D-Amphetamine ER 37.5mg Slt Cmb 3b
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; indirectly acting adrenergic agonist
Pregnancy Category
Not available
FDA Approved
Jun 2017
DEA Schedule
Schedule II
Overview
What is this medicine?
Mydayis is an extended-release medication containing a combination of amphetamine salts. It's used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to improve focus, attention, and control over impulsive behavior. 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 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, locked box or area to prevent accidental ingestion or misuse.
Keep all medications away from pets to avoid accidental ingestion.
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, locked box or area to prevent accidental ingestion or misuse.
Keep all medications away from pets to avoid accidental ingestion.
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 too late in the day can cause sleep problems.
- Swallow the capsule whole; do not chew, crush, or open the capsule and sprinkle the contents on food, as this can affect the extended-release mechanism and lead to a sudden release of the entire dose.
- Avoid alcohol, as it may cause a rapid release of the medication.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Regularly monitor your blood pressure and heart rate as advised by your doctor.
- Maintain a healthy diet and regular exercise. For children, monitor growth and weight regularly.
Available Forms & Alternatives
Available Strengths:
- D-Amphetamine Salt Combo 5mg Tabs
- D-Amphetamine Salt Combo 10mg Tab
- D-Amphetamine Salt Combo 20mg Tabs
- D-Amphetamine Salt Combo 30mg Tabs
- D-Amphetamine Salt Combo 15mg Tabs
- D-Amphetamine Salt Combo 7.5mg Tabs
- D-Amphetamine Salt Combo 12.5mg Tb
- D-Amphetamine ER 30mg Salt Combo CP
- D-Amphetamine ER 20mg Salt Combo CP
- D-Amphetamine ER 10mg Salt Combo CP
- D-Amphetamine ER 5mg Salt Combo CP
- D-Amphetamine ER 25mg Salt Combo CP
- D-Amphetamine ER 15mg Salt Combo CP
- D-Amphetamine Salt Combo 10mg Tab
- D-Amphetamine ER 12.5mg Slt Cmb 3b
- D-Amphetamine ER 37.5mg Slt Cmb 3b
- D-Amphetamine ER 50mg Slt Cmb 3b CP
- D-Amphetamine ER 25mg Slt Cmb 3b CP
Dosing & Administration
Adult Dosing
Standard Dose:
12.5 mg once daily in the morning, titrated weekly by 12.5 mg increments to a maximum of 50 mg/day.
Dose Range:
12.5 - 50 mg
Condition-Specific Dosing:
ADHD:
Initial 12.5 mg once daily in the morning. The 37.5 mg strength is a maintenance dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6-12 years: Initial 12.5 mg once daily in the morning. Titrate weekly by 12.5 mg increments to a maximum of 50 mg/day.
Adolescent:
For adolescents 13-17 years: Initial 12.5 mg once daily in the morning. Titrate weekly by 12.5 mg increments to a maximum of 50 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
For CrCl < 30 mL/min: Consider a lower dose or extended dosing interval. Specific recommendations are not provided in the label, but caution is advised due to reduced excretion.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but caution is advised due to potential for altered metabolism.
Confidence:
Medium
Pharmacology
Mechanism of Action
Dextroamphetamine and amphetamine are non-catecholamine sympathomimetic amines that exert their therapeutic effect in ADHD by increasing the release of norepinephrine and dopamine from presynaptic nerve terminals in the brain, and by blocking the reuptake of these monoamines into the presynaptic neuron. This leads to increased concentrations of norepinephrine and dopamine in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
High (approximately 75% for d-amphetamine, 50% for l-amphetamine)
Tmax:
Mydayis has a triple-bead release system, resulting in three plasma concentration peaks: approximately 4 hours, 8 hours, and 16 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:
Approximately 16-20%
CnssPenetration:
Yes
Elimination:
HalfLife:
D-amphetamine: 10-13 hours; L-amphetamine: 11-14 hours (pH-dependent)
Clearance:
Highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine.
ExcretionRoute:
Renal
Unchanged:
Approximately 30-40% (d-amphetamine) and 50% (l-amphetamine) excreted unchanged in urine at normal urinary pH. Up to 70% in acidic urine.
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours
PeakEffect:
Multiple peaks due to triple-bead release (approx. 4, 8, and 16 hours)
DurationOfAction:
Up to 16 hours
Safety & Warnings
BLACK BOX WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ 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 severe 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 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 immediate medical attention if you experience any signs of heart problems.
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to contact your doctor if you're bothered by 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 possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ 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 severe 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 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 immediate medical attention if you experience any signs of heart problems.
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to contact your doctor if you're bothered by 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 possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, or irritability
- New or worsening thoughts of harming yourself or others
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New or worsening manic symptoms (e.g., extreme energy, racing thoughts)
- Unexplained numbness, tingling, or pain in fingers or toes, or changes in skin color (from pale to blue to red)
- Unexplained weight loss or significant growth deceleration in children
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 take this medication while nursing
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ A history of drug abuse
+ A history of stroke
Kidney disease, as this may affect how your body processes the medication
Current or recent use of certain medications, including:
+ Acetazolamide
+ Sodium bicarbonate
+ Antidepressants or Parkinson's disease medications 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 take this medication while nursing
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
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 lead to 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, and follow their instructions carefully. Report any adverse effects to your doctor.
