Mydayis 37.5mg 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 Stimulant
Pharmacologic Class
Sympathomimetic Amine
Pregnancy Category
C
FDA Approved
Jun 2017
DEA Schedule
Schedule II
Overview
What is this medicine?
Mydayis is an extended-release capsule containing a mixture of amphetamine salts. It's used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to increase focus and reduce impulsivity and hyperactivity. It works by affecting certain natural chemicals in the brain.
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 medicines
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.
* 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 medicines
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.
* 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 once daily in the morning, consistently at the same time, with or without food.
- Do not take Mydayis in the afternoon or evening as it may cause sleep problems.
- Swallow the capsule whole; do not chew, crush, or divide it. If unable to swallow, the capsule may be opened and the contents sprinkled over a spoonful of applesauce and consumed immediately.
- Avoid alcohol consumption while taking this 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.
- Report any new or worsening psychiatric symptoms (e.g., hallucinations, paranoia, aggression) or signs of heart problems (e.g., chest pain, fainting) immediately.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 12.5 mg orally once daily in the morning. Titrate in increments of 12.5 mg at weekly intervals. Max: 50 mg once daily.
Dose Range:
12.5 - 50 mg
Condition-Specific Dosing:
ADHD:
Initial: 12.5 mg once daily. Max: 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. Titrate in increments of 12.5 mg at weekly intervals. Max: 50 mg once daily.
Adolescent:
13-17 years: Initial: 12.5 mg orally once daily in the morning. Titrate in increments of 12.5 mg at weekly intervals. Max: 50 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 60-89 mL/min)
Moderate:
Consider lower dose (CrCl 30-59 mL/min). Max dose 25 mg/day.
Severe:
Contraindicated (CrCl < 30 mL/min)
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
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. They also block the reuptake of these monoamines, leading to increased concentrations in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (dextroamphetamine) to 80% (levoamphetamine) for immediate release, similar for extended release.
Tmax:
Bimodal/Trimodal release: Initial peak at 2-4 hours, second peak at 7-8 hours, third peak at 10-11 hours (for Mydayis).
FoodEffect:
High-fat meal may delay Tmax by 2.5 hours but does not significantly affect AUC or Cmax.
Distribution:
Vd:
0.9-1.2 L/kg
ProteinBinding:
15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Levoamphetamine: 11-14 hours (for Mydayis, due to extended release, effective duration is longer).
Clearance:
Highly dependent on urinary pH.
ExcretionRoute:
Renal
Unchanged:
30-40% (acidic urine), 1% (alkaline urine)
Pharmacodynamics
OnsetOfAction:
Within 1-2 hours (initial release)
PeakEffect:
Multiple peaks, with sustained effect throughout the day.
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 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 while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Other serious 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 sensation in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness
+ Dark urine
+ 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 a history of abnormal heart rhythms or sudden death, inform your doctor. Seek medical help immediately if you experience any signs of heart problems.
Other 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 or seek medical attention if you notice any of the following:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
Weight loss
This is not an exhaustive list of potential side effects. If you have concerns or questions, 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 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 while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Other serious 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 sensation in the hands or feet
+ Sores or wounds on the fingers or toes
+ Muscle pain or weakness
+ Dark urine
+ 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 a history of abnormal heart rhythms or sudden death, inform your doctor. Seek medical help immediately if you experience any signs of heart problems.
Other 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 or seek medical attention if you notice any of the following:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in the mouth
Weight loss
This is not an exhaustive list of potential side effects. If you have concerns or questions, 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
- Fainting or dizziness
- Palpitations (fast or pounding heartbeat)
- Numbness, pain, or discoloration in fingers or toes
- Unexplained wounds on fingers or toes
- New or worsening aggression or hostility
- New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
- New or worsening manic symptoms (e.g., extreme energy, racing thoughts)
- Uncontrolled muscle movements or vocal tics
- 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, 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
+ Certain antidepressants or Parkinson's disease medications (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) taken 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe treatment. Do not 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, 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
+ Certain antidepressants or Parkinson's disease medications (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) taken 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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.
When you first start taking this medication, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. Wait until you understand how this medication affects you before engaging in such activities.
Long-term or high-dose use of this medication can lead to tolerance, where the medication 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 this 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 it is safe for you to take. If you have any questions or concerns, discuss them with your doctor.
This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as directed by your doctor, and have regular blood tests to check for any potential effects on your blood work.
It is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests. Additionally, do not take antacids while taking this medication, as they may interact with it.
There is a risk of new or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, associated with this medication. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor to determine if you are more susceptible to seizures while taking this medication.
