Adzenys XR 18.8mg 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 (CNS) Stimulant
Pharmacologic Class
Sympathomimetic amine; indirectly acting adrenergic
Pregnancy Category
Category C
FDA Approved
Jan 2016
DEA Schedule
Schedule II
Overview
What is this medicine?
Adzenys XR ODT is an extended-release orally disintegrating tablet containing amphetamine, a stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by helping to balance certain natural chemicals in the brain, which can improve focus, attention, and control over impulsive behavior. The tablet dissolves quickly in your mouth without water.
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 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 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
* Certain natural products or aids
Additionally, be aware that different brands of this medication may be suitable for children of different ages. Consult with your doctor before giving this medication to a child.
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.
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. Keep Pets Away: 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 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 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
* Certain natural products or aids
Additionally, be aware that different brands of this medication may be suitable for children of different ages. Consult with your doctor before giving this medication to a child.
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.
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. Keep Pets Away: 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 the medication once daily in the morning, consistently at the same time each day.
- Do not take late in the day to avoid sleep problems.
- Place the tablet on your tongue and allow it to dissolve completely; do not chew or crush it.
- Maintain a healthy diet and ensure adequate sleep.
- Avoid alcohol consumption while taking this medication.
- Store medication securely to prevent misuse or diversion.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
12.5 mg or 18.8 mg once daily in the morning
Dose Range:
6.3 - 18.8 mg
Condition-Specific Dosing:
ADHD:
Initial 6.3 mg or 12.5 mg once daily in the morning. May titrate weekly by 6.3 mg to 12.5 mg or 18.8 mg. Maximum recommended dose is 18.8 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6-12 years: Initial 6.3 mg once daily in the morning. May titrate weekly by 3.1 mg to 6.3 mg. Maximum recommended dose is 12.5 mg/day.
Adolescent:
For adolescents 13-17 years: Initial 12.5 mg once daily in the morning. May titrate weekly by 6.3 mg. Maximum recommended dose is 18.8 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary (CrCl 60-89 mL/min).
Moderate:
Consider lower dose (CrCl 30-59 mL/min).
Severe:
Use with caution; consider lower dose (CrCl <30 mL/min).
Dialysis:
Not well studied; amphetamine is not significantly removed by hemodialysis. Use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended; however, caution is advised due to hepatic metabolism.
Pharmacology
Mechanism of Action
Amphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effects 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 ODT, but generally high for amphetamine.
Tmax:
Approximately 5 hours (range 4-8 hours) for the d-amphetamine component.
FoodEffect:
Administration with a high-fat meal does not significantly affect the absorption or exposure of amphetamine.
Distribution:
Vd:
3.7-5.1 L/kg
ProteinBinding:
15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-13 hours (for d-amphetamine component); 11-14 hours (for l-amphetamine component).
Clearance:
Highly dependent on urine pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal (urine)
Unchanged:
30-50% excreted unchanged in urine, highly dependent on urine pH.
Pharmacodynamics
OnsetOfAction:
Within 30-60 minutes
PeakEffect:
Approximately 5 hours
DurationOfAction:
Up to 16 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
Trouble controlling body movements
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color (hands, feet, or other areas) that may turn pale, blue, gray, purple, or red
Numbness, pain, tingling, or cold sensation in the hands or feet
Sores or wounds on the 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical attention if you experience any of the following side effects or if they persist or bother you:
Dizziness, tiredness, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Sleep disturbances
Headache
Weight loss
Bad taste in the mouth
* Feeling nervous, excitable, or restless
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, 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
Trouble controlling body movements
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in skin color (hands, feet, or other areas) that may turn pale, blue, gray, purple, or red
Numbness, pain, tingling, or cold sensation in the hands or feet
Sores or wounds on the 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical attention if you experience any of the following side effects or if they persist or bother you:
Dizziness, tiredness, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Sleep disturbances
Headache
Weight loss
Bad taste in the mouth
* Feeling nervous, excitable, or restless
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- New or worsening chest pain, shortness of breath, or fainting.
- New or worsening psychiatric symptoms such as hallucinations, paranoia, or mania.
- New or worsening tics or involuntary movements.
- Numbness, coolness, or pain in fingers or toes, or unexplained wounds on fingers or toes.
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have 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 health issues, 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 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have 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 health issues, 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 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. 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 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 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 to monitor your condition. 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 with your specific medication.
Mental Health Precautions
New or worsening behavioral and mood changes, such as altered thinking, anger, or 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, 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, 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. Consult your doctor to discuss the potential risks and benefits.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform 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 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 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 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 to monitor your condition. 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 with your specific medication.
