Dexmethylphenidate ER 10mg 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 and Dopamine Reuptake Inhibitor (NDRI)
Pregnancy Category
Category C
FDA Approved
May 2005
DEA Schedule
Schedule II
Overview
What is this medicine?
Dexmethylphenidate ER is a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD). It's a stimulant that works by affecting certain natural chemicals in the brain to help improve attention, focus, and control impulsive behavior. The 'ER' means extended-release, so it works throughout the day with one dose.
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 onset of action. To minimize sleep disturbances, take your medication early in the day.
It's essential to swallow the medication whole; do not chew or crush it. If you have difficulty swallowing the medication whole, you can sprinkle its contents onto applesauce. If you choose this method, 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 cannot see or access it, and where others cannot easily obtain it. Consider using a locked box or area to ensure its safety. Remember to 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 onset of action. To minimize sleep disturbances, take your medication early in the day.
It's essential to swallow the medication whole; do not chew or crush it. If you have difficulty swallowing the medication whole, you can sprinkle its contents onto applesauce. If you choose this method, 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 cannot see or access it, and where others cannot easily obtain it. Consider using a locked box or area to ensure its safety. Remember to 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 exactly as prescribed, usually once daily in the morning to avoid sleep problems.
- Do not crush, chew, or divide the capsule. Swallow whole or sprinkle contents on a small amount of applesauce and consume immediately.
- Avoid alcohol, as it may affect the release of the medication.
- Maintain a healthy diet and regular exercise, especially for children, to support overall health and manage potential appetite suppression.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
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. May increase by 10 mg increments weekly. Max: 40 mg/day.
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
ADHD:
Initial: 10 mg once daily in the morning. Titrate weekly by 10 mg increments. Max: 40 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 5 mg orally once daily in the morning. May increase by 5-10 mg increments weekly. Max: 30 mg/day.
Adolescent:
13-17 years: Initial 10 mg orally once daily in the morning. May increase by 10 mg increments weekly. Max: 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis:
Not available. Use with caution, as methylphenidate is not significantly dialyzable.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific 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:
Approximately 29% (for methylphenidate, dexmethylphenidate is the active enantiomer)
Tmax:
Biphasic: approximately 1.5 hours and 4.5 hours (for ER formulation)
FoodEffect:
Food (high-fat meal) can delay Tmax by approximately 1.5 hours but does not significantly affect AUC or Cmax.
Distribution:
Vd:
Approximately 2.6 L/kg
ProteinBinding:
Approximately 15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 5-7 hours (for ER formulation)
Clearance:
Not readily available for dexmethylphenidate specifically, but methylphenidate clearance is high.
ExcretionRoute:
Primarily renal (approximately 90% as ritalinic acid)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours
PeakEffect:
Biphasic: approximately 1.5 hours and 4.5 hours
DurationOfAction:
Approximately 10-12 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ 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
Difficulty 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 sensation in hands or feet
Sores or wounds on fingers or toes
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex drive
Erectile Dysfunction Warning
If you experience a painful erection 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 permanent sexual dysfunction.
Cardiac Warning
Sudden deaths have occurred in people with pre-existing heart problems or defects. Inform your doctor if you have any heart condition or defect, or if a family member has an abnormal heartbeat or died suddenly. Seek medical help immediately if you experience:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Mental Health Warning
New or worsening behavioral and mood changes, such as 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 disorder, 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 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 Possible Side Effects
While many people may not experience side effects, some common ones include:
Dizziness or headache
Drowsiness
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Difficulty sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
You can 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ 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
Difficulty 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 sensation in hands or feet
Sores or wounds on fingers or toes
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex drive
Erectile Dysfunction Warning
If you experience a painful erection 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 permanent sexual dysfunction.
Cardiac Warning
Sudden deaths have occurred in people with pre-existing heart problems or defects. Inform your doctor if you have any heart condition or defect, or if a family member has an abnormal heartbeat or died suddenly. Seek medical help immediately if you experience:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Mental Health Warning
New or worsening behavioral and mood changes, such as 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 disorder, 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 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 Possible Side Effects
While many people may not experience side effects, some common ones include:
Dizziness or headache
Drowsiness
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Difficulty sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, or agitation
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New manic symptoms (e.g., unusually high energy, racing thoughts, decreased need for sleep)
- Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes (Raynaud's phenomenon)
- Prolonged or painful erections (priapism)
- Unexplained weight loss or slowed growth in children
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
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 experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of very high blood pressure)
Current 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. Never start, stop, or adjust 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. Be sure to describe the allergic reaction and its symptoms.
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 experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of very high blood pressure)
Current 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. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
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 exceed the prescribed dose.
Before starting this medication, your doctor may recommend 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 with 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 risk of high blood pressure associated with this medication. Monitor your blood pressure and heart rate as directed by your doctor, and seek immediate medical attention if you experience severe headache, dizziness, fainting, or changes in 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 rapid heartbeat. Additionally, avoid consuming alcohol while on this medication.
