Dextroamphetamine and amphetamine (Oral)

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 a group called central nervous system (CNS) stimulants.

The amphetamine and dextroamphetamine combination helps treat ADHD by increasing attention and reducing restlessness in patients who are overactive, have trouble concentrating, or are easily distracted. It is used as part of a complete treatment program that also includes social, educational, and psychological therapy.

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

It is very important for your doctor to check your or your child's progress regularly to make sure this medicine is working properly. Blood tests may be needed to look for any unwanted effects.

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

This medicine may cause serious heart or blood vessel problems. This is more likely to occur in patients with a family history of heart disease. Contact your doctor immediately if you or your child experience 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 checked before starting this medicine and while using it. If you notice any changes in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Inform your doctor immediately if you or your family notice any unusual changes in behavior, including increased aggression, hostility, agitation, irritability, or suicidal thoughts or behaviors. Also, inform your doctor if you or your child experience hallucinations or any unusual thoughts, especially if they are new or worsening quickly.

This medicine may make some people feel an unrealistic sense of well-being or may cause dizziness, lightheadedness, or reduced alertness. 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 think you might be mentally or physically dependent on it, contact your doctor right away. Some signs of dependence may include:

• A strong desire or need to keep using the medicine.
• A need to increase the dose to get 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 monitor your child's height and weight.

This medicine may cause Raynaud's phenomenon, which affects blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or changes in skin color in your 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.

Symptoms of an overdose include: agitation, blurred vision, change in consciousness, chest pain or discomfort, confusion, dark urine, diarrhea, dizziness, faintness or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, fever, headache, inability to speak, loss of consciousness, muscle cramps, spasms, pain, or stiffness, nausea, nervousness, overactive reflexes, pain or discomfort in the arms, jaw, back, or neck, pale, clammy skin, palpitations, pounding in the ears, seeing, hearing, or feeling things that are not there, seizures, shivering, slow or fast heartbeat, slurred speech, sweating, uncontrolled excitement, temporary blindness, thirst, trembling or shaking, trouble breathing, unusual tiredness or weakness, vomiting, or weakness on one side of the body. Call your doctor immediately if you notice these symptoms.

Before any medical tests, inform the medical doctor in charge that you are using this medicine. Some test results may be affected by this medicine.

This medicine may increase your risk of having seizures. This is more likely in patients with a history of seizures or heart rhythm issues. Contact your doctor right away if this occurs.

Contact your doctor immediately if you experience 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 signs 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.

Avoid drinking alcohol while using this medicine.

Avoid using medications that increase stomach or urine alkalinity, including sodium bicarbonate.

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

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important considerations for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare provider know if you have allergies to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems that would limit the use of amphetamine and dextroamphetamine combination to treat ADHD in children. However, safety and effectiveness 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.

Geriatric

There have not been appropriate studies on the effects of Adderall® tablets and Adderall XR® extended-release capsules in older adults. Studies have not shown any specific problems that would limit the use of Mydayis® extended-release capsules in elderly patients. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require caution and a dose adjustment for patients taking this medicine.

Breast Feeding

Research in breastfeeding women has shown harmful effects on infants. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a possible interaction. In these cases, your doctor may want to adjust the dosage or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been highlighted for 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 are taking.

• 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 necessary 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used close to meal times or with certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions have been highlighted for their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical issues may affect how this medicine works. Make sure to tell your doctor if you have any other medical problems, especially:

• Severe agitation
• Severe anxiety
• Severe arteriosclerosis (hardening of the arteries)
• History of drug abuse
• Glaucoma
• Recent heart attack
• Severe heart or blood vessel disease (e.g., cardiomyopathy, coronary artery disease)
• Heart rhythm problems (e.g., arrhythmia, ventricular arrhythmia) or family history of these issues
• Moderate to severe hypertension (high blood pressure)
• Hyperthyroidism (overactive thyroid)
• History of stroke—This medicine should not be used in patients with these conditions.

• Bipolar disorder (manic-depressive illness) or family history of it
• Blood vessel problems (e.g., Raynaud disease)
• Depression or family history of it
• Mild hypertension (high blood pressure)
• History of psychosis (mental illness)
• History of seizures
• Tourette syndrome (tics) or family history of it—Use with caution as it may worsen these conditions.

• Severe kidney disease—Use is not recommended for patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away 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, discomfort, or tightness
• 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
• uncontrolled repeated movements (tics)
• uncontrolled vocal outbursts
• unusual tiredness or weakness

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

Symptoms of overdose

• Agitation
• blurred vision
• change in consciousness
• chest pain or discomfort
• confusion
• dark urine
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• inability to speak
• loss of consciousness
• muscle cramps, spasms, pain, stiffness, or twitching
• nausea
• nervousness
• overactive reflexes
• pain or discomfort in the arms, jaw, back, or neck
• pale, clammy skin
• palpitations
• pounding in the ears
• seeing, hearing, or feeling things that are not there
• seizures
• shivering
• slow or fast heartbeat
• slurred speech
• sweating
• talking or acting with excitement you cannot control
• temporary blindness
• thirst
• trembling or shaking
• trouble breathing
• unusual tiredness or weakness
• vomiting
• weakness in the arm or leg on one side of the body, sudden and severe

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. Your health care professional may also 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.

In the U.S.

• Adderall
• Adderall XR
• Mydayis

In Canada

• 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

Available Dosage Forms:

• Capsule, Extended Release
• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine

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.

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