D-Amphetamine ER 5mg Salt Combo CP
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.
Drug Class
Central Nervous System Stimulant
Pharmacologic Class
Amphetamine; Norepinephrine-Dopamine Reuptake Inhibitor (NDRI) and Releaser
Pregnancy Category
Category C
FDA Approved
Oct 2001
DEA Schedule
Schedule II
Overview
What is this medicine?
Adderall XR is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents, and adults. It contains two types of stimulant medications (dextroamphetamine and amphetamine) that work by affecting certain natural chemicals in the brain to help improve attention, focus, and reduce impulsivity and hyperactivity. The 'XR' means extended-release, so it works throughout the day with a single morning dose.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
It's best to take your medication in the morning.
Swallow the capsule whole - do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can sprinkle the contents onto applesauce. However, do not chew the mixture.
After mixing the medication with applesauce, take your dose immediately. Do not store the mixture for later use.
Important Interactions to Discuss with Your Doctor
Before taking any over-the-counter (OTC) products, talk to your doctor if you're considering using medications that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
Certain natural products or aids
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature, 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 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.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
It's best to take your medication in the morning.
Swallow the capsule whole - do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can sprinkle the contents onto applesauce. However, do not chew the mixture.
After mixing the medication with applesauce, take your dose immediately. Do not store the mixture for later use.
Important Interactions to Discuss with Your Doctor
Before taking any over-the-counter (OTC) products, talk to your doctor if you're considering using medications that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
Certain natural products or aids
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature, 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 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 as it may cause sleep problems.
- Swallow the capsule whole. Do not crush, chew, or divide the capsule. If you cannot swallow the capsule, you may open it and sprinkle the contents over a spoonful of applesauce and consume immediately.
- Avoid alcohol, as it may cause a rapid release of the medication.
- Maintain a healthy diet and regular sleep schedule.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms may occur.
Available Forms & Alternatives
Available Strengths:
- D-Amphetamine Salt Combo 5mg Tabs
- D-Amphetamine Salt Combo 10mg Tab
- D-Amphetamine Salt Combo 20mg Tabs
- D-Amphetamine Salt Combo 30mg Tabs
- D-Amphetamine Salt Combo 15mg Tabs
- D-Amphetamine Salt Combo 7.5mg Tabs
- D-Amphetamine Salt Combo 12.5mg Tb
- D-Amphetamine ER 30mg Salt Combo CP
- D-Amphetamine ER 20mg Salt Combo CP
- D-Amphetamine ER 10mg Salt Combo CP
- D-Amphetamine ER 5mg Salt Combo CP
- D-Amphetamine ER 25mg Salt Combo CP
- D-Amphetamine ER 15mg Salt Combo CP
- D-Amphetamine Salt Combo 10mg Tab
- D-Amphetamine ER 12.5mg Slt Cmb 3b
- D-Amphetamine ER 37.5mg Slt Cmb 3b
- D-Amphetamine ER 50mg Slt Cmb 3b CP
- D-Amphetamine ER 25mg Slt Cmb 3b CP
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg once daily in the morning
Dose Range:
10 - 30 mg
Condition-Specific Dosing:
ADHD:
Initial 20 mg once daily in the morning; may be adjusted in 10 mg increments at weekly intervals to a maximum of 30 mg/day.
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 or 10 mg increments at weekly intervals to a maximum of 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 to a maximum of 30 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended for mild renal impairment (CrCl 60-89 mL/min).
Moderate:
Consider lower starting doses and slower titration. For CrCl 30-59 mL/min, consider 50% of usual dose.
Severe:
Use with caution. For CrCl <30 mL/min, consider 25-50% of usual dose. Contraindicated in end-stage renal disease.
Dialysis:
Not recommended. Amphetamines are not dialyzable to a significant extent.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Use with caution. Consider lower starting doses and slower titration.
Severe:
Use with caution. Consider lower starting doses and slower titration. Specific guidelines are not well-established, but significant impairment may reduce clearance.
Pharmacology
Mechanism of Action
Amphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effects by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, particularly in the prefrontal cortex. It also blocks the reuptake of these monoamines into the presynaptic neuron. The exact mechanism by which it produces its behavioral and clinical effects in ADHD is not fully understood but is thought to involve modulation of attention, impulse control, and hyperactivity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
Biphasic absorption due to dual-bead system: First peak ~3 hours, second peak ~7 hours post-dose.
FoodEffect:
High-fat meals may delay Tmax by approximately 2.5 hours but do not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 3.7-5.1 L/kg
ProteinBinding:
Approximately 16-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (highly dependent on urinary pH)
Clearance:
Highly variable, influenced by urinary pH. Acidic urine increases clearance.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-40% (acidic urine), 1% (alkaline urine)
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes
PeakEffect:
First peak ~3 hours, second peak ~7 hours
DurationOfAction:
Approximately 10-12 hours
Safety & Warnings
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.
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, 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
+ Dizziness
+ Fainting
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Other serious side effects, including:
+ Difficulty getting or maintaining an erection
+ Changes in sex drive
+ 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
+ Numbness, pain, tingling, or cold sensations in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or difficulty urinating
Heart problems, including:
+ Sudden death (rarely occurs in people with pre-existing heart conditions or defects)
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
If you have a heart condition or defect, or if a family member has a history of abnormal heart rhythms or sudden death, inform your doctor. Seek medical help immediately if you experience any signs of heart problems.
