Adderall XR 25mg 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.
đŸˇī¸
Drug Class
Central Nervous System Stimulant
đŸ§Ŧ
Pharmacologic Class
Amphetamine; Norepinephrine-Dopamine Reuptake Inhibitor (NDRI) and Releaser
🤰
Pregnancy Category
Category C
✅
FDA Approved
Oct 2001
âš–ī¸
DEA Schedule
Schedule II

Overview

â„šī¸

What is this medicine?

Adderall XR is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It contains two stimulant medicines, dextroamphetamine and amphetamine, in an extended-release capsule. This means the medicine is released slowly throughout the day, so you usually only need to take it once in the morning. It helps improve focus, attention, and control over impulsive behavior by affecting certain chemicals in your brain.
📋

How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's recommended to take it in the morning. Swallow the capsule whole - do not chew, break, or crush it. If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce, but be sure not to chew the mixture. After mixing with applesauce, take your dose immediately - do not store it for later use.

Before taking any over-the-counter (OTC) products, consult with your doctor, especially if they may increase your blood pressure. These products include cough and 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

Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. To ensure safety, 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 to store your medication. 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.
💡

Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening to avoid sleep problems.
  • Capsules can be swallowed whole or opened and sprinkled on a spoonful of applesauce. Do not chew the beads.
  • Avoid alcohol, as it can affect how the medicine is released.
  • 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., hallucinations, paranoia, aggression).
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 20 mg once daily in the morning
Dose Range: 10 - 60 mg

Condition-Specific Dosing:

ADHD: Initial: 20 mg once daily in the morning. May adjust in 10 mg increments at weekly intervals. Max: 60 mg/day.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial 10 mg once daily in the morning. May increase in 5-10 mg increments at weekly intervals. Max: 30 mg/day.
Adolescent: ADHD (13-17 years): Initial 10 mg once daily in the morning. May increase in 10 mg increments at weekly intervals. Max: 40 mg/day.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: Consider lower doses and monitor for adverse effects. Specific guidelines not well-established.
Severe: Use with caution; consider lower doses or alternative therapy. Specific guidelines not well-established.
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

đŸ”Ŧ

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. 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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 75% (dextroamphetamine) to 90% (amphetamine)
Tmax: Approximately 7 hours (dextroamphetamine) and 8 hours (amphetamine) for XR formulation
FoodEffect: High-fat meal may delay Tmax by 2.5 hours but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 3-5 L/kg
ProteinBinding: Approximately 16-20%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 10-13 hours (dextroamphetamine) and 9-11 hours (amphetamine) in adults; slightly shorter in children.
Clearance: Highly variable, dependent on urinary pH.
ExcretionRoute: Renal (primarily unchanged drug and metabolites)
Unchanged: Approximately 30-40% (acidic urine) to 1% (alkaline urine)
âąī¸

Pharmacodynamics

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

Safety & Warnings

âš ī¸

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.
âš ī¸

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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache 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
Other serious side effects, including:
+ Difficulty getting or maintaining an erection
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
+ Restlessness
+ Changes in eyesight
+ Prolonged or frequent erections
+ Changes in skin color, such as pale, blue, gray, purple, or red discoloration
+ Numbness, pain, tingling, or cold feeling in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or trouble passing urine
Heart problems, including:
+ Sudden death (especially in people with pre-existing heart conditions or defects)
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out

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

Other Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

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 the mouth
* Weight loss

This is not an exhaustive list of possible side effects. 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.
🚨

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
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New or worsening tics (uncontrolled movements or sounds)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained weight loss or lack of growth in children
📋

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 and circumstances to ensure safe treatment:

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

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

Precautions & Cautions

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

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

Long-term or high-dose use of this medication can lead to tolerance, where the drug 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 used to, 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 cause dependence, and stopping it abruptly can lead to withdrawal symptoms. If you need to reduce the dose or stop taking the 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 have regular blood tests to check for any potential changes.

It is also important to note that this medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

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

In some cases, this medication can cause changes in behavior and mood, such as altered thinking, anger, and 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 activities.

