D-Amphetamine ER 12.5mg 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 Stimulant
Pharmacologic Class
Sympathomimetic Amine
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) in people 6 years and older. It works by affecting certain natural chemicals in the brain to help improve attention, focus, and control impulsive behavior.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with or without food, but be consistent in how you take it each time. If you take it with food, always take it with food. If you take it on an empty stomach, always take it on an empty stomach. It's best to take your medication in the morning.
Swallow your medication whole - do not chew, break, or crush it. However, if you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce. Be sure to swallow the applesauce mixture right away without chewing.
Before taking any over-the-counter (OTC) products, talk to your doctor if they may increase your blood pressure. These products include cough and cold medicines, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Do not store it in a bathroom. Store your medication in a safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep your medication safe. Also, keep all medications out of reach of pets.
Missing 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 get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with or without food, but be consistent in how you take it each time. If you take it with food, always take it with food. If you take it on an empty stomach, always take it on an empty stomach. It's best to take your medication in the morning.
Swallow your medication whole - do not chew, break, or crush it. However, if you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce. Be sure to swallow the applesauce mixture right away without chewing.
Before taking any over-the-counter (OTC) products, talk to your doctor if they may increase your blood pressure. These products include cough and cold medicines, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Do not store it in a bathroom. Store your medication in a safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep your medication safe. Also, keep all medications out of reach of pets.
Missing 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. Do not take it in the afternoon or evening as it may cause sleep problems.
- Swallow the capsule whole; do not chew, crush, or open the capsule and sprinkle the contents on food, as this will alter the extended-release properties.
- If you miss a dose, take it as soon as you remember, but only if it's still morning. Do not take a double dose or take it later in the day.
- Avoid alcohol while taking this medication, as it may affect how the medicine is released.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Regularly monitor blood pressure, heart rate, and weight as advised by your doctor.
- Report any new or worsening psychiatric symptoms (e.g., hallucinations, paranoia, aggression) or signs of heart problems (e.g., chest pain, shortness of breath) immediately.
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:
Initially 12.5 mg once daily in the morning. May increase by 12.5 mg weekly to a maximum of 50 mg once daily.
Dose Range:
12.5 - 50 mg
Condition-Specific Dosing:
ADHD:
Initial 12.5 mg once daily, titrate weekly by 12.5 mg to a maximum of 50 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initially 12.5 mg once daily in the morning. May increase by 12.5 mg weekly to a maximum of 50 mg once daily.
Adolescent:
13-17 years: Initially 12.5 mg once daily in the morning. May increase by 12.5 mg weekly to a maximum of 50 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (eGFR 60-89 mL/min/1.73 m²)
Moderate:
Consider lower dose or extended dosing interval (eGFR 30-59 mL/min/1.73 m²). Max 37.5 mg/day.
Severe:
Consider lower dose or extended dosing interval (eGFR <30 mL/min/1.73 m²). Max 25 mg/day.
Dialysis:
Not recommended due to limited data and potential for prolonged exposure.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Amphetamines are non-catecholamine sympathomimetic amines that exert their therapeutic effect by releasing norepinephrine and dopamine from presynaptic nerve terminals in the brain. They also inhibit the reuptake of these monoamines into the presynaptic neuron, thereby increasing their concentrations in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75% (oral)
Tmax:
Bimodal release: First peak at 4-5 hours, second peak at 8-9 hours post-dose.
FoodEffect:
High-fat meal may delay Tmax by 2.5 hours but does not significantly affect AUC or Cmax.
Distribution:
Vd:
Approximately 3.5-4.5 L/kg
ProteinBinding:
Approximately 15-20%
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% (acidic urine), 1% (alkaline urine)
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours
PeakEffect:
Bimodal: 4-5 hours and 8-9 hours
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
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 notice 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 pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Other severe side effects, including:
+ Difficulty getting or maintaining an erection
+ 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, or trouble passing urine
Heart problems, including:
+ Sudden death (rarely occurs in people with pre-existing heart problems or defects)
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
If you have a heart condition or defect, or if a family member has 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 report any concerns to your doctor. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 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 pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Other severe side effects, including:
+ Difficulty getting or maintaining an erection
+ 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, or trouble passing urine
Heart problems, including:
+ Sudden death (rarely occurs in people with pre-existing heart problems or defects)
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
If you have a heart condition or defect, or if a family member has 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 report any concerns to your doctor. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Feeling nervous and excitable
Headache
Trouble sleeping
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Feeling dizzy, tired, or weak
Dry mouth
Bad taste in your mouth
Weight loss
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 (signs of heart problems)
- Numbness, coolness, or pain in fingers or toes (signs of circulation problems)
- New or worsening aggression, hostility, or irritability
- New psychotic symptoms (e.g., hearing voices, believing things that are not true)
- New manic symptoms (e.g., feeling overly excited, talking too much, unusual energy)
- Unexplained muscle weakness or pain, dark urine (rhabdomyolysis)
- 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
+ Antidepressants or Parkinson's disease medications (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) 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
+ Antidepressants or Parkinson's disease medications (such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline) 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 Warnings and Precautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Do not drive or perform tasks that require alertness and clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Testing
Your doctor may require you to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. Regularly monitor your blood pressure and heart rate as directed by your doctor. You will also need to have blood work done as scheduled by your doctor.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests, so it is crucial to inform all 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 altered thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving this medication to a child.