Other 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. Contact your doctor or seek medical attention if you experience any of the following side effects or if they persist or worsen:
Feeling nervous or excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
Weight loss
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
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, 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
+ Dizziness
+ Fainting
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Other serious side effects, including:
+ Difficulty getting or maintaining an erection
+ Changes in sex drive
+ 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
+ Numbness, pain, tingling, or cold sensations in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness, dark urine, or difficulty urinating
Heart problems, including:
+ Sudden death (rarely occurs in people with pre-existing heart conditions or defects)
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
If you have a heart condition or defect, or if a family member has a history of abnormal heart rhythms or sudden death, inform your doctor. Seek medical help immediately if you experience any signs of heart problems.
Other 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. Contact your doctor or seek medical attention if you experience any of the following side effects or if they persist or worsen:
Feeling nervous or excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
Weight loss
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 (seek immediate medical attention)
- 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 numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained weight loss or slowed growth in children
- Blurred vision or other vision changes
- Severe headache
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 you experienced, including the symptoms that occurred.
A family history of certain health problems, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
Existing health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health problems, 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 medications, such as:
+ Linezolid
+ Methylene blue
* Breast-feeding: Do not breast-feed while taking this medication, as it may pose risks to your baby.
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. They will help you determine whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting 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 you experienced, including the symptoms that occurred.
A family history of certain health problems, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
Existing health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health problems, 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 medications, such as:
+ Linezolid
+ Methylene blue
* Breast-feeding: Do not breast-feed while taking this medication, as it may pose risks to your baby.
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. They will help you determine whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor.
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 Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Tests
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor. Regularly check your blood pressure and heart rate as directed by your doctor. Also, have blood work done as instructed by your doctor and report any concerns to them.
Interactions and Lab Tests
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication. Do not take antacids with this medication, as it may interact with the medication.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as altered thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Use
Discuss alcohol consumption with your doctor before drinking while taking this medication.
Pregnancy
If you are pregnant or plan to become pregnant, consult your doctor to discuss the benefits and risks of using this medication during pregnancy.
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 Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Tests
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor. Regularly check your blood pressure and heart rate as directed by your doctor. Also, have blood work done as instructed by your doctor and report any concerns to them.
Interactions and Lab Tests
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication. Do not take antacids with this medication, as it may interact with the medication.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as altered thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Use
Discuss alcohol consumption with your doctor before drinking while taking this medication.
Pregnancy
If you are pregnant or plan to become pregnant, consult your doctor to discuss 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
- Death
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis (do not use within 14 days of MAOI use)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome (especially with high doses or concomitant use of other serotonergic agents)
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, reserpine) - amphetamines may counteract the hypotensive effect.
- Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
- Propoxyphene - may increase amphetamine levels.
Moderate Interactions
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure and prolong half-life, increasing risk of adverse effects.
- Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase gastric pH, potentially increasing amphetamine absorption.
- Antacids - may increase gastric pH, potentially increasing amphetamine absorption.
- Alcohol - may alter the release profile of the extended-release formulation, leading to a more rapid release of amphetamine.
Minor Interactions
- Not available
Monitoring
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 (Pediatric)
Rationale: Stimulants have been associated with growth suppression.
Timing: Prior to initiation of therapy.
Psychiatric History (including family history of suicide, bipolar disorder, depression)
Rationale: To assess risk for emergence or exacerbation of psychiatric symptoms.
Timing: Prior to initiation of therapy.
Cardiac History (including family history of sudden death or arrhythmias)
Rationale: To assess risk for 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 and clinical status.
Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant investigation and potential dose adjustment or discontinuation.
Height and Weight (Pediatric)
Frequency: Every 3-6 months.
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss may require drug holiday or alternative treatment.
Psychiatric Symptoms (e.g., agitation, aggression, psychosis, mania, depression, suicidal ideation)
Frequency: At each visit.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of severe psychiatric symptoms warrants immediate evaluation and potential discontinuation.
Abuse/Diversion Potential
Frequency: At each visit.
Target: No signs of abuse or diversion.
Action Threshold: Signs of abuse or diversion require intervention and potential discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Agitation
- Depressed mood
- Suicidal thoughts
- Unexplained weight loss
- Tics or abnormal movements
- 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 can 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 breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, growth suppression, cardiovascular effects), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderate risk) - Monitor infant for irritability, sleep disturbances, poor feeding, and weight gain. Long-term effects on neurodevelopment are unknown.
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) and cardiovascular parameters regularly. Assess for emergence or worsening of psychiatric symptoms. Long-term safety and efficacy in children younger than 6 years have not been established.
Geriatric Use
Use with caution in elderly patients. Elderly patients may be more sensitive to the effects of stimulant medications, particularly cardiovascular and psychiatric adverse effects. Consider lower starting doses and slower titration. Monitor for cardiovascular events and psychiatric symptoms.
Clinical Information
Clinical Pearls
- Adderall XR uses a dual-bead system for extended release, providing two peaks of plasma concentration, which allows for once-daily dosing.
- Instruct patients to take the medication in the morning to avoid insomnia.
- Counsel patients on the high abuse potential and the importance of storing the medication securely.
- Monitor for signs of peripheral vasculopathy (e.g., Raynaud's phenomenon), especially in children and adolescents.
- Acidic urine (e.g., from high vitamin C intake) can significantly increase amphetamine excretion, potentially reducing efficacy. Alkaline urine can decrease excretion, increasing exposure and risk of toxicity.
- Consider a drug holiday if growth suppression is observed in pediatric patients, under medical supervision.
Alternative Therapies
- Methylphenidate extended-release (e.g., Concerta, Ritalin LA, Focalin XR)
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Non-pharmacological interventions (e.g., behavioral therapy, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
$200 - $400 per 30 capsules (20mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.