Dexmethylphenidate ER 20mg 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 works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. The 'ER' means Extended-Release, so it releases the medicine slowly throughout the day, usually requiring only one dose in the morning.
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. Note that taking it with food may delay its effects. 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. Note that taking it with food may delay its effects. 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 exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening as it may cause sleep problems.
- Swallow the capsule whole. Do not chew, crush, or divide the capsule. 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 the medication to be released too quickly.
- 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.
- Store at room temperature away from moisture and heat. Keep out of reach of children, as it is a controlled substance.
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 once daily in the morning; may be titrated weekly by 10 mg increments.
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
ADHD:
Initial 10 mg once daily in the morning; maximum 40 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6-12 years: Initial 5 mg once daily in the morning; may be titrated weekly by 5 mg increments. Maximum 30 mg once daily.
Adolescent:
For adolescents 13-17 years: Initial 10 mg once daily in the morning; may be titrated weekly by 10 mg increments. Maximum 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 and monitor for adverse effects.
Severe:
No specific dose adjustment recommended, use with caution and monitor for adverse effects. Consider lower initial doses and slower titration.
Dialysis:
Not well studied; use with caution and monitor closely.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution and monitor for adverse effects.
Severe:
No specific dose adjustment recommended, use with caution and monitor for adverse effects. Consider lower initial doses and slower titration.
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 stated as a percentage for oral, but well absorbed.
Tmax:
Biphasic release: First peak ~1.5 hours, second peak ~4.5 hours.
FoodEffect:
Food can delay Tmax by approximately 1 hour but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 2.65 L/kg.
ProteinBinding:
Approximately 15% bound to plasma proteins.
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2.2 hours (for d-methylphenidate).
Clearance:
Not precisely quantified for total clearance, but rapid elimination.
ExcretionRoute:
Primarily renal (approximately 90% excreted in urine as ritalinic acid).
Unchanged:
Less than 1% of the dose is excreted unchanged in the urine.
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour.
PeakEffect:
Approximately 1.5 to 4.5 hours (biphasic peaks).
DurationOfAction:
Approximately 10-12 hours.
Confidence:
High
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 or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting or yellow skin and eyes
Fast heartbeat
Joint pain
Purple patches on the skin or mouth
Changes in eyesight or eye pain, swelling, or redness
Seizures
Shakiness or tremors
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color (hands, feet, or other areas may turn pale, blue, gray, purple, or red)
Numbness, pain, tingling, or cold sensations 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 drive or interest
Erectile Dysfunction Warning
If you experience a painful erection (priapism) 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 certain 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, or hallucinations, have been reported with this medication. Inform your doctor if you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide. Seek medical help immediately if you experience:
Hallucinations
Changes in behavior or mood
Signs of depression, such as thoughts of suicide, nervousness, emotional ups and downs, or lack 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 or coordination
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness or headache
Drowsiness
Feeling nervous or excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Difficulty sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting or yellow skin and eyes
Fast heartbeat
Joint pain
Purple patches on the skin or mouth
Changes in eyesight or eye pain, swelling, or redness
Seizures
Shakiness or tremors
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color (hands, feet, or other areas may turn pale, blue, gray, purple, or red)
Numbness, pain, tingling, or cold sensations 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 drive or interest
Erectile Dysfunction Warning
If you experience a painful erection (priapism) 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 certain 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, or hallucinations, have been reported with this medication. Inform your doctor if you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide. Seek medical help immediately if you experience:
Hallucinations
Changes in behavior or mood
Signs of depression, such as thoughts of suicide, nervousness, emotional ups and downs, or lack 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 or coordination
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness or headache
Drowsiness
Feeling nervous or excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Difficulty sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention).
- New or worsening aggression, hostility, or unusual changes in behavior.
- Seeing or hearing things that are not real (hallucinations), believing things that are not true (delusions).
- New or worsening tics (uncontrolled movements or sounds).
- Prolonged or painful erections (priapism, rare but serious).
- Blurred vision or other vision changes.
- Numbness, tingling, or color change in fingers or toes (Raynaud's phenomenon).
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 specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever had a stroke
Recent use (within the last 14 days) of certain 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. 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 specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever had a stroke
Recent use (within the last 14 days) of certain 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. 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. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.
Long-term use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you experience a decrease in the drug's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Prior to starting this medication, your doctor may recommend heart tests. If you have 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 drug.
There is a potential 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 interactions, limit your consumption of caffeine (found in tea, coffee, cola) and chocolate, as combining these with this medication may cause nervousness, shakiness, and rapid heartbeat. Additionally, avoid consuming alcohol while taking this drug.
