Dextroamphetamine 20mg Tablets

Manufacturer WILSHIRE Active Ingredient Dextroamphetamine Tablets(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
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 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 in ADHD, and to help people stay awake during the day if they have narcolepsy.
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How to Use This Medicine

Taking Your Medication Correctly

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. To minimize the risk of sleep disturbances, 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.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from direct light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. It's essential to keep your medication out of reach of children and pets, and inaccessible to others. Consider storing it in a locked box or secure area. 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 local drug take-back programs.

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.
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Lifestyle & Tips

  • Take exactly as prescribed; do not take more or less than directed.
  • Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms may occur.
  • Avoid alcohol consumption while taking this medication.
  • Limit caffeine intake, as it can increase stimulant effects and side effects.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Store medication securely to prevent misuse or abuse.
  • Maintain a healthy diet and monitor growth (for children).

Dosing & Administration

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Adult Dosing

Standard Dose: ADHD: Initial 5 mg once or twice daily; Narcolepsy: Initial 10 mg daily in divided doses
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial 2.5-5 mg once or twice daily; may increase by 2.5-5 mg weekly to a maximum of 40 mg/day in divided doses. Narcolepsy (6-12 years): Initial 5 mg daily; may increase by 5 mg weekly to a maximum of 60 mg/day in divided doses.
Adolescent: ADHD (13-17 years): Initial 5 mg once or twice daily; may increase by 5 mg weekly to a maximum of 40 mg/day in divided doses. Narcolepsy (12-17 years): Initial 10 mg daily in divided doses; may increase by 10 mg weekly to a maximum of 60 mg/day in divided doses.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor for adverse effects.
Moderate: Consider dose reduction (e.g., 50% reduction for CrCl 15-30 mL/min).
Severe: Avoid use or significantly reduce dose (e.g., 75% reduction for CrCl < 15 mL/min).
Dialysis: Avoid use; not dialyzable to a significant extent.

Hepatic Impairment:

Mild: No specific adjustment, monitor for adverse effects.
Moderate: Caution advised, consider lower starting doses and slower titration.
Severe: Caution advised, consider lower starting doses and slower titration; specific guidelines not well-defined.

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that stimulates the central nervous system. Its primary mechanism of action is thought to be the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, as well as inhibition of their reuptake. This leads to increased concentrations of these neurotransmitters in the synaptic cleft.
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Pharmacokinetics

Absorption:

Bioavailability: 75-100%
Tmax: 2-4 hours (immediate release)
FoodEffect: Food can delay Tmax but generally does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 3-5 L/kg
ProteinBinding: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Adults: 10-12 hours; Children: 6-8 hours (pH-dependent)
Clearance: Highly variable, influenced by urinary pH.
ExcretionRoute: Renal
Unchanged: Approximately 30-40% (highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine).
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 2-4 hours
DurationOfAction: 4-6 hours (immediate release)
Confidence: Medium

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 AND SHOULD BE AVOIDED. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Restlessness or shakiness
Uncontrolled body movements or sounds (e.g., humming, throat clearing, yelling, or making loud noises)
Changes in vision or eye pain, swelling, or redness
Erectile dysfunction or decreased sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or difficulty urinating
Prolonged or frequent erections
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensations in hands or feet
Sores or wounds on fingers or toes

Important Heart-Related Warnings

If you have a pre-existing heart condition or defect, inform your doctor. Additionally, if a family member has a history of abnormal heart rhythms or sudden death, notify your doctor. Seek immediate medical attention if you experience:

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. Call your doctor right away if you experience:

Agitation
Balance problems
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

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Dizziness or headache
Dry mouth
Difficulty sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Unpleasant taste in the mouth
Feeling nervous or excitable
* Hair loss

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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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 mental problems (e.g., hallucinations, delusions, paranoia, mania)
  • Aggressive behavior or hostility
  • New or worsening tics (uncontrolled movements or sounds)
  • Blurred vision or other vision changes
  • Unexplained numbness, pain, or discoloration in fingers or toes (Raynaud's phenomenon)
  • Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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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 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 medications, including:
+ Acetazolamide or sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as they may cause 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 conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dose of any medication without consulting your doctor first.
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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. This will help ensure your safety and prevent any potential interactions or complications.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness or clear vision. This will help prevent accidents and ensure your safety.

Tolerance and Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the medication may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, long-term or regular use can cause dependence, and stopping the medication abruptly may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Monitoring and Tests
You may need to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. Regularly check your blood pressure and heart rate as instructed by your doctor.

Interactions with Other Medications
Certain over-the-counter (OTC) products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, can increase blood pressure. Consult your doctor before using these products.

Lab Tests and Seizure Risk
This medication may affect certain lab tests, so 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, including those with a history of seizures. Discuss your risk with your doctor.

Mental Health and Mood Changes
This medication can cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. If you or a family member have a history of mental or mood problems, 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, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.

