Zenzedi 20mg Tablets

Manufacturer ARBOR PHARMACEUTICALS Active Ingredient Dextroamphetamine Tablets(deks troe am FET a meen) Pronunciation ZEN-zeh-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
CNS Stimulant
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Pharmacologic Class
Sympathomimetic Amine
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Pregnancy Category
Category C
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FDA Approved
Aug 2012
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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 affecting certain natural chemicals in the brain to help improve focus, attention, and control over impulsive behavior in people with ADHD. It can also be used to treat narcolepsy, a sleep disorder.
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How to Use This Medicine

Taking Your Medication

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 to prevent unauthorized access. 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, and consider participating in a local drug take-back program.

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 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. Swallow them whole.
  • 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.
  • Avoid alcohol while taking this medication.
  • Store in a safe place to prevent misuse or theft.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 5 mg once or twice daily. May increase by 5 mg weekly until optimal response. Max: 40 mg/day.
Dose Range: 5 - 40 mg

Condition-Specific Dosing:

ADHD: Initial: 5 mg once or twice daily. May increase by 5 mg weekly until optimal response. Max: 40 mg/day.
Narcolepsy: Initial: 10 mg daily. May increase by 10 mg weekly. Max: 60 mg/day (rarely used for narcolepsy, more common for ADHD).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial 2.5 mg once or twice daily. May increase by 2.5-5 mg weekly. Max: 40 mg/day. (Zenzedi is approved for 6 years and older)
Adolescent: 13-17 years: Initial 5 mg once or twice daily. May increase by 5 mg weekly. Max: 40 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor for adverse effects.
Moderate: Use with caution. Consider lower doses and monitor for adverse effects.
Severe: Use with caution. Consider lower doses and monitor for adverse effects. Avoid if possible.
Dialysis: Not available. Dextroamphetamine is not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: Use with caution. Consider lower doses and monitor for adverse effects.
Severe: Use with caution. Consider lower doses and monitor for adverse effects. Avoid if possible.

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that acts as a central nervous system (CNS) stimulant. 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 are believed to be mediated through its actions on dopaminergic and noradrenergic systems in the prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: High (well absorbed)
Tmax: Approximately 3 hours (for immediate-release tablets)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption. Acidifying agents (e.g., fruit juice) can decrease absorption, while alkalinizing agents (e.g., antacids) can increase absorption.

Distribution:

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

Elimination:

HalfLife: Approximately 10-12 hours (adults), 9-11 hours (children)
Clearance: Highly variable, dependent on urinary pH. Renal clearance is increased in acidic urine and decreased in alkaline urine.
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
PeakEffect: 1-3 hours
DurationOfAction: 4-6 hours (for immediate-release tablets)

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 NONTHERAPEUTIC 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
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in eyesight or eye pain, swelling, or redness
Erectile dysfunction
Decreased sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or 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

Heart Problems: Important Warning

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 immediate medical attention if you experience any signs of heart problems, including:

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 Side Effects

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

Dizziness or headache
Dry mouth
Difficulty 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 irritability
  • New or worsening thoughts of harming yourself or others
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New tics or worsening of existing tics
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained fever, muscle stiffness, or confusion (signs of serotonin syndrome)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you or a family member has a history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
If you have been diagnosed with:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have a history of:
+ Drug abuse
+ Stroke
If you are currently taking or have recently taken certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Antidepressants or Parkinson's disease medications (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may increase the risk of 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 essential to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. This will help ensure your safety while taking this medication. 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 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

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. 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 certain heart tests. If you have any questions or concerns, discuss them with your doctor. 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 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 Mood Changes

This medication may cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. 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 Children and Teens

This medication may affect growth in children and teens. Regular growth checks may be necessary. Discuss any concerns 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 taking this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Aggressiveness
  • Hallucinations
  • Panic states
  • High fever
  • Rhabdomyolysis
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea, vomiting, diarrhea, abdominal cramps
  • Convulsions
  • Coma

What to Do:

Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222.

