Adzenys XR 3.1mg 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-Dopamine Reuptake Inhibitor (NDRI); Dopamine and Norepinephrine Releasing Agent
Pregnancy Category
Category C
FDA Approved
Jan 2016
DEA Schedule
Schedule II
Overview
What is this medicine?
Adzenys XR-ODT is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 years and older, adolescents, and adults. It is an extended-release orally disintegrating tablet that helps improve focus, attention, and control 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 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, allowing it to dissolve. You don't need water, and make 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 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
* Certain natural products or aids
Additionally, if you're considering giving this medication to a child, discuss the appropriateness of the medication with your doctor, as different brands may be suitable for different age groups.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
1. Store at Room Temperature: Keep your medication in a dry place at room temperature.
2. Avoid Bathroom Storage: Do not store your medication in a bathroom.
3. Use the Provided Case: Store blister packs in the plastic case that comes with your medication.
4. Keep Out of Reach: Store your medication in a safe place where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep your medication secure.
5. Protect Your Pets: Keep all medications away from 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 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, allowing it to dissolve. You don't need water, and make 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 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
* Certain natural products or aids
Additionally, if you're considering giving this medication to a child, discuss the appropriateness of the medication with your doctor, as different brands may be suitable for different age groups.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
1. Store at Room Temperature: Keep your medication in a dry place at room temperature.
2. Avoid Bathroom Storage: Do not store your medication in a bathroom.
3. Use the Provided Case: Store blister packs in the plastic case that comes with your medication.
4. Keep Out of Reach: Store your medication in a safe place where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep your medication secure.
5. Protect Your Pets: Keep all medications away from 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 Adzenys XR-ODT once daily in the morning, with or without food. Do not take it in the late afternoon or evening as it may cause sleep problems.
- Place the tablet on your tongue; it will disintegrate rapidly. Swallow the dissolved medication with or without water. Do not chew or crush the tablet.
- Store the medication in a safe place to prevent misuse or abuse.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Avoid alcohol consumption while taking this medication.
- Regularly monitor blood pressure, heart rate, and in children, growth (height and weight).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
6.3 mg (equivalent to 10 mg amphetamine mixed salts) once daily in the morning
Dose Range:
3.1 - 18.8 mg
Condition-Specific Dosing:
ADHD:
Initial dose 6.3 mg once daily in the morning. May increase by 3.1 mg to 6.3 mg at weekly intervals. Maximum dose 18.8 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial dose 6.3 mg once daily in the morning. May increase by 3.1 mg to 6.3 mg at weekly intervals. Maximum dose 18.8 mg/day.
Adolescent:
13-17 years: Initial dose 6.3 mg once daily in the morning. May increase by 3.1 mg to 6.3 mg at weekly intervals. Maximum dose 18.8 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Consider lower doses and monitor for adverse effects.
Severe:
Consider lower doses and monitor for adverse effects. Use with caution.
Dialysis:
Not specifically studied; use with caution and monitor closely due to 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 nerve terminals in the brain, and by blocking the reuptake of these monoamines into the presynaptic neuron. This leads to increased concentrations of norepinephrine and dopamine in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
75-100%
Tmax:
Approximately 5 hours (for Adzenys XR ODT)
FoodEffect:
Food does not affect the extent of absorption (AUC) but may delay Tmax by approximately 2.5 hours.
Distribution:
Vd:
Approximately 3.7-5.1 L/kg
ProteinBinding:
16-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-13 hours (for d-amphetamine and l-amphetamine components)
Clearance:
Not readily available, highly dependent on urinary pH.
ExcretionRoute:
Renal
Unchanged:
30-50% (highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine)
Pharmacodynamics
OnsetOfAction:
Within 1-2 hours
PeakEffect:
Approximately 5 hours (for Adzenys XR ODT)
DurationOfAction:
Up to 16 hours
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including Adzenys XR ODT, have a high potential for abuse and dependence. Administration of CNS stimulants 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 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 or seek medical attention immediately:
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 pass urine
+ 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 the hands or feet
Sores or wounds on the 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, tell your doctor. Seek medical help right away if you experience any signs of heart problems, including:
+ 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 experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling dizzy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Trouble sleeping
Headache
Weight loss
Bad taste in the mouth
Feeling nervous and excitable
Restlessness
Reporting Side Effects
This is not a comprehensive list of all possible side effects. 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 or seek medical attention immediately:
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 pass urine
+ 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 the hands or feet
Sores or wounds on the 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, tell your doctor. Seek medical help right away if you experience any signs of heart problems, including:
+ 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 experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling dizzy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Trouble sleeping
Headache
Weight loss
Bad taste in the mouth
Feeling nervous and excitable
Restlessness
Reporting Side Effects
This is not a comprehensive list of all possible side effects. 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 agitation
- New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
- New or worsening manic symptoms (e.g., extreme high mood, increased energy, racing thoughts)
- New tics or worsening of existing tics
- Unexplained numbness, tingling, or pain in fingers or toes (Raynaud's phenomenon)
- Blurred vision or other vision changes
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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced.
