Dextroamphetamine 10mg 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 (CNS) Stimulant
Pharmacologic Class
Sympathomimetic Amine
Pregnancy Category
Category C
FDA Approved
Jun 1952
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 reduce impulsivity or excessive sleepiness.
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, try to avoid taking it late in the day. It's also important to avoid consuming fruit juice when taking this medication. 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
Keep your medication at room temperature, away from direct light and moisture. Avoid storing it in a bathroom. To prevent accidental ingestion, store your medication in a secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication safe from others. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
Missing 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 a 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, try to avoid taking it late in the day. It's also important to avoid consuming fruit juice when taking this medication. 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
Keep your medication at room temperature, away from direct light and moisture. Avoid storing it in a bathroom. To prevent accidental ingestion, store your medication in a secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication safe from others. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
Missing 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 a missed one.
Lifestyle & Tips
- Take the capsule whole in the morning, usually with or without food. Do not crush, chew, or open the capsule.
- Avoid taking doses late in the day to prevent insomnia.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Avoid alcohol consumption while on this medication.
- Maintain a healthy diet and monitor weight, especially in children.
- Regularly monitor blood pressure and heart rate as advised by your doctor.
- Store medication securely to prevent misuse or diversion.
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:
10 mg ER capsule once daily in the morning
Dose Range:
5 - 40 mg
Condition-Specific Dosing:
ADHD:
Initial 5-10 mg ER once daily in the morning; may increase by 5-10 mg at weekly intervals. Max 40 mg/day.
Narcolepsy:
Initial 10 mg ER once daily in the morning; may increase by 10 mg at weekly intervals. Max 60 mg/day (though ER typically maxes at 40 mg/day for practical purposes, higher doses are sometimes used for narcolepsy with IR formulations).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 5 mg ER once daily in the morning; may increase by 5 mg at weekly intervals. Max 30 mg/day.
Adolescent:
>12 years: Initial 10 mg ER once daily in the morning; may increase by 10 mg at weekly intervals. Max 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, monitor for adverse effects.
Moderate:
Use with caution, consider lower initial dose and slower titration. Monitor for adverse effects.
Severe:
Use with caution, consider lower initial dose and slower titration. Monitor for adverse effects. Contraindicated in end-stage renal disease.
Dialysis:
Not available (significant renal excretion, but data on dialysis is limited; likely not dialyzable due to protein binding and volume of distribution).
Hepatic Impairment:
Mild:
No specific adjustment, monitor for adverse effects.
Moderate:
Use with caution, consider lower initial dose and slower titration. Monitor for adverse effects.
Severe:
Use with caution, consider lower initial dose and slower titration. Monitor for adverse effects.
Pharmacology
Mechanism of Action
Dextroamphetamine is a sympathomimetic amine that acts as a central nervous system (CNS) stimulant. 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 and narcolepsy are believed to be mediated through these actions in the brain.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75-100%
Tmax:
6-10 hours (for ER capsules)
FoodEffect:
Food may delay Tmax but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
3-5 L/kg
ProteinBinding:
Approximately 15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
10-13 hours (adults); 9-11 hours (children). Half-life is highly dependent on urinary pH (shorter in acidic urine, longer in alkaline urine).
Clearance:
Not readily available as a single rate, highly variable with urine pH.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-40% (in acidic urine); <1% (in alkaline urine)
Pharmacodynamics
OnsetOfAction:
1-2 hours (for ER capsules)
PeakEffect:
6-10 hours (for ER capsules)
DurationOfAction:
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. 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 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
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 fainting
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. If you experience any of the following symptoms, contact your doctor right away:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have minor side effects, it's essential to be aware of the following possible 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 or other symptoms bother you or do not go away, contact your doctor for guidance. 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
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 fainting
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. If you experience any of the following symptoms, contact your doctor right away:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have minor side effects, it's essential to be aware of the following possible 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 or other symptoms bother you or do not go away, contact your doctor for guidance. 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 agitation
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- New manic symptoms (e.g., extreme energy, racing thoughts)
- New tics or worsening of existing tics
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained fever, muscle stiffness, or severe confusion (signs of serotonin syndrome, especially if combined with other serotonergic drugs)
- Blurred vision or other vision changes
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:
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 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 (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (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 to ensure safe use. Do not initiate, stop, or modify any medication without consulting your doctor.
It is essential to inform your doctor about the following:
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 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 (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (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 to ensure safe use. Do not initiate, stop, or modify any medication without consulting your doctor.
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. This will help ensure your safety and prevent any potential interactions with other treatments.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Tolerance and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. However, do not take more than the prescribed dose. Additionally, long-term or regular use of this medication can lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this may cause withdrawal symptoms. Instead, consult your doctor, who will provide guidance on how to safely reduce or stop the medication.
Monitoring and Tests
Before starting this medication, you may need to undergo certain heart tests. If you have any questions or concerns, discuss them with your doctor. Additionally, this medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. If you experience severe headache, dizziness, fainting, or changes in vision, seek medical attention immediately.
Interactions with Other Medications
Certain over-the-counter (OTC) products, such as cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, may interact with this medication and increase blood pressure. Consult your doctor before taking any of these products.
Lab Tests and Seizure Risk
This medication may affect certain lab tests, so it is essential to inform all your healthcare providers and lab workers that you are taking this medication. Additionally, this medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.
Mental Health and Mood Changes
This medication may cause changes in behavior and mood, including hallucinations, anger, and depression. 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 signs of mood changes, such as depression, suicidal thoughts, nervousness, or anxiety.
