Mydayis 12.5mg 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
Amphetamine
Pregnancy Category
Not available
FDA Approved
Jun 2017
DEA Schedule
Schedule II
Overview
What is this medicine?
Mydayis is an extended-release capsule containing a combination of two stimulant medications, dextroamphetamine and amphetamine. It is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children 6 years and older. It works by affecting certain natural chemicals in the brain to help improve attention, focus, and reduce impulsivity and hyperactivity.
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 needed, you can sprinkle the contents of the capsule on applesauce, but do not 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 are 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.
Do not store your medication in a bathroom.
* Keep it out of reach of children and pets, and consider storing it in a locked box or secure area to prevent accidental ingestion or misuse.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take a 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 needed, you can sprinkle the contents of the capsule on applesauce, but do not 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 are 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.
Do not store your medication in a bathroom.
* Keep it out of reach of children and pets, and consider storing it in a locked box or secure area to prevent accidental ingestion or misuse.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take a 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 as it may cause sleep problems.
- Swallow the capsule whole. Do not chew, crush, or open the capsule and sprinkle the contents on food, as this will affect the extended-release properties and may lead to a sudden release of the entire dose.
- Avoid alcohol consumption while taking Mydayis, as it may cause the medication to be released too quickly.
- Store at room temperature away from moisture and heat. Keep out of reach of children.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially MAOIs, antidepressants, and blood pressure medications.
- Do not stop taking Mydayis suddenly without consulting your doctor, as withdrawal symptoms may occur.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
12.5 mg orally once daily in the morning
Dose Range:
12.5 - 50 mg
Condition-Specific Dosing:
ADHD:
Initial dose 12.5 mg once daily in the morning. May increase by 12.5 mg increments weekly to a maximum of 50 mg/day. Doses above 50 mg/day have not been studied.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 6 years of age.
Adolescent:
For children 6 to 12 years: Initial dose 12.5 mg orally once daily in the morning. May increase by 12.5 mg increments weekly to a maximum of 50 mg/day. For adolescents 13 to 17 years: Initial dose 12.5 mg orally once daily in the morning. May increase by 12.5 mg increments weekly to a maximum of 50 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (eGFR 60-89 mL/min/1.73 m²)
Moderate:
Consider lower starting dose (eGFR 30-59 mL/min/1.73 m²). Max dose 37.5 mg/day.
Severe:
Consider lower starting dose (eGFR <30 mL/min/1.73 m²). Max dose 25 mg/day.
Dialysis:
Not studied. Avoid use due to potential for accumulation and lack of data.
Hepatic Impairment:
Mild:
No dosage adjustment needed
Moderate:
No dosage adjustment needed
Severe:
No dosage adjustment needed
Pharmacology
Mechanism of Action
Amphetamines are non-catecholamine sympathomimetic amines that exert their therapeutic effect in ADHD by releasing norepinephrine and dopamine from presynaptic nerve terminals in the brain. They also inhibit the reuptake of these monoamines into the presynaptic neuron. 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:
Approximately 75% (for mixed amphetamine salts)
Tmax:
Biphasic absorption: Initial peak at 4 hours, second peak at 8 hours (for Mydayis ER).
FoodEffect:
High-fat meal may delay Tmax by 2.5 hours but does not affect overall absorption (AUC).
Distribution:
Vd:
Approximately 3.7-5.1 L/kg
ProteinBinding:
15-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Levoamphetamine: 11-14 hours (pH dependent)
Clearance:
Highly dependent on urinary pH. Acidic urine increases clearance.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-40% (pH dependent)
Pharmacodynamics
OnsetOfAction:
Within 1-2 hours
PeakEffect:
Approximately 4-8 hours (biphasic release)
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 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 urinate
+ Fever
+ Lower stomach pain or pelvic pain
Other serious side effects, including:
+ Erectile dysfunction
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Uncontrollable 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, or trouble passing urine
Important Heart-Related Information
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dizziness, tiredness, or weakness
Dry mouth
Bad taste in the mouth
Weight loss
Reporting Side Effects
If you have questions about side effects or want to report any side effects, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects 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 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 urinate
+ Fever
+ Lower stomach pain or pelvic pain
Other serious side effects, including:
+ Erectile dysfunction
+ Changes in sex interest
+ Seizures
+ Trouble controlling body movements
+ Uncontrollable 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, or trouble passing urine
Important Heart-Related Information
If you have a heart problem or defect, or if a family member has an abnormal heartbeat or died suddenly, inform your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or passing out
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dizziness, tiredness, or weakness
Dry mouth
Bad taste in the mouth
Weight loss
Reporting Side Effects
If you have questions about side effects or want to report any side effects, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects 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)
- Numbness, pain, skin color change (pale, blue, red) or unexplained wounds on fingers or toes (Raynaud's phenomenon)
- New or worsening mental problems (e.g., hallucinations, delusions, paranoia, aggression, mania)
- Unexplained muscle twitching or tics
- Blurred vision or other vision changes
- Severe headache
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, 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 taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (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 use. 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
+ Antidepressants or Parkinson's disease medications taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (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 use. Do not start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Testing
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor. Regularly check your blood pressure and heart rate as directed by your doctor. Also, have blood work done as instructed by your doctor, and inform them of any unusual results.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug. Do not take antacids with this medication, as it may interact with the drug.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as altered 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 disorder, or if a family member has committed suicide, inform your doctor. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Different brands of this medication may be suitable for different age groups, so 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, discuss the benefits and risks of using this medication with your doctor.
