D-Amphetamine ER 15mg 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 (CNS) Stimulant
Pharmacologic Class
Sympathomimetic Amine; Dopamine and Norepinephrine Reuptake Inhibitor and Releaser
Pregnancy Category
Category C
FDA Approved
Oct 2001
DEA Schedule
Schedule II
Overview
What is this medicine?
Adderall XR is an extended-release medication containing a combination of amphetamine salts. It's used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to improve focus, attention, and control over impulsive behavior. It works by affecting certain natural chemicals in the brain.
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 on applesauce, but be sure not to 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 storage in a bathroom.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. A locked box or area can help keep your medication safe.
Keep all medications away from pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take the missed dose later in the day.
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 on applesauce, but be sure not to 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 storage in a bathroom.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. A locked box or area can help keep your medication safe.
Keep all medications away from pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take the missed dose later in the day.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Do not take in the late 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 alcohol, as it can increase the risk of side effects and may affect how the medication is released.
- Maintain a healthy diet and monitor weight, especially in children, as appetite suppression can occur.
- Practice good sleep hygiene (consistent bedtime, dark room, avoid screens before bed) to help manage potential insomnia.
- Store securely to prevent misuse or diversion, as this medication has a high potential for abuse.
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:
20 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial 20 mg once daily in the morning. May increase by 10 mg increments weekly to a maximum of 60 mg/day.
Narcolepsy:
Not FDA approved for narcolepsy in ER formulation, but immediate-release amphetamine salts are used. If used off-label, typically 20 mg once daily, adjusted based on response.
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 increments weekly to a maximum of 30 mg/day.
Adolescent:
13-17 years: Initial 10 mg once daily in the morning. May increase by 10 mg increments weekly to a maximum of 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for adverse effects.
Moderate:
No specific adjustment recommended, but monitor for adverse effects. Consider lower doses or alternative if severe renal impairment.
Severe:
Use with caution. Consider lower starting doses and slower titration. Monitor for adverse effects. Amphetamine elimination is pH-dependent; decreased renal function will prolong elimination.
Dialysis:
Not available. Amphetamines are not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but use with caution due to hepatic metabolism. Monitor for adverse effects.
Pharmacology
Mechanism of Action
Amphetamine is a non-catecholamine sympathomimetic amine that causes the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain. It also inhibits the reuptake of these monoamines into the presynaptic neuron. The therapeutic effects in ADHD are thought to be mediated through the modulation of dopaminergic and noradrenergic systems in the prefrontal cortex, which are involved in attention, impulse control, and executive function.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75%
Tmax:
Biphasic: First peak 4-5 hours, Second peak 8-9 hours (for ER formulation)
FoodEffect:
High-fat meals can delay absorption (Tmax by 2.5 hours) but do not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
3.5-4.5 L/kg
ProteinBinding:
15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Levoamphetamine: 11-14 hours
Clearance:
Highly dependent on urinary pH; increased with acidic urine, decreased with alkaline urine.
ExcretionRoute:
Renal
Unchanged:
30-50% (pH-dependent)
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes
PeakEffect:
Biphasic: 4-5 hours and 8-9 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 AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUG SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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, including 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 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 may cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Feeling nervous or 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
Reporting Side Effects
This is not an exhaustive list of possible side effects. 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.
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, including 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 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 may cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Feeling nervous or 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
Reporting Side Effects
This is not an exhaustive list of possible side effects. 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.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening heart problems (e.g., palpitations, irregular heartbeat)
- New or worsening mental problems (e.g., hallucinations, delusions, paranoia, mania)
- New or worsening aggressive behavior or hostility
- New tics or worsening of existing tics
- Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes (Raynaud's phenomenon)
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
+ 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 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. Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not 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 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 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. Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
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 or engaging in activities that require alertness and clear vision until you understand how it affects you. If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may need higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not take more than the prescribed dose.
Long-term or regular use of this medication can lead to dependence, and stopping it abruptly may cause withdrawal symptoms. Before reducing the dose or stopping this medication, consult your doctor, and follow their instructions carefully. If you experience any adverse effects, inform your doctor promptly.
Before starting this medication, you may need to undergo certain heart tests. If you have any questions or concerns, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood tests as advised by your doctor.
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.
There is a risk of new or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, associated with this medication. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of 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 medical attention immediately if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In some cases, this medication may affect growth in children and adolescents. They may require regular growth checks. Different brands of this medication may be approved for use in different age groups, so consult your doctor before giving this medication to a child.
Before consuming alcohol, discuss the potential risks with your doctor. If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
When you first start taking this medication, avoid driving or engaging in activities that require alertness and clear vision until you understand how it affects you. If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may need higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not take more than the prescribed dose.
Long-term or regular use of this medication can lead to dependence, and stopping it abruptly may cause withdrawal symptoms. Before reducing the dose or stopping this medication, consult your doctor, and follow their instructions carefully. If you experience any adverse effects, inform your doctor promptly.
Before starting this medication, you may need to undergo certain heart tests. If you have any questions or concerns, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood tests as advised by your doctor.