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 medical history of:
+ 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 to ensure safe use. Do not initiate, stop, or modify any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced.
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 medical history of:
+ 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 to ensure safe use. Do not initiate, stop, or modify 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 engaging in activities that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively. In this case, you may need higher doses to achieve the same effect. If you notice this medication is no longer working well, 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 it 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, have your blood work checked as instructed by your doctor.
Interference 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
You may need to avoid drinking alcohol with this medication. Consult your doctor or pharmacist to determine if you should avoid alcohol consumption.
Mental 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 changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, 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 using 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 engaging in activities that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively. In this case, you may need higher doses to achieve the same effect. If you notice this medication is no longer working well, 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 it 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, have your blood work checked as instructed by your doctor.
Interference 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
You may need to avoid drinking alcohol with this medication. Consult your doctor or pharmacist to determine if you should avoid alcohol consumption.
Mental 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 changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, 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 using 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:
Call 911 or Poison Control (1-800-222-1222) immediately. Seek emergency medical attention. Management includes symptomatic and supportive measures, including gastric lavage, activated charcoal, and sedation for CNS overstimulation.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis)
- Linezolid (reversible MAOI)
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, fentanyl, lithium, tramadol, triptans, St. John's Wort) - risk of serotonin syndrome
- Antihypertensive agents (may decrease hypotensive effect)
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase renal excretion, decrease half-life
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - decrease renal excretion, increase half-life
- Proton Pump Inhibitors (PPIs) and H2-receptor blockers (may increase absorption and exposure)
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of amphetamines
Moderate Interactions
- Antipsychotics (may antagonize stimulant effects)
- Antihistamines (may potentiate CNS effects)
- Ethanol (may alter absorption and increase exposure)
- Phenytoin (may increase phenytoin levels)
- Meperidine (may potentiate analgesic effect)
- Halogenated anesthetics (risk of arrhythmias)
Minor Interactions
- Caffeine (additive stimulant effects)
- Food (delays Tmax but not extent of absorption)
Monitoring
Baseline Monitoring
Cardiovascular assessment (BP, HR, ECG)
Rationale: To identify pre-existing cardiac conditions that may contraindicate use or require close monitoring due to risk of sudden death or serious cardiovascular events.
Timing: Prior to initiation
Psychiatric history (personal and family)
Rationale: To screen for bipolar disorder, psychosis, or tics, which may be exacerbated by stimulants.
Timing: Prior to initiation
Height and Weight (especially in children)
Rationale: To establish baseline for growth monitoring.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure and Heart Rate
Frequency: At each visit or every 3-6 months
Target: Within normal limits for age
Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg SBP/DBP or >10-20 bpm HR) warrant investigation and potential dose adjustment or discontinuation.
Height and Weight (especially in children)
Frequency: Every 3-6 months
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss warrants investigation and potential drug holiday or alternative treatment.
Psychiatric status (mood, anxiety, tics, psychotic symptoms)
Frequency: At each visit
Target: Stable, no emergence or worsening of symptoms
Action Threshold: Emergence of new psychotic symptoms, mania, severe anxiety, or tics warrants immediate evaluation and potential discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- New onset or worsening of tics
- Aggression or hostility
- New or worsening psychotic or manic symptoms (e.g., hallucinations, delusions, paranoia)
- Severe anxiety or agitation
- Unexplained weight loss or growth deceleration (in children)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines can 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:
Potential for increased risk of congenital malformations, particularly cardiovascular defects, though data are conflicting.
Second Trimester:
Potential for growth restriction and premature birth.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence) and premature birth.
Lactation
Amphetamine is excreted into breast 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 to High (L3-L4)
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) regularly, as stimulants have been associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms.
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 extended-release formulation designed for once-daily dosing, providing effects for up to 16 hours.
- The 3.1 mg strength is bioequivalent to 5 mg of mixed amphetamine salts extended-release capsules.
- The orally disintegrating tablet formulation is beneficial for patients who have difficulty swallowing pills.
- Instruct patients not to chew or crush the tablet; it should dissolve on the tongue.
- Counsel patients on the high abuse potential and the importance of storing the medication securely.
- Regular monitoring of cardiovascular parameters and growth (in children) is crucial.
- Be aware of potential drug interactions, especially with MAOIs, serotonergic drugs, and agents that alter urinary or gastric pH.
Alternative Therapies
- Other stimulant medications (e.g., methylphenidate formulations, lisdexamfetamine)
- Non-stimulant medications (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
- Behavioral therapy and psychotherapy for ADHD
Cost & Coverage
Average Cost:
$300 - $450 per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the amount consumed, and the time it occurred.