Focalin XR 25mg 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 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?
Focalin XR is a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is a stimulant that works by affecting certain natural chemicals in the brain to help improve attention, focus, and reduce impulsivity and hyperactivity. The 'XR' means it's an extended-release capsule, designed to work throughout the day with a single morning 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 reach 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 reach 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. 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, the capsule may be opened and the contents sprinkled over a small amount of applesauce and consumed immediately.
- Avoid alcohol, as it may affect the release of the medication.
- Maintain a healthy diet and regular sleep schedule.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms may occur.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg once daily in the morning
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
ADHD:
Initial dose 10 mg once daily in the morning. May be adjusted in 10 mg increments weekly to a maximum of 40 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial dose 5 mg once daily in the morning. May be adjusted in 5 mg increments weekly to a maximum of 30 mg/day.
Adolescent:
13-17 years: Initial dose 10 mg once daily in the morning. May be adjusted in 10 mg increments weekly to a maximum of 40 mg/day.
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.
Confidence:
Medium
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. The precise mechanism of action in ADHD is not fully understood.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified for oral, but well absorbed.
Tmax:
1.5 hours (initial peak), 4.5 hours (second peak) for XR formulation.
FoodEffect:
High-fat meal may delay Tmax by approximately 1 hour and increase Cmax by about 30% for the initial peak, but overall exposure (AUC) is not significantly affected.
Distribution:
Vd:
Not available (for dexmethylphenidate specifically, but methylphenidate is ~2.65 L/kg)
ProteinBinding:
Approximately 15% (for methylphenidate)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2.2 hours (for dexmethylphenidate)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as PPAA)
Unchanged:
<1% (dexmethylphenidate)
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes
PeakEffect:
Approximately 1.5 hours (first peak) and 4.5 hours (second peak) for XR formulation.
DurationOfAction:
Approximately 8-12 hours
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including Focalin XR, 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 treatment.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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 hands or feet
Sores or wounds on fingers or toes
Urination problems, such as inability to pass urine 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 certain heart problems or 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 behavior 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
Most people do not experience serious 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
Feeling sleepy
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Trouble sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
This is not a comprehensive list of all 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 or seek medical attention right away:
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 hands or feet
Sores or wounds on fingers or toes
Urination problems, such as inability to pass urine 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 certain heart problems or 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 behavior 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
Most people do not experience serious 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
Feeling sleepy
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Trouble sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
This is not a comprehensive list of all 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).
- Numbness, coolness, or pain in fingers or toes, or unexplained wounds on fingers/toes (Raynaud's phenomenon).
- New or worsening aggressive behavior, hostility, or agitation.
- Seeing or hearing things that are not real (hallucinations), believing things that are not true (delusions), or feeling suspicious.
- New or worsening tics (uncontrolled movements or sounds).
- Prolonged or painful erection (priapism).
- Blurred vision or other vision changes.
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 in you or your family members, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever had a stroke
Use of certain 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 can lead to very high blood pressure)
Concurrent use of:
+ 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 you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose 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 in you or your family members, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever had a stroke
Use of certain 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 can lead to very high blood pressure)
Concurrent use of:
+ 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 you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose 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 potential interactions with other treatments.
Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you. This is crucial to prevent accidents and ensure your safety.
Long-term use or high doses of this medication can lead to tolerance, which means it may not work as effectively, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.
Before starting this medication, your doctor may recommend heart tests to assess your cardiovascular health. 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 seizure disorders. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
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 medical attention immediately if you experience severe headaches, 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 can cause nervousness, shakiness, and rapid heartbeat. Additionally, avoid consuming alcohol during treatment.
If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough and 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 health conditions, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical attention immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as 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 discuss the potential benefits and risks of this medication to you and your baby.
Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you. This is crucial to prevent accidents and ensure your safety.
Long-term use or high doses of this medication can lead to tolerance, which means it may not work as effectively, and you may need higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.
Before starting this medication, your doctor may recommend heart tests to assess your cardiovascular health. 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 seizure disorders. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
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 medical attention immediately if you experience severe headaches, 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 can cause nervousness, shakiness, and rapid heartbeat. Additionally, avoid consuming alcohol during treatment.
