Mydayis 50mg 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
Jun 2017
DEA Schedule
Schedule II
Overview
What is this medicine?
Mydayis is an extended-release capsule containing a mixture of amphetamine salts. It is a stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6 years and older), adolescents, and adults. 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 you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce, but do not chew the mixture.
After mixing the medication with applesauce, take your dose immediately. Do not prepare a dose ahead of time or store it 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 your blood pressure. These include:
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 your medication out of the reach of children and pets. Store it in a secure location, such as a locked box or cabinet, 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 you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce, but do not chew the mixture.
After mixing the medication with applesauce, take your dose immediately. Do not prepare a dose ahead of time or store it 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 your blood pressure. These include:
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 your medication out of the reach of children and pets. Store it in a secure location, such as a locked box or cabinet, 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 Mydayis once daily in the morning, with or without food. Taking it in the afternoon or evening can cause sleep problems.
- Swallow the capsule whole. Do not crush, chew, or open the capsule and sprinkle the contents on food, as this will affect the extended-release properties and could lead to a sudden release of the entire dose.
- Avoid alcohol consumption, as it may affect the release of the medication.
- Store at room temperature away from moisture and heat.
- Keep out of reach of children and pets, and store in a secure place to prevent misuse or abuse.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 12.5 mg orally once daily in the morning. May increase by 12.5 mg increments at weekly intervals.
Dose Range:
12.5 - 50 mg
Condition-Specific Dosing:
ADHD:
Initial 12.5 mg once daily, maximum 50 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 12.5 mg orally once daily in the morning. May increase by 12.5 mg increments at weekly intervals, maximum 50 mg once daily.
Adolescent:
13-17 years: Initial 12.5 mg orally once daily in the morning. May increase by 12.5 mg increments at weekly intervals, maximum 50 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for adverse effects.
Moderate:
No specific dose adjustment recommended, but monitor for adverse effects.
Severe:
Consider lower starting dose or alternative therapy. Not extensively studied.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Not extensively studied; use with caution and monitor for adverse effects.
Pharmacology
Mechanism of Action
Amphetamines are non-catecholamine sympathomimetic amines that block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Dextroamphetamine and amphetamine are thought to exert their therapeutic effects in ADHD by stimulating the central nervous system.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (well-absorbed)
Tmax:
Biphasic release: First peak ~4 hours, second peak ~8 hours post-dose.
FoodEffect:
Food (high-fat meal) can delay Tmax by approximately 2.5 hours but does not significantly affect AUC or Cmax.
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:
Not available
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 30-40% (dextroamphetamine) and 45-50% (levoamphetamine) excreted unchanged in urine, highly dependent on urinary pH.
Pharmacodynamics
OnsetOfAction:
Approximately 2 hours
PeakEffect:
Biphasic, with peaks around 4 hours and 8 hours post-dose.
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
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to 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 feeling 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 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.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, 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
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 questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to 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 feeling 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 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.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, 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
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 questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening mental problems (e.g., seeing or hearing things that are not real, paranoia, mania, aggression)
- New tics or worsening of existing tics
- Numbness, coolness, or pain in fingers or toes
- Unexplained weight loss or slowed growth in children
- Severe headache, blurred vision, or seizures
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
+ Drugs for depression or Parkinson's disease (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 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
+ Drugs for depression or Parkinson's disease (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 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.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness and clear vision.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may need higher doses to achieve the same effect. This is known as tolerance. 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.
Dependence and Withdrawal
Long-term or regular use of this medication may lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Before reducing the dose or stopping the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood work done as instructed by your doctor.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests. Inform all of your healthcare providers and lab personnel that you are taking this medication. Do not take antacids with this medication.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or mood changes like depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. If you experience agitation, changes in balance, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache, contact your doctor immediately.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Consumption
Avoid drinking alcohol while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of using this medication during pregnancy.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness and clear vision.
Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may need higher doses to achieve the same effect. This is known as tolerance. 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.
Dependence and Withdrawal
Long-term or regular use of this medication may lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. Before reducing the dose or stopping the medication, consult your doctor and follow their instructions. Report any adverse effects to your doctor.
Heart Tests and Monitoring
You may need to undergo heart tests before starting this medication. If you have questions, discuss them with your doctor. This medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor. Additionally, you will need to have regular blood work done as instructed by your doctor.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests. Inform all of your healthcare providers and lab personnel that you are taking this medication. Do not take antacids with this medication.
