D-Amphetamine ER 30mg 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
Amphetamine
Pregnancy Category
Category C
FDA Approved
Oct 2001
DEA Schedule
Schedule II
Overview
What is this medicine?
This medication is an extended-release capsule containing a combination of two stimulant medicines, dextroamphetamine and amphetamine. It is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to improve focus, attention, and control over impulsive behavior. Because it's extended-release, it works throughout the day with a single morning dose.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
It's best to take your medication in the morning.
Swallow the capsule whole - do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can sprinkle the contents onto applesauce. However, do not chew the applesauce after mixing.
Take your dose immediately after mixing with applesauce. Do not prepare a dose ahead of time or store it for later use.
Important Interactions to Discuss with Your Doctor
Before taking your medication, talk to your doctor about any over-the-counter (OTC) products you're using that may increase your blood pressure. These include:
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 and moisture.
Keep it in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom.
Keep it out of reach of children and pets.
* Store your medication in a secure location, such as a locked box or cabinet, to prevent accidental ingestion or misuse by others.
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.
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 prepare a dose ahead of time or store it for later use.
Important Interactions to Discuss with Your Doctor
Before taking your medication, talk to your doctor about any over-the-counter (OTC) products you're using that may increase your blood pressure. These include:
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 and moisture.
Keep it in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom.
Keep it out of reach of children and pets.
* Store your medication in a secure location, such as a locked box or cabinet, to prevent accidental ingestion or misuse by others.
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.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening to avoid sleep problems.
- Can be taken with or without food. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce and swallow immediately without chewing.
- Avoid alcohol, as it may affect the release of the medication.
- Maintain a healthy diet and regular sleep schedule.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Do not share this medication with others, as it 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 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 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 10 mg once daily in the morning. May be adjusted in 10 mg increments at weekly intervals up to a maximum of 30 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
Not specified, use with caution.
Moderate:
Not specified, use with caution. Consider lower doses.
Severe:
Not specified, use with caution. Consider lower doses or avoid.
Dialysis:
Not specified, use with caution. Amphetamines are not dialyzable to a significant extent.
Hepatic Impairment:
Mild:
Not specified, use with caution.
Moderate:
Not specified, use with caution. Consider lower doses.
Severe:
Not specified, use with caution. Consider lower doses or avoid.
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 therapeutic effects in ADHD are thought to be mediated through the modulation of dopamine and norepinephrine in the frontal cortex and subcortical regions.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (relative to immediate-release Adderall)
Tmax:
Biphasic: First peak at 3.5 hours, second peak at 7 hours (for D-amphetamine); First peak at 4 hours, second peak at 8 hours (for L-amphetamine)
FoodEffect:
High-fat meal may delay Tmax by approximately 2.5 hours but does not affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 3.5-4.5 L/kg
ProteinBinding:
Low (15-26%)
CnssPenetration:
Yes
Elimination:
HalfLife:
D-amphetamine: 10-13 hours; L-amphetamine: 11-14 hours (pH dependent)
Clearance:
Highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-40% (acidic urine), 1% (alkaline urine)
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes
PeakEffect:
Approximately 3.5-8 hours (biphasic)
DurationOfAction:
Approximately 10-12 hours
Safety & Warnings
BLACK BOX WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Erectile dysfunction or changes in sex drive
Seizures
Uncontrolled body movements or sounds (such as humming, throat clearing, yelling, or making loud noises)
Restlessness
Changes in vision
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 sensations in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Sudden death has occurred in people with pre-existing heart problems or defects; if you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor and seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or persist:
Feeling nervous or excitable
Headache
Sleep disturbances
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Dizziness, fatigue, or weakness
Dry mouth or bad taste
* Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Erectile dysfunction or changes in sex drive
Seizures
Uncontrolled body movements or sounds (such as humming, throat clearing, yelling, or making loud noises)
Restlessness
Changes in vision
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 sensations in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Sudden death has occurred in people with pre-existing heart problems or defects; if you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor and seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or persist:
Feeling nervous or excitable
Headache
Sleep disturbances
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Dizziness, fatigue, or weakness
Dry mouth or bad taste
* Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, or irritability
- New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
- New or worsening manic symptoms (e.g., extreme energy, racing thoughts)
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
- Blurred vision or other vision changes
- Severe headache
- Uncontrolled muscle movements or tics
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 reactions you have experienced.
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
+ Drugs for depression or Parkinson's disease taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as this may 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 problems with your doctor and pharmacist. They will help determine if it is safe for you to take this medication with your other treatments. 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 reactions you have experienced.
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
+ Drugs for depression or Parkinson's disease taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as this may 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 problems with your doctor and pharmacist. They will help determine if it is safe for you to take this medication with your other treatments. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness and clear vision.
Long-Term Use and Dependence
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 no longer effective, contact your doctor. Do not take more than the prescribed dose.
Additionally, long-term or regular use of this medication can lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Before reducing the dose or stopping the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Pre-Treatment Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor.
Potential Side Effects
This medication may cause high blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. You will also need to have regular blood tests as instructed by your doctor.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests. Inform all of your healthcare providers and lab personnel that you are taking this medication. Do not take antacids with this medication.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as altered thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Consumption
Discuss the risks of consuming alcohol while taking this medication with your doctor.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of using this medication during pregnancy.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness and clear vision.
