Dextroamphetamine 5mg ER Capsules
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 is used to treat narcolepsy.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System Stimulant
Pharmacologic Class
Sympathomimetic Amine
Pregnancy Category
C
FDA Approved
Jun 1976
DEA Schedule
Schedule II
Overview
What is this medicine?
Dextroamphetamine is a stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. It works by affecting certain natural chemicals in the brain to help improve focus, attention, and control over impulsive behavior.
How to Use This Medicine
Taking Your Medication
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. However, to minimize the risk of sleep disturbances, it's best to avoid taking it late in the day. Additionally, do not take this medication with fruit juice. To establish a routine, take your medication at the same time every day. Swallow the tablet whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. It's essential to store your medication in a secure location where children and pets cannot access it, and where others cannot easily get to it. Consider using a locked box or area to keep your medication safe. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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. However, to minimize the risk of sleep disturbances, it's best to avoid taking it late in the day. Additionally, do not take this medication with fruit juice. To establish a routine, take your medication at the same time every day. Swallow the tablet whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. It's essential to store your medication in a secure location where children and pets cannot access it, and where others cannot easily get to it. Consider using a locked box or area to keep your medication safe. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning to avoid sleep problems.
- Do not crush, chew, or open the extended-release capsules; swallow them whole.
- Avoid alcohol while taking this medication.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Monitor for changes in mood, behavior, or thoughts, and report them to your doctor.
- Maintain a healthy diet and monitor growth (especially for children).
- Avoid driving or operating machinery until you know how this medication affects you.
Available Forms & Alternatives
Available Strengths:
- Dextroamphetamine 15mg ER Capsules
- Dextroamphetamine 10mg ER Capsules
- Dextroamphetamine 5mg ER Capsules
- Dextroamphetamine 5mg Tablets
- Dextroamphetamine 10mg Tablets
- Dextroamphetamine 5mg/5ml Solution
- Dextroamphetamine 20mg Tablets
- Dextroamphetamine 30mg Tablets
- Dextroamphetamine 15mg Tablets
- Dextroamphetamine 7.5mg Tablets
- Dextroamphetamine 2.5mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg to 10 mg orally once daily in the morning
Dose Range:
5 - 30 mg
Condition-Specific Dosing:
ADHD:
Initial 5 mg or 10 mg once daily in the morning; may increase by 5 mg to 10 mg weekly to a maximum of 30 mg/day. Doses above 30 mg/day are not recommended.
Narcolepsy:
Initial 10 mg once daily in the morning; may increase by 10 mg weekly to a maximum of 60 mg/day (divided doses for immediate release, but ER is once daily). For ER, typically 10-30 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 5 mg once daily in the morning; may increase by 5 mg weekly to a maximum of 30 mg/day.
Adolescent:
13-17 years: Initial 10 mg once daily in the morning; may increase by 10 mg weekly to a maximum of 30 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dosage adjustment provided, use with caution.
Moderate:
No specific dosage adjustment provided, use with caution. Consider lower initial doses and slower titration.
Severe:
Use with caution; consider lower initial doses and slower titration. Avoid if possible due to renal excretion.
Dialysis:
Not available; likely not dialyzable to a significant extent due to high volume of distribution.
Hepatic Impairment:
Mild:
No specific dosage adjustment provided, use with caution.
Moderate:
No specific dosage adjustment provided, use with caution. Consider lower initial doses and slower titration.
Severe:
No specific dosage adjustment provided, use with caution. Consider lower initial doses and slower titration.
Pharmacology
Mechanism of Action
Dextroamphetamine is a sympathomimetic amine that stimulates the central nervous system. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The therapeutic effects in ADHD are believed to be mediated through the modulation of dopaminergic and noradrenergic neurotransmission in the prefrontal cortex.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75-100% (oral)
Tmax:
Approximately 7-8 hours (for ER capsules)
FoodEffect:
Food does not significantly affect the extent of absorption, but may delay Tmax.
