Dexmethylphenidate 40mg ER Capsules
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System (CNS) Stimulant
Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
Pregnancy Category
Category C
FDA Approved
May 2005
DEA Schedule
Schedule II
Overview
What is this medicine?
Dexmethylphenidate extended-release capsules are a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. The extended-release form means the medication is released slowly over time, providing effects throughout the day.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. However, note that taking it with food may delay its effect. To minimize sleep disturbances, take your medication early in the day. Swallow the tablet whole; do not chew or crush it. If you have difficulty swallowing the tablet whole, you can sprinkle the contents onto applesauce, but be sure to swallow the mixture immediately without chewing.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. Keep your medication in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Keep all medications out of reach of pets.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. However, note that taking it with food may delay its effect. To minimize sleep disturbances, take your medication early in the day. Swallow the tablet whole; do not chew or crush it. If you have difficulty swallowing the tablet whole, you can sprinkle the contents onto applesauce, but be sure to swallow the mixture immediately without chewing.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom. Keep your medication in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Keep all medications out of reach of pets.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed, usually once daily in the morning.
- Do not crush, chew, or divide the capsule. It must be swallowed whole. If unable to swallow whole, the capsule may be opened and the entire contents sprinkled onto a small amount of applesauce and consumed immediately.
- Avoid alcohol, as it may cause a rapid release of the medication.
- Maintain a healthy diet and regular exercise routine.
- Ensure adequate sleep, as stimulants can affect sleep patterns.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Regularly monitor blood pressure and heart rate as advised by your doctor.
- For children, monitor height and weight regularly.
Available Forms & Alternatives
Available Strengths:
- Dexmethylphenidate 10mg Tablets
- Dexmethylphenidate 2.5mg Tablets
- Dexmethylphenidate 5mg Tablets
- Dexmethylphenidate 25mg ER Capsules
- Dexmethylphenidate ER 5mg Capsules
- Dexmethylphenidate ER 20mg Capsules
- Dexmethylphenidate ER 10mg Capsules
- Dexmethylphenidate 15mg ER Capsules
- Dexmethylphenidate 30mg ER Capsules
- Dexmethylphenidate 35mg ER Capsules
- Dexmethylphenidate 40mg ER Capsules
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 10 mg orally once daily in the morning. Titrate in increments of 10 mg weekly. Max: 40 mg once daily.
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
ADHD:
Initial: 10 mg orally once daily in the morning. Titrate in increments of 10 mg weekly. Max: 40 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial: 5 mg orally once daily in the morning. Titrate in increments of 5 mg to 10 mg weekly. Max: 30 mg to 40 mg once daily.
Adolescent:
13-17 years: Initial: 10 mg orally once daily in the morning. Titrate in increments of 10 mg weekly. Max: 40 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Pharmacology
Mechanism of Action
Dexmethylphenidate is the d-threo-enantiomer of methylphenidate. It is a central nervous system (CNS) stimulant. Its therapeutic effect in Attention Deficit Hyperactivity Disorder (ADHD) is thought to be due to its ability to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified, but well absorbed.
Tmax:
Approximately 6.5 to 7 hours (for ER formulation)
FoodEffect:
A high-fat meal can delay Tmax by approximately 1 hour, but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Not available
ProteinBinding:
Approximately 15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 5 to 7 hours (for ER formulation)
Clearance:
Not available
ExcretionRoute:
Primarily renal (urine)
Unchanged:
Approximately 10% of the dose is excreted unchanged in urine; the remainder is excreted as metabolites.
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour
PeakEffect:
Approximately 6.5 to 7 hours
DurationOfAction:
Approximately 10 to 12 hours
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including dexmethylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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 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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Fast heartbeat
Joint pain
Purple patches on the skin or mouth
Changes in eyesight or eye pain, swelling, or redness
Seizures
Shakiness
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or trouble passing urine
Changes in sex interest
Erectile Dysfunction Warning
If you experience a painful erection (hard penis) or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not having sex. If left untreated, it may lead to lasting sexual problems and impotence.
Cardiac Warning
Sudden deaths have occurred in people with pre-existing heart problems or heart defects. Inform your doctor if you have any heart condition or defect. If a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Mental Health Warning
New or worsening behavioral and mood changes, including changes in thinking, anger, and hallucinations, have been reported with this medication. Inform your doctor if you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide. Seek medical help immediately if you experience:
Hallucinations
Changes in behavior
Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life
Serotonin Syndrome Warning
A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Other Side Effects
While many people may not experience side effects or only have minor side effects, it is essential to be aware of the following possible side effects:
Dizziness or headache
Feeling sleepy
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Trouble sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
If any of these side effects or other side effects bother you or do not go away, contact your doctor or seek medical attention.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, contact your doctor for medical advice.
