Adderall XR 5mg 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-er-all EKS-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; Amphetamine
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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 capsule containing a combination of amphetamine and dextroamphetamine. It is a stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to improve focus, attention, and control over impulsive behavior. The 'XR' means it works throughout the day with a single morning dose.
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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. However, do not 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 considering 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, protected from light.
Keep it in a dry place, away from the bathroom.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area.
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 exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening to avoid sleep problems.
  • Do not crush, chew, or open the capsule and sprinkle contents on food if you cannot swallow it whole. If opening, sprinkle on applesauce and consume immediately.
  • Avoid alcohol, as it can affect the release of the medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Report any new or worsening heart problems (e.g., chest pain, shortness of breath, fainting) or mental health changes (e.g., new psychosis, mania, aggression, suicidal thoughts) immediately.
  • Monitor growth in children and adolescents.
  • Store securely to prevent misuse or abuse.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 20 mg once daily in the morning. May be adjusted in 10 mg increments weekly.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 20 mg once daily; maximum 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For ADHD (6-12 years): Initial 10 mg once daily in the morning; maximum 30 mg/day. For ADHD (13-17 years): Initial 10 mg once daily in the morning; maximum 40 mg/day.
Adolescent: For ADHD (13-17 years): Initial 10 mg once daily in the morning; maximum 40 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor for adverse effects.
Moderate: Consider lower doses and monitor for adverse effects. Specific guidelines not available.
Severe: Use with caution; consider lower doses (e.g., 50% of usual dose) and monitor closely. Specific guidelines not available.
Dialysis: Not available; amphetamines are not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; consider lower doses and monitor for adverse effects. Specific guidelines not available.

Pharmacology

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Mechanism of Action

Dextroamphetamine and amphetamine are non-catecholamine sympathomimetic amines that exert their therapeutic effect by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, and by blocking the reuptake of these monoamines into the presynaptic neuron. This leads to increased concentrations of norepinephrine and dopamine in the synaptic cleft.
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Pharmacokinetics

Absorption:

Bioavailability: High (well absorbed orally)
Tmax: Bimodal release: First peak ~3 hours, second peak ~7 hours post-dose.
FoodEffect: Food can delay Tmax by approximately 2.5 hours but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 3-4 L/kg
ProteinBinding: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Dextroamphetamine: 10-13 hours; Levoamphetamine: 9-11 hours (pH-dependent)
Clearance: Highly dependent on urinary pH; increased clearance with acidic urine.
ExcretionRoute: Renal
Unchanged: Approximately 30-40% (dextroamphetamine) and 50% (levoamphetamine) excreted unchanged in urine at normal urinary pH. Up to 75% excreted unchanged in acidic urine.
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes (initial release)
PeakEffect: Bimodal: First peak ~3 hours, second peak ~7 hours
DurationOfAction: Approximately 10-12 hours

Safety & Warnings

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BLACK BOX WARNING

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

Serious Side Effects: Seek Medical Help Immediately

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

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 or dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Erectile dysfunction or changes in sex interest
Seizures
Trouble controlling body movements or sounds (e.g., humming, throat clearing, yelling, or making loud noises)
Restlessness
Changes in eyesight
Prolonged or frequent erections
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or trouble passing urine

Important Heart-Related Information

If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately 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

Like all medications, this drug may cause side effects. Many people experience no side effects or only minor ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in mouth
* Weight loss

Reporting Side Effects

If you have questions about side effects or want to report any, 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
  • Fainting spells
  • Palpitations (fast or pounding heartbeat)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • New or worsening aggression or hostility
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New or worsening manic symptoms (e.g., extreme energy, racing thoughts)
  • Severe anxiety or panic attacks
  • Unexplained weight loss
  • Slowed growth in children
  • Signs of abuse or dependence (e.g., craving, taking more than prescribed, withdrawal symptoms if stopped)
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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. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous instances of:
- Drug abuse
- Stroke
Existing kidney disease
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, such as:
- Isocarboxazid
- Phenelzine
- Tranylcypromine
- Selegiline
- Rasagiline (note: combining these medications can lead to very high blood pressure)
+ Concomitant use of:
- Linezolid
- 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 conditions with your doctor and pharmacist to ensure safe treatment. Do not initiate, terminate, or modify any medication regimen without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.

Tolerance and Dosage
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 not working well, contact your doctor. Do not exceed the prescribed dose.

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

Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. Additionally, have your blood work checked as instructed by your doctor.

Interactions with Lab Tests
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.

Concomitant Medications
Do not take antacids with this medication.

Mental and Mood Changes
New or worsening behavior and mood changes, such as altered thinking, anger, and hallucinations, have been reported 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, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.

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

Effects on Growth in Children and Teens
This medication may affect growth in children and teens. 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.

Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.

Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, discuss the benefits and risks of using this medication with your doctor.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Assaultiveness
  • Hallucinations
  • Panic states
  • Hyperpyrexia (very high fever)
  • Rhabdomyolysis
  • Cardiac arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma
  • Death

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, gastric lavage, activated charcoal, and acidification of urine to enhance excretion. Benzodiazepines may be used for severe agitation or seizures. Alpha-blockers or vasodilators for severe hypertension.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
  • Linezolid (reversible MAOI activity)
  • Methylene blue (reversible MAOI activity)
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Major Interactions

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Antihypertensives - may reduce hypotensive effects
  • Urinary acidifiers (e.g., ascorbic acid, ammonium chloride) - increase amphetamine excretion, decrease efficacy
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease amphetamine excretion, increase efficacy/toxicity
  • Proton Pump Inhibitors (PPIs) and H2 blockers - may increase absorption and exposure
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
  • Alcohol - may alter release profile of extended-release formulation
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Moderate Interactions

  • Tricyclic antidepressants (TCAs) - increased cardiovascular effects, potential for increased amphetamine levels
  • Antacids containing magnesium or aluminum - may increase absorption
  • Opioids - potential for additive CNS effects or reduced opioid efficacy
  • Caffeine and other CNS stimulants - additive stimulant effects
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR, ECG if indicated)

Rationale: To identify pre-existing cardiovascular conditions that may contraindicate or require caution with stimulant use.

Timing: Prior to initiation of therapy

Psychiatric history and assessment

Rationale: To screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy

Height and Weight (pediatric patients)

Rationale: To establish baseline for monitoring potential growth suppression.

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or every 3-6 months

Target: Within normal limits for age; significant sustained increases should prompt evaluation.

Action Threshold: Sustained increase in BP (>10-15 mmHg systolic/diastolic) or HR (>10-20 bpm) above baseline; new onset hypertension or tachycardia.

Height and Weight (pediatric patients)

Frequency: Every 3-6 months

Target: Normal growth trajectory for age.

Action Threshold: Significant growth deceleration or weight loss; falling off growth curve.

Psychiatric status (mood, anxiety, psychosis, aggression)

Frequency: At each visit or every 3-6 months

Target: Stable mood, absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence or worsening of psychotic symptoms, mania, severe anxiety, aggression, or suicidal ideation.

ADHD symptom control and functional improvement

Frequency: At each visit

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

Action Threshold: Lack of therapeutic response or worsening of ADHD symptoms.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Depressed mood
  • Suicidal ideation
  • Unexplained weight loss
  • Growth deceleration (in children)
  • Peripheral vasculopathy (e.g., Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, including premature birth, low birth weight, and withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremor, hypertonia) in the neonate if used during pregnancy.

Trimester-Specific Risks:

First Trimester: Potential for congenital malformations, though data are limited and inconsistent.
Second Trimester: Risk of premature birth and low birth weight.
Third Trimester: Risk of premature birth, low birth weight, and neonatal withdrawal symptoms.
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Lactation

Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, weight loss, cardiovascular effects), 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: Moderate to High (L3-L4). Potential for irritability, poor feeding, sleep disturbances, weight loss, and cardiovascular effects in the infant.
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Pediatric Use

Approved for ADHD in children 6 years and older. Long-term effects on growth and development should be monitored. Growth suppression (weight and/or height) has been reported. Psychiatric adverse events (e.g., psychosis, mania) can occur. Cardiovascular monitoring is essential.

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Geriatric Use

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Use with caution due to increased likelihood of cardiovascular disease and other comorbidities. Start with lower doses and titrate slowly.

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 work day.
  • The capsule can be opened and the contents sprinkled on applesauce for patients who have difficulty swallowing, but the beads should not be chewed or crushed.
  • Careful cardiovascular assessment, including blood pressure and heart rate, is crucial before and during therapy due to the risk of serious cardiovascular events.
  • Monitor for psychiatric adverse effects, including new or worsening psychosis, mania, aggression, or suicidal ideation, especially in patients with pre-existing psychiatric conditions.
  • Growth suppression (weight and height) should be monitored in pediatric patients receiving long-term therapy.
  • High potential for abuse and dependence; prescribe cautiously and monitor for signs of misuse.
  • Avoid concomitant use with MAOIs due to the risk of hypertensive crisis.
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Alternative Therapies

  • Other CNS Stimulants (e.g., Methylphenidate extended-release formulations like Concerta, Ritalin LA, Focalin XR; Lisdexamfetamine (Vyvanse))
  • Non-stimulants (e.g., Atomoxetine (Strattera), Guanfacine extended-release (Intuniv), Clonidine extended-release (Kapvay))
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and strength (e.g., $200-$400+) per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand); Tier 1 or Tier 2 (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 and effective treatment, 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. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.