Adderall XR 15mg 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 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
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Pregnancy Category
Not available
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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 two stimulant medications, amphetamine and dextroamphetamine. It works by increasing certain natural chemicals in the brain that help with focus and attention. It's used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to improve attention, concentration, and control over impulsive behavior.
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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 applesauce after mixing.
Take your dose immediately after mixing with applesauce. Do not store the mixture for later use.

Important Interactions to Discuss with Your Doctor

Before taking your medication, talk to your doctor about any over-the-counter (OTC) products you're using that may increase your blood pressure. These include:

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 can help keep your medication safe.
Keep all medications away from 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.
  • Swallow the capsule whole. Do not crush, chew, or divide. If unable to swallow, the capsule may be opened and the contents sprinkled on a spoonful of applesauce and consumed immediately.
  • Avoid alcohol, as it can affect how the medication is released.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Report any new or worsening mental health symptoms (e.g., anxiety, agitation, hallucinations) or heart-related symptoms (e.g., chest pain, shortness of breath) immediately.
  • Maintain a healthy diet and regular sleep schedule.

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; may be increased in 10 mg increments weekly to a maximum of 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6-12 years: Initial 10 mg once daily in the morning; may be increased in 5-10 mg increments weekly to a maximum of 30 mg/day.
Adolescent: For adolescents 13-17 years: Initial 10 mg once daily in the morning; may be increased in 10 mg increments weekly to a maximum of 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 starting doses and slower titration. Monitor for adverse effects.
Severe: Consider lower starting doses and slower titration. Monitor for adverse effects. Use with caution.
Dialysis: Not available. Amphetamines are not dialyzable to a significant extent.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.

Pharmacology

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Mechanism of Action

Amphetamine and dextroamphetamine 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 their reuptake. This leads to increased concentrations of these neurotransmitters in the synaptic cleft.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 75% (oral)
Tmax: Biphasic absorption: First peak at 4-5 hours, second peak at 8-9 hours post-dose.
FoodEffect: High-fat meal may delay Tmax by 2.5 hours but does not affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 3-5 L/kg
ProteinBinding: Approximately 15-26%
CnssPenetration: Yes

Elimination:

HalfLife: Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (pH-dependent)
Clearance: Highly variable, pH-dependent.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 30-40% (at normal urinary pH); up to 75% (acidic urine); 1% (alkaline urine).
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes (initial effect)
PeakEffect: Approximately 4-5 hours (first peak) and 8-9 hours (second peak)
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 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 medical attention immediately:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Erectile dysfunction or changes in sex drive
Seizures
Uncontrolled body movements or vocalizations (such as humming, throat clearing, yelling, or making loud noises)
Restlessness
Changes in vision
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 sensations in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Sudden cardiac events have occurred in people with pre-existing heart problems or defects. If you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor. Seek immediate medical attention if you experience chest pain, irregular heartbeat, shortness of breath, or severe dizziness or fainting.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor 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 for advice:

Feeling anxious or agitated
Headache
Sleep disturbances
Gastrointestinal issues (constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite)
Dizziness, fatigue, or weakness
Dry mouth or bad taste
* Weight loss

This list is not exhaustive. If you have questions or concerns about side effects, consult 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 (signs of heart problems)
  • New or worsening aggression, hostility, or irritability
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New manic symptoms (e.g., extreme energy, racing thoughts)
  • Unexplained tics or involuntary movements
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Blurred vision or other vision changes
  • Severe headache
  • Unusual sweating or fever
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Before Using This Medicine

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

It is crucial 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 reactions you have experienced.
A 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 (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Kidney disease
Current medications, particularly:
+ Acetazolamide
+ Sodium bicarbonate
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Use of other specific medications, such as:
+ Linezolid
+ Methylene blue
* Breast-feeding: do not breast-feed while taking this medication

This list is not exhaustive. It is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use of this medication. Never start, stop, or change the dose of any medication 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, it may lose its effectiveness, and you may need higher doses to achieve the same effect, a condition known as tolerance. If you notice this medication is not working as well as it should, contact your doctor. Do not exceed the prescribed dose.

Dependence and Withdrawal
Long-term or regular use of this medication can lead to dependence. Stopping it abruptly may cause withdrawal symptoms. Consult your doctor before reducing the dose or discontinuing this medication, and follow their instructions carefully. 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 can 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 and discuss the results with them.

Interactions with Other Substances
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking it. Do not take antacids with this medication.

Mental Health Considerations
New or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, have been associated with this medication. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, 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, particularly in individuals with a history of seizures. Discuss your risk with your doctor.

Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. 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, nausea, vomiting, or severe headache.

Effects on Growth in Children and Teens
This medication may affect growth in some 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
  • High fever
  • Rhabdomyolysis
  • 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.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis. Do not use within 14 days of MAOI administration.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome (though less common with amphetamines alone, caution with co-administration).
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Major Interactions

  • Antacids (e.g., sodium bicarbonate, calcium carbonate) - increase amphetamine absorption and prolong half-life.
  • Urinary alkalinizers (e.g., acetazolamide, thiazide diuretics) - decrease amphetamine excretion, increasing plasma levels and effects.
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase amphetamine excretion, decreasing plasma levels and effects.
  • Antihypertensives - amphetamines may counteract the hypotensive effect.
  • Halogenated anesthetics - risk of arrhythmias.
  • Alcohol - may alter the release profile of extended-release formulations, leading to dose dumping.
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.
  • Phenothiazines (e.g., chlorpromazine) - may inhibit amphetamine effects.
  • Antipsychotics (e.g., haloperidol) - may antagonize amphetamine effects.
  • Proton Pump Inhibitors (PPIs) / H2 Blockers - may increase gastric pH, potentially affecting absorption.
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, ritonavir) - may increase amphetamine exposure.
  • Opioids (e.g., tramadol, fentanyl) - risk of serotonin syndrome (less direct, but caution).
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Minor Interactions

  • Caffeine - additive stimulant effects.
  • Vitamin C (large doses) - may acidify urine, increasing excretion.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).

Timing: Prior to initiation.

Height and Weight (especially in pediatric patients)

Rationale: Risk of growth suppression.

Timing: Prior to initiation.

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

Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new ones.

Timing: Prior to initiation.

Cardiac History (e.g., structural cardiac abnormalities, cardiomyopathy, arrhythmias)

Rationale: Risk of sudden death in patients with pre-existing cardiac conditions.

Timing: Prior to initiation; consider ECG if clinically indicated.

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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; significant increases should prompt evaluation.

Action Threshold: Sustained elevation above baseline or age-appropriate norms (e.g., >95th percentile for BP) should prompt dose reduction, discontinuation, or further cardiac evaluation.

Height and Weight (especially in pediatric patients)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration or weight loss should prompt evaluation, including consideration of drug holiday or alternative treatment.

Psychiatric Status (e.g., emergence of psychosis, mania, aggression, tics)

Frequency: At each visit.

Target: Stable mood and behavior.

Action Threshold: Emergence or worsening of psychiatric symptoms should prompt dose adjustment, discontinuation, or psychiatric consultation.

ADHD Symptom Control and Functional Improvement

Frequency: At each visit.

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

Action Threshold: Lack of efficacy or intolerable side effects should prompt dose adjustment or consideration of alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • New or worsening tics
  • Anxiety
  • Insomnia
  • Appetite suppression
  • Weight loss
  • Growth deceleration (in children)

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, including premature birth and low birth weight. Neonatal withdrawal symptoms may occur if used during pregnancy.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester: Increased risk of premature birth and low birth weight.
Third Trimester: Increased risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence).
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Lactation

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, cardiovascular effects), breastfeeding is generally not recommended during treatment with Adderall XR.

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 children 6 years and older. Monitor growth (height and weight) carefully due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).

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Geriatric Use

Use with caution in elderly patients. Start with lower doses and titrate slowly due to increased sensitivity to adverse effects and potential for comorbidities (e.g., cardiovascular disease) and polypharmacy. Not specifically studied in geriatric populations for ADHD.

Clinical Information

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Clinical Pearls

  • Adderall XR provides a single daily dose with effects lasting 10-12 hours, mimicking two immediate-release doses.
  • Capsules can be opened and sprinkled on applesauce for patients who cannot swallow pills, but the beads should not be chewed.
  • Monitor for signs of stimulant-induced psychosis, mania, or aggression, especially in patients with a history of psychiatric disorders.
  • Regular cardiovascular monitoring (BP, HR) is crucial due to the risk of hypertension and tachycardia.
  • Growth suppression is a concern in pediatric patients; consider drug holidays or alternative therapies if significant growth deceleration occurs.
  • Educate patients on the high abuse potential and the importance of taking the medication exactly as prescribed.
  • Avoid co-administration with MAOIs due to the risk of hypertensive crisis.
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Alternative Therapies

  • Methylphenidate (e.g., Concerta, Ritalin LA, Focalin XR, Quillivant XR, Daytrana)
  • Lisdexamfetamine (Vyvanse)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
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Cost & Coverage

Average Cost: $200 - $400 per 30 capsules (15mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.