Adzenys XR 12.5mg ODT 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 may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System Stimulant
Pharmacologic Class
Sympathomimetic Amine; Norepinephrine and Dopamine Reuptake Inhibitor and Releaser
Pregnancy Category
Category C
FDA Approved
Jan 2016
DEA Schedule
Schedule II
Overview
What is this medicine?
Adzenys XR ODT is an extended-release orally disintegrating tablet containing amphetamine, a stimulant medication. It is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to improve focus, attention, and control over impulsive behaviors.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as prescribed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Timing is Important: Take this medication early in the day to minimize the risk of sleep problems.
3. Food and Administration: You can take this medication with or without food. When you're ready to take it, remove the tablet from the blister pack and place it on your tongue, where it will dissolve. You don't need water, and make sure not to swallow the tablet whole, chew, break, or crush it.
4. Handling the Blister Pack: Use dry hands to open the blister pack, and take the tablet out as directed or as described in the package insert. Take the medication immediately after opening the blister pack, and do not store the removed tablet for future use.
Important Interactions and Precautions
Before using over-the-counter (OTC) products that may increase blood pressure, consult with your doctor. These products include cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Special Considerations for Children
Different brands of this medication may be suitable for children of different ages. Consult with your doctor before giving this medication to a child to ensure you're using the correct brand and dosage.
Storing and Disposing of Your Medication
1. Storage: Keep your medication at room temperature in a dry place, away from the bathroom.
2. Protecting Your Medication: Store the blister packs in the original plastic case, and keep the medication in a safe, secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication.
3. Pet Safety: Keep all medications out of reach of pets.
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 dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses.
To ensure you get the most out of your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as prescribed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Timing is Important: Take this medication early in the day to minimize the risk of sleep problems.
3. Food and Administration: You can take this medication with or without food. When you're ready to take it, remove the tablet from the blister pack and place it on your tongue, where it will dissolve. You don't need water, and make sure not to swallow the tablet whole, chew, break, or crush it.
4. Handling the Blister Pack: Use dry hands to open the blister pack, and take the tablet out as directed or as described in the package insert. Take the medication immediately after opening the blister pack, and do not store the removed tablet for future use.
Important Interactions and Precautions
Before using over-the-counter (OTC) products that may increase blood pressure, consult with your doctor. These products include cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Special Considerations for Children
Different brands of this medication may be suitable for children of different ages. Consult with your doctor before giving this medication to a child to ensure you're using the correct brand and dosage.
Storing and Disposing of Your Medication
1. Storage: Keep your medication at room temperature in a dry place, away from the bathroom.
2. Protecting Your Medication: Store the blister packs in the original plastic case, and keep the medication in a safe, secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication.
3. Pet Safety: Keep all medications out of reach of pets.
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 dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening to avoid sleep problems.
- Place the tablet on your tongue; it will dissolve quickly. Do not chew or crush it. You can take it with or without food.
- Avoid alcohol, as it may increase side effects.
- Maintain a healthy diet and regular sleep schedule.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Do not share this medication with others, as it has a high potential for abuse.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 12.5 mg once daily in the morning. Titrate weekly by 12.5 mg increments.
Dose Range:
12.5 - 37.5 mg
Condition-Specific Dosing:
ADHD:
Initial: 12.5 mg once daily in the morning. Max: 37.5 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 6.3 mg once daily in the morning. Titrate weekly by 6.3 mg increments. Max: 18.8 mg/day.
Adolescent:
13-17 years: Initial 12.5 mg once daily in the morning. Titrate weekly by 12.5 mg increments. Max: 25 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended for mild renal impairment (CrCl 60-89 mL/min/1.73m2).
Moderate:
Consider lower doses or extended dosing intervals (CrCl 30-59 mL/min/1.73m2).
Severe:
Use with caution; consider significant dose reduction or avoid (CrCl <30 mL/min/1.73m2).
Dialysis:
Not available; amphetamine is dialyzable, but specific recommendations for Adzenys XR ODT are not provided. Avoid use due to lack of data and potential for accumulation.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Amphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effects in ADHD by increasing the release of norepinephrine and dopamine from presynaptic neurons in the brain and by blocking their reuptake into the presynaptic neuron. This leads to increased concentrations of these neurotransmitters in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
Approximately 5 hours (for Adzenys XR ODT)
FoodEffect:
Food does not significantly affect the extent of absorption (AUC) but may delay Tmax by approximately 2.5 hours.
Distribution:
Vd:
Approximately 3-5 L/kg
ProteinBinding:
Approximately 15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-13 hours (adults), 9-11 hours (children)
Clearance:
Highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-50% (in acidic urine), <10% (in alkaline urine)
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours
PeakEffect:
Approximately 5 hours
DurationOfAction:
Approximately 10-12 hours
Safety & Warnings
BLACK BOX WARNING
Amphetamines have a high potential for abuse and dependence. 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.
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 experience 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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Shakiness
Changes in eyesight
Seizures
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness
Dark urine
Trouble passing urine
Erectile dysfunction
Changes in sex interest
Prolonged or frequent erections
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, be aware of the following signs of heart problems:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Trouble sleeping
Headache
Weight loss
Bad taste in mouth
Feeling nervous or excitable
Restlessness
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience 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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Shakiness
Changes in eyesight
Seizures
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness
Dark urine
Trouble passing urine
Erectile dysfunction
Changes in sex interest
Prolonged or frequent erections
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, be aware of the following signs of heart problems:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Trouble sleeping
Headache
Weight loss
Bad taste in mouth
Feeling nervous or excitable
Restlessness
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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.