Long-Term Use and Dependence
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 no longer effective, contact your doctor. Do not take more than the prescribed dose.
Additionally, long-term or regular use of this medication can lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Before reducing the dose or stopping the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Pre-Treatment Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor.
Potential Side Effects
This medication may cause high blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. You will also need to have regular blood tests as instructed by your doctor.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests. Inform all of your healthcare providers and lab personnel that you are taking this medication. Do not take antacids with this medication.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as altered thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Consumption
Discuss the risks of consuming alcohol while taking this medication with your doctor.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need 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
- Cardiac arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea
- Abdominal cramps
- Convulsions
- Coma
- Death
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI use (risk of hypertensive crisis)
Major Interactions
- Acidifying agents (e.g., ascorbic acid, guanethidine, reserpine, glutamic acid HCl) - decrease amphetamine blood levels
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life
- Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines
- Selective Serotonin Reuptake Inhibitors (SSRIs) - risk of serotonin syndrome (less common than with other stimulants but possible)
- Antihypertensives - amphetamines may antagonize the hypotensive effects
- Phenothiazines - may inhibit amphetamine effects
- Haloperidol - may inhibit amphetamine effects
- Lithium carbonate - may inhibit amphetamine effects
- Propoxyphene - may increase amphetamine plasma levels
Moderate Interactions
- Adrenergic blockers (e.g., beta-blockers) - may potentiate adrenergic effects
- Antacids (e.g., magnesium hydroxide, aluminum hydroxide) - may increase absorption and bioavailability
- Proton Pump Inhibitors (PPIs) / H2 Blockers - may increase absorption and bioavailability
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure
- Serotonergic drugs (e.g., triptans, fentanyl, tramadol, St. John's Wort) - increased risk of serotonin syndrome
Minor Interactions
- Caffeine - additive stimulant effects
- Alcohol - may alter drug release and increase exposure
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Risk of cardiovascular events (hypertension, tachycardia)
Timing: Prior to initiation
Height and Weight
Rationale: Risk of growth suppression in pediatric patients
Timing: Prior to initiation
Psychiatric History (including family history of tics/Tourette's, bipolar disorder, psychosis)
Rationale: Risk of exacerbating psychiatric conditions or inducing new ones
Timing: Prior to initiation
ECG (if clinically indicated)
Rationale: To screen for underlying cardiac abnormalities in patients with risk factors
Timing: Prior to initiation (if indicated)
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit (e.g., every 3-6 months or more frequently if dose adjusted)
Target: Within normal limits for age
Action Threshold: Sustained elevation outside normal range; consider dose reduction or discontinuation
Height and Weight
Frequency: Every 3-6 months (pediatric patients); annually (adults)
Target: Normal growth trajectory (pediatric)
Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative treatment
Psychiatric Status (e.g., emergence of new or worsening psychotic or manic symptoms, aggression, anxiety, depression, tics)
Frequency: At each visit
Target: Stable mental health
Action Threshold: Emergence or worsening of symptoms; consider dose adjustment, discontinuation, or psychiatric consultation
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 significant side effects; consider dose adjustment or alternative treatment
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Depression
- Motor or verbal tics
- Numbness, coolness, or pain in digits (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amphetamines have been associated with adverse pregnancy outcomes including premature delivery and low birth weight. Neonatal withdrawal symptoms have been reported.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations not definitively established. Avoid if possible.
Second Trimester:
Potential for growth restriction and premature delivery.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, tremor, feeding difficulties) if used close to delivery.
Lactation
L3 (Moderate risk). Amphetamines are excreted into breast milk. Potential for serious adverse reactions in the breastfed infant (e.g., irritability, poor feeding, sleep disturbances, weight loss). Weigh the developmental and health benefits of breastfeeding against the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.
Infant Risk:
Irritability, poor feeding, sleep disturbances, weight loss, and potential long-term neurodevelopmental effects. Monitor infant closely.
Pediatric Use
Closely monitor growth (height and weight) in pediatric patients. Long-term use has been associated with growth suppression. Consider drug holidays or dose adjustments if growth deceleration is observed. Not recommended for children under 6 years of age.
Geriatric Use
Use with caution in elderly patients, generally starting at the lower end of the dosing range, due to 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.
Clinical Information
Clinical Pearls
- Adderall XR is designed for once-daily morning dosing. Taking it later in the day can cause insomnia.
- The capsule can be opened and sprinkled on applesauce for patients who have difficulty swallowing pills, but the beads should not be chewed.
- Patients should be screened for cardiac disease and psychiatric conditions (e.g., bipolar disorder, psychosis, tics) before starting treatment.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
- Educate patients and caregivers about the potential for abuse and diversion, and the importance of secure storage.
- Inform patients about the potential for peripheral vasculopathy, including Raynaud's phenomenon, and to report any new numbness, coolness, or pain in digits.
Alternative Therapies
- Methylphenidate (e.g., Concerta, Ritalin LA, Focalin XR)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy and psychotherapy
Cost & Coverage
Average Cost:
$200 - $400 per 30 capsules (30mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand, generic often Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to 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.