D-Amphetamine ER 25mg Slt Cmb 3b CP
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; Norepinephrine-Dopamine Releasing Agent (NDRA); Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
Pregnancy Category
Not available
FDA Approved
Jun 2017
DEA Schedule
Schedule II
Overview
What is this medicine?
Mydayis is a long-acting stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It helps improve attention, focus, and reduce impulsivity and hyperactivity 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 it's essential to take it the same way each time. Choose to take it either always with food or always on an empty stomach.
Take your medication in the morning.
Swallow the capsule whole; do not chew, break, or crush it. If you have trouble swallowing, you can sprinkle the contents of the capsule on applesauce, but be sure not to chew the mixture.
After mixing the medication with applesauce, take your dose immediately. Do not 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 plan to use 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 it's essential to take it the same way each time. Choose to take it either always with food or always on an empty stomach.
Take your medication in the morning.
Swallow the capsule whole; do not chew, break, or crush it. If you have trouble swallowing, you can sprinkle the contents of the capsule on applesauce, but be sure not to chew the mixture.
After mixing the medication with applesauce, take your dose immediately. Do not 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 plan to use 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 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 crush, chew, or open the capsule, as this will affect the extended-release properties and may lead to a sudden release of the entire dose.
- Avoid alcohol consumption while taking this medication.
- Maintain a healthy diet and regular exercise.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
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:
Initial 12.5 mg orally once daily in the morning. May titrate in 12.5 mg increments weekly.
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; maximum 50 mg once daily.
Adolescent:
13-17 years: Initial 12.5 mg orally once daily in the morning; maximum 50 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended (eGFR 60-89 mL/min/1.73 m2).
Moderate:
Consider lower dose or extended dosing interval (eGFR 30-59 mL/min/1.73 m2).
Severe:
Not recommended (eGFR <30 mL/min/1.73 m2).
Dialysis:
Not recommended.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
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. This action is thought to be responsible for the therapeutic effects in ADHD.
Pharmacokinetics
Absorption:
Bioavailability:
High (approximately 75%)
Tmax:
Tri-phasic: Initial peak ~1.5-2 hours, second peak ~5-7 hours, third peak ~10-11 hours.
FoodEffect:
High-fat meal can delay Tmax by approximately 2.5 hours but does not significantly affect overall exposure (AUC).
Distribution:
Vd:
3.5-4.5 L/kg
ProteinBinding:
Low (15-20%)
CnssPenetration:
Yes
Elimination:
HalfLife:
Dextroamphetamine: 10-13 hours; Amphetamine: 9-11 hours (pH-dependent)
Clearance:
Renal and hepatic
ExcretionRoute:
Renal
Unchanged:
30-40% (highly dependent on urine pH; acidic urine increases excretion, alkaline urine decreases excretion)
Pharmacodynamics
OnsetOfAction:
Within 1-2 hours
PeakEffect:
Tri-phasic, with sustained effects throughout the day.
DurationOfAction:
Up to 16 hours
Safety & Warnings
BLACK BOX WARNING
Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Erectile dysfunction
Decreased sex drive
Seizures
Uncontrolled body movements
Uncontrolled vocalizations, 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 of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Feeling nervous or excitable
Headache
Difficulty sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in mouth
* Weight loss
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Erectile dysfunction
Decreased sex drive
Seizures
Uncontrolled body movements
Uncontrolled vocalizations, 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 of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Feeling nervous or excitable
Headache
Difficulty sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dizziness
Fatigue
Weakness
Dry mouth
Bad taste in mouth
* Weight loss
This is not an exhaustive list of possible side effects. If you have concerns or questions, 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)
- Numbness, pain, skin color change, or unexplained wounds on fingers or toes
- New or worsening mental health symptoms (e.g., hallucinations, paranoia, aggression, severe anxiety)
- New or worsening tics (uncontrolled movements or sounds)
- Blurred vision or other vision changes
- Unexplained fever or muscle stiffness (may indicate serotonin syndrome)
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
+ Monoamine oxidase inhibitors (MAOIs) such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, which you should not take within 14 days of starting this medication due to the risk of very high blood pressure
+ Linezolid or methylene blue, as these may interact with this medication
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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. 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
+ Monoamine oxidase inhibitors (MAOIs) such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, which you should not take within 14 days of starting this medication due to the risk of very high blood pressure
+ Linezolid or methylene blue, as these may interact with this medication
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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Caution When Performing Daily Activities
Until you know how this medication affects you, avoid driving and engaging in other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Long-Term Use and Tolerance
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more medication than prescribed, as this can lead to serious consequences.
Dependence and Withdrawal
Long-term or regular use of this medication can lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. If you need to reduce your dose or stop taking the medication, consult your doctor first. They will provide you with instructions on how to do so safely.
Monitoring Your Health
You may need to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. Additionally, this medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor. You will also need to have regular blood tests to check for any potential side effects.
Interactions with Other Medications and Lab Tests
This medication may affect the results of certain lab tests. Inform all of your healthcare providers and lab personnel that you are taking this medication. Do not take antacids while taking this medication, as they may interact with it.
Mental Health and Mood Changes
This medication may cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience any of the following symptoms, contact your doctor immediately: hallucinations, changes in behavior, depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those who have a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
Taking this medication with certain other medications can cause a severe and potentially life-threatening condition called serotonin syndrome. If you experience any of the following symptoms, contact your doctor immediately: agitation, changes in balance, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. If you are giving this medication to a child, they may need regular growth checks. Different brands of this medication may be approved for use in different age groups, so consult your doctor before giving it to a child.
Alcohol Consumption
Avoid drinking alcohol while taking this medication, as it may interact with it.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. They will discuss the benefits and risks of taking this medication during pregnancy with you.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Caution When Performing Daily Activities
Until you know how this medication affects you, avoid driving and engaging in other activities that require alertness and clear vision. This will help prevent accidents and ensure your safety.
