D-Amphetamine ER 10mg 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
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 onto applesauce. However, do not chew the applesauce after mixing.
Take your dose immediately after mixing with applesauce. 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 plan to use 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. Consider using a locked box or area.
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 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 applesauce after mixing.
Take your dose immediately after mixing with applesauce. 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 plan to use 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. Consider using a locked box or area.
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 schedule. Do not take the missed dose later in the day.
Lifestyle & Tips
- Take the medication once daily in the morning, usually upon waking, to avoid sleep problems.
- Do not take a second dose in the afternoon or evening.
- Capsules can be swallowed whole or opened and sprinkled on a spoonful of applesauce; swallow immediately without chewing.
- Avoid consuming large amounts of vitamin C or acidic foods/juices (e.g., orange juice) around the time of dosing, as they can reduce the absorption 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 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial dose 20 mg once daily in the morning. May be adjusted in 10 mg increments at weekly intervals up to a maximum of 60 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial dose 10 mg once daily in the morning. May be adjusted in 5-10 mg increments at weekly intervals up to a maximum of 30 mg/day.
Adolescent:
13-17 years: Initial dose 10 mg once daily in the morning. May be adjusted in 10 mg increments at weekly intervals up to a maximum of 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment provided, use with caution.
Moderate:
No specific dose adjustment provided, use with caution and consider lower doses.
Severe:
Consider lower doses or avoid use due to significant renal excretion of unchanged drug.
Dialysis:
Not available, likely not recommended due to complex PK and potential for accumulation.
Hepatic Impairment:
Mild:
No specific dose adjustment provided, use with caution.
Moderate:
No specific dose adjustment provided, use with caution and consider lower doses.
Severe:
No specific dose adjustment provided, use with caution and consider lower doses.
Pharmacology
Mechanism of Action
Amphetamine is a non-catecholamine sympathomimetic amine that exerts its 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.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
Biphasic release: First peak at approximately 3-4 hours, second peak at approximately 7-8 hours post-dose.
FoodEffect:
A high-fat meal can delay Tmax by approximately 2.5 hours, but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 3-4 L/kg
ProteinBinding:
Low (16-26%)
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Levoamphetamine: 9-11 hours (pH-dependent)
Clearance:
Highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-40% excreted unchanged in urine at normal urinary pH; up to 75% in acidic urine.
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes
PeakEffect:
Biphasic, corresponding to Tmax peaks (3-4 hours and 7-8 hours)
DurationOfAction:
Up to 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 Immediately
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 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
Other serious side effects, including:
+ Erectile dysfunction
+ 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
If you have a history of heart problems or heart defects, 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 Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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, 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 notice 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
Other serious side effects, including:
+ Erectile dysfunction
+ 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
If you have a history of heart problems or heart defects, 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 Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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, 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 (signs of heart problems)
- Numbness, coolness, or pain in fingers or toes, or unexplained wounds on fingers or toes (signs of circulation problems)
- New or worsening mental problems, such as aggression, hostility, paranoia, hallucinations, or mania
- New or worsening tics (uncontrolled movements or sounds)
- Blurred vision or other vision changes
- Severe headache
- Unexplained fever or muscle stiffness
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 taken within the last 14 days, such as:
- Isocarboxazid
- Phenelzine
- Tranylcypromine
- Selegiline
- Rasagiline (note: combining these medications can lead to 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. Never start, stop, or change the dose of any medication without consulting your doctor first.
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 taken within the last 14 days, such as:
- Isocarboxazid
- Phenelzine
- Tranylcypromine
- Selegiline
- Rasagiline (note: combining these medications can lead to 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. Never start, stop, or change the dose of any medication without consulting your doctor first.
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.
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
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 well as it initially did. In this case, 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 lead to adverse effects.
Long-term or regular use of this medication can lead to dependence, and stopping it suddenly may cause withdrawal symptoms. If you need to reduce the dose or stop taking the medication, consult your doctor first. They will provide guidance on how to do so safely.
Before starting this medication, you may need to undergo heart tests to ensure it is safe for you to take. 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. You will also need to have regular blood tests to check for any potential side effects. Inform your doctor about any adverse effects you experience.
Certain laboratory tests may be affected by this medication, so it is essential to inform all your healthcare providers and lab personnel that you are taking it.
Do not take antacids while taking this medication, as they may interact with it.
In some cases, this medication can cause changes in behavior and mood, such as hallucinations, anger, or changes in thinking. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience any symptoms such as hallucinations, changes in behavior, depression, suicidal thoughts, nervousness, mood swings, or anxiety, contact your doctor immediately.
This medication may increase the risk of seizures in some individuals, particularly those who have had seizures in the past. Discuss your risk with your doctor to determine if you are more likely to experience 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. If you experience symptoms such as agitation, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, sweating, severe diarrhea, nausea, or headache, contact your doctor immediately.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary to monitor this potential side effect. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving it to a child.
Before consuming alcohol while taking this medication, discuss the potential risks with your doctor.
If you are pregnant or plan to become pregnant, inform your doctor. They will help you weigh the benefits and risks of taking this medication during pregnancy.
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
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 well as it initially did. In this case, 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 lead to adverse effects.
Long-term or regular use of this medication can lead to dependence, and stopping it suddenly may cause withdrawal symptoms. If you need to reduce the dose or stop taking the medication, consult your doctor first. They will provide guidance on how to do so safely.
Before starting this medication, you may need to undergo heart tests to ensure it is safe for you to take. 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. You will also need to have regular blood tests to check for any potential side effects. Inform your doctor about any adverse effects you experience.