If you have high blood pressure, consult your doctor before using 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 disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, 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, requiring regular growth checks. 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.
Long-term use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you experience a decrease in the drug's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Prior to starting this medication, your doctor may recommend heart tests. If you have 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 drug.
There is a potential 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 interactions, limit your consumption of caffeine (found in tea, coffee, cola) and chocolate, as combining these with this medication may cause nervousness, shakiness, and rapid heartbeat. Additionally, avoid consuming alcohol while taking this drug.
If you have high blood pressure, consult your doctor before using 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 disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, 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, requiring regular growth checks. 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:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Overdose management typically involves supportive care, including maintaining a clear airway, monitoring vital signs, and managing symptoms.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
Major Interactions
- Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - risk of increased blood pressure.
- 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.
- Antihypertensive drugs - may reduce the effectiveness of antihypertensives.
Moderate Interactions
- Alcohol - may accelerate the release of dexmethylphenidate from the extended-release formulation.
- Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of certain anticonvulsants, requiring dose adjustment.
- Tricyclic Antidepressants (TCAs) - may inhibit metabolism of TCAs, requiring dose adjustment.
Minor Interactions
- Caffeine - additive stimulant effects, increased risk of adverse cardiovascular effects.
Monitoring
Baseline Monitoring
Complete Medical History and Physical Exam
Rationale: To identify pre-existing cardiovascular conditions, psychiatric disorders, or other contraindications/precautions.
Timing: Prior to initiation of therapy.
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Stimulants can cause increases in BP and HR.
Timing: Prior to initiation of therapy.
Height and Weight (Pediatric Patients)
Rationale: To monitor for potential growth suppression.
Timing: Prior to initiation of therapy.
Psychiatric Evaluation
Rationale: To screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each dose adjustment and at least every 3-6 months.
Target: Within normal limits for age.
Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.
Height and Weight (Pediatric Patients)
Frequency: Every 3-6 months.
Target: Consistent growth trajectory.
Action Threshold: Significant deviation from expected growth curve; consider drug holiday or alternative therapy.
Psychiatric Symptoms (e.g., agitation, aggression, new-onset psychosis, mania)
Frequency: At each visit, especially during dose titration.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of severe psychiatric symptoms; discontinue therapy.
ADHD Symptom Control and Functional Improvement
Frequency: Regularly, as clinically indicated.
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning.
Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- Unexplained fainting
- New or worsening aggression
- Hostility
- Psychotic symptoms (e.g., hallucinations, delusions)
- Manic symptoms (e.g., elevated mood, grandiosity, decreased need for sleep)
- Severe anxiety
- Agitation
- Tics or dyskinesias
- Blurred vision
- Priapism (rare)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only 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.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cardiac malformations and oral clefts based on some epidemiological studies with methylphenidate, though data are conflicting and limited.
Second Trimester:
Limited data, generally considered lower risk than first trimester for major malformations.
Third Trimester:
Potential for premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms (e.g., agitation, irritability, poor feeding).
Lactation
Dexmethylphenidate and its metabolites are excreted in human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Infant Risk:
L3 (Moderately Safe). Monitor breastfed infants for agitation, insomnia, decreased weight gain, or poor feeding. Consider using the lowest effective dose and monitoring infant weight and sleep patterns.
Pediatric Use
Approved for 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 (over 65 years). Use with caution due to potential for increased sensitivity to stimulant effects, especially cardiovascular effects. Consider lower initial doses and slower titration.
Clinical Information
Clinical Pearls
- Dexmethylphenidate ER is the d-isomer of methylphenidate, often allowing for a lower dose compared to racemic methylphenidate.
- The extended-release formulation provides a smooth, once-daily dosing profile, typically lasting 10-12 hours.
- Counsel patients on the importance of taking the medication in the morning to avoid sleep disturbances.
- Educate patients and caregivers about the potential for serious cardiovascular and psychiatric adverse events.
- Due to its Schedule II classification, strict prescribing and dispensing regulations apply.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Daytrana, Quillivant XR)
- Amphetamine/Dextroamphetamine (e.g., Adderall, Vyvanse, Dexedrine)
- Lisdexamfetamine (Vyvanse)
- Atomoxetine (Strattera) - non-stimulant
- Guanfacine ER (Intuniv) - non-stimulant
- Clonidine ER (Kapvay) - non-stimulant
- Bupropion (Wellbutrin) - off-label
Cost & Coverage
Average Cost:
Varies widely, typically $100-$400 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic; Tier 3 or higher for brand.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.