Adzenys ER 1.25mg/ml Oral Susp
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
Pregnancy Category
Not available
FDA Approved
Jan 2016
DEA Schedule
Schedule II
Overview
What is this medicine?
Adzenys ER is an extended-release liquid medication containing amphetamine, a stimulant. It is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to improve focus, attention, and control over impulsive behavior. Because it's extended-release, it works throughout the day with a single morning dose.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from 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 Liquid Instructions: You can take this medication with or without food. However, do not add it to food or mix it with other liquids.
4. Measuring Liquid Doses: Shake the medication well before use. Measure liquid doses carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.
5. Storage and Handling: After taking your dose, replace the cap to prevent spills or accidents.
6. Interactions with Other Medications: 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.
7. Pediatric Use: Different brands of this medication may be suitable for children of various ages. Consult with your doctor before giving this medication to a child.
Storing and Disposing of Your Medication
1. Storage: Keep your medication at room temperature in a dry place, away from the bathroom.
2. Safety Precautions: Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep your medication safe.
3. Pet Safety: Keep all medications away from pets.
4. Disposal: Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult with your pharmacist if you have questions about the best way to dispose of your medication. You may also want to check if there are drug take-back programs in your area.
What to Do if You Miss a Dose
1. Take a Missed Dose: If you miss a dose, take it as soon as you remember.
2. Skip a Missed Dose if Necessary: If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
3. Avoid Double Dosing: Do not take two doses at the same time or take extra doses.
To ensure you get the most benefit from 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 Liquid Instructions: You can take this medication with or without food. However, do not add it to food or mix it with other liquids.
4. Measuring Liquid Doses: Shake the medication well before use. Measure liquid doses carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.
5. Storage and Handling: After taking your dose, replace the cap to prevent spills or accidents.
6. Interactions with Other Medications: 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.
7. Pediatric Use: Different brands of this medication may be suitable for children of various ages. Consult with your doctor before giving this medication to a child.
Storing and Disposing of Your Medication
1. Storage: Keep your medication at room temperature in a dry place, away from the bathroom.
2. Safety Precautions: Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep your medication safe.
3. Pet Safety: Keep all medications away from pets.
4. Disposal: Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult with your pharmacist if you have questions about the best way to dispose of your medication. You may also want to check if there are drug take-back programs in your area.
What to Do if You Miss a Dose
1. Take a Missed Dose: If you miss a dose, take it as soon as you remember.
2. Skip a Missed Dose if Necessary: If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
3. Avoid Double Dosing: Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Adzenys ER once daily in the morning, with or without food. Do not take it in the afternoon or evening as it may cause sleep problems.
- Shake the bottle well for at least 10 seconds before each use.
- Use the provided oral dosing syringe to measure the exact dose. Do not use a household spoon.
- Do not chew or crush the medication if it were a tablet; this is a liquid suspension.
- Store at room temperature. Do not freeze.
- Avoid alcohol, as it may affect the release of the medication.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any new or worsening heart problems, mental health issues, or unusual behaviors immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
6.3 mg (5 mL) once daily in the morning
Dose Range:
6.3 - 18.8 mg
Condition-Specific Dosing:
ADHD:
Initial dose 6.3 mg (5 mL) once daily in the morning. May increase by 3.1 mg (2.5 mL) to 6.3 mg (5 mL) at weekly intervals. Maximum dose 12.5 mg (10 mL) for patients 6-17 years, and 18.8 mg (15 mL) for patients 18 years and older.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-17 years: Initial dose 6.3 mg (5 mL) once daily in the morning. May increase by 3.1 mg (2.5 mL) to 6.3 mg (5 mL) at weekly intervals. Maximum dose 12.5 mg (10 mL).
Adolescent:
6-17 years: Initial dose 6.3 mg (5 mL) once daily in the morning. May increase by 3.1 mg (2.5 mL) to 6.3 mg (5 mL) at weekly intervals. Maximum dose 12.5 mg (10 mL).
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed.
Moderate:
Consider lower doses. Specific recommendations not provided in package insert.
Severe:
Consider lower doses. Specific recommendations not provided in package insert.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No dosage adjustment needed.
Moderate:
No dosage adjustment needed.
Severe:
No dosage adjustment needed.
Pharmacology
Mechanism of Action
Amphetamine is a non-catecholamine sympathomimetic amine that exerts its therapeutic effect in ADHD by releasing norepinephrine and dopamine from nerve terminals in the brain, particularly in the prefrontal cortex. It blocks the reuptake of these monoamines into the presynaptic neuron, increasing their concentrations in the synaptic cleft. The exact mechanism by which amphetamines produce their behavioral and clinical effects in ADHD is not fully established.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated for Adzenys ER, but generally high for amphetamines.
Tmax:
Approximately 5 hours (range 4-8 hours) for d-amphetamine and l-amphetamine components.