Growth Effects in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. 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 (overactive reflexes)
  • Rapid respiration
  • Confusion
  • Hallucinations
  • Panic states
  • Hyperpyrexia (very high fever)
  • Rhabdomyolysis (muscle breakdown)
  • Arrhythmias (irregular heartbeats)
  • Hypertension (high blood pressure) or hypotension (low blood pressure)
  • Circulatory collapse
  • Convulsions
  • Coma

What to Do:

In case of suspected overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for cardiovascular and CNS 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, serotonin syndrome)
  • Linezolid (MAOI activity)
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Major Interactions

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome
  • Antihypertensive agents - may antagonize hypotensive effects
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase reabsorption and prolong half-life of dextroamphetamine
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase excretion and decrease efficacy of dextroamphetamine
  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of dextroamphetamine
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Moderate Interactions

  • Antacids (containing magnesium or aluminum) - may increase absorption of dextroamphetamine
  • Phenothiazines (e.g., chlorpromazine) - may inhibit stimulant effects
  • Haloperidol - may inhibit stimulant effects
  • Proton Pump Inhibitors (PPIs) / H2 Blockers - may increase absorption of dextroamphetamine
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Minor Interactions

  • Caffeine - additive stimulant effects
  • Alcohol - may exacerbate adverse effects

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 of therapy.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation of therapy (especially in children).

Psychiatric History (e.g., bipolar disorder, psychosis, tics)

Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new ones.

Timing: Prior to initiation of therapy.

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To identify patients at higher risk for cardiovascular events.

Timing: Prior to initiation of therapy.

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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/individual baseline.

Action Threshold: Sustained elevation above normal range; consider dose adjustment or discontinuation.

Height and Weight

Frequency: Every 3-6 months (pediatric patients); annually (adults).

Target: Normal growth trajectory (pediatric); stable weight (adult).

Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative therapy.

Psychiatric Status (e.g., mood, anxiety, psychotic symptoms, tics)

Frequency: At each visit.

Target: Stable mood, absence of new or worsening psychotic symptoms, tics, or aggressive behavior.

Action Threshold: Emergence of new psychotic symptoms, mania, severe anxiety, aggression, or tics; consider discontinuation.

ADHD/Narcolepsy Symptom Control

Frequency: At each visit.

Target: Improved focus, reduced hyperactivity/impulsivity, improved wakefulness.

Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope (fainting)
  • Palpitations
  • New-onset psychosis (hallucinations, delusions)
  • Mania or hypomania
  • Severe anxiety or agitation
  • Aggressive behavior or hostility
  • New or worsening tics
  • Blurred vision or other visual disturbances
  • Unexplained numbness, pain, or discoloration in fingers or toes (Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy should be avoided unless 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 in utero may experience withdrawal symptoms (e.g., agitation, tremor, hypotonia, feeding difficulties).

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations, though data are inconsistent.
Second Trimester: Risk of growth restriction and premature birth.
Third Trimester: Risk of neonatal withdrawal symptoms and persistent pulmonary hypertension of the newborn.
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Lactation

L3 (Moderate risk). Dextroamphetamine is excreted into breast milk. The American Academy of Pediatrics considers amphetamines to be drugs for which the effect on the nursing infant is unknown but may be of concern. Monitor breastfed infants for irritability, poor feeding, sleep disturbances, and weight loss.

Infant Risk: Irritability, poor feeding, sleep disturbances, weight loss, potential for long-term neurodevelopmental effects (though data are limited).
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Pediatric Use

Dextroamphetamine is approved for use in children 3 years and older for ADHD and 6 years and older for narcolepsy. Close monitoring of growth (height and weight) is essential due to the risk of growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).

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Geriatric Use

Use with caution in elderly patients, generally starting with lower doses and titrating slowly due to increased sensitivity to adverse effects, particularly cardiovascular and psychiatric. Elderly patients may have age-related decreases in renal function, which can affect drug clearance.

Clinical Information

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Clinical Pearls

  • Dextroamphetamine has a high potential for abuse and dependence; assess patients for risk factors prior to prescribing and monitor for signs of abuse and dependence during treatment.
  • Monitor cardiovascular status (BP, HR) regularly due to risk of hypertension and tachycardia. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, or coronary artery disease.
  • Monitor for emergence or exacerbation of psychiatric symptoms, including psychosis, mania, aggression, and tics.
  • Growth suppression (weight loss and slowed height gain) can occur in pediatric patients; monitor growth parameters closely.
  • Avoid abrupt discontinuation, especially after prolonged high-dose therapy, to prevent withdrawal symptoms (e.g., severe fatigue, depression).
  • Urinary pH significantly affects dextroamphetamine excretion; acidic urine increases excretion, while alkaline urine decreases it, potentially prolonging effects and increasing toxicity.
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Alternative Therapies

  • Methylphenidate (Ritalin, Concerta, Focalin)
  • Lisdexamfetamine (Vyvanse)
  • Atomoxetine (Strattera)
  • Guanfacine (Intuniv)
  • Clonidine (Kapvay)
  • Modafinil (Provigil) - for narcolepsy
  • Armodafinil (Nuvigil) - for narcolepsy
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Cost & Coverage

Average Cost: Varies widely ($20 - $100+) per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred, to facilitate prompt and appropriate treatment.