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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Fast heartbeat
Joint pain
Purple patches on the skin or mouth
Changes in eyesight or eye pain, swelling, or redness
Seizures
Shakiness
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or trouble passing urine
Changes in sex interest
Erectile Dysfunction Warning
If you experience a painful erection (hard penis) or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not having sex. If left untreated, it may lead to lasting sexual problems and impotence.
Cardiac Warning
Sudden deaths have occurred in people with pre-existing heart problems or heart defects. Inform your doctor if you have any heart condition or defect. If a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Mental Health Warning
New or worsening behavioral and mood changes, including changes in thinking, anger, and hallucinations, have been reported with this medication. Inform your doctor if you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide. Seek medical help immediately if you experience:
Hallucinations
Changes in behavior
Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life
Serotonin Syndrome Warning
A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Other Side Effects
While many people may not experience side effects or only have minor side effects, it is essential to be aware of the following possible side effects:
Dizziness or headache
Feeling sleepy
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Trouble sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
If any of these side effects or other side effects bother you or do not go away, contact your doctor or seek medical attention.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, contact your doctor for medical advice.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, or agitation
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- New or worsening manic symptoms (e.g., extreme elation, irritability, racing thoughts)
- Numbness, tingling, or coldness in fingers or toes, or unexplained wounds on fingers or toes
- Unexplained tics or abnormal movements
- Blurred vision or other vision changes
- Severe headache
- Unexplained weight loss
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A 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 (you or a family member)
Presence of other health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever had a stroke
Use of specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs may lead to very high blood pressure)
Concurrent use of certain medications, such as:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A 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 (you or a family member)
Presence of other health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever had a stroke
Use of specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs may lead to very high blood pressure)
Concurrent use of certain medications, such as:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions. Do not initiate, stop, or modify 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.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. If you suspect you have developed tolerance, contact your doctor. Do not take more than the prescribed dose.
Before starting this medication, your doctor may recommend some heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may increase the risk of seizures, particularly in individuals who have a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
There is a possibility that this medication may cause high blood pressure. Monitor your blood pressure and heart rate as directed by your doctor, and seek immediate medical attention if you experience severe headaches, dizziness, fainting, or changes in your vision.
To minimize potential side effects, limit your consumption of caffeine (found in tea, coffee, cola, and chocolate) while taking this medication, as it may cause nervousness, shakiness, and a rapid heartbeat. Additionally, avoid drinking alcohol while on this medication.
If you have high blood pressure, consult your doctor before taking any over-the-counter (OTC) products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products or aids, as they may increase your blood pressure.
This medication may cause changes in behavior and mood, including altered thinking, anger, and hallucinations. 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. 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 a lack of interest in life.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication to you and your baby.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. If you suspect you have developed tolerance, contact your doctor. Do not take more than the prescribed dose.
Before starting this medication, your doctor may recommend some heart tests to ensure your safety. If you have any questions or concerns, discuss them with your doctor.
This medication may increase the risk of seizures, particularly in individuals who have a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
There is a possibility that this medication may cause high blood pressure. Monitor your blood pressure and heart rate as directed by your doctor, and seek immediate medical attention if you experience severe headaches, dizziness, fainting, or changes in your vision.
To minimize potential side effects, limit your consumption of caffeine (found in tea, coffee, cola, and chocolate) while taking this medication, as it may cause nervousness, shakiness, and a rapid heartbeat. Additionally, avoid drinking alcohol while on this medication.
If you have high blood pressure, consult your doctor before taking any over-the-counter (OTC) products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products or aids, as they may increase your blood pressure.
This medication may cause changes in behavior and mood, including altered thinking, anger, and hallucinations. 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. 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 a lack of interest in life.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Vomiting
- Agitation
- Tremors
- Hyperreflexia
- Muscle twitching
- Convulsions (may be followed by coma)
- Confusion
- Hallucinations
- Delirium
- Sweating
- Flushing
- Headache
- Hyperpyrexia (very high fever)
- Tachycardia (fast heart rate)
- Palpitations
- Cardiac arrhythmias
- Hypertension (high blood pressure)
- Mydriasis (dilated pupils)
- Dry mouth
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, maintaining circulation and respiration, external cooling for hyperpyrexia, and benzodiazepines for severe agitation or convulsions.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or use within 14 days following discontinuation of an MAOI is contraindicated due to risk of hypertensive crisis.
