Adzenys XR 9.4mg 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
Amphetamine; Norepinephrine-Dopamine Reuptake Inhibitor (NDRI) 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 medicine used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It contains amphetamine, a stimulant that helps improve focus, attention, and control over impulsive behavior by affecting certain 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 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 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, and certain natural products or aids.
Special Considerations for Children
Different brands of this medication may be suitable for children of various 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 other people 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 resume 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 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 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, and certain natural products or aids.
Special Considerations for Children
Different brands of this medication may be suitable for children of various 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 other people 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 resume 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 as it may cause sleep problems.
- Place the tablet on your tongue; it will dissolve quickly. Swallow with or without water.
- Do not chew, crush, or break the tablet.
- Store in the original blister pack and use immediately after opening.
- Avoid alcohol consumption.
- Maintain a healthy diet and regular exercise.
- Report any new or worsening heart problems, mental health issues, or growth concerns to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 12.5 mg (equivalent to 20 mg mixed amphetamine salts) once daily in the morning. Max: 18.8 mg (equivalent to 30 mg mixed amphetamine salts) once daily.
Dose Range:
9.4 - 18.8 mg
Condition-Specific Dosing:
ADHD:
Initial 12.5 mg once daily in the morning. May increase to 18.8 mg after 1 week if needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 6.3 mg (equivalent to 10 mg mixed amphetamine salts) once daily in the morning. May increase to 9.4 mg after 1 week, then 12.5 mg after another week, up to a maximum of 18.8 mg once daily. Doses should be individualized.
Adolescent:
13-17 years: Initial 12.5 mg (equivalent to 20 mg mixed amphetamine salts) once daily in the morning. May increase to 18.8 mg after 1 week if needed.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Consider lower doses. Specific recommendations not provided in package insert.
Severe:
Use with caution; consider lower doses or alternative treatment. Specific recommendations not provided in package insert.
Dialysis:
Not available
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 their reuptake. This leads to increased concentrations of these neurotransmitters in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated for Adzenys XR, but generally high for amphetamines.
Tmax:
Biphasic absorption: Initial peak at approximately 1.5 hours, second peak at approximately 5 hours.
FoodEffect:
High-fat meal does not affect absorption or exposure, but may delay Tmax by approximately 2.5 hours.
Distribution:
Vd:
Approximately 3.7 L/kg (for d-amphetamine).
ProteinBinding:
Approximately 16% (for d-amphetamine).
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-13 hours (for d-amphetamine and l-amphetamine components).
Clearance:
Highly dependent on urinary pH.
ExcretionRoute:
Renal (primarily unchanged drug and metabolites).
Unchanged:
Approximately 30-50% (dependent on urinary pH; higher in acidic urine).
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes.
PeakEffect:
Biphasic, with effects lasting throughout the day.
DurationOfAction:
Up to 12-14 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
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Shakiness
Changes in vision
Seizures
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color (pale, blue, gray, purple, or red) on 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 urinating
Erectile dysfunction or changes in sex drive
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, or severe dizziness or fainting.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Dizziness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Sleep disturbances
Headache
Weight loss
Bad taste in mouth
* Feeling nervous, excitable, or restless
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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Shakiness
Changes in vision
Seizures
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color (pale, blue, gray, purple, or red) on 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 urinating
Erectile dysfunction or changes in sex drive
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, or severe dizziness or fainting.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Dizziness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Sleep disturbances
Headache
Weight loss
Bad taste in mouth
* Feeling nervous, excitable, or restless
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
- Fainting spells
- New or worsening aggression or hostility
- Seeing or hearing things that are not real (psychosis)
- New manic symptoms (e.g., extreme energy, racing thoughts)
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained weight loss
- New tics or worsening of existing tics
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 you experienced, including the symptoms that occurred.
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, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may increase the risk of 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 conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or modify the dosage 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 you experienced, including the symptoms that occurred.
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, including:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may increase the risk of 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 conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or modify the dosage 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 engaging in activities 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 can lead to tolerance, where the medication may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Additionally, regular use of this medication can cause dependence. Stopping the medication abruptly may lead to withdrawal symptoms. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions carefully. 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 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. Regular blood work may also be necessary, as advised by your doctor.