Long-Term Use and Tolerance
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more medication than prescribed, as this can lead to serious consequences.
Dependence and Withdrawal
Long-term or regular use of this medication can lead to dependence. Stopping the medication abruptly may cause withdrawal symptoms. If you need to reduce your dose or stop taking the medication, consult your doctor first. They will provide you with instructions on how to do so safely.
Monitoring Your Health
You may need to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. Additionally, this medication may cause high blood pressure, so it is essential to monitor your blood pressure and heart rate as directed by your doctor. You will also need to have regular blood tests to check for any potential side effects.
Interactions with Other Medications and Lab Tests
This medication may affect the results of certain lab tests. Inform all of your healthcare providers and lab personnel that you are taking this medication. Do not take antacids while taking this medication, as they may interact with it.
Mental Health and Mood Changes
This medication may cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience any of the following symptoms, contact your doctor immediately: hallucinations, changes in behavior, depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those who have a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
Taking this medication with certain other medications can cause a severe and potentially life-threatening condition called serotonin syndrome. If you experience any of the following symptoms, contact your doctor immediately: agitation, changes in balance, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. If you are giving this medication to a child, they may need regular growth checks. Different brands of this medication may be approved for use in different age groups, so consult your doctor before giving it to a child.
Alcohol Consumption
Avoid drinking alcohol while taking this medication, as it may interact with it.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. They will discuss the benefits and risks of taking this medication during pregnancy with you.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- Hyperpyrexia
- Rhabdomyolysis
- Convulsions
- Coma
- Arrhythmias
- Hypertension or hypotension
- Circulatory collapse
- Nausea, vomiting, diarrhea, abdominal cramps
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for cardiovascular and CNS effects.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
- Antihypertensives - may decrease the hypotensive effect of these drugs
- Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide, thiazide diuretics) - increase amphetamine blood levels and prolong half-life
- Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine blood levels and shorten half-life
- Alcohol - may alter the release rate of amphetamine from the extended-release formulation
Moderate Interactions
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize the stimulant effects of amphetamines
- Tricyclic Antidepressants (TCAs) - may increase cardiovascular effects of amphetamines
- Proton Pump Inhibitors (PPIs) / H2 Blockers - may alter absorption, though clinical significance for Mydayis is generally low
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).
Timing: Prior to initiation.
Height and Weight
Rationale: Risk of growth suppression in pediatric patients.
Timing: Prior to initiation (pediatric).
Psychiatric History (e.g., bipolar disorder, psychosis, tics)
Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new ones.
Timing: Prior to initiation.
Family History of Sudden Cardiac Death or Arrhythmias
Rationale: To identify patients at higher risk for cardiovascular events.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit
Target: Within normal limits for age/baseline
Action Threshold: Sustained elevation requiring intervention or dose adjustment.
Weight
Frequency: Monthly/Quarterly
Target: Stable or appropriate gain for age
Action Threshold: Significant weight loss or failure to gain weight in pediatric patients.
Height (Pediatric)
Frequency: Quarterly
Target: Appropriate growth velocity for age
Action Threshold: Growth deceleration or plateau.
Psychiatric Symptoms (e.g., psychosis, mania, aggression, anxiety, tics)
Frequency: At each visit
Target: Absence or stable management of symptoms
Action Threshold: Emergence or worsening of symptoms requiring intervention.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- New-onset psychosis
- Mania
- Aggression
- Severe anxiety
- Tics
- Growth deceleration
- Unexplained wounds on fingers/toes (peripheral vasculopathy)
Special Patient Groups
Pregnancy
Based on animal data and postmarketing experience, amphetamine use during pregnancy may cause fetal harm (e.g., premature birth, low birth weight, withdrawal symptoms in neonates). Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data on congenital malformations; potential for increased risk based on animal studies.
Second Trimester:
Increased risk of premature birth and low birth weight.
Third Trimester:
Risk of neonatal withdrawal syndrome (agitation, irritability, poor feeding, tremor, hypertonia, vomiting, diarrhea) if used late in pregnancy.
Lactation
Amphetamine is present in human milk. Advise mothers not to breastfeed during treatment due to potential for serious adverse reactions in the infant (e.g., irritability, poor feeding, insomnia, weight loss, psychomotor agitation).
Infant Risk:
High
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) regularly due to risk of growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).
Geriatric Use
Not typically used in the geriatric population for ADHD. Use with caution due to increased sensitivity to adverse effects (e.g., cardiovascular, psychiatric) and potential for comorbidities. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Mydayis is a very long-acting stimulant, providing symptom control for up to 16 hours, which may be beneficial for patients needing coverage into the evening.
- The capsule contains three types of beads with different release profiles, contributing to its extended duration of action.
- Thorough cardiovascular and psychiatric screening is essential before initiating treatment with Mydayis.
- Patients and caregivers should be educated on the signs of abuse, misuse, and diversion, as amphetamines have a high potential for abuse.
- Regular monitoring of blood pressure, heart rate, and growth (in pediatric patients) is crucial during treatment.
- Avoid abrupt discontinuation after prolonged high-dose therapy to prevent potential withdrawal symptoms (e.g., extreme fatigue, depression).
Alternative Therapies
- Other Stimulants: Methylphenidate (e.g., Concerta, Ritalin LA, Focalin XR, Quillivant XR, Adhansia XR), Lisdexamfetamine (Vyvanse), Dexmethylphenidate (Focalin)
- Non-Stimulants: Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree)
Cost & Coverage
Average Cost:
Highly variable 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 is essential to contact your doctor promptly. 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 is a valuable patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you 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 detailed information, including the substance taken, the amount, and the time it occurred.