If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough and 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 health conditions, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical attention immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as 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 discuss the potential 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 911 or your local emergency number immediately. Contact a poison control center at 1-800-222-1222. Seek immediate medical attention. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for agitation, hyperthermia, and cardiovascular effects.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis).
Major Interactions
- Vasopressors (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) - theoretical risk of serotonin syndrome, though less pronounced than with other stimulants.
Moderate Interactions
- Antihypertensive Drugs (e.g., ACE inhibitors, beta-blockers) - may reduce the effectiveness of antihypertensives.
- Coumarin Anticoagulants (e.g., warfarin) - may prolong prothrombin time (monitor INR).
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of these drugs, increasing serum concentrations.
- Tricyclic Antidepressants (TCAs) - may increase plasma concentrations of TCAs.
Minor Interactions
- Alcohol - may alter the release profile of the extended-release formulation.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: CNS stimulants can cause increases in BP and HR.
Timing: Prior to initiation of treatment.
Cardiac History and Family History
Rationale: To identify pre-existing cardiac conditions that may contraindicate use or require further evaluation.
Timing: Prior to initiation of treatment.
Psychiatric History
Rationale: To assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated.
Timing: Prior to initiation of treatment.
Height and Weight (Pediatric Patients)
Rationale: To establish baseline for growth monitoring.
Timing: Prior to initiation of treatment.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly (e.g., at each visit or every 3-6 months)
Target: Within normal limits for age/individual
Action Threshold: Sustained clinically significant increases; consider dose reduction or discontinuation.
Growth (Height and Weight) in Pediatric Patients
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration; consider drug holiday or alternative treatment.
Emergence or Worsening of Psychiatric Symptoms (e.g., psychosis, mania, aggression, anxiety)
Frequency: Regularly (at each visit)
Target: Absence of new or worsening symptoms
Action Threshold: New onset or significant worsening of symptoms; consider dose reduction or discontinuation.
Signs of Abuse/Dependence
Frequency: Regularly (at each visit)
Target: Absence of signs
Action Threshold: Evidence of abuse/dependence; reassess treatment plan.
Peripheral Vasculopathy (e.g., Raynaud's phenomenon)
Frequency: Periodically
Target: Absence of symptoms
Action Threshold: New onset or worsening of symptoms; consider discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Numbness, coolness, or pain in fingers/toes
- Unexplained wounds on fingers/toes
- Blurred vision
- Persistent priapism
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Limited data suggest a possible association with cardiac malformations and other congenital anomalies with methylphenidate exposure during the first trimester.
Trimester-Specific Risks:
First Trimester:
Possible increased risk of cardiac malformations (e.g., ventricular septal defects) and other congenital anomalies based on some studies of methylphenidate. Data are conflicting.
Second Trimester:
Not well studied, but generally considered less risk for structural malformations compared to first trimester.
Third Trimester:
Potential for premature delivery and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremor, poor feeding) may occur if used close to delivery.
Lactation
Dexmethylphenidate is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, reduced weight gain), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderate risk). Potential for irritability, poor feeding, insomnia, and reduced weight gain in the infant. Monitor infant for adverse effects.
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) carefully. Long-term effects on growth are a concern. Psychiatric adverse events (e.g., psychosis, mania) can occur.
Geriatric Use
Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to stimulant effects (e.g., cardiovascular effects, anxiety, insomnia). Generally not recommended for this population unless compelling reasons and close monitoring.
Clinical Information
Clinical Pearls
- Focalin XR is the d-isomer of methylphenidate, meaning it is the more pharmacologically active enantiomer, allowing for lower doses compared to racemic methylphenidate.
- Administer once daily in the morning to avoid insomnia.
- Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing, but the beads should not be chewed.
- Monitor blood pressure and heart rate regularly, especially in patients with pre-existing cardiovascular conditions.
- Be aware of the potential for growth suppression in pediatric patients; consider drug holidays if growth deceleration is significant.
- Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
- Assess for underlying psychiatric conditions (e.g., bipolar disorder, psychosis) before initiating treatment, as stimulants can exacerbate these conditions.
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
- Behavioral therapy for ADHD
Cost & Coverage
Average Cost:
$200 - $400+ per 30 capsules (25mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
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, which provides crucial information for patients. It is important to 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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.