If you have high blood pressure, consult your doctor before taking any over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
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, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
In some cases, this medication may affect growth in children and adolescents. 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 exceed the prescribed dose.
Before starting this medication, your doctor may recommend 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 with 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 risk of high blood pressure associated with this medication. Monitor your blood pressure and heart rate as directed by your doctor, and seek immediate medical attention if you experience severe headache, dizziness, fainting, or changes in 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 rapid heartbeat. Additionally, avoid consuming alcohol while on this medication.
If you have high blood pressure, consult your doctor before taking any over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
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, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
In some cases, this medication may affect growth in children and adolescents. 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)
- Euphoria
- Confusion
- Hallucinations
- Delirium
- Sweating
- Flushing
- Headache
- Hyperpyrexia
- Tachycardia
- Palpitations
- Cardiac arrhythmias
- Hypertension
- Mydriasis
- Dry mouth
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
Major Interactions
- Vasopressor agents (e.g., phenylephrine, pseudoephedrine): Risk of hypertensive crisis.
- Halogenated anesthetics (e.g., halothane, isoflurane): 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): Risk of serotonin syndrome.
Moderate Interactions
- Antihypertensive drugs: May reduce the effectiveness of antihypertensive medications.
- Coumarin anticoagulants (e.g., warfarin): May prolong prothrombin time; monitor INR.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of these drugs, increasing plasma concentrations.
- Tricyclic antidepressants (TCAs): May inhibit metabolism of TCAs, increasing plasma concentrations and potential for adverse effects.
Minor Interactions
- Alcohol: May alter the release profile of the extended-release formulation.
Monitoring
Baseline Monitoring
Cardiovascular assessment (BP, HR, ECG if clinically indicated)
Rationale: To identify pre-existing cardiovascular conditions that may be exacerbated by stimulant use.
Timing: Prior to initiation of therapy
Height and Weight
Rationale: To establish baseline for monitoring growth in pediatric patients.
Timing: Prior to initiation of therapy
Psychiatric history (personal and family)
Rationale: To assess risk for psychiatric adverse events (e.g., psychosis, mania).
Timing: Prior to initiation of therapy
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: Significant or sustained elevations warrant dose reduction or discontinuation.
Height and Weight (pediatric patients)
Frequency: Every 3-6 months
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss may require dose adjustment or drug holiday.
Psychiatric symptoms (e.g., agitation, aggression, hallucinations, mania)
Frequency: At each visit
Target: Absence of new or worsening symptoms
Action Threshold: Emergence of new psychotic or manic symptoms warrants immediate evaluation and discontinuation.
ADHD symptom control and functional improvement
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
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
- Growth deceleration (in children)
- Priapism (prolonged and painful erections)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data from a pregnancy registry suggest an increased risk of cardiac malformations with methylphenidate exposure in the first trimester, but overall risk is low.
Trimester-Specific Risks:
First Trimester:
Potential increased risk of cardiac malformations (based on methylphenidate data), though absolute risk is low.
Second Trimester:
Limited data, potential for fetal growth restriction.
Third Trimester:
Limited data, potential for withdrawal symptoms in neonate if exposed near term.
Lactation
Dexmethylphenidate and/or its metabolites are excreted into human milk. Monitor breastfed infants for signs of adverse reactions (e.g., agitation, insomnia, decreased weight gain). Weigh the developmental and health benefits of breastfeeding against the mother’s clinical need for dexmethylphenidate and any potential adverse effects on the breastfed infant.
Infant Risk:
Low to moderate risk. Monitor for irritability, poor feeding, and sleep disturbances.
Pediatric Use
Safety and efficacy established in pediatric patients 6 to 17 years of age. Monitor growth (height and weight) regularly, as long-term use may be associated with 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 potential for increased sensitivity to adverse effects, particularly cardiovascular effects, and presence of comorbidities.
Clinical Information
Clinical Pearls
- Administer in the morning to minimize the risk of insomnia.
- Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules, but the mixture should be consumed immediately.
- Monitor for signs of diversion or abuse, especially in patients with a history of substance abuse.
- Consider drug holidays (e.g., weekends, school breaks) in pediatric patients to assess continued need for medication and potentially mitigate growth suppression, though this should be discussed with a healthcare provider.
- Patients should be advised to avoid activities requiring mental alertness, such as driving or operating machinery, until they know how the medication affects them.
Alternative Therapies
- Methylphenidate (various formulations: immediate-release, extended-release, transdermal patch, chewable tablets)
- Amphetamine/dextroamphetamine (various formulations: Adderall, Vyvanse, Mydayis)
- Lisdexamfetamine (Vyvanse)
- Atomoxetine (Strattera) - non-stimulant
- Guanfacine extended-release (Intuniv) - non-stimulant
- Clonidine extended-release (Kapvay) - non-stimulant
Cost & Coverage
Average Cost:
Varies widely, e.g., $150-$400 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand, generic often Tier 1)
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 crucial patient fact sheet. Please read it carefully and review it again each time 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 seeking help, be prepared to provide information about what was taken, the amount, and the time it occurred.