Mydayis 25mg ER Capsules
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
Pregnancy Category
Not available
FDA Approved
Jan 2015
DEA Schedule
Schedule II
Overview
What is this medicine?
Mydayis is an extended-release capsule containing a combination of amphetamine salts. It's used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in people 13 years and older. It works by affecting certain natural chemicals in the brain to help improve attention, focus, and reduce impulsivity and hyperactivity. Because it's extended-release, it's designed to work for up to 16 hours 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:
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 it's essential to take it the same way each time. Choose to always take it with food or always 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, you can sprinkle the contents of the capsule on applesauce, but be sure not to chew the mixture.
After mixing the medication with applesauce, take your dose immediately. 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're 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, avoiding storage 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.
* 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 it's essential to take it the same way each time. Choose to always take it with food or always 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, you can sprinkle the contents of the capsule on applesauce, but be sure not to chew the mixture.
After mixing the medication with applesauce, take your dose immediately. 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're 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, avoiding storage 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.
* 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 Mydayis exactly as prescribed by your doctor, usually once daily in the morning. Taking it in the afternoon or evening can cause trouble sleeping.
- Do not crush, chew, or divide the capsule. Swallow it whole. If you cannot swallow the capsule whole, you may open it and sprinkle the contents onto a spoonful of applesauce and consume immediately.
- Avoid alcohol while taking this medication, as it can increase side effects.
- Maintain a healthy diet and regular exercise. Monitor your weight, especially if you experience appetite suppression.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, as interactions can occur.
- Store the medication securely to prevent misuse or abuse.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 12.5 mg once daily in the morning. May be titrated weekly by 12.5 mg increments.
Dose Range:
12.5 - 50 mg
Condition-Specific Dosing:
ADHD:
Administer orally once daily in the morning. Do not take in the afternoon or evening due to potential for insomnia. Capsules may be swallowed whole or opened and sprinkled onto a spoonful of applesauce.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Mydayis is approved for adolescents 13 years and older)
Adolescent:
For patients 13 years and older: Initial 12.5 mg once daily in the morning. May be titrated weekly by 12.5 mg increments up to a maximum of 50 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Consider lower doses or avoid use in patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease (ESRD).
Dialysis:
Not specifically studied, but amphetamines are not significantly removed by hemodialysis. Consider lower doses or avoid.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but use with caution due to potential for altered 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 their reuptake. The exact mechanism of action in ADHD is not fully understood but is thought to involve modulation of central noradrenergic and dopaminergic pathways.
Pharmacokinetics
Absorption:
Bioavailability:
High (approximately 75% for dextroamphetamine, 60% for levoamphetamine)
Tmax:
Mydayis exhibits a tri-phasic release profile. Initial peak at approximately 4-5 hours, followed by second and third peaks at approximately 8-9 hours and 12-13 hours post-dose, respectively.
FoodEffect:
Food (high-fat meal) can delay Tmax by approximately 2.5 hours but does not significantly affect AUC (extent of absorption).
Distribution:
Vd:
Approximately 3-4 L/kg
ProteinBinding:
Low (15-20%)
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Levoamphetamine: 9-11 hours (pH-dependent)
Clearance:
Highly variable, dependent on urinary pH.
ExcretionRoute:
Renal (primarily unchanged drug and metabolites)
Unchanged:
Approximately 30-50% (dextroamphetamine) and 40% (levoamphetamine) excreted unchanged in urine at normal urinary pH. Increases with acidic urine, decreases with alkaline urine.
Pharmacodynamics
OnsetOfAction:
Within 1-2 hours (initial release)
PeakEffect:
Multiple peaks due to tri-phasic release, with effects sustained throughout the day.
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
Urgent 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 or seek immediate 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 or 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 or pelvic pain
Other severe side effects, including:
+ Erectile dysfunction
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
+ Restlessness
+ Changes in eyesight
+ Prolonged or frequent erections
+ Changes in skin color, such as pale, blue, gray, purple, or red discoloration
+ 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, or trouble passing urine
Heart problems, including:
+ Sudden death (rarely occurs in people with pre-existing heart problems or defects)
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
If you have a heart condition or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek immediate medical attention if you experience any signs of heart problems.