Growth and Pregnancy
This medication may affect growth in children and teenagers. Regular growth checks may be necessary. If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.
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.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Tolerance and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. However, do not take more than the prescribed dose. Additionally, long-term or regular use of this medication can lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this may cause withdrawal symptoms. Instead, consult your doctor, who will provide guidance on how to safely reduce or stop the medication.
Monitoring and Tests
Before starting this medication, you may need to undergo certain heart tests. If you have any questions or concerns, discuss them with your doctor. Additionally, this medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. If you experience severe headache, dizziness, fainting, or changes in vision, seek medical attention immediately.
Interactions with Other Medications
Certain over-the-counter (OTC) products, such as cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, may interact with this medication and increase blood pressure. Consult your doctor before taking any of these products.
Lab Tests and Seizure Risk
This medication may affect certain lab tests, so it is essential to inform all your healthcare providers and lab workers that you are taking this medication. Additionally, this medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.
Mental Health and Mood Changes
This medication may cause changes in behavior and mood, including hallucinations, anger, and depression. 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 signs of mood changes, such as depression, suicidal thoughts, nervousness, or anxiety.
Growth and Pregnancy
This medication may affect growth in children and teenagers. Regular growth checks may be necessary. If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- Arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea
- Abdominal cramps
- Convulsions
- Coma
- Death
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center. Call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
- Linezolid (reversible MAOI activity)
- Methylene Blue (reversible MAOI activity)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome
- Tricyclic Antidepressants (TCAs) - may increase amphetamine levels and potentiate cardiovascular effects
- Urinary Alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease urinary excretion of amphetamine, increasing plasma levels and prolonging half-life
- Antihypertensives - amphetamines may antagonize the hypotensive effects of guanethidine and other antihypertensives
- Halogenated Anesthetics - increased risk of arrhythmias
Moderate Interactions
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide) - may increase absorption of amphetamines
- Proton Pump Inhibitors (PPIs) - may increase absorption of amphetamines
- Urinary Acidifiers (e.g., ammonium chloride, ascorbic acid) - increase urinary excretion of amphetamine, decreasing plasma levels and shortening half-life
- Phenothiazines (e.g., chlorpromazine) - may inhibit amphetamine effects
- Antipsychotics (e.g., haloperidol) - 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. Baseline assessment helps identify pre-existing cardiovascular risk.
Timing: Prior to initiation of therapy.
Height and Weight (Pediatric Patients)
Rationale: Amphetamines are associated with growth suppression in pediatric patients.
Timing: Prior to initiation of therapy.
Psychiatric History (including family history of tics/Tourette's, bipolar disorder, psychosis)
Rationale: Amphetamines can exacerbate pre-existing psychiatric conditions or induce new psychotic/manic symptoms or tics.
Timing: Prior to initiation of therapy.
Electrocardiogram (ECG)
Rationale: Consider for patients with pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.
Timing: Prior to initiation of therapy, if indicated.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit (e.g., every 3-6 months or more frequently during titration)
Target: Within normal limits for age; monitor for significant increases from baseline.
Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex or significant increase from baseline) warrants further evaluation and potential dose adjustment or discontinuation.
Weight (Pediatric Patients)
Frequency: Every 3-6 months
Target: Maintain appropriate growth trajectory.
Action Threshold: Significant weight loss or growth deceleration warrants nutritional assessment and potential dose adjustment or drug holiday.
Psychiatric Status (e.g., mood, anxiety, tics, psychotic symptoms)
Frequency: At each visit
Target: Stable mood, absence of new or worsening psychiatric symptoms.
Action Threshold: Emergence of new psychotic symptoms, mania, severe anxiety, or tics warrants immediate evaluation and potential discontinuation.
ADHD/Narcolepsy Symptom Control
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity, reduced excessive daytime sleepiness.
Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Symptom Monitoring
- Insomnia
- Anorexia/Appetite suppression
- Nervousness/Anxiety
- Irritability
- Headache
- Dry mouth
- Gastrointestinal upset (nausea, diarrhea, constipation)
- Tics or abnormal movements
- Changes in mood or behavior (e.g., aggression, agitation, psychosis, mania)
- Cardiovascular symptoms (e.g., palpitations, chest pain, shortness of breath, syncope)
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for increased risk of congenital malformations cannot be ruled out.
Second Trimester:
Potential for premature delivery and low birth weight.
Third Trimester:
Risk of premature delivery, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia) if used near term.
Lactation
Dextroamphetamine is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, weight loss), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Moderate risk (L3)
Pediatric Use
Safety and efficacy have been established in pediatric patients 6 years and older for ADHD. Not recommended for children under 6 years of age. Monitor growth (height and weight) due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may be more sensitive to the cardiovascular and CNS effects of stimulants.
Clinical Information
Clinical Pearls
- Extended-release capsules should be swallowed whole; crushing or chewing can lead to rapid release and absorption of a potentially fatal dose.
- Patients should be screened for cardiac abnormalities and psychiatric conditions prior to initiation.
- Monitor for signs of abuse and diversion, especially in patients with a history of substance use disorder.
- Consider drug holidays in pediatric patients to assess growth and need for continued therapy.
- Educate patients and caregivers on the importance of proper storage to prevent accidental ingestion or misuse.
Alternative Therapies
- Methylphenidate (e.g., Concerta, Ritalin LA, Focalin XR)
- Atomoxetine (Strattera)
- Guanfacine ER (Intuniv)
- Clonidine ER (Kapvay)
- Bupropion (Wellbutrin - off-label for ADHD)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$400+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic); Tier 3 or Tier 4 (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. 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.