Adderall XR 10mg 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 EX-R (Deks-troe-am-FET-uh-meen & Am-FET-uh-meen)
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; Norepinephrine-Dopamine Reuptake Inhibitor and Releaser
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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 a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It helps improve focus, attention, and control over impulsive behaviors by affecting certain natural chemicals in the brain. It's an extended-release capsule, meaning it releases medicine slowly throughout the day.
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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 it 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 and moisture.
Keep it in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom.
Keep it out of reach of children and pets, and consider storing it in a locked box or area to prevent accidental ingestion.
* Keep all medications away from pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and take your next dose at the usual time. Do not take a missed dose later in the day.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning to avoid sleep problems.
  • Do not crush, chew, or open the capsule and sprinkle contents on food (unless specifically instructed by your doctor for applesauce).
  • Avoid consuming large amounts of acidic foods or drinks (e.g., citrus fruits, juices) as they can reduce the absorption of the medication.
  • Limit caffeine intake, as it can increase stimulant effects and side effects.
  • Maintain a healthy diet and regular sleep schedule.
  • Store in a safe place to prevent misuse or theft, 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. May increase to 40 mg or 60 mg daily if needed, typically not exceeding 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. May increase by 5-10 mg weekly to a maximum of 30 mg/day.
Adolescent: 13-17 years: Initial 10 mg once daily in the morning. May increase to 20 mg after 1 week if needed. Maximum 20 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, monitor for adverse effects.
Moderate: Consider lower starting dose and monitor closely. Specific guidelines not available.
Severe: CrCl < 30 mL/min: Use with caution, consider significant dose reduction or avoidance due to increased exposure and prolonged half-life.
Dialysis: Avoid or use with extreme caution; not dialyzable to a significant extent. Monitor for toxicity.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, monitor for adverse effects.
Moderate: No specific dose adjustment recommended, monitor for adverse effects.
Severe: No specific dose adjustment recommended, monitor for adverse effects. Primarily renally excreted, hepatic metabolism is minor.

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 their reuptake into the presynaptic neuron. This leads to increased concentrations of these neurotransmitters in the synaptic cleft, enhancing neurotransmission in areas of the brain associated with attention and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: ~75%
Tmax: First peak: ~3 hours; Second peak: ~7 hours (bimodal release)
FoodEffect: High-fat meals can delay Tmax by approximately 2.5 hours but do not significantly affect the extent of absorption (AUC). Acidic foods (e.g., fruit juice) can decrease absorption.

Distribution:

Vd: 3-5 L/kg
ProteinBinding: 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (adults). Longer in children.
Clearance: Highly variable, pH-dependent.
ExcretionRoute: Renal (urine)
Unchanged: 30-40% (adults); 50% (children) excreted unchanged in urine. Excretion is increased in acidic urine and decreased in alkaline urine.
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Pharmacodynamics

OnsetOfAction: ~30-60 minutes (initial release)
PeakEffect: ~3-7 hours (bimodal peaks)
DurationOfAction: ~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
Uncontrollable 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 of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine

Important Heart-Related Information

If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek medical help immediately if you experience any signs of heart problems, including:

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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:

Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dizziness, tiredness, or weakness
Dry mouth
Bad taste in mouth
Weight loss

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 (signs of heart problems)
  • New or worsening mental problems (e.g., hearing voices, believing things that are not true, paranoia, aggression)
  • New or worsening tics (uncontrolled movements or sounds)
  • Numbness, pain, skin color change (pale, blue, red), or unexplained wounds on fingers or toes (signs of circulation problems)
  • Blurred vision or other changes in eyesight
  • Severe headache
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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
+ Antidepressants or Parkinson's disease medications taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

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

Caution with Daily Activities

Until you understand how this medication affects you, avoid driving and engaging in activities that require alertness and clear vision.

Long-Term Use and Dosage

If you have been taking this medication for an extended period or at high doses, you may develop tolerance, meaning it may not work as effectively, and you might need higher doses to achieve the same effect. 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. Before reducing the dose or stopping the medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor.

Pre-Treatment Tests and Monitoring

You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. Regularly check your blood pressure and heart rate as advised by your doctor. Additionally, have blood work done as directed by your doctor and discuss the results with them.

Potential Side Effects and Interactions

This medication may cause high blood pressure. It can also affect the results of certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication. Do not take antacids with this medication.

Mental Health Considerations

There have been reports of new or worsening behavioral and mood changes, including 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 like 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 this medication is taken 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, stomach upset, vomiting, or severe headache.

Effects on Growth in Children and Teens

In some cases, this medication may affect growth in children and adolescents, who may require regular growth checks. Different brands of this medication may be approved for use in different age groups of children, so consult your doctor before giving this medication to a child.

