Zenzedi 30mg Tablets
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.
Drug Class
Central Nervous System Stimulant
Pharmacologic Class
Sympathomimetic Amine
Pregnancy Category
Category C
FDA Approved
Feb 2013
DEA Schedule
Schedule II
Overview
What is this medicine?
Zenzedi is a medication containing dextroamphetamine, a stimulant used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children 6 years and older. It works by affecting certain natural chemicals in the brain to help improve attention, focus, and reduce impulsivity and hyperactivity.
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 effectiveness 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 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 or explore 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.
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 effectiveness 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 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 or explore 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.
Lifestyle & Tips
- Take exactly as prescribed by your doctor. Do not take more or less than directed.
- Do not crush, chew, or split the tablets if they are extended-release (Zenzedi is immediate release, but general caution applies to all stimulants).
- Avoid abrupt discontinuation, especially after prolonged use, as it can lead to withdrawal symptoms.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Avoid alcohol consumption while taking this medication.
- Store in a safe place to prevent misuse or abuse by others.
- Maintain a healthy diet and regular sleep schedule.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 5 mg once or twice daily; titrate by 5 mg increments weekly. Max 40 mg/day.
Dose Range:
5 - 40 mg
Condition-Specific Dosing:
ADHD:
Initial 5 mg once or twice daily; titrate by 5 mg increments weekly to a maximum of 40 mg/day, given in divided doses (e.g., 2-3 times daily). The 30mg tablet is typically for once-daily or split dosing in established patients.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 2.5 mg once or twice daily; titrate by 2.5-5 mg increments weekly. Max 40 mg/day. (Zenzedi is approved for children 6 years and older).
Adolescent:
13-17 years: Initial 5 mg once or twice daily; titrate by 5 mg increments weekly. Max 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for adverse effects.
Moderate:
Caution advised, consider lower initial dose and slower titration.
Severe:
Dose reduction recommended (e.g., 50% reduction for CrCl < 30 mL/min). Monitor closely for adverse effects.
Dialysis:
Not well-studied; likely not dialyzable to a significant extent. Avoid or use with extreme caution and significant dose reduction.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Caution advised, monitor for increased adverse effects.
Severe:
Caution advised, consider lower initial dose and slower titration due to hepatic metabolism. Not well-studied.
Pharmacology
Mechanism of Action
Dextroamphetamine is 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. The exact therapeutic mechanism in ADHD is not fully understood but is thought to involve the modulation of catecholamine neurotransmission.
Pharmacokinetics
Absorption:
Bioavailability:
75-100%
Tmax:
2-4 hours (immediate release)
FoodEffect:
Food may delay Tmax but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
3-5 L/kg
ProteinBinding:
15-25%
CnssPenetration:
Yes
Elimination:
HalfLife:
10-13 hours (adults); 6-8 hours (children). Highly dependent on urinary pH.
Clearance:
Approximately 0.7 L/kg/hr (pH dependent)
ExcretionRoute:
Renal
Unchanged:
30-50% (highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine)
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
2-4 hours
DurationOfAction:
4-6 hours (immediate release)
Confidence:
High
Safety & Warnings
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.
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 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. Call your doctor right away if you experience any of the following symptoms:
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 potential side effects:
Dizziness or headache
Dry mouth
Sleep disturbances
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Unpleasant taste in the mouth
Feeling nervous or excitable
* Hair loss
If any of these side effects or other concerns bother you or persist, 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.
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 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. Call your doctor right away if you experience any of the following symptoms:
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 potential side effects:
Dizziness or headache
Dry mouth
Sleep disturbances
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Unpleasant taste in the mouth
Feeling nervous or excitable
* Hair loss
If any of these side effects or other concerns bother you or persist, 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.
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
- 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 numbness, pain, skin color change, or sensitivity to temperature in fingers or toes
- Blurred vision or other vision changes
- Any signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 medications, including:
+ Acetazolamide or sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as they may cause very high blood pressure)
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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 medications, including:
+ Acetazolamide or sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as they may cause very high blood pressure)
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be needed 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 result in 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 instructed 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, mood, or thinking, including hallucinations, anger, or depression. 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 any unusual changes in behavior or mood, such as depression, suicidal thoughts, nervousness, or anxiety, contact your doctor immediately.
Pediatric Considerations
This medication may affect growth in children and adolescents. Regular growth checks may be necessary, 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.
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
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be needed 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 result in 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 instructed 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, mood, or thinking, including hallucinations, anger, or depression. 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 any unusual changes in behavior or mood, such as depression, suicidal thoughts, nervousness, or anxiety, contact your doctor immediately.