Distribution:
Vd:
Approximately 3.5-4.5 L/kg
ProteinBinding:
Approximately 15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-12 hours (adults), 9-11 hours (children)
Clearance:
Highly variable, pH-dependent renal excretion
ExcretionRoute:
Renal (urine)
Unchanged:
30-40% (highly dependent on urine pH; increased with acidic urine, decreased with alkaline urine)
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for ER capsules)
PeakEffect:
Approximately 7-8 hours (for ER capsules)
DurationOfAction:
Approximately 10-12 hours (for ER capsules)
Safety & Warnings
BLACK BOX WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF PATIENTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUG SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Side Effects
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, 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
Restlessness
Shakiness
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in eyesight or eye pain, swelling, or redness
Erectile dysfunction
Decreased sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or trouble passing urine
Frequent or prolonged erections
Changes in skin color, such as pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes
Important Heart-Related Warnings
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Serotonin Syndrome: A Potentially Life-Threatening Condition
Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. Call your doctor right away if you experience any of the following symptoms:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have minor ones, it's essential to be aware of the following potential side effects:
Dizziness or headache
Dry mouth
Trouble sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Bad taste in mouth
Feeling nervous and excitable
Hair loss
If any of these side effects bother you or persist, contact your doctor for guidance. Remember, this is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing side effects.
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, 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
Restlessness
Shakiness
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in eyesight or eye pain, swelling, or redness
Erectile dysfunction
Decreased sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or trouble passing urine
Frequent or prolonged erections
Changes in skin color, such as pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes
Important Heart-Related Warnings
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Serotonin Syndrome: A Potentially Life-Threatening Condition
Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. Call your doctor right away if you experience any of the following symptoms:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have minor ones, it's essential to be aware of the following potential side effects:
Dizziness or headache
Dry mouth
Trouble sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Bad taste in mouth
Feeling nervous and excitable
Hair loss
If any of these side effects bother you or persist, contact your doctor for guidance. Remember, this is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening high blood pressure or heart rate
- New or worsening mental problems (e.g., hallucinations, paranoia, mania)
- New or worsening tics (uncontrolled movements or sounds)
- Unexplained weight loss or slowed growth in children
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Blurred vision or other vision changes
- Severe headache
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
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed 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 to take this medication with your other treatments and health conditions. 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
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed 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 to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may need higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of this medication may lead to dependence. Stopping this medication abruptly may cause withdrawal symptoms. Consult your doctor before reducing the dose or stopping this medication, and follow their instructions carefully. Report any adverse effects to your doctor.
Cardiovascular Precautions
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication may cause high blood pressure, so monitor your blood pressure and heart rate as directed by your doctor. Be aware of the signs of high blood pressure, such as severe headache, dizziness, fainting, or changes in vision, and contact your doctor immediately if you experience any of these symptoms.
Interactions with Other Medications
Before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids, consult your doctor.
Lab Tests and Seizure Risk
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests. This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk of seizures with your doctor.
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 disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Growth Effects in Children and Teens
This medication may affect growth in children and adolescents. They may require regular growth checks. Discuss this with your doctor.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may need higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of this medication may lead to dependence. Stopping this medication abruptly may cause withdrawal symptoms. Consult your doctor before reducing the dose or stopping this medication, and follow their instructions carefully. Report any adverse effects to your doctor.
Cardiovascular Precautions
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication may cause high blood pressure, so monitor your blood pressure and heart rate as directed by your doctor. Be aware of the signs of high blood pressure, such as severe headache, dizziness, fainting, or changes in vision, and contact your doctor immediately if you experience any of these symptoms.
Interactions with Other Medications
Before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids, consult your doctor.
Lab Tests and Seizure Risk
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests. This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk of seizures with your doctor.
