D-Amphetamine ER 25mg 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
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). It contains two stimulant medicines, dextroamphetamine and amphetamine, in an extended-release capsule. This means it releases medicine slowly throughout the day to help improve focus, attention, and control impulsive behaviors.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it in the morning. Swallow the capsule whole - do not chew, break, or crush it. If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce, but be sure not to chew the mixture. After mixing with applesauce, take your dose immediately - do not store it for later use.
Before taking this medication, talk to your doctor about any over-the-counter (OTC) products you're using that may increase your blood pressure. These include cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Store it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication out of reach. Keep all medications away from pets to avoid any potential harm.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take a missed dose later in the day. Return to your regular dosing schedule as soon as possible.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it in the morning. Swallow the capsule whole - do not chew, break, or crush it. If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce, but be sure not to chew the mixture. After mixing with applesauce, take your dose immediately - do not store it for later use.
Before taking this medication, talk to your doctor about any over-the-counter (OTC) products you're using that may increase your blood pressure. These include cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Store it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication out of reach. Keep all medications away from pets to avoid any potential harm.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take a missed dose later in the day. Return to your regular dosing schedule as soon as possible.
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.
- Do not crush, chew, or open the capsule. Swallow it whole. If unable to swallow, the capsule may be opened and the contents sprinkled on a small amount of applesauce and consumed immediately.
- Avoid alcohol, as it can increase side effects.
- Maintain a healthy diet and regular sleep schedule.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Store safely to prevent misuse or 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.
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. (Note: 25mg is a higher dose, typically for older children/adolescents or those requiring higher doses)
Adolescent:
13-17 years: Initial 10 mg once daily in the morning; may increase by 5-10 mg increments weekly to a maximum of 60 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for adverse effects.
Moderate:
Consider lower doses or extended dosing intervals. Specific guidelines not well-defined.
Severe:
Use with caution; consider lower doses or extended dosing intervals. Not recommended for ESRD.
Dialysis:
Not recommended due to potential for accumulation and lack of data on dialyzability.
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.
Pharmacology
Mechanism of Action
Amphetamines are non-catecholamine sympathomimetic amines that exert their therapeutic effect by releasing norepinephrine and dopamine from presynaptic nerve terminals in the brain. They also inhibit the reuptake of these monoamines into the presynaptic neuron. The exact mechanism 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:
Bimodal release: First peak ~3 hours, second peak ~7 hours post-dose.
FoodEffect:
High-fat meal may delay Tmax by 2.5 hours but does not affect extent of absorption (AUC).
Distribution:
Vd:
0.9-1.2 L/kg
ProteinBinding:
15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (pH-dependent)
Clearance:
Highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal
Unchanged:
30-50% (highly dependent on urinary pH)
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes
PeakEffect:
Approximately 3-7 hours (due to extended-release formulation)
DurationOfAction:
Approximately 10-12 hours
Confidence:
Medium
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
+ 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 pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Erectile dysfunction (inability to get or keep an erection)
Changes in sex interest
Seizures
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Restlessness
Changes in eyesight
Prolonged or frequent erections
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or trouble passing urine
Important Heart-Related Warnings
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. 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
Throwing up
Decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in mouth
Weight loss
Reporting Side Effects
If you have questions about side effects or want to report any, 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 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
+ 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 pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Erectile dysfunction (inability to get or keep an erection)
Changes in sex interest
Seizures
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Restlessness
Changes in eyesight
Prolonged or frequent erections
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or trouble passing urine
Important Heart-Related Warnings
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. 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
Throwing up
Decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in mouth
Weight loss
Reporting Side Effects
If you have questions about side effects or want to report any, 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 aggression, hostility, or irritability
- New or worsening thoughts of harming yourself or others
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New or worsening tics (uncontrolled movements or sounds)
- Unexplained weight loss or slowed growth in children
- Numbness, tingling, or coldness 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dose of any medication without consulting your doctor 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 (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may increase the risk of very high blood pressure
+ Linezolid or methylene blue
If you are breast-feeding, as you should not breast-feed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems 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.
When you first start taking this medication, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. Wait until you understand how this medication affects you before engaging in these activities.
Long-term or high-dose use of this medication can lead to tolerance, where the medication becomes less effective, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.
Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can result in withdrawal symptoms. If you need to reduce the dose or stop taking this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor promptly.
Before starting this medication, you may need to undergo heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as directed by your doctor, and have regular blood tests to check for any potential effects.
It is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests. Do not take antacids while taking this medication, as they may interact with it.
Some individuals may experience behavioral or mood changes, such as altered thinking, anger, or hallucinations, while taking 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. Seek immediate medical attention if you experience hallucinations, changes in behavior, or mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
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 may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary, and different brands of this medication may be suitable for different age groups. Consult your doctor before giving this medication to a child.
