Zenzedi 2.5mg Tablets

Manufacturer ARBOR Active Ingredient Dextroamphetamine Tablets(deks troe am FET a meen) Pronunciation ZEN-zeh-dee (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 Stimulant
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Pharmacologic Class
Sympathomimetic Amine
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Pregnancy Category
Not available
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FDA Approved
Jan 1975
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Zenzedi is a medication that contains dextroamphetamine, a stimulant. It works by increasing certain natural substances in the brain that help with focus and attention, and reduce hyperactivity. It's used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy (a sleep disorder).
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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 accompanying information carefully. 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 consume this medication with fruit juice. Establish a routine by taking your medication at the same time every day.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. Keep your medication in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.

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 one.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less than directed.
  • Do not crush, chew, or break the tablets if they are extended-release (Zenzedi is immediate-release, so this is less critical but generally good advice for stimulants).
  • Avoid taking doses late in the day to prevent sleep problems.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Limit or avoid caffeine intake, as it can increase stimulant effects and side effects.
  • Maintain a healthy diet and regular exercise, especially for children, to support overall health and manage potential appetite suppression.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • Report any new or worsening mental health symptoms (e.g., anxiety, agitation, hallucinations) immediately.

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: 2.5 - 40 mg

Condition-Specific Dosing:

ADHD: Initial 5 mg once or twice daily, increasing by 5 mg weekly until optimal response. Max 40 mg/day.
Narcolepsy: Initial 10 mg daily in divided doses, increasing by 10 mg weekly. Max 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial 2.5 mg twice daily, increasing by 2.5-5 mg weekly. Max 40 mg/day. Narcolepsy (6-12 years): Initial 5 mg daily, increasing by 5 mg weekly. Max 60 mg/day.
Adolescent: ADHD (13-17 years): Initial 5 mg once or twice daily, increasing by 5 mg weekly. Max 40 mg/day. Narcolepsy (13-17 years): Initial 10 mg daily in divided doses, increasing by 10 mg weekly. Max 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: Adjustment needed (monitor for increased effects)
Moderate: Adjustment needed (consider lower doses, monitor closely)
Severe: Adjustment needed (consider lower doses, monitor closely)
Dialysis: Not well studied; caution, likely not dialyzable due to high Vd.

Hepatic Impairment:

Mild: Adjustment (monitor for increased effects)
Moderate: Adjustment (consider lower doses, monitor closely)
Severe: Adjustment (consider lower doses, monitor closely)

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that acts as a non-selective monoamine releasing agent. It primarily increases the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, particularly in the mesocorticolimbic system and locus coeruleus. It also has some effect on serotonin release and inhibits the reuptake of these neurotransmitters. This leads to increased synaptic concentrations of these monoamines, resulting in CNS stimulation, appetite suppression, and increased wakefulness.
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Pharmacokinetics

Absorption:

Bioavailability: 75-100%
Tmax: 2-4 hours (immediate-release)
FoodEffect: Food may delay Tmax but does not significantly affect AUC.

Distribution:

Vd: 3.5-4.6 L/kg
ProteinBinding: 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: Adults: 10-13 hours; Children: 9-11 hours
Clearance: Not readily available (highly variable due to pH-dependent excretion)
ExcretionRoute: Renal (pH-dependent)
Unchanged: 30-50% (highly dependent on urine pH; more excreted unchanged in acidic urine)
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Pharmacodynamics

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

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 PATIENTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC 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

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 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
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 heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify 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 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
  • Fainting spells
  • Fast or pounding heartbeat
  • Numbness, coolness, or pain in fingers or toes
  • Unexplained wounds on fingers or toes
  • New or worsening aggression or hostility
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New manic symptoms (e.g., extreme energy, racing thoughts)
  • Severe headache
  • Blurred vision
  • Unexplained weight loss (especially in children)
  • Slowed growth (in children)
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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 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 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 Precautions

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. Long-term or regular use of this medication can also 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 taper off the medication.

Monitoring and Follow-up

Before starting this medication, you may need to undergo heart tests to ensure your safety. Your doctor will discuss the results with you and provide further instructions. 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 your 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 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. 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 Development

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary to monitor any potential effects. Consult your doctor for more information.

