Dextroamphetamine 7.5mg Tablets

Manufacturer WINDER LABORATORIES Active Ingredient Dextroamphetamine Tablets(deks troe am FET a meen) Pronunciation deks-troe-AM-fet-uh-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
Jun 1975
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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 that help with focus and wakefulness. It's a stimulant, so it can help improve attention, reduce hyperactivity, and control sleepiness.
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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. You can take this medication with or without food. To minimize sleep disturbances, avoid taking it late in the day. Additionally, do not take this medication with fruit juice. Consistency is key, so take your medication at the same time every day.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. 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 keep your medication secure. 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. Instead, check with your pharmacist for guidance on the best disposal method, and explore local drug take-back programs.

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.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less, or more often than prescribed.
  • Do not crush, chew, or break the tablets if they are extended-release. This specific product is 7.5mg tablets, which are typically immediate-release and can be scored.
  • Avoid taking doses late in the day (e.g., after 6 PM) to prevent sleep problems.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Avoid alcohol while taking this medication.
  • Store in a safe place to prevent misuse or diversion.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor growth (height and weight) regularly.

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. Doses >40 mg/day are rarely needed.
Narcolepsy: Initial 10 mg daily in divided doses; may increase by 10 mg weekly to a maximum of 60 mg/day. Doses >60 mg/day are rarely needed.
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Pediatric Dosing

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

Renal Impairment:

Mild: No specific dosage adjustment provided, use with caution.
Moderate: No specific dosage adjustment provided, use with caution.
Severe: Use with caution; consider lower doses and monitor for adverse effects due to potential for increased plasma levels.
Dialysis: Not well studied; likely not dialyzable due to high protein binding and volume of distribution. Use with extreme caution.

Hepatic Impairment:

Mild: No specific dosage adjustment provided.
Moderate: No specific dosage adjustment provided.
Severe: Use with caution; consider lower doses and monitor for adverse effects due to potential for altered metabolism.

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that stimulates the central nervous system. Its therapeutic effects are thought to result from the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, particularly in the cerebral cortex and reticular activating system. It also inhibits the reuptake of these monoamines.
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Pharmacokinetics

Absorption:

Bioavailability: High (well absorbed)
Tmax: Oral tablet: 2-4 hours
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: 3.5-4.5 L/kg
ProteinBinding: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Adults: 10-12 hours (acidic urine decreases half-life, alkaline urine increases half-life); Children: 9-11 hours
Clearance: Highly dependent on urinary pH
ExcretionRoute: Renal
Unchanged: 30-50% (highly dependent on urinary pH; up to 70% in acidic urine, <10% in alkaline urine)
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Pharmacodynamics

OnsetOfAction: Oral tablet: 30-60 minutes
PeakEffect: Oral tablet: 2-4 hours
DurationOfAction: Oral tablet: 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 MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF PATIENTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUG SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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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
Difficulty 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 difficulty 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 sensation 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 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 mild ones, it's essential to be aware of the following potential side effects:

Dizziness or headache
Dry mouth
Trouble sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Bad taste in mouth
Feeling nervous and excitable
Hair loss

If you're concerned about any side effects or have questions, 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 aggression, hostility, or agitation
  • Seeing or hearing things that are not real (hallucinations)
  • New manic symptoms (e.g., extreme energy, racing thoughts, decreased need for sleep)
  • Unexplained numbness, coolness, or pain in fingers or toes
  • Changes in skin color of fingers or toes (e.g., pale, blue, red)
  • Unexplained tics or repetitive movements
  • Severe headache
  • Blurred vision
  • 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 health issues, such as:
+ Drug abuse
+ Stroke
Current medications, including:
+ Acetazolamide
+ 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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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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 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 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 this, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication can cause dependence, and stopping it suddenly may lead to withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.

Monitoring and Tests

Before starting this medication, you may need to undergo heart tests. 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

This medication may interact with 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, which 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 it. 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 Behavior

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. Contact your doctor immediately if you experience hallucinations, changes in behavior, or mood changes like depression, thoughts of suicide, nervousness, or anxiety.