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 disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Growth Effects in Children and Teens
This medication may affect growth in children and adolescents. They may require regular growth checks. Discuss this with your doctor.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Aggressiveness
- 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 includes 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 (reversible MAOI activity)
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensives - reduced hypotensive effect
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increased dextroamphetamine levels and prolonged duration
- Urinary acidifiers (e.g., ascorbic acid, ammonium chloride) - decreased dextroamphetamine levels and reduced duration
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of dextroamphetamine
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
Moderate Interactions
- Proton Pump Inhibitors (PPIs) / H2 Blockers - may slightly increase absorption
- Antacids - may increase absorption
- Adrenergic blockers (e.g., beta-blockers) - may potentiate pressor effects of dextroamphetamine
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, ritonavir) - increased dextroamphetamine exposure
- Alcohol - may increase plasma levels of dextroamphetamine and lead to adverse cardiovascular events
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 (especially in pediatric patients)
Rationale: Risk of growth suppression
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 ventricular arrhythmia
Rationale: Identify patients at higher risk for 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
Action Threshold: Sustained elevation (e.g., >95th percentile for age/sex/height or significant increase from baseline) warrants investigation and potential dose adjustment/discontinuation.
Height and Weight (especially in pediatric patients)
Frequency: Every 3-6 months
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines) warrants investigation and potential drug holiday or alternative treatment.
Psychiatric status (e.g., emergence of psychosis, mania, aggression, tics)
Frequency: At each visit
Target: Stable mental state
Action Threshold: New or worsening psychiatric symptoms warrant immediate evaluation and potential discontinuation.
ADHD symptom control
Frequency: At each visit
Target: Improved focus, reduced hyperactivity/impulsivity
Action Threshold: Lack of efficacy or intolerable side effects warrant dose adjustment or alternative treatment.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening tics
- Hallucinations
- Delusions
- Mania
- Aggression
- Severe anxiety
- Unexplained weight loss
- Insomnia
- Anorexia
Special Patient Groups
Pregnancy
Category C. Use 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. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are conflicting.
Second Trimester:
Risk of premature delivery and low birth weight.
Third Trimester:
Risk of withdrawal symptoms (e.g., agitation, tremor, feeding difficulties) in the neonate.
Lactation
L3 (Moderate Risk). Dextroamphetamine is excreted into breast milk. Potential for adverse effects in the infant (e.g., irritability, poor feeding, insomnia, weight loss). Monitor infant for signs of stimulant effects. Consider avoiding or using the lowest effective dose and monitoring infant closely.
Infant Risk:
Irritability, insomnia, poor feeding, weight loss, cardiovascular effects. Long-term effects unknown.
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 and tics.
Geriatric Use
Use with caution. Elderly patients may be more sensitive to the effects of stimulant medications, particularly cardiovascular and psychiatric adverse effects. Start with lower doses and titrate slowly. Monitor for pre-existing cardiovascular disease.
Clinical Information
Clinical Pearls
- Extended-release capsules should be swallowed whole; do not crush, chew, or open. This is crucial for maintaining the extended-release properties and preventing dose dumping.
- Administer in the morning to minimize insomnia.
- Patients should be screened for cardiac disease and psychiatric conditions prior to initiation.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is essential.
- Educate patients and caregivers about the high abuse potential and the importance of secure storage.
- Consider drug holidays in pediatric patients to assess growth and continued need for medication.
- Urine pH significantly affects dextroamphetamine excretion; avoid concurrent use with urinary acidifiers or alkalinizers unless carefully managed.
Alternative Therapies
- Methylphenidate (Concerta, Ritalin LA, Focalin XR)
- Atomoxetine (Strattera)
- Guanfacine ER (Intuniv)
- Clonidine ER (Kapvay)
- Bupropion (Wellbutrin XL - off-label for ADHD)
Cost & Coverage
Average Cost:
$100 - $300 per 30 capsules (5mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (generic often Tier 1 or 2)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek emergency medical attention right away. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek emergency medical attention right away. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care.