D-Amphetamine ER 50mg Slt Cmb 3b CP
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
Amphetamine; Norepinephrine-Dopamine Reuptake Inhibitor (NDRI) and Releaser
Pregnancy Category
Not assigned (Risk Summary: May cause fetal harm based on animal data and mechanism of action)
FDA Approved
Jun 2017
DEA Schedule
Schedule II
Overview
What is this medicine?
Mydayis is an extended-release medication containing two stimulant drugs, dextroamphetamine and amphetamine. It works by increasing certain natural substances in the brain (norepinephrine and dopamine) that help with focus and attention. It's used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in people aged 6 years and older.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food, but be consistent in how you take it each time. Choose to always take it with food or always take it on an empty stomach.
Take your medication in the morning.
Swallow the capsule whole - do not chew, break, or crush it. If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce, but be sure not to chew the mixture.
If you mix the medication with applesauce, take your dose immediately and do not store the mixture for later use.
Important Interactions to Discuss with Your Doctor
Before taking any over-the-counter (OTC) products, talk to your doctor if you are considering using medications that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
Certain natural products or aids
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature, away from light and moisture.
Keep it in a dry place, such as a closet or drawer, and avoid storing it in a bathroom.
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 protect your medication.
* Keep all medications out of reach of pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take the missed dose later in the day.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food, but be consistent in how you take it each time. Choose to always take it with food or always take it on an empty stomach.
Take your medication in the morning.
Swallow the capsule whole - do not chew, break, or crush it. If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce, but be sure not to chew the mixture.
If you mix the medication with applesauce, take your dose immediately and do not store the mixture for later use.
Important Interactions to Discuss with Your Doctor
Before taking any over-the-counter (OTC) products, talk to your doctor if you are considering using medications that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
Certain natural products or aids
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature, away from light and moisture.
Keep it in a dry place, such as a closet or drawer, and avoid storing it in a bathroom.
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 protect your medication.
* Keep all medications out of reach of pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take the missed dose later in the day.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning, with or without food. Do not take in the afternoon or evening due to potential for sleep problems.
- Swallow the capsule whole; do not chew, crush, or divide. If unable to swallow, the capsule may be opened and the contents sprinkled on a spoonful of applesauce and consumed immediately.
- 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.
- Regularly monitor blood pressure and heart rate as advised by your doctor.
- Maintain a healthy diet and regular exercise. For children, monitor growth regularly.
Available Forms & Alternatives
Available Strengths:
- D-Amphetamine Salt Combo 5mg Tabs
- D-Amphetamine Salt Combo 10mg Tab
- D-Amphetamine Salt Combo 20mg Tabs
- D-Amphetamine Salt Combo 30mg Tabs
- D-Amphetamine Salt Combo 15mg Tabs
- D-Amphetamine Salt Combo 7.5mg Tabs
- D-Amphetamine Salt Combo 12.5mg Tb
- D-Amphetamine ER 30mg Salt Combo CP
- D-Amphetamine ER 20mg Salt Combo CP
- D-Amphetamine ER 10mg Salt Combo CP
- D-Amphetamine ER 5mg Salt Combo CP
- D-Amphetamine ER 25mg Salt Combo CP
- D-Amphetamine ER 15mg Salt Combo CP
- D-Amphetamine Salt Combo 10mg Tab
- D-Amphetamine ER 12.5mg Slt Cmb 3b
- D-Amphetamine ER 37.5mg Slt Cmb 3b
- D-Amphetamine ER 50mg Slt Cmb 3b CP
- D-Amphetamine ER 25mg Slt Cmb 3b CP
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 12.5 mg orally once daily in the morning. May increase by 12.5 mg increments weekly.
Dose Range:
12.5 - 50 mg
Condition-Specific Dosing:
ADHD:
Initial 12.5 mg once daily; maximum 50 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 12.5 mg orally once daily in the morning. May increase by 12.5 mg increments weekly to a maximum of 25 mg once daily.
Adolescent:
13-17 years: Initial 12.5 mg orally once daily in the morning. May increase by 12.5 mg increments weekly to a maximum of 50 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment recommended.
Moderate:
No adjustment recommended.
Severe:
CrCl < 30 mL/min: Consider lower dose or alternative treatment. Max dose 25 mg/day for adults and adolescents (13-17 years), 12.5 mg/day for children (6-12 years).
