Adderall XR 30mg 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-ARR
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 capsule containing a combination of amphetamine and dextroamphetamine. It's a stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by increasing the levels of certain natural substances in the brain that help with focus and impulse control.
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How to Use This Medicine

Taking Your Medication

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

Before taking this medication, talk to your doctor about any over-the-counter (OTC) products you are using that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Store your medication in a safe and secure location where children and pets cannot access it, such as a locked box or area. This will help prevent accidental ingestion or misuse.

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. Instead, wait until the next morning to take your medication as usual.
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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 the capsule. If unable to swallow, the capsule may be opened and the contents sprinkled on a spoonful of applesauce and consumed immediately.
  • Avoid abrupt discontinuation, especially after prolonged use, as it can lead to withdrawal symptoms.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Limit or avoid alcohol consumption.
  • Maintain a healthy diet and regular sleep schedule.
  • Store securely to prevent misuse or diversion.

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 adjusted in 10 mg increments at weekly intervals. Maximum 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 be adjusted in 5-10 mg increments at weekly intervals. Maximum 30 mg/day.
Adolescent: 13-17 years: Initial 10 mg once daily in the morning. May be adjusted in 10 mg increments at weekly intervals. Maximum 40 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor for adverse effects.
Moderate: Consider lower starting dose and slower titration. Monitor for adverse effects.
Severe: Use with caution. Consider significant dose reduction (e.g., 50% of usual dose) or avoid. Amphetamines are renally excreted.
Dialysis: Not well-studied. Likely not dialyzable to a significant extent. Avoid or use with extreme caution and significant dose reduction.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: Use with caution. Consider lower starting dose and slower titration.
Severe: Use with caution. Consider significant dose reduction or avoid due to hepatic metabolism.

Pharmacology

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Mechanism of Action

Dextroamphetamine and amphetamine are non-catecholamine sympathomimetic amines that exert their therapeutic effect by blocking the reuptake of norepinephrine and dopamine into the presynaptic neuron and increasing the release of these monoamines into the extraneuronal space. The exact mechanism of action in ADHD is not fully understood but is thought to involve modulation of central noradrenergic and dopaminergic pathways.
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Pharmacokinetics

Absorption:

Bioavailability: High (approximately 75% for amphetamine, 70% for dextroamphetamine)
Tmax: Biphasic absorption: 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 3-5 L/kg
ProteinBinding: Low (15-26%)
CnssPenetration: Yes

Elimination:

HalfLife: Dextroamphetamine: 10-13 hours; Levoamphetamine: 9-11 hours (pH-dependent)
Clearance: Highly variable, pH-dependent. Increased in acidic urine, decreased in alkaline urine.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 30-40% of amphetamine and 45-50% of dextroamphetamine are excreted unchanged in urine at normal urinary pH. Up to 70% can be excreted unchanged in acidic urine.
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes
PeakEffect: Approximately 3-7 hours (due to biphasic release)
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 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 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 can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. Common side effects include:

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 experience any of these side effects or any other concerns, contact your doctor for advice. 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 high blood pressure or heart rate
  • New or worsening mental problems (e.g., psychosis, mania, aggression, hallucinations)
  • New or worsening tics or Tourette's syndrome
  • Unexplained weight loss or slowed growth in children
  • Blurred vision
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
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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, and describe the symptoms you experienced.
A personal or 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
Existing health problems, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, such as:
+ Drug abuse
+ Stroke
Kidney disease
Current medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain drugs for depression or Parkinson's disease taken in the last 14 days (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline), as they may cause very high blood pressure
+ Linezolid or methylene blue
* Breast-feeding status: Do 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. Never start, stop, or change the dose of any medication without consulting your doctor.
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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, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. Wait until you understand how this medication affects you before engaging in such activities.

Long-term or high-dose use of this medication can lead to tolerance, where the medication becomes less effective, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not take more than the prescribed dose, as this can increase the risk of adverse effects.

Prolonged or regular use of this medication may result in dependence, and suddenly stopping it can cause withdrawal symptoms. If you need to reduce the dose or stop taking this medication, consult your doctor, who will provide guidance on how to do so safely.

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

This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as directed by your doctor, and report any changes or concerns.

Regular blood tests may be necessary to monitor your health while taking this medication. Follow your doctor's instructions for scheduling these tests, and discuss any concerns or questions you may have.

It is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.

Do not take antacids while using this medication, as they may interact with it.

In some cases, this medication can cause changes in behavior and mood, such as altered thinking, anger, or hallucinations. If you or a family member have a history of mental health conditions, such as depression or bipolar disorder, or if a family member has attempted suicide, inform your doctor. Seek immediate medical attention 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.