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 (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Antihypertensives (may counteract effects)
  • Halogenated anesthetics (risk of arrhythmias)
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine levels
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine levels
  • Proton pump inhibitors (PPIs) and H2 blockers (may increase absorption of some extended-release formulations, less relevant for IR)
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Moderate Interactions

  • Antipsychotics (may antagonize stimulant effects)
  • Antidepressants (TCAs, bupropion - may increase risk of cardiovascular effects or seizures)
  • Antacids containing magnesium or aluminum (may increase absorption)
  • Phenytoin (may alter phenytoin levels)
  • Ethosuximide (may alter ethosuximide levels)
  • Phenobarbital (may alter phenobarbital levels)
  • Opioids (potential for additive CNS effects, respiratory depression)
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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.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation (pediatric).

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

Rationale: Risk of new or worsening psychiatric symptoms (psychosis, mania, aggression).

Timing: Prior to initiation.

ECG (if clinically indicated, e.g., family history of sudden cardiac death, structural heart disease)

Rationale: To rule out underlying cardiac conditions that could be exacerbated by stimulants.

Timing: Prior to initiation (if indicated).

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly (e.g., at each visit or every 3-6 months)

Target: Within normal limits for age/individual

Action Threshold: Sustained elevation outside normal range; symptomatic changes.

Height and Weight

Frequency: Every 3-6 months (pediatric)

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric Status (mood, behavior, thought processes)

Frequency: Regularly (e.g., at each visit)

Target: Stable, improved ADHD symptoms, no new or worsening psychiatric symptoms

Action Threshold: Emergence of psychotic symptoms, manic episodes, severe anxiety, aggression, suicidal ideation.

Abuse/Diversion Potential

Frequency: Regularly (e.g., at each visit)

Target: No signs of misuse or diversion

Action Threshold: Signs of drug-seeking behavior, escalating doses, loss of control.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • 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

Generally not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus. Amphetamines have been associated with adverse pregnancy outcomes.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for increased risk of congenital malformations (e.g., cardiac defects) has been suggested in some studies, though not consistently proven.
Second Trimester: Potential for growth restriction, premature birth.
Third Trimester: Risk of withdrawal symptoms (e.g., agitation, tremor, poor feeding) in the neonate if used late in pregnancy. Potential for maternal hypertension and preeclampsia.
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Lactation

Dextroamphetamine is excreted into breast milk. Use is generally not recommended due to potential for serious adverse effects in the infant (e.g., irritability, poor feeding, sleep disturbances, weight loss, cardiovascular effects).

Infant Risk: L3 (Moderate risk) - Monitor infant for irritability, sleep disturbances, poor feeding, and weight loss. Consider alternative or temporary cessation of breastfeeding.
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Pediatric Use

Approved for children 6 years and older for ADHD. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Monitor for psychiatric adverse events.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to stimulant effects and higher prevalence of cardiovascular disease. Start with lower doses and titrate slowly. Monitor cardiovascular status closely.

Clinical Information

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Clinical Pearls

  • Dextroamphetamine is a potent CNS stimulant with a high abuse potential; careful prescribing and monitoring are essential.
  • Individualize dosing based on patient response and tolerability, starting low and titrating slowly.
  • Educate patients and caregivers on the importance of proper storage and disposal to prevent diversion.
  • Monitor for cardiovascular changes (BP, HR) and psychiatric symptoms (psychosis, mania, aggression) at each visit.
  • For pediatric patients, regular growth monitoring (height and weight) is crucial.
  • Avoid abrupt discontinuation, especially after prolonged high-dose therapy, to prevent withdrawal symptoms (e.g., severe fatigue, depression).
  • Urinary pH significantly impacts dextroamphetamine excretion; advise patients to avoid large amounts of vitamin C or acidic juices, and discuss antacid use.
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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: $300 - $600+ per 30 tablets (20mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand name), 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, which provides crucial information for patients. Please 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. 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.