Alcohol Consumption
Avoid consuming alcohol while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, discuss the benefits and risks of using this medication with your doctor.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Do not drive or perform tasks that require alertness and clear vision until you understand how this medication affects you.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose. Additionally, regular use of this medication may cause dependence, and sudden cessation may result in withdrawal symptoms. Consult your doctor before reducing the dose or stopping the medication, and follow their instructions carefully.
Monitoring and Testing
Your doctor may require you to undergo heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor. Regularly monitor your blood pressure and heart rate as directed by your doctor. You will also need to have blood work done as scheduled by your doctor.
Interactions with Other Medications and Lab Tests
This medication may affect certain lab tests, so it is crucial to inform all 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 altered thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Immediately contact your doctor if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Discuss your risk with your doctor.
Serotonin Syndrome
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek immediate medical attention if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Effects on Growth in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Different brands of this medication may be suitable for different age groups, so consult your doctor before giving this medication to a child.
Alcohol Consumption
Avoid consuming alcohol while taking this medication.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, discuss the benefits and risks of using this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremor
- Hyperreflexia
- Rapid breathing
- Confusion
- Assaultiveness
- Hallucinations
- Panic states
- High fever
- Rhabdomyolysis
- Hypertensive crisis
- Arrhythmias
- Convulsions
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
Major Interactions
- Urinary Alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase amphetamine levels and prolong half-life
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
- Antihypertensives - amphetamines may reduce their effect
- Proton Pump Inhibitors (PPIs) and H2 Blockers - may increase amphetamine absorption
- Alcohol - may alter release profile of extended-release formulations
Moderate Interactions
- Urinary Acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease amphetamine levels and shorten half-life
- Antipsychotics (e.g., phenothiazines, haloperidol) - may antagonize stimulant effects
- Antihistamines - may potentiate CNS stimulation
- Opioids - risk of respiratory depression and sedation (if combined with CNS depressants)
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.
Timing: Prior to initiation
Height and Weight
Rationale: Risk of growth suppression in pediatric patients.
Timing: Prior to initiation (pediatric patients)
Psychiatric History (including family history of suicide, bipolar disorder, depression)
Rationale: Risk of new or worsening psychiatric symptoms (e.g., psychosis, mania).
Timing: Prior to initiation
Pre-existing cardiac conditions (e.g., structural cardiac abnormalities, cardiomyopathy, serious arrhythmia)
Rationale: Risk of sudden death in patients with pre-existing cardiac conditions.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or every 3-6 months
Target: Within normal limits for age
Action Threshold: Persistent elevation requiring intervention or discontinuation
Height and Weight
Frequency: Every 3-6 months (pediatric patients)
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss
Psychiatric Status (e.g., emergence of psychotic or manic symptoms, aggression, anxiety)
Frequency: At each visit
Target: Stable or improved symptoms
Action Threshold: New or worsening psychiatric symptoms requiring intervention
ADHD symptom control and functional improvement
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity
Action Threshold: Lack of efficacy or intolerable side effects
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- New psychotic symptoms (e.g., hallucinations, delusions)
- Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
- Severe anxiety or agitation
- Unexplained weight loss
- Tics or dyskinesias
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Amphetamines can cause fetal harm, including premature delivery and low birth weight. Neonates exposed to amphetamines during the third trimester are at risk for withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester:
Potential for growth restriction and adverse neurodevelopmental outcomes.
Third Trimester:
Risk of premature delivery, low birth weight, and neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremor, hypotonia, respiratory distress).
Lactation
Amphetamines are excreted into human milk. Breastfeeding is not recommended during treatment with Mydayis due to the potential for serious adverse reactions in the breastfed infant (e.g., irritability, poor feeding, sleep disturbances, weight loss).
Infant Risk:
Moderate to High (L3)
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Closely monitor for emergence or worsening of psychiatric symptoms.
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 longer duration of action (up to 16 hours) compared to other amphetamine formulations, potentially allowing for once-daily dosing that covers the entire waking day.
- The triple-bead release system provides three peaks of drug release, aiming for sustained symptom control.
- Counsel patients on the importance of taking the medication early in the morning to avoid insomnia.
- Emphasize the importance of swallowing the capsule whole to maintain the extended-release properties.
- Careful cardiovascular and psychiatric screening is crucial before initiating treatment and throughout therapy.
- Due to its abuse potential, Mydayis should be prescribed and stored with caution.
Alternative Therapies
- Methylphenidate (e.g., Concerta, Ritalin LA, Quillivant XR)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy
Cost & Coverage
Average Cost:
$300 - $600+ per 30 capsules
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a detailed patient information sheet. It is crucial to read this guide carefully and thoroughly, and to review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide critical information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a detailed patient information sheet. It is crucial to read this guide carefully and thoroughly, and to review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide critical information, including the name of the medication taken, the amount consumed, and the time it occurred.