Pediatric Considerations
This medication may affect growth in children and adolescents. Regular growth checks may be necessary, 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.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia (very high fever)
- Rhabdomyolysis
- Cardiac arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea, abdominal cramps
- Convulsions
- Coma
- Death
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Seek immediate medical attention. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for cardiovascular and CNS effects.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
- Advanced arteriosclerosis
- Symptomatic cardiovascular disease
- Moderate to severe hypertension
- Hyperthyroidism
- Glaucoma
- Agitated states
- History of drug abuse
Major Interactions
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide): Increase reabsorption and prolong half-life of dextroamphetamine, leading to increased effects and potential toxicity.
- Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of dextroamphetamine.
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans): Increased risk of serotonin syndrome.
- Antihypertensives: May antagonize the hypotensive effects of antihypertensive agents.
- Halogenated Anesthetics: Increased risk of sudden death due to ventricular arrhythmias.
Moderate Interactions
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid): Increase excretion and decrease half-life of dextroamphetamine, leading to decreased effects.
- Proton Pump Inhibitors (PPIs) / H2 Blockers: May alter gastric pH and affect absorption, though less significant than urinary pH effects.
- Antipsychotics: May antagonize the stimulant effects of dextroamphetamine.
- Lithium: May inhibit the stimulant effects of dextroamphetamine.
- Phenytoin, Phenobarbital: May alter metabolism of dextroamphetamine.
Minor Interactions
- Caffeine: Additive stimulant effects, increased risk of nervousness, insomnia, and other CNS side effects.
Monitoring
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.
Electrocardiogram (ECG)
Rationale: Consider for patients with pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.
Timing: Prior to initiation if indicated.
Height and Weight
Rationale: Monitor for growth suppression in pediatric patients.
Timing: Prior to initiation and periodically during treatment.
Psychiatric History and Status
Rationale: Assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) and monitor for emergence or exacerbation of psychiatric symptoms.
Timing: Prior to initiation and periodically during treatment.
Drug Abuse History
Rationale: Assess for risk of abuse and dependence.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At least every 3-6 months, or more frequently if clinically indicated.
Target: Maintain within normal limits for age/baseline.
Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex/height or significant increase from baseline) warrants dose adjustment or discontinuation.
Height and Weight
Frequency: Every 3-6 months for pediatric patients.
Target: Maintain normal growth trajectory.
Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines) warrants evaluation and potential treatment interruption.
Psychiatric Status
Frequency: Regularly at follow-up visits.
Target: Stable mood, absence of psychotic symptoms, aggression, or severe anxiety.
Action Threshold: Emergence of new psychotic symptoms, manic episodes, severe anxiety, or aggression warrants immediate evaluation and potential discontinuation.
ADHD Symptom Control
Frequency: Regularly at follow-up visits.
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Fainting spells
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Numbness or tingling in fingers/toes (Raynaud's phenomenon)
- Unexplained wounds on fingers/toes
- Changes in vision
- Unusual changes in behavior or mood
- Signs of drug-seeking behavior or dependence
Special Patient Groups
Pregnancy
Dextroamphetamine is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, and there are no adequate and well-controlled studies in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Neonates exposed to amphetamines in utero may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are conflicting and limited.
Second Trimester:
Potential for growth restriction and premature birth.
Third Trimester:
Risk of withdrawal symptoms (e.g., agitation, tremor, feeding difficulties) in the neonate if used close to delivery.
Lactation
Dextroamphetamine is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, poor feeding, weight loss, cardiovascular effects), breastfeeding is generally not recommended while taking this medication. If used, monitor the infant closely for adverse effects.
Infant Risk:
High (L4 - Possibly hazardous)
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Monitor for emergence or exacerbation of psychiatric symptoms.
Geriatric Use
Use with caution in elderly patients, generally starting with lower doses and titrating slowly, due to increased likelihood of comorbidities (especially cardiovascular) and polypharmacy. Monitor for cardiovascular and psychiatric adverse effects.
Clinical Information
Clinical Pearls
- Zenzedi is an immediate-release formulation of dextroamphetamine, offering flexible dosing but requiring multiple daily doses for sustained effect.
- Due to its high abuse potential, careful patient selection, monitoring, and secure storage are crucial.
- Patients should be advised to avoid abrupt discontinuation to prevent withdrawal symptoms.
- Monitor blood pressure and heart rate regularly, especially in patients with pre-existing cardiovascular risk factors.
- Growth suppression is a concern in pediatric patients; regular height and weight monitoring is essential.
- Educate patients and caregivers on the signs of psychiatric adverse events (e.g., new psychosis, mania, aggression) and the importance of reporting them immediately.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Focalin)
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Bupropion (Wellbutrin - off-label for ADHD)
Cost & Coverage
Average Cost:
$200 - $500+ per 30 tablets (30mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand Zenzedi); Tier 1 (for generic dextroamphetamine)
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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.