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Testing
You may need to undergo heart tests before starting this medication. If you have questions or concerns, discuss them with your doctor. Regularly check your blood pressure and heart rate as directed by your doctor. Also, have blood work done as instructed by your doctor, and inform them of any unusual results.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug. Do not take antacids with this medication, as it may interact with the drug.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as altered 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 disorder, or if a family member has committed suicide, inform your doctor. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Different brands of this medication may be suitable for different age groups, so 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, discuss the benefits and risks of using this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- Hypertensive crisis
- Cardiac arrhythmias
- Circulatory collapse
- Seizures
- Coma
What to Do:
Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis)
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
Major Interactions
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine levels and prolong half-life
- Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine levels and shorten half-life
- Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines
- Antihypertensives - amphetamines may reduce the effectiveness of antihypertensive drugs
- Alcohol - may alter release rate of amphetamine from ER capsules, leading to dose dumping
Moderate Interactions
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure
- Phenothiazines (e.g., chlorpromazine) - may inhibit amphetamine effects
- Haloperidol - may inhibit amphetamine effects
- Lithium - may inhibit amphetamine effects
- Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may alter gastric pH, potentially affecting absorption (less significant for ER formulations)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Amphetamines can cause increases in BP and HR.
Timing: Prior to initiation of therapy.
Height and Weight
Rationale: Monitor for growth suppression, especially in pediatric patients.
Timing: Prior to initiation of therapy.
Cardiac history (personal and family)
Rationale: Assess for pre-existing cardiac conditions that may contraindicate stimulant use.
Timing: Prior to initiation of therapy.
Psychiatric history (personal and family)
Rationale: Assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated.
Timing: Prior to initiation of therapy.
Drug abuse history
Rationale: Assess for risk of abuse and dependence.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly, at each visit or at least every 3-6 months.
Target: Maintain within normal limits for age.
Action Threshold: Significant or sustained increases warrant dose reduction or discontinuation.
Height and Weight
Frequency: Every 3-6 months in pediatric patients.
Target: Maintain normal growth trajectory.
Action Threshold: Significant growth deceleration may require drug holiday or alternative treatment.
ADHD symptom control
Frequency: Regularly, at each visit.
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or re-evaluation.
Emergence of new psychiatric symptoms (e.g., psychosis, mania, aggression)
Frequency: Regularly, at each visit.
Target: Absence of new or worsening symptoms.
Action Threshold: Prompt evaluation and potential discontinuation.
Signs of drug abuse or diversion
Frequency: Regularly, at each visit.
Target: Absence of signs.
Action Threshold: Address immediately, consider discontinuation or referral.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Depression
- Tics or dyskinesia
- Numbness, coolness, or pain in fingers/toes (Raynaud's phenomenon)
- Unexplained wounds on fingers/toes
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, including premature birth and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations (limited data, but generally avoided).
Second Trimester:
Risk of premature birth and low birth weight.
Third Trimester:
Risk of premature birth, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence).
Lactation
Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, poor feeding, weight loss, cardiovascular effects), breastfeeding is not recommended during Mydayis treatment.
Infant Risk:
High (L5)
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms.
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 is a triple-bead extended-release formulation designed to provide symptom control for up to 16 hours, potentially covering the entire school/work day and into the evening.
- The capsule should be swallowed whole; opening or crushing the capsule will disrupt the extended-release mechanism and can lead to dose dumping and increased side effects.
- Patients should be advised to take Mydayis as early in the morning as possible to avoid insomnia.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
- Educate patients and caregivers about the high abuse potential and the importance of secure storage and proper disposal.
- Consider a drug holiday if growth suppression is observed in pediatric patients, or if long-term efficacy needs re-evaluation.
Alternative Therapies
- Methylphenidate-based stimulants (e.g., Concerta, Ritalin LA, Focalin XR, Quillivant XR, Jornay PM)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy and psychotherapy
Cost & Coverage
Average Cost:
Varies widely, typically $300-$600 per 30 capsules
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription drug)
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 provides crucial information for patients. 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 your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the quantity, and the time it occurred.