Adderall XR 20mg Capsules

Manufacturer SHIRE US INC Active Ingredient Dextroamphetamine and Amphetamine Extended-Release Capsules (Adderall XR)(deks troe am FET a meen & am FET a meen) Pronunciation ADD-uh-ral EX-AR
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Sympathomimetic Amine
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Pregnancy Category
Category C
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FDA Approved
Oct 2001
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Adderall XR is an extended-release stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It helps improve focus, attention, and control impulsive behaviors by affecting certain natural chemicals in the brain.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
It's best to take your medication in the morning.
Swallow the capsule whole - do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can sprinkle the contents onto applesauce, but be sure not to chew the mixture.
After mixing the medication with applesauce, take your dose immediately - do not store the mixture for later use.

Important Interactions to Discuss with Your Doctor

Before taking any over-the-counter (OTC) products, talk to your doctor if you're using medications that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
Certain natural products or aids

Storing and Disposing of Your Medication

To keep your medication safe and effective:
Store it at room temperature, away from light.
Keep it in a dry place, avoiding bathrooms.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it - a locked box or area may be helpful.
Keep all medications out of reach of pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and return to your regular dosing schedule. Do not take the missed dose later in the day.
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Lifestyle & Tips

  • Take the medication once daily in the morning, usually upon waking, to avoid sleep problems.
  • Do not take it in the late afternoon or evening.
  • Capsules can be swallowed whole or opened and sprinkled on a spoonful of applesauce and consumed immediately.
  • Avoid alcohol consumption while taking this medication.
  • Maintain a healthy diet, regular exercise, and consistent sleep schedule.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not share your medication with others, as it is a controlled substance.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg once daily in the morning
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 20 mg once daily in the morning. Dosage may be adjusted in 10 mg increments at weekly intervals. Maximum recommended dose is 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial 10 mg once daily in the morning. Dosage may be adjusted in 5-10 mg increments at weekly intervals. Maximum recommended dose is 30 mg/day.
Adolescent: 13-17 years: Initial 10 mg once daily in the morning. Dosage may be increased to 20 mg/day after 1 week. Maximum recommended dose is 20 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution. Consider lower doses if severe.
Severe: Use with caution; consider lower doses or alternative therapy due to reduced excretion. Not well studied.
Dialysis: Not established. Amphetamines are not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; consider lower doses or alternative therapy. Not primarily metabolized by the liver, but caution is advised.

Pharmacology

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Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines that cause the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain. They also block the reuptake of these monoamines into the presynaptic neuron, thereby increasing their concentrations in the synaptic cleft. The therapeutic effects in ADHD are thought to be mediated through the modulation of these neurotransmitters in areas of the brain associated with attention and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 75% (oral)
Tmax: Dextroamphetamine: 7 hours; Levoamphetamine: 8 hours (after single dose)
FoodEffect: Food (high-fat meal) can delay Tmax by approximately 2.5 hours but does not significantly affect AUC (extent of absorption).

Distribution:

Vd: Dextroamphetamine: 3.7-5.1 L/kg; Levoamphetamine: 3.7-5.1 L/kg
ProteinBinding: 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Dextroamphetamine: 10-13 hours; Levoamphetamine: 11-14 hours (pH-dependent)
Clearance: Not readily available as a single value, highly dependent on urinary pH.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 30-40% (dextroamphetamine) and 45-50% (levoamphetamine) excreted unchanged in urine at normal urinary pH. Excretion increases with acidic urine and decreases with alkaline urine.
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes
PeakEffect: Approximately 7-8 hours
DurationOfAction: Up to 10-12 hours

Safety & Warnings

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BLACK BOX WARNING

Amphetamines have a high potential for abuse and dependence. Administration of amphetamines for prolonged periods of time may lead to drug dependence and should be avoided. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Other severe side effects, including:
+ Difficulty getting or maintaining an erection
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
+ Restlessness
+ Changes in eyesight
+ Prolonged or frequent erections
+ Changes in skin color, such as pale, blue, gray, purple, or red discoloration
+ Numbness, pain, tingling, or cold sensation in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or trouble urinating

Important Heart-Related Warnings

If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek immediate medical help if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out

Other Possible Side Effects

While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Feeling nervous and excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
* Weight loss

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening psychiatric symptoms such as hallucinations (seeing or hearing things that are not real), paranoia, or mania (unusual excitement, overactivity, or irritability)
  • New or worsening motor or vocal tics (uncontrolled movements or sounds)
  • Numbness, coolness, or pain in fingers or toes, or unexplained wounds on fingers or toes (signs of circulation problems)
  • Blurred vision
  • Severe headache
  • Unexplained fever or muscle stiffness
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ A history of drug abuse
+ A history of stroke
Kidney disease, as this may affect how your body processes the medication
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may increase the risk of very high blood pressure
+ Linezolid or methylene blue
If you are breast-feeding, as you should not breast-feed while taking this medication

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.

When you first start taking this medication, avoid driving and other activities that require alertness and clear vision until you understand how it affects you.

If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may need higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not take more than the prescribed dose.

Long-term or regular use of this medication can lead to dependence. Stopping it abruptly may cause withdrawal symptoms. Before reducing the dose or stopping the medication, consult your doctor, and follow their instructions. Report any adverse effects to your doctor.

Before starting this medication, you may need to undergo certain heart tests. If you have questions or concerns, discuss them with your doctor.

This medication may cause high blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. Additionally, have blood work done as scheduled by your doctor, and discuss the results with them.

This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

Do not take antacids while using this medication.

There is a risk of new or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, associated with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, mood swings, abnormal thinking, anxiety, or loss of interest in life.

This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.