Pregnancy and Breastfeeding

If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor. This will help you make an informed decision about your treatment.
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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:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
  • Linezolid (MAOI activity)
  • Methylene blue (MAOI activity)
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Major Interactions

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
  • Antihypertensive agents - may reduce hypotensive effect
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase dextroamphetamine levels and prolong half-life
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine levels and shorten half-life
  • Proton Pump Inhibitors (PPIs) / H2 blockers - may increase absorption and exposure
  • Antipsychotics - may antagonize stimulant effects
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - increased cardiovascular effects
  • Antacids containing magnesium or aluminum - may increase absorption
  • Opioids - potential for reduced analgesic effect or increased stimulant effect
  • Alcohol - may increase CNS adverse effects
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Minor Interactions

  • Caffeine - additive stimulant 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 and periodically during treatment.

Height and Weight (Pediatric patients)

Rationale: Risk of growth suppression.

Timing: Prior to initiation and periodically during treatment.

Psychiatric history and current symptoms

Rationale: Risk of exacerbating pre-existing psychiatric conditions (e.g., psychosis, bipolar disorder) 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 stimulant use.

Timing: Prior to initiation, if indicated.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At least annually, or more frequently if clinically indicated.

Target: Within normal limits for age/patient.

Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.

Height and Weight (Pediatric patients)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

Action Threshold: Significant deviation from expected growth curve; consider drug holiday or alternative treatment.

Psychiatric symptoms (e.g., agitation, aggression, hallucinations, mania)

Frequency: Regularly during follow-up visits.

Target: Absence of new or worsening symptoms.

Action Threshold: Emergence or worsening of psychiatric symptoms; consider dose reduction or discontinuation.

ADHD/Narcolepsy symptom control and functional improvement

Frequency: Regularly during follow-up visits.

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

Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative treatment.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Fainting
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Agitation
  • Unexplained weight loss
  • Growth deceleration (in children)
  • Numbness, coolness, or pain in fingers/toes (Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Use during pregnancy should be avoided unless the potential benefit outweighs the potential risk to the fetus. Amphetamines may cause fetal harm, including premature birth and low birth weight. Neonates exposed to amphetamines in utero may experience withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations (e.g., cardiac defects), though data are conflicting.
Second Trimester: Potential for growth restriction and premature birth.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., agitation, tremor, feeding difficulties, respiratory distress) if used near term.
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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, cardiovascular effects), breastfeeding is generally not recommended during treatment with dextroamphetamine.

Infant Risk: High (L3 - Moderately safe, but caution due to potential for serious adverse effects)
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Pediatric Use

Approved for ADHD and narcolepsy in children 6 years and older. Monitor growth (height and weight) carefully. Risk of growth suppression. Monitor for psychiatric adverse events.

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Geriatric Use

Use with caution in elderly patients, generally starting at the lower end of the dosing range, due to increased sensitivity to adverse effects (especially cardiovascular and psychiatric). Consider age-related decreases in renal function.

Clinical Information

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Clinical Pearls

  • Administer the last dose of the day at least 6 hours before bedtime to minimize insomnia.
  • Patients should be screened for cardiac disease prior to initiation, especially if they have a family history of sudden cardiac death or arrhythmias.
  • Monitor for signs of abuse or diversion, as dextroamphetamine has a high potential for abuse.
  • Consider drug holidays in pediatric patients to assess the need for continued therapy and to mitigate potential growth suppression.
  • Inform patients about the potential for Raynaud's phenomenon (peripheral vasculopathy) and to seek medical attention if symptoms occur.
  • Urine pH significantly affects dextroamphetamine excretion; acidic urine increases excretion, while alkaline urine decreases it, potentially leading to higher drug levels.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta)
  • Atomoxetine (Strattera)
  • Guanfacine (Intuniv)
  • Clonidine (Kapvay)
  • Modafinil (Provigil - for narcolepsy)
  • Armodafinil (Nuvigil - for narcolepsy)
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Cost & Coverage

Average Cost: $200 - $400 per 30 tablets (2.5mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand); Tier 1 (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 use, 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. Please read this guide carefully and review it again whenever you receive a refill of this medication. 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.