Dextroamphetamine 15mg ER Capsules

Manufacturer MALLINCKRODT PHARM Active Ingredient Dextroamphetamine Sustained- Release Capsules(deks troe am FET a meen) Pronunciation deks troe am FET a meen
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.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Sympathomimetic Amine
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Dextroamphetamine is a stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD) by helping to improve focus, attention, and control over impulsive behavior. It is also used to treat narcolepsy, a sleep disorder, by helping people stay awake during the day.
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How to Use This Medicine

Taking Your Medication

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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD: Initial 5 mg once daily in the morning; Narcolepsy: Initial 10 mg once daily in the morning.
Dose Range: 5 - 40 mg

Condition-Specific Dosing:

ADHD: Initial 5 mg once daily in the morning; may increase by 5 mg weekly to a maximum of 40 mg/day.
Narcolepsy: Initial 10 mg once daily in the morning; may increase by 10 mg weekly to a maximum of 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial 5 mg once daily in the morning; may increase by 5 mg weekly. Max 30 mg/day.
Adolescent: ADHD (13-17 years): Initial 10 mg once daily in the morning; may increase by 10 mg weekly. Max 40 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider lower doses.
Moderate: Use with caution; consider lower doses and extended dosing intervals.
Severe: Use with caution; consider lower doses and extended dosing intervals. Contraindicated in end-stage renal disease.
Dialysis: Not well studied; likely not dialyzable to a significant extent. Avoid use or use with extreme caution.

Hepatic Impairment:

Mild: Use with caution; no specific guidelines, but metabolism occurs in liver.
Moderate: Use with caution; no specific guidelines, but metabolism occurs in liver.
Severe: Use with caution; no specific guidelines, but metabolism occurs in liver.

Pharmacology

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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.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 75-100%
Tmax: Biphasic release: Initial peak at 2-4 hours, second peak at 6-8 hours (for ER formulations)
FoodEffect: Food may delay Tmax but generally does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 2-5 L/kg
ProteinBinding: Approximately 15-25%
CnssPenetration: Yes

Elimination:

HalfLife: Adults: 10-12 hours; Children: 6-8 hours (pH-dependent)
Clearance: Highly variable, pH-dependent
ExcretionRoute: Renal (urine)
Unchanged: Approximately 30-40% (higher with acidic urine, lower with alkaline urine)
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes (for initial release from ER capsule)
PeakEffect: Approximately 6-8 hours (for ER capsule)
DurationOfAction: Approximately 10-12 hours (for ER capsule)

Safety & Warnings

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BLACK BOX WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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.
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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
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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 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.
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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 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.
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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

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI use (risk of hypertensive crisis)
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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
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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
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Minor Interactions

  • Caffeine - additive stimulant effects
  • Antacids - may slightly increase absorption

Monitoring

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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 in children.

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.

ECG (if cardiac risk factors present)

Rationale: To screen for underlying cardiac abnormalities that could be exacerbated by stimulants.

Timing: Prior to initiation, if indicated.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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.

Weight and Height (pediatric patients)

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.

Psychiatric Status (mood, anxiety, psychosis, tics)

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.

Abuse Potential

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.

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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

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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:

First Trimester: Potential for increased risk of congenital malformations, though data are mixed.
Second Trimester: Risk of premature birth and low birth weight.
Third Trimester: Risk of withdrawal symptoms in the neonate (e.g., agitation, tremor, feeding difficulties, respiratory distress).
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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.

Infant Risk: Potential for irritability, poor sleep, poor feeding, and weight loss in the infant. Long-term effects are unknown.
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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).

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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

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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.
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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
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Cost & Coverage

Average Cost: $150 - $400+ per 30 capsules (15mg ER)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
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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, 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.