Certain laboratory tests may be affected by this medication, so it is essential to inform all your healthcare providers and lab personnel that you are taking it.
Do not take antacids while taking this medication, as they may interact with it.
In some cases, this medication can cause changes in behavior and mood, such as hallucinations, anger, or changes in thinking. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience any symptoms such as hallucinations, changes in behavior, depression, suicidal thoughts, nervousness, mood swings, or anxiety, contact your doctor immediately.
This medication may increase the risk of seizures in some individuals, particularly those who have had seizures in the past. Discuss your risk with your doctor to determine if you are more likely to experience 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. If you experience symptoms such as agitation, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, sweating, severe diarrhea, nausea, or headache, contact your doctor immediately.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary to monitor this potential side effect. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving it to a child.
Before consuming alcohol while taking this medication, discuss the potential risks with your doctor.
If you are pregnant or plan to become pregnant, inform your doctor. They will help you weigh the benefits and risks of taking this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia (overactive reflexes)
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia (very high fever)
- Rhabdomyolysis (muscle breakdown)
- Convulsions
- Coma
- Circulatory collapse
- Cardiac arrhythmias
- Hypertension or hypotension
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is generally supportive and may include gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, cooling for hyperthermia).
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
- Halogenated Anesthetics - risk of sudden death
Major Interactions
- Acidifying agents (e.g., ascorbic acid, fruit juices) - decrease absorption and increase excretion, reducing efficacy
- Alkalinizing agents (e.g., sodium bicarbonate, antacids, proton pump inhibitors) - increase absorption and decrease excretion, increasing toxicity risk
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of amphetamines
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans) - increased risk of serotonin syndrome
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
- Antihypertensives - amphetamines may reduce the hypotensive effect
Moderate Interactions
- Urinary acidifiers (e.g., ammonium chloride, methenamine salts) - increase urinary excretion of amphetamines
- Urinary alkalinizers (e.g., acetazolamide, thiazide diuretics) - decrease urinary excretion of amphetamines
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase amphetamine exposure
- Adrenergic blockers (e.g., beta-blockers) - may potentiate pressor effects of amphetamines
Minor Interactions
- Not many specific minor interactions commonly cited; general caution with other CNS stimulants or depressants.
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
Rationale: Risk of growth suppression in pediatric patients and weight loss in all patients.
Timing: Prior to initiation of therapy.
Cardiovascular Assessment
Rationale: To screen for pre-existing cardiac conditions that may contraindicate stimulant use (e.g., structural cardiac abnormalities, cardiomyopathy, serious arrhythmia). ECG may be considered based on clinical judgment.
Timing: Prior to initiation of therapy.
Psychiatric History
Rationale: To screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.
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: Maintain within normal limits for age; significant or sustained increases warrant evaluation.
Action Threshold: Persistent elevation above baseline or age-appropriate norms; consider dose reduction, discontinuation, or referral to cardiology.
Weight and Height (pediatric)
Frequency: Every 3-6 months.
Target: Maintain normal growth trajectory; monitor for significant deviations.
Action Threshold: Growth deceleration or significant weight loss; consider drug holiday, dose reduction, or alternative therapy.
ADHD Symptom Control and Side Effects
Frequency: At each visit.
Target: Optimal symptom control with tolerable side effects.
Action Threshold: Inadequate symptom control, emergence of new or worsening psychiatric symptoms (e.g., agitation, anxiety, psychosis, tics), or intolerable side effects.
Psychiatric Status
Frequency: At each visit.
Target: Stable mood, absence of psychotic symptoms or severe anxiety.
Action Threshold: Emergence of new or worsening aggression, hostility, psychosis, mania, or suicidal ideation; consider discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Fainting
- Palpitations
- Unexplained wounds on fingers or toes (Raynaud's phenomenon)
- New or worsening aggression or hostility
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- New or worsening manic symptoms
- Severe headache
- Blurred vision
- Unusual changes in behavior or mood
- Tics or involuntary movements
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm. There are reports of premature delivery and low birth weight in infants born to mothers dependent on amphetamines. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremor, hypertonia).
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are conflicting and limited.
Second Trimester:
Risk of premature birth and low birth weight.
Third Trimester:
Risk of premature birth, low birth weight, and neonatal withdrawal symptoms.
Lactation
Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, 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:
L3 (Moderately safe; potential for adverse effects, monitor infant closely).
Pediatric Use
Approved for use in children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., aggression, psychosis, tics).
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.
Clinical Information
Clinical Pearls
- Adderall XR is an extended-release formulation, designed for once-daily dosing, typically in the morning to avoid insomnia.
- The capsule can be opened and the contents sprinkled on applesauce for patients who have difficulty swallowing capsules whole; the mixture should be consumed immediately without chewing.
- Monitor cardiovascular vital signs (BP, HR) regularly due to the risk of increases.
- Be vigilant for psychiatric side effects, including new or worsening aggression, psychosis, or mania, especially in patients with pre-existing psychiatric conditions.
- Educate patients and caregivers about the potential for abuse and dependence, and the importance of proper storage and disposal.
- Acidic foods and beverages (e.g., citrus juices, vitamin C) can decrease the absorption of amphetamines, potentially reducing efficacy. Advise patients to avoid these around the time of dosing.
Alternative Therapies
- Other stimulant medications (e.g., methylphenidate extended-release formulations, lisdexamfetamine)
- Non-stimulant medications (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
- Behavioral therapy and psychotherapy for ADHD
Cost & Coverage
Average Cost:
$200 - $400+ per 30 capsules (brand)
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 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 provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
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 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 provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.