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, inform your doctor. You will need 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
  • Assaultiveness
  • Hallucinations
  • Panic states
  • High fever
  • Rhabdomyolysis
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea, vomiting, diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma
  • Death

What to Do:

Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Treatment is generally supportive and symptomatic, including gastric lavage, activated charcoal, and sedation for CNS overstimulation.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
  • Linezolid
  • Methylene blue
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
  • Antihypertensive agents (may decrease hypotensive effect)
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase renal excretion, decrease efficacy
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease renal excretion, increase efficacy/toxicity
  • Proton pump inhibitors (e.g., omeprazole) - may increase absorption and exposure
  • Antipsychotics (e.g., haloperidol, chlorpromazine) - may antagonize stimulant effects
  • Alcohol (may increase CNS adverse effects)
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Moderate Interactions

  • Tricyclic antidepressants (TCAs) - increased cardiovascular effects
  • Antacids (containing magnesium or aluminum) - may increase absorption
  • Opioids (potential for additive CNS effects, abuse potential)
  • Caffeine (additive stimulant effects)
  • Phenytoin (may alter phenytoin levels)
  • Ethosuximide (may alter ethosuximide levels)
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Minor Interactions

  • Not specifically categorized as minor for dextroamphetamine, but general caution with other CNS active drugs.

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 (Pediatric)

Rationale: Risk of growth suppression in children.

Timing: Prior to initiation of therapy.

Psychiatric History (including family history of suicide, bipolar disorder, depression)

Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new psychotic/manic symptoms.

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, 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: Sustained elevation (e.g., >95th percentile for age/sex/height or significant increase from baseline) warrants investigation and potential dose adjustment/discontinuation.

Height and Weight (Pediatric)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines) warrants investigation and potential drug holiday or alternative therapy.

Psychiatric Status (mood, anxiety, psychotic symptoms, suicidal ideation)

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 suicidal ideation warrants immediate evaluation and discontinuation.

Abuse/Diversion Potential

Frequency: At each visit.

Target: No signs of abuse or diversion.

Action Threshold: Signs of abuse or diversion warrant intervention and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hostility
  • Psychotic symptoms (hallucinations, delusions)
  • Manic symptoms (elevated mood, decreased need for sleep, racing thoughts)
  • Severe anxiety
  • Depression
  • Suicidal ideation
  • Unexplained weight loss
  • Tics or dyskinesias
  • Peripheral vasculopathy (e.g., Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Amphetamines have been associated with adverse pregnancy outcomes, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester: Potential for growth restriction and premature delivery.
Third Trimester: Risk of premature delivery, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, respiratory distress).
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Lactation

L3 (Moderate Risk). Dextroamphetamine is excreted into breast milk. Potential for serious adverse reactions in the breastfed infant (e.g., irritability, poor feeding, sleep disturbances, weight loss, cardiovascular effects). Weigh the developmental and health benefits of breastfeeding against the mother's clinical need for the drug and any potential adverse effects on the breastfed infant.

Infant Risk: Moderate risk. Monitor infant for irritability, sleep disturbances, poor feeding, and weight loss. Long-term effects on neurodevelopment are unknown.
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Pediatric Use

Safety and efficacy established for ADHD in children 3-16 years and narcolepsy in children 6-16 years. Not recommended for children under 3 years for ADHD or under 6 years for narcolepsy. Monitor growth (height and weight) carefully due to potential for growth suppression. Psychiatric adverse events (e.g., psychosis, mania) can occur.

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Geriatric Use

Use with caution in elderly patients. Start with lower doses and titrate slowly due to increased sensitivity to stimulant effects and potential for comorbidities and polypharmacy. Monitor cardiovascular status closely.

Clinical Information

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Clinical Pearls

  • Dextroamphetamine has a high potential for abuse and dependence; careful patient selection and monitoring are crucial.
  • Immediate-release formulations typically require multiple daily doses due to their shorter duration of action.
  • Urinary pH significantly impacts dextroamphetamine excretion; acidic urine increases excretion, while alkaline urine decreases it, potentially leading to increased drug levels and toxicity.
  • Patients should be advised to avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., extreme fatigue, depression, sleep disturbances).
  • Cardiovascular and psychiatric adverse events are significant concerns; thorough baseline assessment and ongoing monitoring are essential.
  • Growth suppression in pediatric patients is a known side effect; regular height and weight monitoring is necessary, and drug holidays may be considered if growth is significantly affected.
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Alternative Therapies

  • Methylphenidate (Ritalin, Concerta, Focalin)
  • Atomoxetine (Strattera)
  • Guanfacine (Intuniv)
  • Clonidine (Kapvay)
  • Bupropion (Wellbutrin) - off-label for ADHD
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Cost & Coverage

Average Cost: $30 - $100 per 30 tablets (7.5mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for generics, brand may be higher)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. When you receive this medication, you will also get a Medication Guide, which is an important patient fact sheet. Please read it carefully and review it again whenever you get a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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. Be prepared to provide information about what was taken, the amount, and the time it happened, as this will help healthcare professionals provide you with appropriate care.