Major Interactions
- Vasopressor agents: May potentiate the pressor effect of vasopressor agents.
- Halogenated anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort): Increased risk of serotonin syndrome.
- Antipsychotics: May antagonize the effects of antipsychotics; caution with dose adjustments.
- Antacids/H2 blockers/PPIs: May alter the release profile of some ER formulations (though less significant for Dexmethylphenidate ER).
Moderate Interactions
- Antihypertensive drugs: May reduce the effectiveness of drugs used to treat hypertension.
- Coumarin anticoagulants: May prolong prothrombin time; monitor coagulation parameters.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit their metabolism, leading to increased plasma concentrations.
- Tricyclic antidepressants (TCAs): May inhibit their metabolism, leading to increased plasma concentrations.
Minor Interactions
- Alcohol: May accelerate the release rate of dexmethylphenidate from the extended-release capsule, leading to a more rapid absorption of a larger amount of the drug.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Stimulants can cause increases in BP and HR; screen for pre-existing cardiovascular conditions.
Timing: Prior to initiation of therapy
Height and Weight
Rationale: Monitor for potential growth suppression in pediatric patients.
Timing: Prior to initiation of therapy
Psychiatric History and Symptoms
Rationale: Screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.
Timing: Prior to initiation of therapy
Family History of Sudden Cardiac Death or Arrhythmias
Rationale: Identify individuals at higher risk for cardiovascular events.
Timing: Prior to initiation of therapy
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
Action Threshold: Persistent elevation above normal range; consider dose reduction or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric patients)
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative therapy.
ADHD Symptom Assessment
Frequency: Regularly (e.g., every 3-6 months or as clinically indicated)
Target: Improved attention, reduced hyperactivity/impulsivity
Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative therapy.
Psychiatric Status (e.g., emergence of new or worsening psychotic or manic symptoms, anxiety, agitation)
Frequency: At each visit
Target: Stable mood and behavior
Action Threshold: Emergence of new or worsening psychiatric symptoms; consider discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- Unexplained wounds on fingers or toes (Raynaud's phenomenon)
- Numbness or tingling in extremities
- Changes in skin color (pale, blue)
- Hallucinations
- Delusional thinking
- Mania
- Aggression
- Agitation
- Anxiety
- Depression
- Tics or abnormal movements
- Blurred vision
- Persistent headache
- Unexplained weight loss
- Insomnia
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown some evidence of developmental toxicity at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cardiac malformations (based on some studies of methylphenidate, though data are conflicting).
Second Trimester:
Not specifically studied, but continued exposure may carry risks.
Third Trimester:
Not specifically studied, but continued exposure may carry risks. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms.
Lactation
Dexmethylphenidate and its metabolites are excreted into human milk. Caution should be exercised when administered to a nursing mother. Monitor the infant for adverse effects such as agitation, insomnia, or poor feeding.
Infant Risk:
Low to moderate risk. Monitor for irritability, poor feeding, and sleep disturbances in the infant. The American Academy of Pediatrics considers methylphenidate (racemic mixture) to be compatible with breastfeeding with caution.
Pediatric Use
Dexmethylphenidate ER is approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms.
Geriatric Use
Safety and efficacy have not been established in geriatric patients. Use with caution due to increased sensitivity to stimulant effects, potential for cardiovascular events, and comorbidities. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Dexmethylphenidate is the more pharmacologically active d-isomer of methylphenidate, often allowing for lower doses compared to racemic methylphenidate.
- The extended-release formulation provides once-daily dosing, typically lasting 10-12 hours, which can improve adherence and reduce the need for school-time dosing.
- Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules, but the entire contents must be consumed immediately.
- Careful cardiovascular screening is essential before initiating therapy and during treatment.
- Monitor for psychiatric adverse effects, especially in patients with a history of bipolar disorder or psychosis.
- Regular growth monitoring is crucial for pediatric patients on long-term therapy.
Alternative Therapies
- Other CNS Stimulants (e.g., methylphenidate, amphetamine, lisdexamfetamine)
- Non-stimulants (e.g., atomoxetine, guanfacine ER, clonidine ER)
- Behavioral therapy
- Cognitive behavioral therapy (CBT)
Cost & Coverage
Average Cost:
$200 - $400 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 name of the medication taken, the quantity, and the time it occurred.