FoodEffect:
High-fat meal does not significantly affect Cmax or AUC of amphetamine, but may delay Tmax by approximately 2.5 hours.
Distribution:
Vd:
Approximately 3.7 L/kg for d-amphetamine and 4.4 L/kg for l-amphetamine.
ProteinBinding:
Approximately 16% to 18% for d-amphetamine and 13% to 14% for l-amphetamine.
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-13 hours for d-amphetamine and 11-14 hours for l-amphetamine (pH-dependent).
Clearance:
Highly dependent on urinary pH.
ExcretionRoute:
Renal (primarily unchanged drug, especially in acidic urine).
Unchanged:
Approximately 30-50% excreted unchanged in urine; up to 70% in acidic urine.
Pharmacodynamics
OnsetOfAction:
Within 30-60 minutes (for immediate release, extended release will be slower but sustained).
PeakEffect:
Approximately 5 hours (Tmax).
DurationOfAction:
Up to 12-13 hours.
Safety & Warnings
BLACK BOX WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Side Effects
Serious Side Effects: Seek Medical Help 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
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. If a family member has an abnormal heartbeat or died suddenly, tell your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
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
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. If a family member has an abnormal heartbeat or died suddenly, tell your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
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 (signs of heart problems)
- New or worsening aggression, hostility, or irritability
- New psychotic symptoms (e.g., hearing voices, believing things that are not true)
- New manic symptoms (e.g., extreme high mood, increased energy, racing thoughts)
- Unexplained wounds on fingers or toes, or numbness/pain/color change in digits (signs of peripheral vasculopathy)
- Blurred vision or other vision changes
- Severe headache
- Uncontrolled muscle movements or 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 and its symptoms.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Any past medical conditions, such as:
+ Drug abuse
+ Stroke
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Drugs for depression or Parkinson's disease (e.g., isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This is crucial to prevent accidents and ensure your safety.
Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can increase the risk of adverse effects.
Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can lead to withdrawal symptoms. If you need to reduce the dose or stop taking the medication, consult your doctor, who will provide guidance on how to do so safely.
Before starting this medication, you may need to undergo heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood tests to check for any potential effects on your blood work. Inform your doctor about any changes or concerns you may have.
Certain laboratory tests may be affected by this medication, so it is crucial to inform all your healthcare providers and lab personnel that you are taking it.
You may need to avoid consuming alcohol while taking this medication, as it can interact with the drug. Consult your doctor or pharmacist to determine if you should avoid alcohol.
This medication can cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience any symptoms such as hallucinations, changes in behavior, depression, suicidal thoughts, nervousness, mood swings, or anxiety, contact your doctor immediately.
This medication may increase the risk of seizures, particularly in individuals who have a history of seizure disorders. Discuss your risk with your doctor to determine if you need to take any precautions.
A rare but potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience symptoms such as agitation, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, sweating, severe diarrhea, nausea, vomiting, or severe headache.
In some cases, this medication may affect growth in children and adolescents, so regular growth checks may be necessary. Consult your doctor to determine if your child needs regular monitoring.
If you are pregnant or plan to become pregnant, inform your doctor, as this medication may pose risks to the fetus. Taking this medication during pregnancy can lead to withdrawal symptoms in the newborn, so it is essential to discuss the benefits and risks with your doctor.
Until you know how this medication affects you, avoid driving and other activities that require alertness and clear vision. This is crucial to prevent accidents and ensure your safety.
Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can increase the risk of adverse effects.
Prolonged or regular use of this medication may cause dependence, and stopping it abruptly can lead to withdrawal symptoms. If you need to reduce the dose or stop taking the medication, consult your doctor, who will provide guidance on how to do so safely.
Before starting this medication, you may need to undergo heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood tests to check for any potential effects on your blood work. Inform your doctor about any changes or concerns you may have.
Certain laboratory tests may be affected by this medication, so it is crucial to inform all your healthcare providers and lab personnel that you are taking it.
You may need to avoid consuming alcohol while taking this medication, as it can interact with the drug. Consult your doctor or pharmacist to determine if you should avoid alcohol.
This medication can cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience any symptoms such as hallucinations, changes in behavior, depression, suicidal thoughts, nervousness, mood swings, or anxiety, contact your doctor immediately.
This medication may increase the risk of seizures, particularly in individuals who have a history of seizure disorders. Discuss your risk with your doctor to determine if you need to take any precautions.
A rare but potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience symptoms such as agitation, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, sweating, severe diarrhea, nausea, vomiting, or severe headache.
In some cases, this medication may affect growth in children and adolescents, so regular growth checks may be necessary. Consult your doctor to determine if your child needs regular monitoring.
If you are pregnant or plan to become pregnant, inform your doctor, as this medication may pose risks to the fetus. Taking this medication during pregnancy can lead to withdrawal symptoms in the newborn, so it is essential to discuss the benefits and risks with your doctor.