This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Discuss your risk with your doctor to determine if you are more susceptible to seizures while taking this medication.

A rare but potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other medications. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, 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.

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and your doctor will discuss the potential risks and benefits with you. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving this medication to a child.

Before consuming alcohol while taking this medication, discuss the potential risks and benefits with your doctor.

If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the benefits and risks of using this medication during pregnancy with you.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Aggressiveness
  • Hallucinations
  • Panic states
  • High fever
  • Rhabdomyolysis
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea, vomiting, diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, managing symptoms like hyperthermia, seizures, and cardiovascular effects.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to 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.
  • Tricyclic Antidepressants (TCAs) - may increase amphetamine levels, leading to enhanced effects and potential toxicity.
  • Urinary Acidifiers (e.g., ammonium chloride, ascorbic acid) - increase renal excretion of amphetamines, decreasing efficacy.
  • Urinary Alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease renal excretion of amphetamines, increasing efficacy and potential toxicity.
  • Antihypertensives - amphetamines may antagonize the hypotensive effects of these drugs.
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Moderate Interactions

  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase amphetamine absorption and exposure.
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
  • Alcohol - may alter the release profile of extended-release formulations, leading to dose dumping.
  • Opioids - potential for additive CNS depression and respiratory depression.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Amphetamines can cause dose-related increases in BP and HR. Baseline assessment is crucial to identify pre-existing cardiovascular risk.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Stimulants can cause growth suppression in children. Baseline measurements are needed for ongoing monitoring.

Timing: Prior to initiation of therapy.

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

Rationale: Stimulants can exacerbate or unmask psychiatric conditions.

Timing: Prior to initiation of therapy.

Cardiac History and Family History of Sudden Death/Arrhythmias

Rationale: To identify individuals at increased risk for serious cardiovascular events.

Timing: Prior to initiation of therapy. ECG may be considered 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 sustained increases should prompt evaluation.

Action Threshold: Sustained elevation above normal range, or significant increase from baseline (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR).

Height and Weight

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

Target: Normal growth trajectory for age; stable weight in adults.

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric Symptoms (e.g., agitation, anxiety, psychosis, mania, tics)

Frequency: At each visit.

Target: Absence or control of symptoms.

Action Threshold: Emergence or worsening of psychotic or manic symptoms, severe anxiety, agitation, or new/worsening tics.

ADHD Symptom Control and Functional Improvement

Frequency: At each visit.

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

Action Threshold: Lack of efficacy or worsening of ADHD symptoms.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening anxiety
  • Agitation
  • Hallucinations
  • Delusions
  • Manic symptoms
  • New or worsening tics
  • Unexplained weight loss
  • Sleep disturbances

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 may cause fetal harm.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for increased risk of congenital malformations not definitively established.
Second Trimester: Potential for premature birth and low birth weight.
Third Trimester: Risk of withdrawal symptoms in the neonate (e.g., agitation, feeding difficulties, tremor, hypertonia) if used late in pregnancy.
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Lactation

Amphetamines are excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, poor feeding, 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: Moderate risk (L3). Potential for irritability, poor sleep, poor weight gain, and cardiovascular effects in the infant.
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Pediatric Use

Safety and efficacy not established in children younger than 6 years. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.

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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. Generally, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Increased sensitivity to adverse effects (e.g., cardiovascular, psychiatric) is possible.

Clinical Information

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Clinical Pearls

  • Adderall XR is designed for once-daily morning dosing. Taking it later in the day can cause insomnia.
  • The capsule can be opened and sprinkled on applesauce for patients who have difficulty swallowing, but the contents should not be chewed or crushed.
  • Patients should be screened for cardiac abnormalities and psychiatric conditions (e.g., bipolar disorder, psychosis) prior to initiation.
  • Regular monitoring of blood pressure, heart rate, height, and weight is crucial, especially in pediatric patients.
  • Educate patients and caregivers about the high potential for abuse and dependence, and the importance of secure storage.
  • Avoid abrupt discontinuation after prolonged use to prevent withdrawal symptoms.
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Alternative Therapies

  • Methylphenidate (e.g., Concerta, Ritalin LA, Focalin XR)
  • Lisdexamfetamine (Vyvanse)
  • Atomoxetine (Strattera) - non-stimulant
  • Guanfacine extended-release (Intuniv) - non-stimulant
  • Clonidine extended-release (Kapvay) - non-stimulant
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Cost & Coverage

Average Cost: $200 - $400+ per 30 capsules (30mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand); Tier 1 or Tier 2 (for 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. If you have any questions or concerns about this medication, don't hesitate to 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 incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.