
• confusion
• diarrhea
• dizziness
• false or unusual sense of well-being
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• headache
• nervousness
• overactive reflexes
• pounding in the ears
• restlessness
• shakiness in the legs, arms, hands, or feet
• shivering
• slow or fast heartbeat
• sweating
• talking or acting with excitement you cannot control
• trouble sleeping
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• uncontrolled vocal outbursts or tics (uncontrolled repeated body movements)

Get emergency help immediately if any of the following symptoms of overdose occur while taking amphetamine:

• Abdominal or stomach cramps
• dark-colored urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• muscle cramps or spasms
• muscle pain or stiffness
• nausea
• seizures
• sweating
• unusual tiredness or weakness
• vomiting

Some side effects of amphetamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• dry mouth
• hives or welts, itching, or skin rash
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• loss of appetite
• redness of the skin
• unpleasant taste
• weight loss