In some cases, this medication may affect growth in children and adolescents. They may require regular growth checks. Discuss this with your doctor, and note that different brands of this medication may be approved for use in different age groups.

Before consuming alcohol, consult your doctor. If you are pregnant or plan to become pregnant, discuss the benefits and risks of using this medication during pregnancy with your doctor.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia (overactive reflexes)
  • Rapid respiration
  • Confusion
  • Assaultiveness
  • Hallucinations
  • Panic states
  • Hyperpyrexia (very high fever)
  • Rhabdomyolysis (muscle breakdown)
  • Arrhythmias (irregular heartbeats)
  • Hypertension (high blood pressure) or Hypotension (low blood pressure)
  • Circulatory collapse
  • Convulsions
  • Coma

What to Do:

If overdose is suspected, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
  • Antihypertensives - amphetamines may reduce the hypotensive effect.
  • Acidifying agents (e.g., ascorbic acid, fruit juices, ammonium chloride) - increase urinary excretion of amphetamines, decreasing efficacy.
  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease urinary excretion of amphetamines, increasing plasma levels and potential for toxicity.
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase absorption of amphetamines.
  • Adrenergic blockers (e.g., guanethidine) - amphetamines may inhibit the hypotensive effect.
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Minor Interactions

  • Not many specific minor interactions beyond general caution with other CNS stimulants or depressants.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Amphetamines can cause increases in BP and HR. Baseline assessment is crucial.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: To monitor for potential growth suppression in pediatric patients and weight loss in all patients.

Timing: Prior to initiation of therapy.

Cardiovascular History and Examination

Rationale: To screen for pre-existing cardiac conditions that may contraindicate stimulant use (e.g., structural cardiac abnormalities, cardiomyopathy, serious arrhythmia). ECG may be considered if clinically indicated.

Timing: Prior to initiation of therapy.

Psychiatric History (e.g., bipolar disorder, psychosis, tics)

Rationale: Stimulants can exacerbate pre-existing psychiatric conditions or induce new psychotic/manic symptoms or tics.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or at least every 3-6 months.

Target: Within normal limits for age and clinical status.

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg BP, >10-20 bpm HR) warrant further investigation and potential dose adjustment or discontinuation.

Height and Weight

Frequency: Every 3-6 months in children and adolescents; periodically in adults.

Target: Normal growth trajectory for children; stable weight for adults.

Action Threshold: Significant growth deceleration or unexplained weight loss warrants investigation and potential dose adjustment or drug holiday.

Psychiatric Status (mood, anxiety, psychosis, tics)

Frequency: At each visit.

Target: Stable mood, absence of new or worsening psychotic symptoms, tics, or severe anxiety.

Action Threshold: Emergence of new psychotic symptoms, mania, severe anxiety, or tics warrants immediate evaluation and potential discontinuation.

ADHD Symptom Control and Functional Improvement

Frequency: At each visit.

Target: Improved attention, reduced impulsivity/hyperactivity, improved academic/occupational/social functioning.

Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope (fainting)
  • Palpitations
  • New or worsening psychiatric symptoms (e.g., hallucinations, paranoia, mania, severe anxiety)
  • New or worsening motor or vocal tics
  • Unexplained wounds on fingers or toes (Raynaud's phenomenon)
  • Blurred vision
  • Severe headache

Special Patient Groups

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Pregnancy

Category C. There are no adequate and well-controlled studies in pregnant women. Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to amphetamines in utero may experience withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations not definitively established, but caution advised.
Second Trimester: Risk of premature delivery and low birth weight reported with chronic maternal amphetamine abuse.
Third Trimester: Risk of withdrawal symptoms (e.g., agitation, tremor, feeding difficulties) in the neonate if used close to delivery.
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Lactation

L3 (Moderately Safe). Amphetamines are excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, weight loss), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Risk of irritability, sleep disturbances, poor feeding, and potential long-term neurodevelopmental effects. Monitor infant closely.
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Pediatric Use

Approved for children 6 years of age and older. Monitor growth (height and weight) and cardiovascular parameters (BP, HR) regularly. Long-term effects on growth have been reported. Psychiatric monitoring for new or worsening symptoms is also crucial.

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Geriatric Use

Safety and efficacy have not been established in geriatric patients. Use with caution in elderly patients due to increased sensitivity to sympathomimetic effects and potential for comorbidities (e.g., cardiovascular disease). Lower initial doses and careful titration may be warranted if used.

Clinical Information

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Clinical Pearls

  • Adderall XR is an extended-release formulation designed for once-daily dosing, typically in the morning, to provide symptom control throughout the school or workday.
  • Capsules can be opened and the contents sprinkled on applesauce for patients who have difficulty swallowing pills; the beads should not be chewed or crushed.
  • Monitor patients for signs of abuse or diversion, as amphetamines are Schedule II controlled substances.
  • Consider drug holidays (e.g., weekends, school breaks) to assess ongoing need for medication and to potentially mitigate growth suppression or tolerance, though this should be discussed with a healthcare provider.
  • Educate patients and caregivers on the importance of consistent dosing and potential side effects, especially cardiovascular and psychiatric effects.
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Alternative Therapies

  • Other amphetamine formulations (e.g., Vyvanse (lisdexamfetamine), Adzenys XR-ODT, Dyanavel XR)
  • Methylphenidate formulations (e.g., Concerta, Ritalin LA, Focalin XR, Quillivant XR, Jornay PM)
  • Non-stimulant medications (e.g., Atomoxetine (Strattera), Guanfacine extended-release (Intuniv), Clonidine extended-release (Kapvay))
  • Behavioral therapy and psychotherapy
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Cost & Coverage

Average Cost: Varies widely, typically $200-$400+ per 30 capsules (20mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand-name), Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.