Adzenys XR 15.7mg 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
Norepinephrine-Dopamine Reuptake Inhibitor and Releaser
Pregnancy Category
Not available
FDA Approved
Jan 2016
DEA Schedule
Schedule II
Overview
What is this medicine?
Adzenys XR-ODT is an extended-release medication containing amphetamine, a stimulant, used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It helps improve focus, attention, and control over impulsive behavior by affecting certain natural chemicals in the brain.
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 directed by your doctor. Read all the information provided with your prescription, and follow the instructions carefully.
2. Timing is Everything: 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, allowing it to dissolve. You don't need water, and be sure not to swallow it 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 instructed or 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 taking this medication, talk to your doctor about any over-the-counter (OTC) products you're using that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
* Certain natural products or aids
Additionally, consult with your doctor before giving this medication to a child, as different brands may be suitable for different age groups.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
1. Store at Room Temperature: Keep your medication in a dry place at room temperature, away from the bathroom.
2. Protect the Blister Packs: Store the blister packs in the original plastic case provided with your medication.
3. Secure Storage: Keep your 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.
4. Keep Pets Away: 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 directed by your doctor. Read all the information provided with your prescription, and follow the instructions carefully.
2. Timing is Everything: 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, allowing it to dissolve. You don't need water, and be sure not to swallow it 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 instructed or 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 taking this medication, talk to your doctor about any over-the-counter (OTC) products you're using that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
* Certain natural products or aids
Additionally, consult with your doctor before giving this medication to a child, as different brands may be suitable for different age groups.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
1. Store at Room Temperature: Keep your medication in a dry place at room temperature, away from the bathroom.
2. Protect the Blister Packs: Store the blister packs in the original plastic case provided with your medication.
3. Secure Storage: Keep your 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.
4. Keep Pets Away: 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 and allow it to disintegrate without chewing or crushing. Swallow with or without water.
- Do not take more than the prescribed dose.
- 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.
- Regularly monitor blood pressure and heart rate as advised by your doctor.
- For children, monitor height and weight regularly.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 6.3 mg once daily in the morning. Titrate weekly by 3.1 mg or 6.3 mg increments. Max: 18.8 mg once daily.
Dose Range:
6.3 - 18.8 mg
Condition-Specific Dosing:
ADHD:
Initial: 6.3 mg once daily in the morning. Titrate weekly by 3.1 mg or 6.3 mg increments. Max: 18.8 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 6.3 mg once daily in the morning. Titrate weekly by 3.1 mg or 6.3 mg increments. Max: 12.5 mg once daily.
Adolescent:
13-17 years: Initial 6.3 mg once daily in the morning. Titrate weekly by 3.1 mg or 6.3 mg increments. Max: 18.8 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
Use with caution; consider lower doses and monitor for adverse effects due to potential for increased exposure.
Dialysis:
Not available; use with caution.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Confidence:
Medium
Pharmacology
Mechanism of Action
Amphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effects in ADHD by increasing the synaptic concentrations of norepinephrine and dopamine in the central nervous system. It achieves this by blocking the reuptake of these monoamines into the presynaptic neuron and by promoting their release from the presynaptic nerve terminals.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified for Adzenys XR, but well absorbed.
Tmax:
Approximately 5 hours (for amphetamine from Adzenys XR ODT)
FoodEffect:
High-fat meal does not significantly affect absorption or exposure.
Distribution:
Vd:
Approximately 3.7-5.1 L/kg
ProteinBinding:
15% to 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-13 hours (for amphetamine from Adzenys XR ODT)
Clearance:
Highly dependent on urinary pH; faster in acidic urine.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-50% (highly dependent on urinary pH)
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours
PeakEffect:
Approximately 5 hours
DurationOfAction:
Approximately 10-12 hours
Confidence:
Medium
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. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
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
Signs of high blood pressure, including:
+ Severe headache or 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 or pelvic pain
Shakiness
Changes in eyesight
Seizures
Trouble controlling body movements
Difficulty 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 sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine
Erectile dysfunction or changes in sex interest
Prolonged or frequent erections
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor. Seek medical help immediately if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or if they persist or bother you, contact your doctor:
Dizziness, tiredness, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Trouble sleeping
Headache
Weight loss
Bad taste in mouth
Feeling nervous or excitable
Restlessness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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
Signs of high blood pressure, including:
+ Severe headache or 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 or pelvic pain
Shakiness
Changes in eyesight
Seizures
Trouble controlling body movements
Difficulty 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 sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty passing urine
Erectile dysfunction or changes in sex interest
Prolonged or frequent erections
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor. Seek medical help immediately if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or if they persist or bother you, contact your doctor:
Dizziness, tiredness, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Trouble sleeping
Headache
Weight loss
Bad taste in mouth
Feeling nervous or excitable
Restlessness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 psychotic symptoms (e.g., hallucinations, delusions)
- New or worsening manic symptoms (e.g., extreme energy, racing thoughts)
- New or worsening tics (uncontrolled repetitive movements or sounds)
- Unexplained numbness, pain, or discoloration in fingers or toes (Raynaud's phenomenon)
- Severe headache, blurred vision, or confusion (signs of hypertensive crisis)
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
+ 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 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
+ 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
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.