Interactions with Lab Tests and Alcohol
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication. You may need to avoid consuming alcohol with this medication; consult your doctor or pharmacist to determine if this is necessary.
Mental and Mood Changes
New or worsening behavior 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 or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of 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 teens. 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 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 Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the medication may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Additionally, regular use of this medication can cause dependence. Stopping the medication abruptly may lead to withdrawal symptoms. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions carefully. 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 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. Regular blood work may also be necessary, as advised by your doctor.
Interactions with Lab Tests and Alcohol
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this medication. You may need to avoid consuming alcohol with this medication; consult your doctor or pharmacist to determine if this is necessary.
Mental and Mood Changes
New or worsening behavior 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 or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of 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 teens. 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 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 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis).
- Linezolid (MAOI activity).
- Methylene blue (MAOI activity).
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.
- Antihypertensives (may reduce hypotensive effect).
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - increase amphetamine excretion, decrease efficacy.
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - decrease amphetamine excretion, increase efficacy/toxicity.
- Proton Pump Inhibitors (PPIs) and H2-receptor antagonists (may increase amphetamine absorption/exposure).
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines.
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects.
- Lithium - may antagonize stimulant effects.
- Opioids (e.g., meperidine) - increased risk of serotonin syndrome.
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure.
- Adrenergic blockers (e.g., guanethidine) - amphetamines may inhibit their hypotensive effect.
Minor Interactions
- Antacids (may increase absorption slightly).
- Caffeine (additive stimulant effects).
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Risk of cardiovascular effects (hypertension, tachycardia).
Timing: Prior to initiation.
Height and Weight (especially in children)
Rationale: Risk of growth suppression.
Timing: Prior to initiation.
Psychiatric history (including family history of tics, Tourette's, bipolar disorder, psychosis)
Rationale: Risk of exacerbating psychiatric conditions or precipitating new ones.
Timing: Prior to initiation.
ECG (if clinically indicated, e.g., pre-existing cardiac conditions)
Rationale: To assess for underlying cardiac abnormalities.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or at least every 3-6 months.
Target: Within normal limits for age.
Action Threshold: Persistent elevation requiring intervention or dose adjustment.
Height and Weight (especially in children)
Frequency: Every 3-6 months.
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss.
Psychiatric symptoms (e.g., agitation, aggression, psychosis, mania, tics)
Frequency: At each visit.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of psychiatric symptoms.
ADHD symptom control and functional improvement
Frequency: At each visit.
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hostility
- Psychotic symptoms (hallucinations, delusions)
- Manic symptoms (euphoria, grandiosity, racing thoughts)
- New or worsening tics
- Unexplained weight loss
- Growth deceleration
- Peripheral vasculopathy (Raynaud's phenomenon)
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 adverse pregnancy outcomes, 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, though data are conflicting.
Second Trimester:
Risk of premature delivery and low birth weight.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence).
Lactation
Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, reduced weight gain), breastfeeding is not recommended during treatment with Adzenys XR-ODT.
Infant Risk:
High (agitation, insomnia, anorexia, reduced weight gain, potential for cardiovascular effects).
Pediatric Use
Safety and effectiveness established in pediatric patients 6 to 17 years of age. Growth suppression (weight and/or height) has been reported with long-term stimulant use; monitor growth regularly.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Use with caution, generally starting at the low end of the dosing range, due to 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 orally disintegrating tablet, offering convenience for patients who have difficulty swallowing pills.
- The 9.4 mg strength of Adzenys XR-ODT is bioequivalent to 15 mg of mixed amphetamine salts extended-release capsules (e.g., Adderall XR). Dosing conversion is important.
- Instruct patients to place the ODT on the tongue, allow it to dissolve without chewing, and swallow the dissolved medication.
- Due to its extended-release nature, it should be taken once daily in the morning to avoid sleep disturbances.
- Regular monitoring of cardiovascular parameters (BP, HR) and growth (in children) is crucial due to potential side effects.
- Counsel patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
Alternative Therapies
- Methylphenidate extended-release formulations (e.g., Concerta, Focalin XR, Quillivant XR, Jornay PM)
- Lisdexamfetamine (Vyvanse)
- Dexmethylphenidate (Focalin, Focalin XR)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy for ADHD
Cost & Coverage
Average Cost:
Approximately $300-$400+ per 30 tablets
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription)
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.