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 report any concerns to your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
* Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, 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 or seek immediate 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 or 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 or pelvic pain
Other severe side effects, including:
+ Erectile dysfunction
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
+ Restlessness
+ Changes in eyesight
+ Prolonged or frequent erections
+ Changes in skin color, such as pale, blue, gray, purple, or red discoloration
+ 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, or trouble passing urine
Heart problems, including:
+ Sudden death (rarely occurs in people with pre-existing heart problems or defects)
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
If you have a heart condition or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek immediate medical attention if you experience any signs of heart problems.
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 report any concerns to your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
* Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, or irritability
- New or worsening thoughts of harming yourself or others
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New or worsening tics (uncontrolled movements or sounds)
- Unexplained numbness, pain, or discoloration in fingers or toes
- Severe headache, blurred vision, or confusion (signs of high blood pressure)
- Unexplained weight loss or significant appetite suppression
- Severe insomnia
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, 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
+ A history of drug abuse
+ A history of stroke
Kidney disease, as this may affect how your body processes the medication
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Antidepressants or Parkinson's disease medications (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 breast-feed while taking this medication
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. 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, 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
+ A history of drug abuse
+ A history of stroke
Kidney disease, as this may affect how your body processes the medication
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Antidepressants or Parkinson's disease medications (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 breast-feed while taking this medication
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor.
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. This will help ensure that you receive the best possible care.
Caution: Potential Effects on Daily Activities
Until you know how this medication affects you, avoid driving and engaging in other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Tolerance and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. However, do not take more than the prescribed dose. Long-term or regular use of this medication can also lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this may cause withdrawal symptoms. Instead, consult your doctor, who will provide guidance on how to safely reduce or stop the medication.
Monitoring and Follow-Up
Before starting this medication, you may need to undergo certain heart tests. Your doctor will discuss this with you and answer any questions you may have. While taking this medication, 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 to check for any potential side effects. Be sure to inform your doctor about any adverse effects you experience.
Interactions with Other Medications and Lab Tests
This medication may interact with 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 while taking this medication, as this can interfere with its effectiveness.
Mental Health and Mood Changes
In some cases, this medication can cause changes in behavior and mood, including hallucinations, anger, and changes in 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 of the following symptoms, contact your doctor immediately: hallucinations, changes in behavior, depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those who have a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Serotonin Syndrome
A rare but potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other medications. If you experience any of the following symptoms, contact your doctor immediately: 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.
Effects on Growth in Children and Teens
In some cases, this medication can affect growth in children and teens. If your child is taking this medication, they may need regular growth checks. Different brands of this medication may be approved for use in different age groups, so consult your doctor before giving this medication to a child.
Alcohol and Pregnancy
Avoid consuming alcohol while taking this medication. If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the benefits and risks of taking this medication during pregnancy with you.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Caution: Potential Effects on Daily Activities
Until you know how this medication affects you, avoid driving and engaging in other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Tolerance and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. However, do not take more than the prescribed dose. Long-term or regular use of this medication can also lead to dependence. If you need to stop taking this medication, do not do so abruptly, as this may cause withdrawal symptoms. Instead, consult your doctor, who will provide guidance on how to safely reduce or stop the medication.
Monitoring and Follow-Up
Before starting this medication, you may need to undergo certain heart tests. Your doctor will discuss this with you and answer any questions you may have. While taking this medication, 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 to check for any potential side effects. Be sure to inform your doctor about any adverse effects you experience.
Interactions with Other Medications and Lab Tests
This medication may interact with 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 while taking this medication, as this can interfere with its effectiveness.
Mental Health and Mood Changes
In some cases, this medication can cause changes in behavior and mood, including hallucinations, anger, and changes in 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 of the following symptoms, contact your doctor immediately: hallucinations, changes in behavior, depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those who have a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Serotonin Syndrome
A rare but potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other medications. If you experience any of the following symptoms, contact your doctor immediately: 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.
Effects on Growth in Children and Teens
In some cases, this medication can affect growth in children and teens. If your child is taking this medication, they may need regular growth checks. Different brands of this medication may be approved for use in different age groups, so consult your doctor before giving this medication to a child.
Alcohol and Pregnancy
Avoid consuming alcohol while taking this medication. If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the benefits and risks of taking this medication during pregnancy with you.