Heart-Related Precautions
You may need to undergo heart tests before starting this medication. If you have questions or concerns, 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.
Lab Tests and Monitoring
Regular blood work is necessary while taking this medication. Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.
Interactions with Other Substances
You may need to avoid consuming alcohol with this medication. Consult your doctor or pharmacist to determine if alcohol consumption is safe while taking this medication.
Mental Health Precautions
New or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, have been reported with this medication. 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. Seek immediate medical attention if you experience hallucinations, changes in behavior, or mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those 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 changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Growth Effects in Children and Teens
This medication may affect growth in children and adolescents. Regular growth checks may be necessary. 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
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.
Heart-Related Precautions
You may need to undergo heart tests before starting this medication. If you have questions or concerns, 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.
Lab Tests and Monitoring
Regular blood work is necessary while taking this medication. Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.
Interactions with Other Substances
You may need to avoid consuming alcohol with this medication. Consult your doctor or pharmacist to determine if alcohol consumption is safe while taking this medication.
Mental Health Precautions
New or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, have been reported with this medication. 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. Seek immediate medical attention if you experience hallucinations, changes in behavior, or mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those 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 changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Growth Effects in Children and Teens
This medication may affect growth in children and adolescents. Regular growth checks may be necessary. 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
What to Do:
Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use)
Major Interactions
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine levels and prolong half-life
- Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine levels and shorten half-life
- Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans) - increased risk of serotonin syndrome
- Antihypertensives - amphetamines may antagonize the hypotensive effects
- Halogenated Anesthetics - increased risk of sudden death or ventricular arrhythmias
Moderate Interactions
- Proton Pump Inhibitors (PPIs) / H2 Blockers - may alter gastric pH and affect absorption (though Adzenys XR is less sensitive to pH changes than immediate-release forms)
- Antipsychotics - may antagonize stimulant effects
- Lithium - may antagonize stimulant effects
- Phenytoin, Phenobarbital - may alter metabolism of amphetamine
- Opioids (e.g., meperidine) - increased risk of hyperpyrexia and convulsions
Minor Interactions
- Not specifically listed for minor interactions, but general caution with other CNS stimulants or depressants.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Amphetamines can cause dose-related increases in BP and HR, which may pose risks for patients with pre-existing cardiovascular conditions.
Timing: Prior to initiation of therapy.
Height and Weight (Pediatric)
Rationale: Stimulants have been associated with growth suppression in pediatric patients.
Timing: Prior to initiation of therapy.
Psychiatric History
Rationale: Assess for pre-existing bipolar disorder, psychosis, or tics, as stimulants can exacerbate these conditions.
Timing: Prior to initiation of therapy.
Cardiovascular History (ECG if indicated)
Rationale: Screen for structural cardiac abnormalities or other serious heart problems that could increase risk of sudden death.
Timing: Prior to initiation of therapy, especially if family history or symptoms suggest cardiac issues.
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/patient
Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.
Height and Weight (Pediatric)
Frequency: Every 3-6 months
Target: Normal growth trajectory
Action Threshold: Significant deviation from expected growth curve; consider drug holiday or alternative therapy.
Psychiatric Status (e.g., emergence of new psychotic symptoms, mania, aggression, tics)
Frequency: Regularly (e.g., at each visit)
Target: Stable mental health
Action Threshold: Emergence or worsening of psychiatric symptoms; consider dose adjustment or discontinuation.
ADHD Symptom Control and Functional Improvement
Frequency: Regularly (e.g., at each visit)
Target: Improved attention, reduced hyperactivity/impulsivity, improved functioning
Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- New or worsening tics
- Unexplained weight loss
- Sleep disturbances
- Anxiety
- Irritability
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, including premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations (e.g., cardiac defects) based on some studies, though data are conflicting.
Second Trimester:
Risk of premature delivery and low birth weight.
Third Trimester:
Risk of premature delivery, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence).
Lactation
Amphetamines are excreted into human milk. Breastfeeding is not recommended during treatment with Adzenys XR due to the potential for serious adverse reactions in the breastfed infant (e.g., irritability, poor feeding, sleep disturbances, weight loss).
Infant Risk:
High risk (L4 - Possibly hazardous)
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) and cardiovascular parameters closely. Long-term safety and efficacy in children under 6 years have not been established.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, 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 orally disintegrating tablet, making it suitable for patients who have difficulty swallowing pills.
- The extended-release formulation provides a smooth, once-daily dosing profile, typically lasting 10-12 hours.
- Patients should be advised not to chew, crush, or cut the ODT tablet; it should be placed on the tongue and allowed to dissolve.
- Despite being an ODT, it is not designed for sublingual absorption; it is swallowed after disintegration.
- Counsel patients on the importance of taking the medication in the morning to avoid insomnia.
- Regular monitoring of cardiovascular parameters and growth in children is crucial due to known stimulant side effects.
Alternative Therapies
- Non-stimulant medications for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy
- Cognitive behavioral therapy (CBT)
Cost & Coverage
Average Cost:
$300 - $450 per 30 tablets
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it was taken.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it was taken.