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 tics (uncontrolled movements or sounds)
- Seeing or hearing things that are not real (psychosis)
- Feeling manic or extremely agitated
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
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 family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications 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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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 Dosage
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may need higher doses to achieve the same effect. This is known as tolerance. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of this medication may lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Before reducing the dose or stopping the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood work done as instructed by your doctor.
Interactions with Lab Tests
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Alcohol Consumption
Depending on the specific product, you may need to avoid drinking alcohol while taking this medication. Consult your doctor or pharmacist to determine if you should avoid alcohol.
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 or mood problems, 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.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.
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 taking this medication during pregnancy. Taking this medication during pregnancy may lead to withdrawal symptoms in the newborn.
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 Dosage
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may need higher doses to achieve the same effect. This is known as tolerance. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of this medication may lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Before reducing the dose or stopping the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication may cause high blood pressure, so it is crucial to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood work done as instructed by your doctor.
Interactions with Lab Tests
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Alcohol Consumption
Depending on the specific product, you may need to avoid drinking alcohol while taking this medication. Consult your doctor or pharmacist to determine if you should avoid alcohol.
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 or mood problems, 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.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.
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 taking this medication during pregnancy. Taking this medication during pregnancy may lead to withdrawal symptoms in the newborn.
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:
In case of overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Management includes symptomatic and supportive measures, including gastric lavage, activated charcoal, and sedation for CNS overstimulation. Acidification of urine may increase excretion.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
Major Interactions
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine plasma levels and prolong half-life
- Acidifying agents (e.g., ascorbic acid, ammonium chloride, cranberry juice) - decrease amphetamine plasma levels and shorten half-life
- Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol, St. John's Wort) - increased risk of serotonin syndrome
- Antihypertensive agents - amphetamines may reduce the effectiveness of antihypertensives
- Halogenated Anesthetics - increased risk of sudden death due to ventricular arrhythmias
Moderate Interactions
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines
- Lithium - may inhibit the stimulant effects of amphetamines
- Proton Pump Inhibitors (PPIs) / H2 Blockers - may increase gastric pH, potentially affecting absorption (less significant for ER formulations)
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure
Minor Interactions
- Alcohol - may increase risk of adverse events and alter release profile of extended-release formulations (though not specifically for Adzenys XR ODT)
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Amphetamines can cause increases in BP and HR; screen for pre-existing cardiovascular conditions.
Timing: Prior to initiation and periodically during treatment.
Height and Weight
Rationale: Monitor for growth suppression in pediatric patients.
Timing: Prior to initiation and periodically during treatment.
Psychiatric History (including family history of tics, Tourette's syndrome, bipolar disorder, psychosis)
Rationale: Screen for pre-existing psychiatric conditions that may be exacerbated or unmasked.
Timing: Prior to initiation.
Drug Abuse History
Rationale: Assess risk for abuse and dependence.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At least annually, or more frequently if clinically indicated.
Target: Within normal limits for age and baseline.
Action Threshold: Sustained clinically significant increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant further evaluation and potential dose adjustment or discontinuation.
Height and Weight
Frequency: Every 3-6 months in pediatric patients.
Target: Consistent growth trajectory.
Action Threshold: Significant growth deceleration or weight loss warrants evaluation and potential treatment interruption.
Psychiatric Symptoms (e.g., agitation, aggression, new-onset psychosis, mania, tics)
Frequency: Regularly at follow-up visits.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence of severe psychiatric symptoms warrants immediate evaluation and potential discontinuation.
ADHD Symptom Control and Functional Improvement
Frequency: Regularly at follow-up visits.
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning.
Action Threshold: Lack of efficacy or intolerable side effects warrants dose adjustment or alternative treatment.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- New or worsening tics/Tourette's syndrome
- Hallucinations
- Delusions
- Mania
- Agitation
- Anxiety
- Severe headache
- Numbness, coolness, or pain in digits (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm, including premature birth and low birth weight. Neonates exposed to amphetamines during the third trimester may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester:
Potential for growth restriction and adverse neurodevelopmental outcomes.
Third Trimester:
Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, tremor, feeding difficulties).
Lactation
Amphetamine is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, weight loss), breastfeeding is not recommended during treatment with Adzenys XR ODT.
Infant Risk:
Moderate risk (L3) - potential for irritability, poor feeding, sleep disturbances, weight loss, and long-term neurodevelopmental effects.
Pediatric Use
Safety and efficacy established in pediatric patients 6 years and older. Long-term effects on growth (weight and height) should be monitored. Psychiatric adverse events (e.g., psychosis, mania, aggression) can occur. Cardiovascular monitoring is essential.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Generally, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Adzenys XR ODT is an extended-release formulation designed for once-daily morning dosing. Its orally disintegrating tablet form is beneficial for patients who have difficulty swallowing pills.
- The dose of Adzenys XR ODT is expressed in amphetamine base equivalents. Ensure correct conversion if switching from other amphetamine products.
- Counsel patients on the importance of taking the medication early in the morning to avoid insomnia.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial due to potential cardiovascular and growth-related side effects.
- Educate patients and caregivers about the signs of serious psychiatric adverse events (e.g., new-onset psychosis, mania) and the need for immediate medical attention if they occur.
- Due to its abuse potential, proper storage and disposal of Adzenys XR ODT should be emphasized.
Alternative Therapies
- Other amphetamine-based stimulants (e.g., Adderall XR, Vyvanse)
- Methylphenidate-based stimulants (e.g., Concerta, Ritalin LA, Focalin XR, Quillivant XR, Jornay PM)
- Non-stimulants (e.g., Strattera (atomoxetine), Intuniv (guanfacine ER), Kapvay (clonidine ER))
Cost & Coverage
Average Cost:
$300 - $450 per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand)
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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.