Dextroamphetamine 15mg ER Capsules
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. To minimize sleep disturbances, avoid taking this medication late in the day. Additionally, do not take this medication with fruit juice. Establish a routine by taking your medication at the same time every day. Swallow the medication whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. To ensure safety, store your medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area to store your medication. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 dose.
Lifestyle & Tips
- Take the capsule whole; do not crush, chew, or open it, as this can lead to a rapid release of the drug and increase side effects.
- Take in the morning to avoid insomnia.
- Avoid alcohol, as it can increase the risk of side effects.
- Limit caffeine intake, as it can add to stimulant effects.
- Maintain a healthy diet and monitor weight, especially in children.
- Ensure adequate sleep hygiene.
- Store safely 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
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
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 medical attention right away:
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 hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
Important Heart-Related Warnings
If you have a heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, tell 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
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 possible side effects:
Dizziness or headache
Dry mouth
Trouble sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Bad taste in your mouth
Feeling nervous and excitable
Hair loss
If you experience any of these side effects or any other unusual symptoms, contact your doctor or seek medical attention. Remember to report any 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 high blood pressure or heart rate
- Numbness, pain, skin color change, or sensitivity to temperature in fingers or toes
- New or worsening mental problems (e.g., hallucinations, paranoia, aggression, agitation)
- New or worsening tics (uncontrolled movements or sounds)
- Unexplained weight loss or growth suppression in children
- Blurred vision or other vision changes
- Severe headache
Before Using This Medicine
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 medical history of:
+ 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 the safety of taking this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & 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 operating a vehicle or engaging in activities that require alertness and clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Additionally, long-term or regular use of this medication may cause dependence. Stopping the medication abruptly may result in withdrawal symptoms. Consult your doctor before reducing the dose or discontinuing the 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 or concerns, discuss them with your doctor.
This medication may cause high blood pressure. Seek immediate medical attention if you experience severe headache, dizziness, fainting, or changes in vision. Monitor your blood pressure and heart rate as directed by your doctor.
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, or 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 in some individuals, including those 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, or 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. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Pediatric Considerations
This medication may affect growth in children and adolescents. Regular growth checks may be necessary. Discuss this with your doctor.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, consult 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 (hyperpyrexia)
- Rhabdomyolysis
- Arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea, abdominal cramps
- Seizures
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for hyperthermia, seizures, and cardiovascular effects.
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, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease urinary excretion, increase plasma levels and duration of action of dextroamphetamine
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase urinary excretion, decrease plasma levels and duration of action of dextroamphetamine
- Adrenergic blockers (e.g., guanethidine) - may inhibit the hypotensive effect of adrenergic blockers
- Antihypertensives - may reduce the hypotensive effect of antihypertensive drugs
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - may potentiate the cardiovascular effects of dextroamphetamine
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of dextroamphetamine
- Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may alter gastric pH, potentially affecting absorption of ER formulations (though generally minimal for dextroamphetamine ER)
- Alcohol - may increase the risk of adverse effects and alter drug release from ER formulations
Minor Interactions
- Caffeine - additive stimulant effects
- Antacids - may slightly increase absorption
Monitoring
Baseline Monitoring
Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).
Timing: Prior to initiation.
Rationale: Risk of growth suppression in children.
Timing: Prior to initiation.
Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new ones.
Timing: Prior to initiation.
Rationale: To screen for underlying cardiac abnormalities that could be exacerbated by stimulants.
Timing: Prior to initiation, if indicated.
Routine Monitoring
Frequency: At each visit or every 3-6 months.
Target: Within normal limits for age.
Action Threshold: Significant or sustained elevation (e.g., >10-20 mmHg increase in BP, >20 bpm increase in HR) warrants investigation and potential dose adjustment or discontinuation.
Frequency: Every 3-6 months.
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss warrants investigation and potential drug holiday or alternative treatment.
Frequency: At each visit or every 3-6 months.
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.
Frequency: At each visit.
Target: No signs of drug-seeking behavior or misuse.
Action Threshold: Evidence of misuse or diversion warrants intervention and potential discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Palpitations
- Severe headache
- Dizziness
- Fainting
- Numbness or weakness on one side of the body
- Slurred speech
- Unexplained wounds on fingers or toes (peripheral vasculopathy)
- Hallucinations
- Paranoia
- New or worsening tics
- Aggression
- Agitation
- Anxiety
- Insomnia
- Loss of appetite
- Unexplained weight loss
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
Lactation
L3 (Moderately Safe). Dextroamphetamine is excreted into breast milk. Monitor breastfed infants for signs of agitation, irritability, poor feeding, and weight loss. Consider avoiding breastfeeding or using an alternative medication if possible.
Pediatric Use
Not recommended for children under 6 years of age. Monitor growth (height and weight) carefully. Risk of growth suppression and psychiatric adverse events (e.g., new-onset psychosis, mania, tics).
Geriatric Use
Use with caution. Start with lower doses and titrate slowly due to increased sensitivity to adverse effects (e.g., cardiovascular, psychiatric). Monitor for cardiovascular and psychiatric adverse events.
Clinical Information
Clinical Pearls
- Dextroamphetamine ER capsules should be swallowed whole; do not crush, chew, or open, as this can lead to dose dumping and increased side effects.
- Take the dose in the morning to minimize the risk of insomnia.
- Patients should be advised about the high potential for abuse and dependence.
- Regular monitoring of blood pressure, heart rate, and weight (especially in children) is crucial.
- Educate patients and caregivers on signs of serious cardiovascular or psychiatric adverse events requiring immediate medical attention.
- Consider drug holidays for pediatric patients to assess growth and continued need for medication.
Alternative Therapies
- Non-stimulants for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy for ADHD
- Modafinil/Armodafinil for Narcolepsy
- Sodium oxybate for Narcolepsy
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to 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 for guidance.
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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.