Zenzedi 7.5mg 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
Central Nervous System Stimulant
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Pharmacologic Class
Sympathomimetic Amine
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Pregnancy Category
Category C
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FDA Approved
Apr 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 reduce impulsivity in people with ADHD, or to help people with narcolepsy stay awake during the day.
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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 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

Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. Keep your medication in a safe and secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or area to store your medication. 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, consult with your pharmacist for guidance on the best disposal method. You may also want to 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 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 split tablets unless specifically instructed by your doctor.
  • 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 abuse.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

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

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

Renal Impairment:

Mild: Use with caution; consider lower initial doses and slower titration.
Moderate: Use with caution; consider lower initial doses and slower titration.
Severe: Use with caution; consider significant dose reduction or avoidance due to potential for accumulation.
Dialysis: Not well studied; likely not dialyzable to a significant extent due to high volume of distribution. Use with extreme caution.

Hepatic Impairment:

Mild: Use with caution; consider lower initial doses and slower titration.
Moderate: Use with caution; consider lower initial doses and slower titration.
Severe: Use with caution; consider significant dose reduction or avoidance due to extensive hepatic metabolism.

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that acts as a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
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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: 0.8-1.2 L/kg
ProteinBinding: 15-25%
CnssPenetration: Yes

Elimination:

HalfLife: 10-12 hours (adults); 6-8 hours (children)
Clearance: Not available
ExcretionRoute: Renal
Unchanged: 30-40% (highly dependent on urine pH; increased excretion in acidic urine, decreased in alkaline urine)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 2-4 hours
DurationOfAction: 4-6 hours

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. 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
+ 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
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in eyesight or eye pain, swelling, or redness
Erectile dysfunction or changes in sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or trouble 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 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 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 experience any of these side effects or have concerns, contact your doctor for guidance. 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 unusual behavior
  • Seeing or hearing things that are not real (psychosis)
  • Feeling unusually happy, energetic, or irritable (mania)
  • Numbness, tingling, or coldness in fingers or toes (Raynaud's phenomenon)
  • Unexplained weight loss or slowed growth (in children)
  • Severe headache or blurred vision
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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 health issues, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (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 medications 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 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

Long-term or high-dose use of this medication can lead to tolerance, where the medication may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.

Additionally, long-term or regular use of this medication may cause dependence. Stopping the medication abruptly can 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.

Blood Pressure Monitoring

This medication may cause high blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. Be aware of the signs of high blood pressure, such as severe headache, dizziness, fainting, or changes in vision, and contact your doctor immediately if you experience any of these symptoms.

Interactions with Other Medications

Certain over-the-counter (OTC) products, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, may increase blood pressure. Consult your doctor before using any of these products.

Lab Tests and Seizure Risk

This medication may affect certain lab tests. 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 or mood 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 signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.

Growth Effects in Children and Teens

This medication may affect growth in children and teens. They may require regular growth checks. Discuss this with your doctor.

Pregnancy and Breastfeeding

If you are pregnant or plan to become pregnant, consult your doctor to discuss the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Restlessness, tremor, hyperreflexia, 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. Management is primarily supportive, including gastric lavage, activated charcoal, and sedation for CNS overstimulation.

Drug Interactions

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Contraindicated Interactions

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

  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
  • Antihypertensives - may antagonize effects
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine levels and duration
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine levels and duration
  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase absorption and exposure
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Moderate Interactions

  • Antipsychotics - may antagonize stimulant effects
  • Antihistamines - may potentiate CNS effects
  • Opioids - potential for additive CNS depression or paradoxical effects
  • Alcohol - may exacerbate adverse CNS effects
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Minor Interactions

  • Caffeine - additive stimulant effects
  • Nicotine - additive stimulant effects

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR, ECG if indicated)

Rationale: To identify pre-existing cardiac conditions or risk factors for adverse cardiovascular events.

Timing: Prior to initiation

Psychiatric history and assessment

Rationale: To screen for bipolar disorder, psychosis, or other psychiatric comorbidities that may be exacerbated.

Timing: Prior to initiation

Height and weight (especially in children)

Rationale: To establish baseline for growth monitoring.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At least annually, or more frequently if clinically indicated (e.g., dose changes, symptoms)

Target: Within normal limits for age

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

Height and Weight (children/adolescents)

Frequency: Every 3-6 months

Target: Consistent growth trajectory

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

Psychiatric status (mood, behavior, emergence of new symptoms)

Frequency: Regularly, at each follow-up visit

Target: Stable mood, absence of psychotic or manic symptoms

Action Threshold: Emergence of aggression, hostility, new psychotic symptoms, or manic episodes; consider discontinuation.

ADHD/Narcolepsy symptom control

Frequency: Regularly, at each follow-up visit

Target: Improved focus, reduced hyperactivity/impulsivity, reduced excessive daytime sleepiness

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

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hostility
  • Psychotic symptoms (hallucinations, delusions)
  • Manic symptoms (euphoria, grandiosity, decreased need for sleep)
  • Severe anxiety or agitation
  • Unexplained weight loss
  • Growth deceleration (in children)
  • 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 may cause fetal harm, including premature delivery and low birth weight. Withdrawal symptoms may occur in neonates exposed in utero.

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, feeding difficulties, tremor) if used close to delivery.
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Lactation

Dextroamphetamine is excreted into breast milk. The American Academy of Pediatrics considers amphetamines to be drugs for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for irritability, poor feeding, and sleep disturbances. Use with caution or consider alternatives.

Infant Risk: Moderate risk (L3). Potential for irritability, insomnia, poor feeding, and weight loss in the infant. Long-term effects are unknown.
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Pediatric Use

Safety and efficacy in children under 6 years of age have not been established. Monitor growth (height and weight) regularly, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms.

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Geriatric Use

Use with caution in elderly patients, generally starting with lower doses and titrating slowly, due to increased sensitivity to adverse effects (especially cardiovascular and psychiatric) and potential for comorbidities and polypharmacy. Renal function should be monitored.

Clinical Information

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Clinical Pearls

  • Zenzedi is an immediate-release formulation of dextroamphetamine, allowing for flexible dosing throughout the day.
  • The 7.5mg strength is unique to Zenzedi, offering more precise titration options.
  • Patients should be advised to take the last dose several hours before bedtime to avoid insomnia.
  • Counsel patients on the importance of adherence and the risks of misuse, abuse, and diversion.
  • Regular monitoring of blood pressure, heart rate, and psychiatric status is crucial.
  • For children, consistent growth monitoring is essential; consider drug holidays if growth suppression is observed.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Focalin)
  • Atomoxetine (Strattera)
  • Guanfacine (Intuniv)
  • Clonidine (Kapvay)
  • Modafinil/Armodafinil (for narcolepsy)
  • Non-pharmacological interventions (e.g., behavioral therapy, lifestyle modifications)
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Cost & Coverage

Average Cost: $300 - $500+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand-name, may require prior authorization)
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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 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.