Dialysis:
Not specifically studied; use with caution. Amphetamines are not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended. Use with caution due to hepatic metabolism.
Pharmacology
Mechanism of Action
Amphetamines are non-catecholamine sympathomimetic amines that exert their therapeutic effect by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, and by blocking the reuptake of these monoamines into the presynaptic neuron. This leads to increased concentrations of norepinephrine and dopamine in the extraneuronal space.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated as a single percentage due to ER formulation, but well-absorbed.
Tmax:
Tri-phasic release: First peak ~4 hours, second peak ~8 hours, third peak ~12 hours post-dose.
FoodEffect:
High-fat meal may delay absorption and Tmax but does not significantly affect overall exposure (AUC).
Distribution:
Vd:
Dextroamphetamine: 2.7-3.9 L/kg; Amphetamine: 3.7-5.1 L/kg
ProteinBinding:
Dextroamphetamine: 16-18%; Amphetamine: 15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (variable with urine pH)
Clearance:
Highly dependent on urine pH; increased clearance with acidic urine.
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 30-40% of dextroamphetamine and 45-50% of amphetamine are excreted unchanged in urine at normal urine pH.
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (initial release)
PeakEffect:
Multiple peaks due to tri-phasic release (4, 8, 12 hours)
DurationOfAction:
Up to 16 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 notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
+ Fainting
+ Changes in vision
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Erectile dysfunction
Decreased sex drive
Seizures
Uncontrolled body movements
Uncontrolled vocalizations, such as humming, throat clearing, yelling, or making loud noises
Restlessness
Changes in vision
Prolonged or frequent erections
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Important Heart-Related Information
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heart rhythms or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:
Chest pain
Abnormal heartbeat
Shortness of breath
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 contact your doctor if you notice any of the following:
Feeling nervous or excitable
Headache
Difficulty sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
Weight loss
Reporting 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 notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
+ Fainting
+ Changes in vision
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Erectile dysfunction
Decreased sex drive
Seizures
Uncontrolled body movements
Uncontrolled vocalizations, such as humming, throat clearing, yelling, or making loud noises
Restlessness
Changes in vision
Prolonged or frequent erections
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Important Heart-Related Information
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heart rhythms or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:
Chest pain
Abnormal heartbeat
Shortness of breath
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 contact your doctor if you notice any of the following:
Feeling nervous or excitable
Headache
Difficulty sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
Weight loss
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, or agitation
- New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
- Manic symptoms (e.g., feeling unusually excited, racing thoughts, decreased need for sleep)
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained muscle weakness or pain
- Blurred vision
- Severe headache
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, other drugs, foods, or substances. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous instances of drug abuse or stroke
Kidney disease, as it may affect how your body processes this medication
Current or recent use of certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Drugs for depression or Parkinson's disease (such as 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 breast-feeding, as you should not take this medication while nursing
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 you determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, other drugs, foods, or substances. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous instances of drug abuse or stroke
Kidney disease, as it may affect how your body processes this medication
Current or recent use of certain medications, including:
+ Acetazolamide or sodium bicarbonate
+ Drugs for depression or Parkinson's disease (such as 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 breast-feeding, as you should not take this medication while nursing
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 you determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution When Performing Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other tasks that require alertness and clear vision.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not work as effectively. In such cases, you may require higher doses to achieve the same effect. If you notice the medication is not working as well as it should, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of this medication can lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Before reducing the dose or stopping the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions 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 work done as instructed by your doctor.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests, so it is essential to inform all of your healthcare providers and lab workers that you are taking this medication. Do not take antacids with this medication.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
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 severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. If you experience agitation, changes in balance, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache, contact your doctor immediately.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Consumption
Avoid consuming alcohol while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution When Performing Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other tasks that require alertness and clear vision.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not work as effectively. In such cases, you may require higher doses to achieve the same effect. If you notice the medication is not working as well as it should, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Long-term or regular use of this medication can lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Before reducing the dose or stopping the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions 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 work done as instructed by your doctor.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests, so it is essential to inform all of your healthcare providers and lab workers that you are taking this medication. Do not take antacids with this medication.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
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 severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. If you experience agitation, changes in balance, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache, contact your doctor immediately.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Consumption
Avoid consuming alcohol while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- Convulsions
- Coma
- Circulatory collapse
- Cardiac arrhythmias
- Hypertension or hypotension
What to Do:
Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Management includes symptomatic treatment, gastric lavage, activated charcoal, and acidification of urine to enhance excretion.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
- Linezolid (reversible MAOI)
- Methylene blue (reversible MAOI)
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensive agents - may decrease 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) - may increase amphetamine absorption/exposure (e.g., omeprazole)
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects of amphetamines
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
- Antihistamines (e.g., diphenhydramine) - may potentiate CNS stimulation
- Ethosuximide - decreased ethosuximide levels
- Phenobarbital, Phenytoin - altered seizure threshold
- Propoxyphene - increased amphetamine levels
- Norepinephrine reuptake inhibitors (e.g., atomoxetine) - additive sympathomimetic effects
Minor Interactions
- Caffeine - additive stimulant effects
- Alcohol - may alter release profile of ER formulations
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Amphetamines can cause dose-related increases in BP and HR.