Mental Health Precautions
New or worsening behavioral and mood changes, such as altered thinking, anger, or 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, 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, 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. Consult your doctor to discuss the potential risks and benefits.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform 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
- Hyperpyrexia (very high fever)
- Rhabdomyolysis (muscle breakdown)
- Cardiac arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Seizures
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes symptomatic and supportive measures, with particular attention to maintaining a patent airway, cardiovascular function, and body temperature.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis)
Major Interactions
- Acidifying agents (e.g., ascorbic acid, fruit juices, ammonium chloride) - decrease absorption and increase excretion, reducing efficacy.
- Alkalinizing agents (e.g., sodium bicarbonate, antacids, acetazolamide) - increase absorption and decrease excretion, increasing toxicity.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, ritonavir) - increase amphetamine exposure, potentially leading to increased side effects.
- Antihypertensive agents - amphetamines may reduce the hypotensive effect of guanethidine and other antihypertensives.
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
- Tricyclic antidepressants - may increase cardiovascular effects of amphetamines.
Moderate Interactions
- Adrenergic blockers (e.g., beta-blockers) - may antagonize the effects of amphetamines.
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
- Lithium - may inhibit the stimulant effects of amphetamines.
- Ethosuximide - amphetamines may inhibit the absorption of ethosuximide.
- Meperidine - amphetamines may potentiate the analgesic effect of meperidine.
- Norepinephrine - amphetamines may potentiate the adrenergic effect of norepinephrine.
Minor Interactions
- Not specifically categorized as minor, but caution with any drug affecting CNS or cardiovascular system.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Amphetamines can cause increases in BP and HR; screen for pre-existing cardiovascular conditions.
Timing: Prior to initiation
Height and Weight
Rationale: Monitor growth in pediatric patients due to potential for growth suppression.
Timing: Prior to initiation
Psychiatric History and Status
Rationale: Screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated.
Timing: Prior to initiation
Family History of Sudden Cardiac Death or Arrhythmias
Rationale: Identify individuals at higher risk for cardiovascular events.
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/sex
Action Threshold: Sustained elevation requiring intervention or discontinuation.
Height and Weight
Frequency: Every 3-6 months in pediatric patients
Target: Consistent growth trajectory
Action Threshold: Significant growth deceleration or weight loss.
Psychiatric Status (e.g., mood, anxiety, tics, psychotic symptoms)
Frequency: At each visit
Target: Stable or improved symptoms, absence of new psychiatric symptoms
Action Threshold: Emergence or worsening of psychotic symptoms, mania, aggression, or severe anxiety/agitation.
ADHD Symptom Control
Frequency: At each visit
Target: Improved focus, reduced impulsivity/hyperactivity
Action Threshold: Lack of efficacy or intolerable side effects.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Fainting (syncope)
- New or worsening psychiatric symptoms (e.g., hallucinations, paranoia, mania)
- New or worsening tics
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
- Signs of abuse or dependence (e.g., drug-seeking behavior, escalating dose)
Special Patient Groups
Pregnancy
Category C. Amphetamines may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are limited and inconsistent.
Second Trimester:
Not well studied, but continued exposure may lead to growth restriction.
Third Trimester:
Risk of premature delivery, low birth weight, and withdrawal symptoms (e.g., agitation, feeding difficulties) in the neonate if used near term.
Lactation
Amphetamine is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, weight loss), advise mothers not to breastfeed during treatment with Adzenys XR ODT.
Infant Risk:
Moderate concern (L3). Potential for irritability, poor feeding, sleep disturbances, and weight loss in the infant. Long-term effects on neurodevelopment are unknown.
Pediatric Use
Safety and efficacy established in children 6 years and older. Monitor growth (height and weight) and cardiovascular parameters. Assess for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression).
Geriatric Use
Safety and efficacy have not been established in geriatric patients. Not typically used in this population for ADHD. Use with caution due to increased susceptibility to cardiovascular effects and potential for comorbidities.
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 orally disintegrating tablet formulation is beneficial for patients who have difficulty swallowing pills.
- Instruct patients to place the tablet on the tongue and allow it to dissolve without chewing or crushing, then swallow with saliva.
- Due to its abuse potential, prescribe the smallest effective quantity and monitor for signs of misuse or diversion.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
- Educate patients and caregivers on potential psychiatric side effects and the importance of reporting any new or worsening symptoms.
Alternative Therapies
- Methylphenidate (e.g., Concerta, Ritalin LA, Daytrana)
- Atomoxetine (Strattera)
- Guanfacine extended-release (Intuniv)
- Clonidine extended-release (Kapvay)
- Non-pharmacological interventions (e.g., behavioral therapy, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$500 per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (preferred or 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 valuable resource that provides important information about its use. 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 discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication, the amount taken, and the time it was taken, to facilitate prompt and appropriate treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its use. 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 discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication, the amount taken, and the time it was taken, to facilitate prompt and appropriate treatment.