Dextroamphetamine and amphetamine

In the U.S.

• Adderall
• Adderall XR
• Mydayis

In Canada

• Adderall XR - 10mg
• Adderall XR - 15mg
• Adderall XR - 20mg
• Adderall XR - 25mg
• Adderall XR - 30mg
• Adderall XR - 5mg

Available Dosage Forms:

• Tablet
• Capsule, Extended Release

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine

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:

• 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

• Cold or flu-like symptoms
• cough or hoarseness
• fever or chills

• Blistering, peeling, or loosening of the skin
• chest pain or discomfort
• confusion
• dark-colored urine
• diarrhea
• difficulty breathing
• difficulty with speaking
• difficulty with swallowing
• dizziness
• double vision
• faintness
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• itching, skin rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of bladder control
• muscle cramps or spasms
• muscle pain or stiffness
• muscle spasm or jerking of all extremities
• nausea
• 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
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sudden loss of consciousness
• sweating
• swelling of the feet or lower legs
• tightness in the chest
• uncontrolled repeated movements (tics)
• uncontrolled vocal outbursts
• 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:

• Anxiety
• dry mouth
• lack or loss of strength
• stomach pain
• weight loss

• 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.

• Amphet Asp/Amphet/D-Amphet
• Amphetamine and Dextroamphetamine
• Dextroamphetam/Amphetam(Base)
• Dextroamphetamine/Amphetamine

Immediate-release tablet: 4 to 6 hours (Dopheide 2009); Mydayis: ≤16 hours

Half-Life Elimination

Children 6 to 12 years: d-amphetamine: 9 hours; l-amphetamine: 11 hours

Adolescents 13 to 17 years: d-amphetamine: 11 hours; l-amphetamine: 13 to 14 hours

Adults: d-amphetamine: 10 hours; l-amphetamine: 13 hours

Weight: Weight is the primary determinant of apparent differences in the pharmacokinetics of d- and l-amphetamine across the age range. Systemic exposure measured by AUC∞ and Cmax decreased with increases in body weight, while apparent oral volume of distribution, apparent oral clearance, and elimination half-life increased with increases in body weight.

Note: Use lowest effective individualized dose; administer first dose as soon as awake.

ADHD: Oral:

Note: Interrupt therapy occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Immediate release: Initial: 5 mg once or twice daily; may increase daily dose in 5 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 5 to 40 mg/day in 1 to 3 divided doses. Note: Although doses greater than 40 mg/day will rarely be necessary, doses as high as 60 mg/day have been shown to be safe and effective (Spencer 2001).

Extended release:

Adderall XR: Initial: 20 mg once daily in the morning; higher doses (up to 60 mg/day) have been evaluated; however, there is not adequate evidence that higher doses afforded additional benefit.

Conversion from immediate release to Adderall XR: Switch to Adderall XR at the same total daily dose.

Mydayis: Initial: 12.5 mg to 25 mg once daily in the morning; may increase daily dose by 12.5 mg no sooner than once weekly; maximum: 50 mg/day.

Conversion from other dextroamphetamine and amphetamine formulations to Mydayis: Discontinue previous formulation and titrate using above schedule; do not substitute on a mg-per-mg basis.

Narcolepsy: Immediate release: Oral: Initial: 10 mg once daily in the morning; may increase daily dose in 10 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 5 to 60 mg/day in 1 to 3 divided doses.

Note: Use lowest effective individualized dose; administer first dose as soon as awake.

ADHD: Oral:

Note: Interrupt therapy occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Children <3 years: Use is not recommended.

Children 3 to 5 years: Immediate release: Initial 2.5 mg once daily in the morning; may increase daily dose in 2.5 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 2.5 to 40 mg/day in 1 to 3 divided doses.

Children ≥6 years:

Immediate release: Initial: 5 mg once or twice daily; may increase daily dose in 5 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 5 to 40 mg/day in 1 to 3 divided doses.

Extended release: Adderall XR: 5 to 10 mg once daily in the morning; may increase daily dose in 5 to 10 mg increments at weekly intervals until optimal response is obtained; maximum: 30 mg/day.

Conversion from immediate release to Adderall XR: Switch to Adderall XR at the same total daily dose.

Adolescents:

Immediate release: Initial: 5 mg once or twice daily; may increase daily dose in 5 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 5 to 40 mg/day in 1 to 3 divided doses.

Extended release:

Adderall XR: Initial: 10 mg once daily in the morning; may increase to 20 mg daily after 1 week if needed; higher doses (up to 60 mg/day) have been evaluated; however, there is not adequate evidence that higher doses afforded additional benefit.

Conversion from immediate release to Adderall XR: Switch to Adderall XR at the same total daily dose.

Mydayis: Initial: 12.5 mg once daily in the morning; may increase daily dose by 12.5 mg no sooner than weekly; maximum: 25 mg/day.

Conversion from other dextroamphetamine and amphetamine formulations to Mydayis: Discontinue previous formulation and titrate using above schedule; do not substitute on a mg-per-mg basis.

Narcolepsy: Immediate release: Oral:

Children ≥6 years: Initial: 5 mg daily; may increase daily dose in 5 mg increments at weekly intervals until optimal response is obtained; usual dosage: 5 to 60 mg/day in 1 to 3 divided doses.

Adolescents: Refer to adult dosing.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain, lack of appetite, insomnia, constipation, diarrhea, dry mouth, bad taste, or weight loss. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), angina, shortness of breath, severe dizziness, passing out, tachycardia, severe anxiety, severe headache, sexual dysfunction, decreased libido, abnormal heartbeat, seizures, abnormal movements, agitation, vision changes, priapism, change in color of hands or feet from pale to blue or red, burning or numbness of hands or feet, cold sensation, signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), wounds on fingers or toes, dark urine, change in amount of urine passed, muscle pain, muscle weakness, signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), mood changes, hallucinations, or behavioral changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.