Alcohol Consumption and Pregnancy

Discuss alcohol consumption with your doctor before drinking while taking this medication. If you are pregnant or plan to become pregnant, consult your doctor to weigh the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia (overactive reflexes)
  • Rapid breathing
  • Confusion
  • Hallucinations
  • Panic states
  • High fever
  • Rhabdomyolysis (muscle breakdown)
  • Arrhythmias (irregular heartbeats)
  • Hypertension (high blood pressure) or hypotension (low blood pressure)
  • Circulatory collapse
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management typically involves supportive care, including gastric lavage, activated charcoal, and symptomatic treatment for cardiovascular and CNS effects.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
  • Linezolid
  • Methylene Blue (IV)
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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.
  • Adrenergic drugs (e.g., decongestants, vasopressors) - increased risk of hypertensive crisis and arrhythmias.
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase renal excretion, decreasing amphetamine levels.
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease renal excretion, increasing amphetamine levels and prolonging half-life.
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
  • Proton Pump Inhibitors (PPIs) - may increase amphetamine absorption.
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.
  • Antihypertensives - amphetamines may reduce the effectiveness of antihypertensive drugs.
  • Opioids - additive CNS depressant effects if used concurrently with other CNS depressants.
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Minor Interactions

  • Not typically categorized as minor due to the potent nature and potential for serious interactions with amphetamines.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To establish baseline cardiovascular status and identify pre-existing hypertension or tachycardia.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: To establish baseline growth parameters, especially in pediatric patients, due to potential for growth suppression.

Timing: Prior to initiation of therapy.

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

Rationale: To assess risk for new or worsening psychiatric symptoms.

Timing: Prior to initiation of therapy.

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

Rationale: To identify patients at increased risk for sudden cardiac death or other serious cardiovascular events.

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

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit (e.g., every 3-6 months or as clinically indicated)

Target: Within normal limits for age and clinical status

Action Threshold: Persistent elevation above normal range; consider dose reduction, discontinuation, or referral to cardiology.

Weight and Height (pediatric patients)

Frequency: Every 3-6 months

Target: Consistent growth along established growth curves

Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative therapy.

Psychiatric Symptoms (e.g., mood changes, anxiety, tics, aggression, psychotic symptoms)

Frequency: At each visit

Target: Stable or improved psychiatric status

Action Threshold: New onset or worsening of severe psychiatric symptoms; consider dose adjustment or discontinuation.

ADHD Symptom Control

Frequency: At each visit

Target: Improved attention, focus, and impulse control with minimal side effects

Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope (fainting)
  • Palpitations
  • New or worsening aggression
  • New or worsening psychotic symptoms (e.g., hallucinations, paranoia)
  • New or worsening manic symptoms
  • New or worsening tics or Tourette's syndrome
  • Unexplained wounds on fingers or toes (peripheral vasculopathy)
  • Blurred vision or other visual disturbances
  • Severe headache

Special Patient Groups

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Pregnancy

Risk cannot be ruled out. Studies in animals have shown adverse effects on fetal development. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations, though data are conflicting.
Second Trimester: Not well-studied, but continued exposure may lead to growth restriction.
Third Trimester: Potential for premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor) if used near term.
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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, poor weight gain, sleep disturbances), 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 risk (L3). Monitor infant for signs of adverse effects.
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Pediatric Use

Approved for ADHD in children 6 years of age and older. Monitor growth (height and weight) carefully due to potential for growth suppression. Monitor for new or worsening psychiatric symptoms and cardiovascular effects.

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Geriatric Use

Use with caution. Geriatric patients may be more sensitive to the effects of stimulant medications, particularly cardiovascular and psychiatric adverse effects. Consider lower initial doses and slower titration. Monitor closely for adverse reactions.

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 day and minimize evening insomnia.
  • The capsule can be opened and the entire contents sprinkled on a spoonful of applesauce and consumed immediately for patients who have difficulty swallowing capsules whole. Do not chew the beads.
  • Patients should be screened for pre-existing cardiac conditions and psychiatric disorders (e.g., bipolar disorder, psychosis) before initiating therapy.
  • Regular monitoring of blood pressure, heart rate, and weight (especially in children) is crucial.
  • Due to its Schedule II classification, strict prescribing and dispensing regulations apply, and there is a high potential for abuse and dependence.
  • Inform patients about the potential for peripheral vasculopathy, including Raynaud's phenomenon, and to report any new numbness, pain, or skin discoloration in fingers or toes.
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Alternative Therapies

  • Other stimulant medications (e.g., methylphenidate extended-release formulations like Concerta, Ritalin LA; lisdexamfetamine (Vyvanse))
  • Non-stimulant medications (e.g., atomoxetine (Strattera), guanfacine extended-release (Intuniv), clonidine extended-release (Kapvay))
  • Behavioral therapy and psychotherapy (often used in conjunction with pharmacotherapy for ADHD)
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Cost & Coverage

Average Cost: $200 - $350+ per 30 capsules (10mg strength)
Generic Available: Yes
Insurance Coverage: Generic formulations are typically covered as Tier 1 or Tier 2. Brand-name Adderall XR may be Tier 2 or Tier 3, requiring higher co-pays or prior authorization.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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. Please read this guide carefully and review it again whenever you receive a refill. 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 call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.