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or mood changes like depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, contact your doctor immediately.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. If you experience agitation, changes in balance, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache, contact your doctor immediately.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Different brands of this medication may be approved for use in different age groups. Consult your doctor before giving this medication to a child.
Alcohol Consumption
Avoid drinking alcohol while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid respiration
- Confusion
- Hallucinations
- Panic states
- Hyperpyrexia (very high fever)
- Rhabdomyolysis
- Cardiac arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Convulsions
- Coma
What to Do:
Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Management is primarily supportive, including gastric lavage, activated charcoal, and acidification of the urine to enhance excretion.
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, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome (concurrent use generally not recommended, or use with extreme caution and monitor)
Major Interactions
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life, increasing risk of toxicity.
- Acidifying agents (e.g., ascorbic acid, ammonium chloride, cranberry juice) - decrease amphetamine blood levels and shorten half-life, reducing efficacy.
- Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines.
- Antihypertensive agents - amphetamines may antagonize the hypotensive effects of these drugs.
- Alcohol - may alter the release of amphetamine from the extended-release formulation.
Moderate Interactions
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the CNS stimulant effects of amphetamines.
- Lithium - may inhibit the stimulant effects of amphetamines.
- Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase gastric pH, potentially affecting absorption and increasing exposure.
- CYP2D6 inhibitors (e.g., quinidine, ritonavir, fluoxetine, paroxetine) - may increase amphetamine exposure, increasing risk of adverse effects.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Amphetamines can cause dose-related increases in BP and HR; screen for pre-existing cardiovascular conditions.
Timing: Prior to initiation
Height and Weight
Rationale: Monitor for growth suppression in pediatric patients and weight loss in all patients.
Timing: Prior to initiation
Psychiatric History (e.g., bipolar disorder, psychosis, tics)
Rationale: Amphetamines can exacerbate or induce psychiatric symptoms.
Timing: Prior to initiation
Cardiovascular Assessment (e.g., ECG)
Rationale: Consider if patient has pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.
Timing: Prior to initiation (as clinically indicated)
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or every 3-6 months
Target: Within normal limits for age/patient
Action Threshold: Sustained elevation requiring intervention or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric); annually (adult)
Target: Normal growth trajectory (pediatric); stable weight (adult)
Action Threshold: Significant growth deceleration or unexplained weight loss.
Psychiatric Symptoms (e.g., agitation, aggression, psychosis, mania, tics)
Frequency: At each visit
Target: Absence of new or worsening symptoms
Action Threshold: Emergence or worsening of symptoms requiring dose adjustment or discontinuation.
ADHD Symptom Control and Functional Improvement
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity, improved functioning
Action Threshold: Lack of efficacy or intolerable side effects.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- New or worsening psychiatric symptoms (e.g., hallucinations, paranoia, mania, aggression)
- New onset or worsening tics
- Unexplained weight loss
- Sleep disturbances
- Anxiety
- Restlessness
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended. Amphetamines may 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 increased risk of congenital malformations, though data are conflicting.
Second Trimester:
Risk of premature birth and low birth weight.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress).
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 treatment with Mydayis.
Infant Risk:
High (L4 - Potentially hazardous)
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Monitor for cardiovascular and psychiatric adverse events. Safety and efficacy in children younger than 6 years have not been established.
Geriatric Use
Use with caution in elderly patients. Start with the lowest effective dose and titrate slowly, as geriatric patients may be more sensitive to the adverse effects of stimulants, particularly cardiovascular effects.
Clinical Information
Clinical Pearls
- Mydayis is the longest-acting amphetamine formulation available, providing up to 16 hours of symptom control, which can be beneficial for patients needing coverage throughout the school/work day and into the evening.
- The triple-bead technology provides a unique release profile, with three different types of beads releasing medication at different times.
- Due to its long duration of action, it should be taken early in the morning to avoid sleep disturbances.
- Patients should be educated on the importance of swallowing the capsule whole to maintain the extended-release properties and prevent dose dumping.
- Careful monitoring for cardiovascular and psychiatric side effects is crucial, especially in patients with pre-existing conditions.
Alternative Therapies
- Methylphenidate extended-release formulations (e.g., Concerta, Ritalin LA, Quillivant XR, Adhansia XR)
- Non-stimulants (e.g., Atomoxetine (Strattera), Guanfacine extended-release (Intuniv), Clonidine extended-release (Kapvay))
- Behavioral therapy
Cost & Coverage
Average Cost:
Varies, typically $300-$600+ per 30 capsules
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.