Timing: Prior to initiation of therapy.
Height and Weight (Pediatric)
Rationale: Stimulants can be associated with growth suppression.
Timing: Prior to initiation of therapy.
Cardiac history and family history of sudden death/arrhythmias
Rationale: To identify pre-existing cardiac conditions that may contraindicate use.
Timing: Prior to initiation of therapy.
Psychiatric history (e.g., bipolar disorder, psychosis, tics)
Rationale: To assess risk of exacerbation of psychiatric symptoms or emergence of new ones.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or every 3-6 months
Target: Within normal limits for age/individual
Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.
Height and Weight (Pediatric)
Frequency: Every 3-6 months
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration; consider drug holiday or alternative.
ADHD symptom control and functional improvement
Frequency: Regularly, at each visit
Target: Improved attention, reduced hyperactivity/impulsivity
Action Threshold: Lack of efficacy or worsening symptoms; reassess diagnosis or treatment plan.
Emergence of new psychiatric symptoms (e.g., psychosis, mania, aggression, tics)
Frequency: Regularly, at each visit
Target: Absence of new symptoms
Action Threshold: Any new or worsening psychiatric symptoms; discontinue or reduce dose.
Signs of abuse/misuse
Frequency: Regularly, at each visit
Target: No signs of diversion or misuse
Action Threshold: Evidence of abuse; implement risk mitigation strategies.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression/hostility
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
- Motor or vocal tics
- Unexplained weight loss
- Blurred vision
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
Special Patient Groups
Pregnancy
Mydayis may cause fetal harm based on animal data and its mechanism of action. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. There is a pregnancy exposure registry for women exposed to ADHD medications during pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations (e.g., cardiac defects) based on some studies of amphetamine exposure, though data are conflicting.
Second Trimester:
Potential for adverse fetal growth effects (e.g., lower birth weight, preterm birth).
Third Trimester:
Risk of withdrawal symptoms in the neonate (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence) if used late in pregnancy.
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 Mydayis.
Infant Risk:
High (L4 - Potentially Hazardous)
Pediatric Use
Approved for children 6 years and older. Growth suppression (weight and height) has been reported with long-term stimulant use; monitor growth regularly. Psychiatric adverse events (e.g., psychosis, mania) can occur. Cardiovascular monitoring is essential.
Geriatric Use
Clinical studies of Mydayis did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Mydayis offers a longer duration of action (up to 16 hours) compared to other extended-release amphetamine products, making it a once-daily option for some patients.
- The tri-phasic release mechanism aims to provide consistent symptom control throughout the day.
- Counsel patients on the importance of taking the medication early in the morning to avoid sleep disturbances.
- Emphasize the importance of swallowing the capsule whole or sprinkling on applesauce; crushing or chewing can lead to rapid release and potential overdose.
- Regularly assess for signs of abuse, misuse, or diversion, given the Schedule II classification.
- Monitor for cardiovascular and psychiatric adverse effects, especially at treatment initiation and during dose adjustments.
Alternative Therapies
- Methylphenidate (e.g., Concerta, Ritalin LA, Focalin XR, Quillivant XR, Jornay PM)
- Atomoxetine (Strattera)
- Guanfacine Extended-Release (Intuniv)
- Clonidine Extended-Release (Kapvay)
- Bupropion (Wellbutrin - off-label for ADHD)
Cost & Coverage
Average Cost:
$300 - $450 per 30 capsules
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor 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 is a patient fact sheet that provides important information. 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 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. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.