Pronunciation:

am-FET-a-meen a-SPAR-tate, am-FET-a-meen SUL-fate, dex-troe-am-FET-a-meen SAK-a-rate, dex-troe-am-FET-a-meen SUL-fate

Brand Names:

• Adderall
• Adderall XR
• Mydayis
• ACT Amphetamine XR - 10MG Tablet
• ACT Amphetamine XR - 15MG Tablet
• ACT Amphetamine XR - 20MG Tablet
• ACT Amphetamine XR - 25MG Tablet
• ACT Amphetamine XR - 30MG Tablet
• ACT Amphetamine XR - 5MG Tablet
• APO-Amphetamine XR - 10MG Tablet
• APO-Amphetamine XR - 15MG Tablet
• APO-Amphetamine XR - 20MG Tablet
• APO-Amphetamine XR - 25MG Tablet
• APO-Amphetamine XR - 30MG Tablet
• APO-Amphetamine XR - 5MG Tablet

Dosage Forms:

• Capsule, Extended Release
• Tablet

Warnings:

Amphetamines have a high potential for abuse and administration for prolonged periods of time may lead to drug dependence. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse reactions .

CNS stimulants, including dextroamphetamine/amphetamine extended-release capsules, 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 .

Classifications:

Therapeutic—

CNS Stimulant

Chemical—

Amphetamine

Uses of This Medicine:

Amphetamine and dextroamphetamine combination is used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep). These two medicines belong to the group of medicines called central nervous system (CNS) stimulants.

Amphetamine and dextroamphetamine combination works in the treatment of ADHD to increase attention and decrease restlessness in patients who are overactive, cannot concentrate, or are easily distracted. It is used as part of a total treatment program that also includes social, educational, and psychological therapy.

This medicine is available only with a doctor's prescription. Prescriptions cannot be refilled. A new prescription must be obtained from your doctor each time you need this medicine.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amphetamine and dextroamphetamine combination to treat ADHD in children. However, safety and efficacy have not been established in children younger than 3 years of age for Adderall® tablets, in children younger than 6 years of age for Adderall XR® extended-release capsules, and in children younger than 13 years of age for Mydayis® extended-release capsules.

Older adults—

Appropriate studies on the relationship of age to the effects of Adderall® tablets and Adderall XR® extended-release capsules have not been performed in the geriatric population.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Mydayis® extended-release capsules in the elderly. 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—

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.

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Bipolar disorder (manic-depressive illness), or a family history of or
• Depression, or a family history of or
• Heart rhythm problems (eg, arrhythmia), or a family history of or
• Hypertension (high blood pressure), mild or
• Mania, history of or
• Psychosis (mental illness), history of or
• Raynaud disease or
• Seizures, history of or
• Tachycardia (fast heart rate) or
• Tourette syndrome (tics), or a family history of—Use with caution. May make these conditions worse.

• Kidney disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much, the medicine may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Talk to your doctor or pharmacist if you have any questions.

If you think this medicine is not working properly after you have taken it for several weeks, do not increase the dose and check with your doctor.

Take the regular tablet in the morning and early afternoon. If you take the tablet in the evening, you may have trouble falling asleep at night.

If you are using the extended-release capsule:

• Swallow the capsule whole with water or other liquids. Do not crush, break, or chew it.
• Take the capsule in the morning right after you wake up. If you take it in the afternoon or evening, you may have trouble falling asleep at night.
• You may take the capsule with or without food, but make sure to take it the same way each time.
• If you cannot swallow the capsule, carefully open it and sprinkle the small beads over a spoonful of applesauce. Swallow the mixture right away without chewing. Do not store the mixture for future use. Do not crush or chew the beads from the capsule.

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 attention deficit hyperactivity disorder (ADHD):
  • For oral dosage form (Adderall XR® extended-release capsules):
    • Adults—20 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed.
    • Children 13 to 17 years of age—At first, 10 mg once a day in the morning. Your doctor may adjust your dose as needed.
    • Children 6 to 12 years of age—At first, 10 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (Mydayis® extended-release capsules):
    • Adults—At first, 12.5 milligrams (mg) once a day in the morning right after you wake up. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.
    • Children 13 to 17 years of age—At first, 12.5 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25 mg per day.
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (Adderall® tablets):
    • Adults and children 6 years of age and older—At first, 5 milligrams (mg) given 1 or 2 times a day. Your doctor may adjust your dose as needed.
    • Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may adjust your dose as needed.
    • Children younger than 3 years of age—Use is not recommended.
• For narcolepsy:
  • For oral dosage form (Adderall® tablets):
    • Adults and children 12 years of age and older—At first, 10 milligrams (mg) per day, divided and given into 2 doses. Your doctor may adjust your dose as needed.
    • Children 6 to 12 years of age—At first, 5 mg per day. Your doctor may adjust your dose as needed.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

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 this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Do not take amphetamine and dextroamphetamine combination with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking this medicine during the 2 weeks after you stop an MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, headaches, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

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

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

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 behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

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 know how this medicine affects you.

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 such as mental depression, nausea or vomiting, stomach cramps or pain, trembling, or unusual tiredness or weakness.

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 Raynaud phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you 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.

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.

This medicine may increase your risk of having seizures. This is more likely to occur in patients with a history of seizures or heart rhythm problems. Check with your doctor right away if this happens.

Check with your doctor right away if you 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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter (OTC)) medicines, herbal supplements (eg, St. John's wort), and especially those for appetite control, asthma, colds, cough, hay fever, allergies, 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

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

fast, pounding, or irregular heartbeat or pulse

frequent urge to urinate

lower back or side pain

Less common

Chills

cough

diarrhea

fever

general feeling of discomfort or illness

headache

hoarseness

joint pain

loss of appetite

muscle aches and pains

nausea

runny nose

shivering

sore throat

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Incidence not known

Blistering, peeling, or loosening of the skin

chest pain or discomfort

confusion

dark urine

difficulty breathing

difficulty with speaking

difficulty with swallowing

dizziness

double vision

faintness

inability to move the arms, legs, or facial muscles

inability to speak

itching, skin rash

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

loss of bladder control

muscle cramps or stiffness

muscle spasm or jerking of the arms and legs

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

red skin lesions, often with a purple center

red, irritated eyes

seeing, hearing, or feeling things that are not there

seizures

slow speech

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

sudden loss of consciousness

swelling of the feet or lower legs

tightness in the chest

uncontrolled repeated movements (tics)

uncontrolled vocal outbursts

unusual tiredness or weakness

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

Anxiety

dry mouth

lack or loss of strength

stomach pain

weight loss

Incidence not known

Constipation

decreased interest in sexual intercourse

false or unusual sense of well-being

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

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.