Before starting this medication, you may need to undergo heart tests to ensure your safety. 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. Additionally, follow your doctor's instructions for regular blood work to ensure your safety while taking this medication.
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. Do not take antacids while taking this medication, as they may interact with it.
Some individuals may experience changes in behavior or mood, such as altered thinking, anger, or hallucinations, while taking 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 some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary, and your doctor will discuss the potential risks and benefits with you. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving this medication to a child.
Avoid consuming alcohol while taking this medication, as it may interact with the medication and increase the risk of adverse effects.
If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the potential benefits and risks of taking this medication during pregnancy with you.
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 lead to 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, and follow their instructions carefully. Report any adverse effects to your doctor.
Before starting this medication, you may need to undergo heart tests to ensure your safety. 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. Additionally, follow your doctor's instructions for regular blood work to ensure your safety while taking this medication.
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. Do not take antacids while taking this medication, as they may interact with it.
Some individuals may experience changes in behavior or mood, such as altered thinking, anger, or hallucinations, while taking 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 some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary, and your doctor will discuss the potential risks and benefits with you. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving this medication to a child.
Avoid consuming alcohol while taking this medication, as it may interact with the medication and increase the risk of adverse effects.
If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the potential benefits and risks of taking this medication during pregnancy with you.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- Cardiac arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea
- Abdominal cramps
- Convulsions
- Coma
- Death
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of hypertensive crisis)
Major Interactions
- Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine levels and prolong half-life, increasing risk of toxicity.
- Acidifying agents (e.g., ascorbic acid, ammonium chloride) - decrease amphetamine levels and shorten half-life, reducing efficacy.
- Tricyclic Antidepressants (TCAs) - may potentiate cardiovascular effects of amphetamines.
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
- Antihypertensive agents - amphetamines may antagonize the hypotensive effects.
Moderate Interactions
- Proton Pump Inhibitors (PPIs) and H2-receptor antagonists - may increase amphetamine absorption and exposure.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, ritonavir) - may increase amphetamine exposure, though amphetamine metabolism by CYP2D6 is minor.
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines.
- Lithium - may inhibit the stimulant effects of amphetamines.
Minor Interactions
- Alcohol - may alter the release profile of extended-release formulations, leading to dose dumping.
- Antacids - may increase absorption.
Monitoring
Baseline Monitoring
Cardiovascular assessment (BP, HR, ECG if indicated)
Rationale: To identify pre-existing cardiac conditions that may contraindicate stimulant use or require close monitoring.
Timing: Prior to initiation
Psychiatric history and assessment
Rationale: To screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.
Timing: Prior to initiation
Height and weight (pediatric patients)
Rationale: To establish baseline for monitoring potential growth suppression.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or at least every 3-6 months
Target: Within normal limits for age/patient
Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex/height or significant increase from baseline) warrants investigation and potential dose adjustment or discontinuation.
Weight and Height (pediatric patients)
Frequency: Every 3-6 months
Target: Consistent growth along established growth curves
Action Threshold: Significant growth deceleration or weight loss warrants investigation, nutritional counseling, and potential drug holiday or alternative treatment.
Psychiatric status (mood, anxiety, psychosis, aggression)
Frequency: At each visit
Target: Stable or improved psychiatric symptoms
Action Threshold: Emergence or worsening of psychotic symptoms, mania, severe anxiety, or aggression warrants immediate evaluation and potential discontinuation.
ADHD symptom control and functional improvement
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning
Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- New or worsening manic symptoms
- Severe anxiety or agitation
- Unexplained weight loss
- Sleep disturbances
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines may cause fetal harm, including premature birth and low birth weight. Neonates exposed to amphetamines during the third trimester may experience withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for increased risk of congenital malformations cannot be ruled out.
Second Trimester:
Potential for adverse pregnancy outcomes (e.g., premature birth, low birth weight).
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypertonia, somnolence, respiratory distress) and potential for premature birth and low birth weight.
Lactation
Amphetamines are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sleep disturbances, growth suppression, cardiovascular effects), breastfeeding is not recommended during treatment with Mydayis.
Infant Risk:
High (L3 - Moderately hazardous, L4 - Potentially hazardous, depending on dose and infant sensitivity)
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) carefully, as stimulants have been associated with growth suppression. Psychiatric and cardiovascular monitoring is crucial.
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) due to its triple-bead release technology, which may be beneficial for patients needing symptom control throughout the school/work day and into the evening.
- Patients should be advised not to open, chew, or crush the capsules to maintain the extended-release properties and prevent dose dumping.
- Careful cardiovascular screening is essential before initiating treatment, especially in patients with pre-existing cardiac conditions or a family history of sudden cardiac death.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is critical throughout treatment.
- Educate patients and caregivers about the signs of stimulant-induced psychosis or mania, and the importance of reporting these symptoms immediately.
- Consider drug holidays or dose adjustments if growth suppression is observed in pediatric patients.
Alternative Therapies
- Methylphenidate extended-release formulations (e.g., Concerta, Ritalin LA, Quillivant XR, Adhansia XR)
- Non-stimulants (e.g., Strattera (atomoxetine), Intuniv (guanfacine ER), Kapvay (clonidine ER))
- Behavioral therapy and psychotherapy for ADHD
Cost & Coverage
Average Cost:
$300 - $450 per 30 capsules
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription)
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 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 quantity, and the time it occurred.