Zenzedi 10mg Tablets

Manufacturer ARBOR Active Ingredient Dextroamphetamine Tablets(deks troe am FET a meen) Pronunciation zen-ZEE-dee (DEX-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 1976
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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 type of stimulant. It works by affecting certain natural chemicals in the brain to help improve focus, attention, and control over impulsive behavior in people with ADHD, and to help people stay awake 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. Consistency is key, so take your medication at the same time every day.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. It's essential to store your medication in a secure location where children and pets cannot access it, and where others cannot easily get to it. Consider using a locked box or area to keep your medication safe. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.

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 crush, chew, or break tablets; swallow whole if extended-release.
  • Avoid alcohol consumption.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Store securely to prevent misuse or diversion.
  • Maintain a healthy diet and regular sleep schedule.
  • Report any new or worsening mental health symptoms immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized, typically 5-60 mg/day 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 until optimal response, not to exceed 40 mg/day (for Zenzedi, max 60mg/day for other formulations).
Narcolepsy: Initial 10 mg daily; may increase by 10 mg weekly until optimal response, typically 10-60 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 mg once or twice daily; may increase by 2.5-5 mg weekly until optimal response, not to exceed 30 mg/day (for Zenzedi, max 40mg/day for other formulations).
Adolescent: ADHD (13-17 years): Initial 5 mg once or twice daily; may increase by 5 mg weekly until optimal response, not to exceed 40 mg/day (for Zenzedi, max 60mg/day for other formulations).
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment provided, use with caution.
Moderate: Use with caution; consider lower doses and monitor for adverse effects.
Severe: Contraindicated in end-stage renal disease due to potential for accumulation and toxicity.
Dialysis: Not dialyzable; contraindicated in ESRD.

Hepatic Impairment:

Mild: No specific dose adjustment provided, use with caution.
Moderate: Use with caution; consider lower doses and monitor for adverse effects.
Severe: Use with caution; consider lower doses and monitor for adverse effects.

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. It also inhibits the reuptake of these monoamines, leading to increased concentrations in the synaptic cleft. The therapeutic effects in ADHD and narcolepsy are believed to be mediated through these actions in the brainstem arousal system and the cortex.
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Pharmacokinetics

Absorption:

Bioavailability: High (approximately 75-100%)
Tmax: Oral tablet: 2-4 hours (immediate release)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

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

Elimination:

HalfLife: Adults: 10-13 hours (acidic urine decreases half-life, alkaline urine increases half-life); Children: 9-11 hours.
Clearance: Highly dependent on urinary pH.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 30-50% (highly dependent on urinary pH; up to 70% in acidic urine, less than 10% in alkaline urine).
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (immediate release)
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 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 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 immediately or seek emergency 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 heart 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, a severe and potentially deadly condition. 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

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:

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

If you're concerned about any side effects or have questions, consult 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 (especially with exercise)
  • Numbness, coolness, or pain in fingers or toes
  • Unexplained wounds on fingers or toes
  • New or worsening aggression, hostility, or irritability
  • 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)
  • Unexplained fever, muscle stiffness, or severe confusion (signs of serotonin syndrome)
  • Blurred vision or other vision changes
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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, including:
+ Drug abuse
+ Stroke
Current medications, particularly:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken in 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 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.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness and clear vision.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, 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, regular use of this medication may cause dependence, and sudden cessation 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 monitor your blood pressure and heart rate as directed by your doctor.

Interactions and Warnings
This medication may cause high blood pressure, so it is crucial to recognize the signs, such as severe headache, dizziness, fainting, or changes in vision. If you experience any of these symptoms, contact your doctor immediately. 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, 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. Additionally, this medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.

Mental Health and Mood Changes
This medication may cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental health issues, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.

Pediatric Considerations
In some cases, this medication may affect growth in children and adolescents. They may require regular growth checks, so 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
  • Assaultiveness
  • Hallucinations
  • Panic states
  • Hyperpyrexia
  • Rhabdomyolysis
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea, vomiting, diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma
  • Death

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes symptomatic and supportive measures, 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) - risk of hypertensive crisis.
  • Linezolid (MAOI activity)
  • Methylene Blue (MAOI activity)
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Major Interactions

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
  • Antihypertensives - may antagonize hypotensive effects.
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life.
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine blood levels and shorten half-life.
  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase absorption and exposure.
  • Antipsychotics (e.g., haloperidol, chlorpromazine) - may antagonize stimulant effects.
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Moderate Interactions

  • Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, ritonavir) - may increase amphetamine exposure.
  • Adrenergic blockers (e.g., beta-blockers) - may potentiate pressor effects of amphetamines.
  • Antacids containing magnesium or aluminum - may delay absorption.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Amphetamines can cause dose-related increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Growth suppression has been reported in pediatric patients.

Timing: Prior to initiation of therapy (pediatric patients).

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

Rationale: To assess risk for new or worsening psychiatric symptoms.

Timing: Prior to initiation of therapy.

Cardiovascular History (including family history of sudden death or ventricular arrhythmia)

Rationale: To assess risk for serious 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.

Action Threshold: Persistent elevation requiring intervention or discontinuation.

Height and Weight

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

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric Status (e.g., emergence of psychotic or manic symptoms, aggression, anxiety)

Frequency: At each visit.

Target: Stable mood and behavior.

Action Threshold: New or worsening psychiatric symptoms.

Abuse Potential

Frequency: At each visit.

Target: No signs of diversion or misuse.

Action Threshold: Signs of drug-seeking behavior or misuse.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Numbness, coolness, or pain in fingers/toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers/toes

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy 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: Potential for increased risk of congenital malformations, though data are limited and inconsistent.
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

L4 (Potentially Hazardous). 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), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: High; potential for irritability, poor feeding, sleep disturbances, weight loss, and cardiovascular effects in the infant.
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Pediatric Use

Approved for ADHD in children 6 years and older, and narcolepsy in children 12 years and older. Growth suppression (weight and/or height) has been reported with long-term stimulant use; monitor growth regularly. Psychiatric adverse events (e.g., psychosis, mania) can occur.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to sympathomimetic effects (e.g., cardiovascular effects, anxiety, insomnia). Start with lower doses and titrate slowly. Monitor for cardiovascular and psychiatric adverse events.

Clinical Information

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Clinical Pearls

  • Dextroamphetamine is a Schedule II controlled substance due to its high potential for abuse and dependence. Prescribe and dispense sparingly.
  • Individualize dosing based on patient response and tolerability. Start low and titrate slowly.
  • Monitor blood pressure and heart rate regularly, especially at baseline and after dose adjustments.
  • Educate patients and caregivers about the risk of growth suppression in children and the importance of monitoring height and weight.
  • Counsel patients on the signs and symptoms of serotonin syndrome and the importance of avoiding concomitant use with MAOIs and other serotonergic drugs.
  • Be aware of the potential for new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression) and advise patients to report these immediately.
  • Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., extreme fatigue, depression, sleep disturbances).
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Alternative Therapies

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

Average Cost: Varies widely, typically $200-$400+ per 30 tablets (10mg)
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 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. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.