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:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes symptomatic and supportive measures, including gastric lavage, activated charcoal, and sedation for CNS overstimulation. External cooling for hyperpyrexia. Intravenous phentolamine for severe hypertension. Acidification of urine may increase excretion but is generally not recommended due to risk of renal failure.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI use (risk of hypertensive crisis).
- Halogenated Anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure increase and arrhythmias.
Major Interactions
- Alkalinizing Agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life, increasing risk of toxicity.
- Acidifying Agents (e.g., ascorbic acid, ammonium chloride, cranberry juice) - decrease amphetamine blood levels and shorten half-life, reducing efficacy.
- Antihypertensives (e.g., guanethidine, clonidine) - amphetamines may antagonize the hypotensive effects.
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
- Propoxyphene - increased risk of seizures.
- Alcohol - may alter the release profile of amphetamine from the extended-release formulation.
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects (e.g., arrhythmias, blood pressure elevation).
- Proton Pump Inhibitors (PPIs) and H2 Blockers - may alter gastric pH, potentially affecting absorption (though less significant for ER formulations designed for pH independence).
- CYP2D6 Inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure, increasing risk of toxicity.
- Urinary Alkalinizers (e.g., potassium citrate) - increase amphetamine reabsorption and prolong half-life.
Minor Interactions
- Antacids (containing magnesium or aluminum hydroxide) - may slightly increase absorption.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Amphetamines can cause increases in BP and HR. Baseline assessment is crucial.
Timing: Prior to initiation of treatment.
Height and Weight (Pediatric)
Rationale: Stimulants can be associated with growth suppression in pediatric patients.
Timing: Prior to initiation of treatment.
Cardiovascular History and Examination
Rationale: To identify pre-existing cardiac conditions that may contraindicate stimulant use (e.g., structural cardiac abnormalities, cardiomyopathy, serious arrhythmias).
Timing: Prior to initiation of treatment.
Psychiatric History
Rationale: To screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.
Timing: Prior to initiation of treatment.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each dose adjustment and at least every 3-6 months during stable treatment.
Target: Within normal limits for age; monitor for significant increases.
Action Threshold: Persistent elevation above baseline or age-appropriate norms; consider dose reduction or discontinuation.
Height and Weight (Pediatric)
Frequency: Every 3-6 months.
Target: Maintain normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative treatment.
Psychiatric Status
Frequency: Regularly, especially during dose titration and with any behavioral changes.
Target: Stable mood, absence of new or worsening psychotic or manic symptoms.
Action Threshold: Emergence of psychotic symptoms, mania, aggression, or severe anxiety; discontinue treatment.
ADHD Symptom Control
Frequency: Regularly, at each visit.
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Persistent insomnia
- Loss of appetite
- Tics or dyskinesias
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
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 pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data are limited and inconsistent.
Second Trimester:
Risk of premature birth and low birth weight.
Third Trimester:
Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence).
Lactation
Amphetamines are excreted into human milk. Breastfeeding is not recommended during treatment with Adzenys ER due to potential for serious adverse reactions in the breastfed infant (e.g., irritability, poor feeding, sleep disturbances, weight loss).
Infant Risk:
L3 (Moderate risk - amphetamines are excreted into breast milk and can cause adverse effects in infants. Monitor for irritability, sleep disturbances, poor feeding, and weight loss. Consider alternative feeding or alternative medication.)
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) carefully. Long-term effects on growth are a concern. Monitor for emergence or worsening of psychiatric symptoms.
Geriatric Use
Safety and efficacy in patients 65 years and older have not been established. Generally not recommended due to increased risk of cardiovascular adverse events and other comorbidities. If used, start with lower doses and titrate slowly, monitoring closely for adverse effects.
Clinical Information
Clinical Pearls
- Adzenys ER is an extended-release liquid formulation, which can be beneficial for patients who have difficulty swallowing pills or prefer a liquid form.
- The dose of Adzenys ER is not equivalent on a milligram-to-milligram basis to other amphetamine products due to differences in salt forms and extended-release technology. Always refer to specific dosing guidelines for Adzenys ER.
- Ensure patients and caregivers are properly trained on how to measure the dose using the provided oral dosing syringe.
- Counsel patients on the importance of taking the medication consistently in the morning to avoid sleep disturbances.
- Regular monitoring of cardiovascular parameters and growth in children is crucial.
- Be vigilant for signs of abuse, misuse, or diversion, given the Schedule II classification.
Alternative Therapies
- Methylphenidate (e.g., Concerta, Ritalin LA, Quillivant XR, Jornay PM)
- Lisdexamfetamine (Vyvanse)
- Dexmethylphenidate (Focalin XR)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy
Cost & Coverage
Average Cost:
$300 - $500+ per 300 mL bottle (approx. 30 doses)
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 provides crucial information about its use. 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, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.