A rare but potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, 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.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and your doctor will discuss the potential risks and benefits with you. Note that 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.
Avoid consuming alcohol while taking this medication, as it may increase the risk of adverse effects. If you are pregnant or plan to become pregnant, discuss the potential benefits and risks of taking this medication with your doctor.
When you first start taking this medication, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. Wait until you understand how this medication affects you before engaging in such activities.
Long-term or high-dose use of this medication can lead to tolerance, where the medication 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 this 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 it is safe for you to take. If you have any questions or concerns, discuss them with your doctor.
This medication may cause an increase in blood pressure. Monitor your blood pressure and heart rate as directed by your doctor, and have regular blood tests to check for any potential effects on your blood work.
It is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests. Additionally, do not take antacids while taking this medication, as they may interact with it.
There is a risk of new or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, associated with this medication. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor to determine if you are more susceptible to seizures while taking this medication.
A rare but potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience symptoms such as agitation, balance problems, 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.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and your doctor will discuss the potential risks and benefits with you. Note that 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.
Avoid consuming alcohol while taking this medication, as it may increase the risk of adverse effects. If you are pregnant or plan to become pregnant, discuss the potential benefits and risks of taking this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid respiration
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia
- 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.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine levels
Major Interactions
- Acidifying agents (e.g., ascorbic acid, guanethidine) - decrease amphetamine levels
- Tricyclic Antidepressants (TCAs) - increased cardiovascular effects
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans) - risk of serotonin syndrome
- Antihypertensives - amphetamines may counteract effects
- Halogenated Anesthetics - risk of arrhythmias
Moderate Interactions
- Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may alter absorption
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - increase amphetamine exposure
- Antipsychotics - may antagonize stimulant effects
- Lithium - may inhibit stimulant effects
Minor Interactions
- Not specifically categorized as minor, but caution with other CNS stimulants or adrenergic agents.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Risk of cardiovascular events, including hypertension and tachycardia.
Timing: Prior to initiation
Height and Weight
Rationale: Risk of growth suppression in pediatric patients.
Timing: Prior to initiation
Psychiatric History (including family history of suicide, bipolar disorder, tics)
Rationale: Risk of new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression, tics).
Timing: Prior to initiation
Pre-existing cardiac conditions (e.g., structural abnormalities, arrhythmias)
Rationale: Contraindicated in patients with symptomatic cardiovascular disease.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or every 3-6 months
Target: Within normal limits for age/sex
Action Threshold: Sustained elevation requiring intervention or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric patients)
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss.
Psychiatric Status (e.g., mood, behavior, presence of tics, psychotic symptoms)
Frequency: At each visit
Target: Stable, improved ADHD symptoms, no new or worsening psychiatric symptoms
Action Threshold: Emergence of psychosis, mania, severe anxiety, aggression, or tics.
ADHD Symptom Control
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity
Action Threshold: Lack of efficacy or intolerable side effects.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Repetitive movements or vocalizations (tics)
- Unexplained weight loss
- Blurred vision
Special Patient Groups
Pregnancy
Category C. Amphetamines may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to amphetamines in utero may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are conflicting.
Second Trimester:
Risk of premature birth, low birth weight.
Third Trimester:
Risk of withdrawal symptoms (e.g., agitation, tremor, poor feeding) in the neonate.
Lactation
Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, poor feeding, weight loss, cardiovascular effects), advise mothers not to breastfeed during treatment with Mydayis.
Infant Risk:
L3 (Moderate risk) - Potential for irritability, poor sleep, poor weight gain, and cardiovascular effects in the infant. Long-term effects unknown.
Pediatric Use
Approved for ADHD in patients 6 years and older. Monitor growth (height and weight) regularly, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Generally, 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 long duration of action (up to 16 hours), which may be beneficial for patients needing symptom control throughout the school/work day and into the evening.
- The triple-bead release system provides three distinct peaks of plasma concentration, aiming for sustained efficacy.
- Counsel patients on the importance of morning dosing to avoid insomnia.
- Emphasize the abuse potential and the importance of storing the medication securely.
- Regular monitoring of cardiovascular parameters and growth in children is crucial.
- Patients should be screened for pre-existing cardiac conditions and psychiatric disorders before initiation.
Alternative Therapies
- Methylphenidate extended-release formulations (e.g., Concerta, Ritalin LA, Quillivant XR, Jornay PM)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy
Cost & Coverage
Average Cost:
$300 - $500+ per 30 capsules
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
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, a patient fact sheet that provides crucial information. 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 call 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 taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. 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 call 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 taken, the quantity, and the time it occurred.