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.
There is a risk of new or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, associated with this medication. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of 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 medical attention immediately if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In some cases, this medication may affect growth in children and adolescents. They may require regular growth checks. Different brands of this medication may be approved for use in different age groups, so consult your doctor before giving this medication to a child.
Before consuming alcohol, discuss the potential risks with your doctor. If you are pregnant or plan to become pregnant, inform 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:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management includes symptomatic and supportive measures, gastric lavage, activated charcoal, and acidification of urine to enhance excretion.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis. Do not use within 14 days of MAOI administration.
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans) - risk of serotonin syndrome (relative contraindication, requires careful monitoring).
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, guanethidine) - decrease amphetamine blood levels and shorten half-life, reducing efficacy.
- Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines.
- Antihypertensives - amphetamines may counteract the hypotensive effect.
- Halogenated Anesthetics - risk of sudden death due to ventricular arrhythmias.
Moderate Interactions
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
- Lithium - may inhibit the stimulant effects of amphetamines.
- Opioids - potential for additive CNS effects, respiratory depression.
- Alcohol - may increase the risk of adverse cardiovascular events and lead to dose dumping of ER formulation.
- Proton Pump Inhibitors (PPIs) / H2 Blockers - may increase gastric pH, potentially altering absorption (though less significant for ER formulation).
Minor Interactions
- Caffeine - additive stimulant effects, increased risk of nervousness, insomnia, palpitations.
- Antacids - may increase gastric pH, potentially altering absorption.
Monitoring
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 conditions or risk factors.
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 (including family history)
Rationale: To assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis, tics) that may be exacerbated by stimulants.
Timing: Prior to initiation of therapy
Cardiovascular History (including family history of sudden death or arrhythmias)
Rationale: To identify potential risks for serious cardiovascular events.
Timing: Prior to initiation of therapy
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.
Height and Weight (for children/adolescents)
Frequency: Every 3-6 months
Target: Consistent growth along established growth curves
Action Threshold: Significant deviation from growth curve; consider drug holiday, dose reduction, or alternative therapy.
Psychiatric Status (e.g., mood, anxiety, tics, psychotic symptoms)
Frequency: At each visit
Target: Stable mood, absence of new or worsening psychiatric symptoms
Action Threshold: Emergence of new psychotic symptoms, mania, severe anxiety, or tics; consider discontinuation or psychiatric consultation.
ADHD Symptom Control and Functional Improvement
Frequency: At each visit
Target: Improved attention, reduced impulsivity/hyperactivity, improved academic/social functioning
Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment, adherence check, or re-evaluation of diagnosis.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New onset or worsening tics
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Aggression
- Unexplained weight loss
- Insomnia
- Irritability
- Signs of drug abuse or diversion
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Based on animal data and its mechanism of action, Adderall XR may cause fetal harm. There are reports of adverse pregnancy outcomes, including premature birth and low birth weight, in infants born to mothers taking amphetamines during pregnancy. Neonates exposed to amphetamines during the third trimester may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited human data, but animal studies suggest potential for developmental toxicity.
Second Trimester:
Limited human data.
Third Trimester:
Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress).
Lactation
Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, weight loss, insomnia), breastfeeding is not recommended during treatment with Adderall XR.
Infant Risk:
L4 (Possibly Hazardous) - Potential for irritability, poor feeding, weight loss, insomnia, and other adverse effects in the infant. Long-term effects on neurodevelopment are unknown.
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics). Cardiovascular assessment is important before and during therapy.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, 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. Elderly patients may be more sensitive to the cardiovascular and CNS effects of stimulants.
Clinical Information
Clinical Pearls
- Adderall XR is a prodrug formulation with two types of beads (immediate-release and delayed-release) to provide a biphasic release profile, mimicking two doses of immediate-release amphetamine.
- Instruct patients to take the medication first thing in the morning to avoid insomnia, even if they forget a dose, they should not take it in the afternoon or evening.
- Counsel patients on the high abuse potential and the importance of storing the medication securely and not sharing it.
- For children, consider drug holidays (e.g., weekends, school breaks) to mitigate potential growth suppression, but discuss with the prescriber.
- Monitor for signs of stimulant-induced psychosis or mania, especially in patients with a personal or family history of psychiatric disorders.
- Patients should avoid consuming large amounts of vitamin C or acidic foods/juices around the time of dosing, as this can decrease absorption and efficacy.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Focalin)
- Dexmethylphenidate (e.g., Focalin)
- Atomoxetine (Strattera - non-stimulant)
- Guanfacine ER (Intuniv - non-stimulant)
- Clonidine ER (Kapvay - non-stimulant)
- Bupropion (Wellbutrin - off-label for ADHD)
- Cognitive Behavioral Therapy (CBT)
- Behavioral therapy
- Lifestyle modifications (e.g., exercise, diet, sleep hygiene)
Cost & Coverage
Average Cost:
Varies widely, typically $200-$400+ per 30 capsules (15mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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 its use. It is crucial to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its use. It is crucial to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.