Pronunciation:

am-FET-a-meen

Brand Names:

• Adzenys ER
• Adzenys XR ODT
• Dyanavel XR
• Evekeo
• Evekeo ODT

Dosage Forms:

• Tablet, Extended Release, Disintegrating
• Tablet, Extended Release, Chewable
• Suspension, Extended Release
• Tablet, Disintegrating
• Tablet

Warnings:

CNS stimulants, including amphetamine extended-release oral formulations, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy .

CNS stimulants, including amphetamine sulfate orally disintegrating tablets, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy .

Abuse potential is high with the use of amphetamines. Using amphetamines for a prolonged period of time may lead to drug dependence and must be avoided. Pay particular attention to the possibility of patients obtaining amphetamines for distribution to others or for nontherapeutic use. Prescribe and dispense amphetamines sparingly. Sudden death and serious cardiovascular adverse events may occur with misuse of amphetamines .

Classifications:

Therapeutic—

Central Nervous System Agent

Chemical—

Amphetamine (class)

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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, extended-release tablets, Adzenys XR-ODT® extended-release oral disintegrating tablets, and Evekeo ODT® extended-release oral disintegrating tablets in children with ADHD who are younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

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, extended-release tablets, and extended-release oral disintegrating tablets in the geriatric population. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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
• Ozanimod
• 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 Acetate
• Acetazolamide
• Alfentanil
• Almotriptan
• Aluminum
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anileridine
• Benzhydrocodone
• Benzthiazide
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Calcium Carbonate
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cimetidine
• Cinacalcet
• Citalopram
• Clobazam
• Clomipramine
• Cobicistat
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dexlansoprazole
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Dihydroxyaluminum Aminoacetate
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Esomeprazole
• Ethylmorphine
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Gepirone
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Iobenguane I 131
• Ketobemidone
• Lansoprazole
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Magaldrate
• Magnesium Carbonate
• Melitracen
• Meperidine
• Metaxalone
• Methadone
• Milnacipran
• Mirabegron
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Omeprazole
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Palonosetron
• Pantoprazole
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Polythiazide
• Protriptyline
• Quinidine
• Quinine
• Rabeprazole
• Remifentanil
• Ritonavir
• 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

Other interactions—

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—Avoid use 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.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken, it may become habit-forming (causing mental or physical dependence). If you feel that the medicine is not working properly after using it for several weeks, check with your doctor first and do not increase the dose.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Amphetamine is used for different conditions and comes in different forms. Make sure you understand how to take your prescribed brand.

It is best to take this medicine when you wake up in the morning. You may take this medicine with or without food or liquid.

You may chew or swallow the Dyanavel® XR tablet whole. You may divide the Dyanavel® XR 5-mg tablet into equal parts at the score line.

Measure the extended-release oral suspension with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Shake the bottle before each use. Do not mix Adzenys ER™ with any food or liquid before taking it.

If you are using the extended-release oral disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove Adzenys XR-ODT® from the blister pack by peeling back the foil, then taking the tablet out. Do not push Adzenys XR-ODT® through the foil. You may push Evekeo ODT® through the back of the foil to remove it. Place the whole tablet on your tongue. It should melt quickly. Do not chew or crush it. You may move the tablet around between the tongue and the roof of the mouth until it melts.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ADHD:
  • For oral dosage form (extended-release oral disintegrating tablets):
    • Adzenys XR-ODT®:
      • Adults—12.5 milligrams (mg) once a day, in the morning.
      • Children 13 to 17 years of age and older—At first, 6.3 mg once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 12.5 mg per day.
      • Children 6 to 12 years of age—At first, 6.3 mg once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 18.8 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • Evekeo ODT®:
      • Children 6 to 17 years of age—At first, 5 milligrams (mg) 1 or 2 times a day, in the morning. You may add another dose after 4 to 6 hours. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • Adults and children 6 years of age and older—At first, 2.5 or 5 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release suspension):
    • Adzenys ER™:
      • Adults—12.5 milligrams (mg) (10 mL) once a day, in the morning.
      • Children 13 to 17 years of age and older—At first, 6.3 mg (5 mL) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 12.5 mg (10 mL) per day.
      • Children 6 to 12 years of age—At first, 6.3 mg (5 mL) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 18.8 mg (15 mL) per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • Dyanavel® XR:
      • Adults and children 6 years of age and older—At first, 2.5 or 5 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and children 6 years of age and older—At first, 5 milligrams (mg) 1 or 2 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
    • Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may increase your dose as needed.
    • Children younger than 3 years of age—Use is not recommended.
• For narcolepsy:
  • For oral dosage form (tablets):
    • Adults and children 12 years of age and older—At first, 10 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children 6 to 11 years of age—At first, 5 mg once a day, in the morning. Your doctor may increase your dose as needed.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
• For weight loss:
  • For oral dosage form (tablets):
    • Adults and children 12 years of age and older—5 to 10 milligrams (mg) per day, taken 30 to 60 minutes before each meal. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mg per day.
    • Children younger than 12 years of age—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly. Blood and blood pressure tests may be needed to check for unwanted effects. Your doctor may occasionally stop treatment to check symptoms of ADHD.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]), within the past 14 days.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may be:

• A strong desire or need to continue using the medicine.
• A need to increase the dose to receive the same effects.
• Withdrawal effects after stopping the medicine including agitation, generalized slowing of mental and physical activity, increased appetite, trouble sleeping, unable to sleep, unpleasant dreams, unusual tiredness or weakness, or unusually deep sleep or long duration of sleep.

This medicine may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, fast or uneven heartbeat, trouble breathing, or fainting while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

Symptoms of an overdose include: aggressive, angry, confusion, dark-colored urine, fever, muscle cramps, spasms, pains, or stiffness, panic state, restlessness, seeing, hearing, or feeling things that are not there, shakiness in the legs, arms, hands, or feet, trembling or shaking of hands or feet. Call your doctor right away if you notice these symptoms.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. It may also cause blurred vision or other vision problems. Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you or your child have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Avoid drinking alcohol while using this medicine.

Use with medications that increase stomach or urine alkalinity, including sodium bicarbonate, acetazolamide, and some thiazide diuretics (water pill) should be avoided. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal (eg, St. John's wort) or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

Agitation

anxiety

bladder pain

bloody or cloudy urine

crying

delusions of persecution, mistrust, suspiciousness, or combativeness

difficult, burning, or painful urination

false or unusual sense of well-being

feeling of unreality

frequent urge to urinate

lower back or side pain

mental depression

nervousness

quick to react or overreact emotionally

rapidly changing moods

sense of detachment from self or body

Less common

Chills

cough

fever

hoarseness

Rare

Seeing, hearing, or feeling things that are not there

severe mental changes

Incidence not known

Blistering, peeling, loosening of the skin

blurred vision

chest pain or discomfort

confusion

dark urine

diarrhea

difficulty breathing

dizziness

fainting

fast, irregular, pounding, or racing heartbeat or pulse

headache

hives, itching, skin rash

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

mood swings

muscle cramps, pain, stiffness, or spasms

nausea

overactive reflexes

pain or discomfort in the arms, jaw, back, or neck

paleness or cold feeling in the fingertips and toes

pounding in the ears

red skin lesions, often with a purple center

red, irritated eyes

restlessness

shakiness in the legs, arms, hands, or feet

shivering

slow or fast heartbeat

sore throat

sores, ulcers, or white spots in the mouth or on the lips

sweating

swelling of the feet or lower legs

talking or acting with excitement you cannot control

tingling or pain in the fingers or toes when exposed to cold temperatures

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)

unusual tiredness or weakness

vomiting

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

Symptoms of overdose

Aggressive

angry

confusion

dark urine

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast breathing

fast, slow, or irregular heartbeat

loss of consciousness

muscle cramps, spasms, pain, or stiffness

nausea

restlessness

seeing, hearing, or feeling things that are not there

seizures

stomach cramps

sweating

tremor

unusual tiredness or weakness

vomiting

Some side effects 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:

More common

Dry mouth

loss of appetite

stomach ache

voice changes

weight loss

Less common

Belching

heartburn

indigestion

stomach discomfort, upset, or pain

Incidence not known

Constipation

decreased interest in sexual intercourse

difficulty having a bowel movement

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

redness of the skin

thinning or loss of hair

unpleasant taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.