D-Amphetamine ER 20mg Salt Combo CP
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System (CNS) Stimulant
Pharmacologic Class
Sympathomimetic Amine
Pregnancy Category
Category C
FDA Approved
Oct 2001
DEA Schedule
Schedule II
Overview
What is this medicine?
Adderall XR is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It contains two types of stimulant medicines (dextroamphetamine and amphetamine) that work by increasing certain natural chemicals in the brain. This helps improve attention, focus, and reduce impulsivity and hyperactivity. It's an extended-release capsule, meaning it releases medicine slowly throughout the day, so you usually only need to take it once in the morning.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
It's best to take your medication in the morning.
Swallow the capsule whole - do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce, but be sure not to chew the mixture.
After mixing the medication with applesauce, take your dose immediately - do not store it for later use.
Important Interactions to Discuss with Your Doctor
Before taking any over-the-counter (OTC) products, talk to your doctor if you're using medications that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
Certain natural products or aids
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature, away from light.
Keep it in a dry place, avoiding bathrooms.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. A locked box or area can help keep your medication safe.
Keep all medications away from pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take the missed dose later in the day.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
It's best to take your medication in the morning.
Swallow the capsule whole - do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce, but be sure not to chew the mixture.
After mixing the medication with applesauce, take your dose immediately - do not store it for later use.
Important Interactions to Discuss with Your Doctor
Before taking any over-the-counter (OTC) products, talk to your doctor if you're using medications that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
Certain natural products or aids
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature, away from light.
Keep it in a dry place, avoiding bathrooms.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. A locked box or area can help keep your medication safe.
Keep all medications away from pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take the missed dose later in the day.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening to avoid sleep problems.
- Do not crush, chew, or open the capsule and sprinkle contents on food (unless specifically instructed by your doctor for ease of swallowing, and then consume immediately).
- Avoid alcohol, as it can increase side effects.
- Maintain a healthy diet and regular exercise, as stimulants can sometimes affect appetite and growth (especially in children).
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Store in a safe place to prevent misuse or diversion.
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.
Adolescent:
13-17 years: Initial 10 mg once daily in the morning; may increase to 20 mg/day after one week if needed. Maximum 20 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for adverse effects.
Moderate:
No specific dose adjustment recommended, but monitor for adverse effects. Consider lower starting dose.
Severe:
Use with caution. Consider lower starting dose and slower titration. Monitor closely for adverse effects. Amphetamine excretion is reduced in severe renal impairment.
Dialysis:
Not well studied. Amphetamines are likely dialyzable due to low protein binding and small molecular weight, but clinical data is limited. Avoid use or use with extreme caution and close monitoring.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended, but monitor for adverse effects.
Severe:
Use with caution. No specific guidelines, but consider lower starting dose and slower titration due to hepatic metabolism.
Pharmacology
Mechanism of Action
Amphetamines are non-catecholamine sympathomimetic amines that exert their therapeutic effect by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, and by blocking the reuptake of these monoamines into the presynaptic neuron. This leads to increased concentrations of norepinephrine and dopamine in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
Biphasic: First peak ~7 hours, Second peak ~10.5 hours (due to dual-bead release)
FoodEffect:
Food (high-fat meal) can delay Tmax by approximately 2.5 hours but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 3.5-4.5 L/kg
ProteinBinding:
Approximately 15-26%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Levoamphetamine: 9-11 hours
Clearance:
Highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 30-40% (dextroamphetamine), 50% (levoamphetamine) excreted unchanged in urine at normal urinary pH.
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes
PeakEffect:
Biphasic: First peak ~7 hours, Second peak ~10.5 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 Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention 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 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
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 your 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 experience 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 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
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 your 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 (seek immediate medical attention)
- New or worsening mental problems (e.g., hearing voices, believing things that are not true, becoming suspicious)
- New or worsening aggressive behavior or hostility
- New or worsening tics (uncontrolled movements or sounds)
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained fever, muscle stiffness, or confusion (signs of serotonin syndrome, especially if taking other serotonergic drugs)
- Severe headache, blurred vision, or seizures (signs of hypertensive crisis)
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) taken 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 treatment. Do not 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) taken 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 treatment. Do not 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 is crucial to prevent accidents and ensure your safety.
Long-term or high-dose use of this medication can lead to tolerance, where the drug 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 increase the risk of adverse effects.
Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can lead to withdrawal symptoms. If you need to reduce the dose or stop taking the 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 certain heart tests. If you have any questions or concerns, discuss them with your doctor. This medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you may need to have regular blood tests to check for any potential effects on your blood.
This medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication. Do not take antacids while using this medication, as they may interact with it.
Some people taking this medication may experience changes in behavior or mood, such as altered thinking, anger, or hallucinations. 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. Seek medical attention immediately 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. Discuss your risk with your doctor to determine if you are more susceptible to seizures while taking this medication.
A rare but potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. Seek medical attention immediately if you experience 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. They may require regular growth checks, and different brands of this medication may be suitable for different age groups. Consult your doctor before giving this medication to a child.
Before consuming alcohol, discuss the potential risks with your doctor. If you are pregnant or plan to become pregnant, inform your doctor to weigh the benefits and risks of using this medication during pregnancy.
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This is crucial to prevent accidents and ensure your safety.
Long-term or high-dose use of this medication can lead to tolerance, where the drug 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 increase the risk of adverse effects.
Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can lead to withdrawal symptoms. If you need to reduce the dose or stop taking the 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 certain heart tests. If you have any questions or concerns, discuss them with your doctor. This medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you may need to have regular blood tests to check for any potential effects on your blood.
This medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication. Do not take antacids while using this medication, as they may interact with it.
Some people taking this medication may experience changes in behavior or mood, such as altered thinking, anger, or hallucinations. 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. Seek medical attention immediately 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. Discuss your risk with your doctor to determine if you are more susceptible to seizures while taking this medication.
A rare but potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. Seek medical attention immediately if you experience 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. They may require regular growth checks, and different brands of this medication may be suitable for different age groups. Consult your doctor before giving this medication to a child.
Before consuming alcohol, discuss the potential risks with your doctor. If you are pregnant or plan to become pregnant, inform your doctor to weigh the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- Arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea
- Abdominal cramps
- Convulsions
- Coma
- Death
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, gastric lavage, activated charcoal, and acidification of urine to enhance excretion. Benzodiazepines for agitation/seizures, alpha-blockers for hypertension.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use) - risk of hypertensive crisis.
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase renal excretion of amphetamines, decreasing efficacy.
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease renal excretion of amphetamines, increasing plasma levels and risk of toxicity.
- Tricyclic Antidepressants (TCAs) - may increase amphetamine levels and potentiate cardiovascular effects.
Moderate Interactions
- Antihypertensive agents - amphetamines may counteract the hypotensive effect of these drugs.
- Antacids and H2-receptor blockers (e.g., omeprazole, cimetidine) - may increase amphetamine absorption.
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure and risk of toxicity.
- Phenothiazines (e.g., chlorpromazine) - may inhibit amphetamine effects.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Amphetamines can cause dose-related increases in BP and HR; screen for pre-existing cardiovascular conditions.
Timing: Prior to initiation
Height and Weight
Rationale: Monitor for growth suppression in pediatric patients and weight loss in all patients.
Timing: Prior to initiation
Psychiatric History (e.g., bipolar disorder, psychosis, tics)
Rationale: Amphetamines can exacerbate or unmask psychiatric symptoms.
Timing: Prior to initiation
Cardiac History (e.g., structural cardiac abnormalities, cardiomyopathy, arrhythmias)
Rationale: Screen for conditions that may increase risk of sudden death or serious cardiovascular events.
Timing: Prior to initiation (ECG may be considered if clinically indicated)
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/patient
Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant investigation and potential dose adjustment or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric); annually (adult)
Target: Normal growth trajectory (pediatric); stable weight (adult)
Action Threshold: Significant growth deceleration (pediatric) or clinically significant weight loss (all patients) warrants investigation and potential dose adjustment or drug holiday.
Psychiatric Status (e.g., mood, anxiety, psychosis, tics)
Frequency: At each visit
Target: Stable mood, absence of new or worsening psychotic symptoms, tics, or severe anxiety.
Action Threshold: Emergence or worsening of psychotic symptoms, mania, severe anxiety, or tics warrants immediate evaluation and potential discontinuation.
ADHD Symptom Control and Functional Improvement
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/occupational/social functioning.
Action Threshold: Lack of efficacy or intolerable side effects warrant dose adjustment or consideration of alternative therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New onset or worsening psychosis
- Mania
- Aggression
- Severe anxiety
- Depression
- Tics
- Blurred vision
- Numbness/tingling in extremities (Raynaud's phenomenon)
- Unexplained weight loss
- Sleep disturbances
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus. Amphetamines cross the placenta. Category C.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for increased risk of congenital malformations cannot be ruled out.
Second Trimester:
Potential for premature birth and low birth weight.
Third Trimester:
Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, poor weight gain) if used near term.
Lactation
Amphetamines are excreted into breast milk. Use is generally not recommended due to potential for serious adverse reactions in the infant (e.g., irritability, poor feeding, sleep disturbances, weight loss, cardiovascular effects). L3 (Moderate risk).
Infant Risk:
Irritability, poor feeding, sleep disturbances, weight loss, and potential long-term neurodevelopmental effects. Monitor infant for signs of stimulant exposure.
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) closely due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics). Cardiovascular monitoring is essential.
Geriatric Use
Use with caution in elderly patients. Start with lower doses and titrate slowly due to increased sensitivity to stimulant effects and potential for comorbidities (e.g., cardiovascular disease, glaucoma, hyperthyroidism). Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- High potential for abuse and diversion; assess risk prior to prescribing and monitor during treatment.
- Take in the morning to avoid insomnia. Do not take in the afternoon or evening.
- Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing, but the entire contents must be consumed immediately without chewing.
- Monitor for cardiovascular adverse events (BP, HR) and psychiatric adverse events (psychosis, mania, aggression, tics).
- Consider drug holidays for pediatric patients to assess growth and need for continued therapy.
- Inform patients about the risk of Raynaud's phenomenon (numbness, coolness, pain in fingers/toes).
Alternative Therapies
- Methylphenidate extended-release (Concerta, Ritalin LA, Quillivant XR, Jornay PM)
- Methylphenidate immediate-release (Ritalin, Focalin)
- Atomoxetine (Strattera) - non-stimulant
- Guanfacine extended-release (Intuniv) - non-stimulant
- Clonidine extended-release (Kapvay) - non-stimulant
- Bupropion (Wellbutrin) - off-label for ADHD
- Cognitive Behavioral Therapy (CBT)
- Behavioral therapy
Cost & Coverage
Average Cost:
Varies widely, typically $150-$400+ per 30 capsules (brand)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (brand), Tier 1 (generic) for most commercial and Medicare Part D plans. May require prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.