This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Discuss your risk factors 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 drugs. 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, nausea or vomiting, or severe headache.

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and the medication's suitability for different age groups may vary depending on the brand. 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 weigh the benefits and risks of using this medication during pregnancy.
🆘

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

What to Do:

Seek immediate medical attention or call Poison Control (1-800-222-1222). Management includes symptomatic and supportive measures, including gastric lavage, activated charcoal, and sedation for CNS overstimulation.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
  • Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome (relative contraindication/major interaction)
🔴

Major Interactions

  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life, increasing risk of toxicity.
  • Acidifying agents (e.g., ascorbic acid, ammonium chloride, cranberry juice) - decrease amphetamine blood levels and shorten half-life, reducing efficacy.
  • Antihypertensives (e.g., guanethidine, clonidine) - amphetamines may antagonize hypotensive effects.
  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.
  • Halogenated Anesthetics - risk of sudden death due to ventricular arrhythmias.
🟡

Moderate Interactions

  • CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure and risk of adverse effects.
  • Proton Pump Inhibitors (PPIs) / H2 Blockers - may slightly increase absorption due to reduced gastric acidity.
  • Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
  • Lithium - may inhibit the anorectic and stimulant effects of amphetamines.
  • Alcohol - may alter the release profile of the extended-release formulation, leading to dose dumping.
đŸŸĸ

Minor Interactions

  • Not available

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Amphetamines can cause dose-related increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation of therapy (pediatric).

Psychiatric History (including family history of suicide, bipolar disorder, depression)

Rationale: Risk of new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression).

Timing: Prior to initiation of therapy.

Cardiac History (including family history of sudden death or ventricular arrhythmia)

Rationale: Risk of serious cardiovascular events.

Timing: Prior to initiation of therapy.

📊

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.

Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months (pediatric); annually (adults).

Target: Normal growth trajectory.

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

Psychiatric Symptoms (e.g., mood changes, agitation, hallucinations, paranoia)

Frequency: At each visit.

Target: Absence of new or worsening symptoms.

Action Threshold: Emergence or worsening of symptoms; consider dose reduction, discontinuation, or psychiatric consultation.

Abuse/Diversion Potential

Frequency: At each visit.

Target: No signs of abuse or diversion.

Action Threshold: Signs of abuse/diversion; consider discontinuation and referral for substance abuse treatment.

đŸ‘ī¸

Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Paranoia
  • Mania
  • Severe anxiety
  • Unexplained weight loss
  • Tics or dyskinesia
  • Peripheral vasculopathy (e.g., Raynaud's phenomenon)

Special Patient Groups

🤰

Pregnancy

Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Potential for congenital malformations, though data are limited and inconsistent.
Second Trimester: Risk of premature delivery and low birth weight.
Third Trimester: Risk of premature delivery, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia).
🤱

Lactation

Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, poor feeding, weight loss), breastfeeding is not recommended during treatment with Adderall XR.

Infant Risk: Moderate to High (L3 - L4)
đŸ‘ļ

Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully. Long-term effects on growth are not fully established. Risk of new or worsening psychiatric symptoms.

👴

Geriatric Use

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

Clinical Information

💎

Clinical Pearls

  • Adderall XR is an extended-release formulation, typically taken once daily in the morning. It should not be taken in the afternoon or evening due to the risk of insomnia.
  • Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing pills, but the beads should not be chewed or crushed.
  • Patients should be screened for pre-existing cardiac conditions and psychiatric disorders before initiating therapy.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of storing the medication securely.
  • Acidifying agents (e.g., vitamin C, cranberry juice) can decrease amphetamine absorption and increase excretion, potentially reducing efficacy. Alkalinizing agents (e.g., antacids, sodium bicarbonate) can increase absorption and decrease excretion, potentially increasing toxicity.
🔄

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
  • Bupropion (Wellbutrin) - off-label for ADHD
💰

Cost & Coverage

Average Cost: $200 - $400+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand); Tier 1 (Generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. 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 amount, and the time it occurred.