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 your local emergency number. For poison control, call 1-800-222-1222. Management typically involves symptomatic and supportive measures, including gastric lavage, activated charcoal, and acidification of urine to enhance excretion.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Antihypertensive agents - amphetamines may decrease the hypotensive effect of these drugs
- Halogenated anesthetics - risk of sudden blood pressure and heart rate increases
- Urinary alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life
- Urinary acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine blood levels and shorten half-life
Moderate Interactions
- Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines
- CYP2D6 inhibitors (e.g., quinidine, paroxetine, fluoxetine, bupropion) - may increase amphetamine exposure
- Phenothiazines (e.g., chlorpromazine) - may inhibit amphetamine effects
- Antacids containing magnesium or aluminum - may delay absorption of amphetamines
Minor Interactions
- Not specifically categorized as minor, but general caution with other CNS stimulants or adrenergic agents.
Monitoring
Baseline Monitoring
Cardiovascular assessment (BP, HR, ECG if clinically indicated)
Rationale: To identify pre-existing cardiac conditions that may contraindicate or require caution with stimulant use.
Timing: Prior to initiation
Psychiatric history (including family history of bipolar disorder, psychosis, tics)
Rationale: To assess risk for stimulant-induced psychiatric symptoms or exacerbation of underlying conditions.
Timing: Prior to initiation
Height and Weight (especially in pediatric/adolescent patients)
Rationale: To establish baseline for monitoring growth suppression.
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; monitor for sustained elevations
Action Threshold: Persistent elevation above normal range, or significant increase from baseline (e.g., >10-20 mmHg SBP/DBP, >10-20 bpm HR) warrants investigation and potential dose adjustment or discontinuation.
Weight and Height (pediatric/adolescent)
Frequency: Every 3-6 months
Target: Maintain growth trajectory
Action Threshold: Significant deviation from expected growth curve (e.g., crossing two major percentile lines) warrants investigation and potential dose adjustment or drug holiday.
Psychiatric status (mood, anxiety, tics, psychotic symptoms, aggression)
Frequency: At each visit
Target: Stable mood, absence of new or worsening psychiatric symptoms
Action Threshold: Emergence of new psychotic symptoms, manic episodes, severe anxiety, aggression, or tics warrants immediate evaluation and potential discontinuation.
ADHD symptom control and functional improvement
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning
Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- New or worsening manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
- New or worsening tics
- Severe anxiety or agitation
- Unexplained weight loss
- Insomnia
- Dry mouth
- Loss of appetite
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, including premature birth and low birth weight. Neonates exposed to amphetamines during the third trimester are at risk for withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for increased risk of congenital malformations not definitively established.
Second Trimester:
Potential for growth restriction and premature birth.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress) and premature birth.
Lactation
Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, insomnia, weight loss, cardiovascular effects), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderate risk) - Monitor infant for irritability, sleep disturbances, poor feeding, and weight loss. Long-term effects are unknown.
Pediatric Use
Mydayis is approved for adolescents 13 years and older. Safety and effectiveness have not been established in pediatric patients younger than 13 years of age. Monitor growth (height and weight) in pediatric patients receiving long-term stimulant treatment.
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 the longest duration of action (up to 16 hours) among currently available amphetamine products, making it suitable for patients needing symptom control throughout the entire school or workday.
- The tri-phasic release profile aims to provide consistent symptom control with multiple peaks, reducing the need for midday dosing.
- It is crucial to administer Mydayis early in the morning to avoid insomnia, given its prolonged duration of action.
- Patients should be advised not to crush, chew, or open the capsules unless sprinkling on applesauce, as this can alter the extended-release properties and lead to a rapid release of the drug, increasing side effects and abuse potential.
- Careful cardiovascular and psychiatric screening is essential before initiating treatment and throughout therapy due to the potential for serious adverse events.
- Monitor for signs of abuse or diversion, as amphetamines are Schedule II controlled substances.
Alternative Therapies
- Lisdexamfetamine (Vyvanse - prodrug of dextroamphetamine)
- Methylphenidate extended-release products (e.g., Concerta, Ritalin LA, Quillivant XR, Jornay PM)
- Non-stimulants (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay))
- Behavioral therapy and psychotherapy
Cost & Coverage
Average Cost:
Varies widely, typically $300-$500+ per 30 capsules
Insurance Coverage:
Tier 2 or Tier 3 (Brand-name prescription drug), may require prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, 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 provides crucial information about its use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication, the amount taken, and the time it was ingested.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication, the amount taken, and the time it was ingested.