Avoid consuming alcohol while taking this medication, and consult your doctor before doing so. If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.
When you first start taking this medication, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. Wait until you understand how this medication affects you before engaging in these activities.
Long-term or high-dose use of this medication can lead to tolerance, where the medication becomes less effective, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.
Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can result in withdrawal symptoms. If you need to reduce the dose or stop taking this medication, consult your doctor, and follow their instructions carefully. Report any adverse effects to your doctor promptly.
Before starting this medication, you may need to undergo heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as directed by your doctor, and have regular blood tests to check for any potential effects.
It is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests. Do not take antacids while taking this medication, as they may interact with it.
Some individuals may experience behavioral or mood changes, such as altered thinking, anger, or hallucinations, while taking 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. Seek immediate medical attention if you experience hallucinations, changes in behavior, or mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
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 may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary, and different brands of this medication may be suitable for different age groups. Consult your doctor before giving this medication to a child.
Avoid consuming alcohol while taking this medication, and consult your doctor before doing so. If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- Arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea, abdominal cramps
- Convulsions
- Coma
What to Do:
Call 911 or Poison Control (1-800-222-1222) immediately. Seek emergency medical attention. Management typically involves supportive care, gastric lavage, activated charcoal, and acidification of urine to enhance excretion.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
- Linezolid (MAOI activity)
- Methylene Blue (MAOI activity)
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensives - may reduce hypotensive effect
- Urinary alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine levels and prolong half-life
- Urinary acidifying agents (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine levels and shorten half-life
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of amphetamines
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
Moderate Interactions
- Proton Pump Inhibitors (PPIs) and H2 blockers - may alter absorption (less significant for ER formulation)
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, ritonavir) - may increase amphetamine exposure
- Adrenergic blockers (e.g., beta-blockers) - may potentiate pressor effects
- Antacids - may increase absorption
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia)
Timing: Prior to initiation
Height and Weight
Rationale: Risk of growth suppression in pediatric patients; general health assessment
Timing: Prior to initiation
Psychiatric history (e.g., bipolar disorder, psychosis, tics)
Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new ones
Timing: Prior to initiation
Family history of sudden cardiac death or arrhythmias
Rationale: Risk of serious cardiovascular events
Timing: Prior to initiation
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/baseline
Action Threshold: Sustained elevation (e.g., >95th percentile for age/sex/height or significant increase from baseline) warrants investigation/intervention.
Height and Weight
Frequency: Every 3-6 months (pediatric); annually (adult)
Target: Normal growth trajectory (pediatric); stable weight (adult)
Action Threshold: Significant growth deceleration or weight loss warrants investigation/intervention.
Psychiatric symptoms (e.g., agitation, aggression, new-onset psychosis, mania, tics)
Frequency: At each visit
Target: Absence of new or worsening symptoms
Action Threshold: Emergence or worsening of symptoms warrants dose adjustment or discontinuation.
ADHD symptom control and functional improvement
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning
Action Threshold: Lack of efficacy or worsening symptoms warrants dose adjustment or re-evaluation of diagnosis/treatment plan.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Tics
- Unexplained weight loss
- Sleep disturbances
- Anxiety
- Irritability
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus. Amphetamines cross the placenta.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for increased risk of congenital malformations (e.g., cardiac defects, gastroschisis) based on some studies, though not consistently proven.
Second Trimester:
Potential for premature birth, low birth weight, and withdrawal symptoms in the neonate.
Third Trimester:
Increased risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, tremor, feeding difficulties, respiratory distress) if used near term.
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), breastfeeding is not recommended during treatment.
Infant Risk:
High
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully. Risk of growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, tics).
Geriatric Use
Use with caution in elderly patients, generally not recommended due to increased risk of cardiovascular adverse events and other comorbidities. Start with lower doses and titrate slowly. Monitor cardiovascular status closely.
Clinical Information
Clinical Pearls
- Adderall XR has a bimodal release profile, providing two peaks of plasma concentration, which contributes to its extended duration of action.
- The capsule can be opened and sprinkled on applesauce for patients who have difficulty swallowing, but the beads should not be chewed.
- Patients should avoid taking doses in the late afternoon or evening to prevent insomnia.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
- Educate patients and caregivers about the high abuse potential and the importance of secure storage.
- Consider a 'drug holiday' (e.g., weekends or school breaks) for pediatric patients to assess baseline ADHD symptoms and potentially mitigate growth suppression, though this practice is debated and should be discussed with a physician.
Alternative Therapies
- Methylphenidate (e.g., Concerta, Ritalin LA, Focalin XR)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy
Cost & Coverage
Average Cost:
$200 - $400+ per 30 capsules (25mg strength)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (brand); Tier 1 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.