Focalin XR 40mg 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?
Focalin XR is an extended-release capsule used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It helps improve focus, attention, and control over impulsive behavior by affecting certain natural chemicals in the brain.
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. Swallow the tablet whole; do not chew or crush it. If you have difficulty swallowing the tablet whole, you may mix the contents with applesauce, but be sure to swallow the mixture immediately without chewing.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. Keep your medication in a secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or area to store your medication. This will help prevent accidental ingestion or misuse.
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. Swallow the tablet whole; do not chew or crush it. If you have difficulty swallowing the tablet whole, you may mix the contents with applesauce, but be sure to swallow the mixture immediately without chewing.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. Keep your medication in a secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or area to store your medication. This will help prevent accidental ingestion or misuse.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the capsule whole with or without food in the morning. Do not crush, chew, or divide the capsule.
- If you cannot swallow the capsule whole, you may open it and sprinkle the beads over a small amount of applesauce and swallow immediately without chewing.
- Avoid taking the medication in the late afternoon or evening to prevent sleep problems.
- Maintain a regular sleep schedule.
- Eat a balanced diet and stay hydrated.
- Engage in regular physical activity.
- Avoid alcohol, as it may affect the release of the medication.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 10 mg orally once daily in the morning; may increase by 10 mg weekly.
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
ADHD:
Maximum recommended dose is 40 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6-12 years: Initial 5 mg orally once daily in the morning; may increase by 5 mg weekly to a maximum of 30 mg/day.
Adolescent:
For adolescents 13-17 years: Initial 10 mg orally once daily in the morning; may increase by 10 mg 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; caution advised due to potential for accumulation of metabolites.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution; monitor for adverse effects.
Pharmacology
Mechanism of Action
Dexmethylphenidate is the d-threo-enantiomer of methylphenidate. It is believed 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 by which it produces its therapeutic effects in ADHD is not fully known.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified for dexmethylphenidate, but generally considered high (similar to methylphenidate ~95%).
Tmax:
Biphasic absorption with two peaks: first peak at approximately 1.5 hours and second peak at approximately 4.5 hours post-dose.
FoodEffect:
High-fat meals can delay the first peak Tmax by approximately 1 hour and the second peak Tmax by approximately 2.5 hours, but do not significantly affect the overall extent of absorption (AUC).
Distribution:
Vd:
Approximately 2.6 L/kg (for methylphenidate, similar for dexmethylphenidate).
ProteinBinding:
Approximately 15% (for methylphenidate, similar for dexmethylphenidate).
CnssPenetration:
Yes, readily crosses the blood-brain barrier.
Elimination:
HalfLife:
Approximately 2.2 hours (terminal elimination half-life).
Clearance:
Approximately 0.53 L/hr/kg (for methylphenidate, similar for dexmethylphenidate).
ExcretionRoute:
Primarily renal (approximately 90% of the dose excreted in urine as PPAA, less than 10% as unchanged drug).
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes.
PeakEffect:
First peak at 1.5 hours, second peak at 4.5 hours.
DurationOfAction:
Approximately 10-12 hours.
Confidence:
High
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including Focalin XR, other methylphenidate-containing products, and amphetamines, 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
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 vision 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 (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Urination problems, such as difficulty starting or stopping urination, 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 (priapism) or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not engaging in sexual activity. If left untreated, priapism can lead to permanent sexual dysfunction.
Cardiovascular Warning
Sudden deaths have occurred in people with pre-existing heart problems or heart defects. Inform your doctor if you have any heart condition or defect, or if a family member has a history of abnormal heart rhythms or sudden death. 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 health conditions, 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 or mood, such as depression, suicidal thoughts, nervousness, emotional instability, 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 medications. 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 significant 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 resolve:
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 potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor 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 vision 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 (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Urination problems, such as difficulty starting or stopping urination, 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 (priapism) or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not engaging in sexual activity. If left untreated, priapism can lead to permanent sexual dysfunction.
Cardiovascular Warning
Sudden deaths have occurred in people with pre-existing heart problems or heart defects. Inform your doctor if you have any heart condition or defect, or if a family member has a history of abnormal heart rhythms or sudden death. 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 health conditions, 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 or mood, such as depression, suicidal thoughts, nervousness, emotional instability, 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 medications. 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 significant 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 resolve:
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 potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention).
- New or worsening aggression, hostility, or irritability.
- New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true).
- New manic symptoms (e.g., extreme energy, racing thoughts).
- Unexplained wounds on fingers or toes, or changes in skin color (Raynaud's phenomenon).
- Uncontrolled movements or tics.
- Blurred vision or other vision changes.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial 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 (if you or a family member has been diagnosed)
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 certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Current use of certain medications, such as:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is essential 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 whether 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 crucial 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 (if you or a family member has been diagnosed)
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 certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Current use of certain medications, such as:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is essential 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 whether 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. 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.
Before 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 headaches, dizziness, fainting, or changes in vision.
To minimize potential interactions, 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 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 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. 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.
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.
Before 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 headaches, dizziness, fainting, or changes in vision.
To minimize potential interactions, 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 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 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. 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 (very high fever)
- Tachycardia (fast heart rate)
- Palpitations
- Cardiac arrhythmias
- Hypertension (high blood pressure)
- Mydriasis (dilated pupils)
- Dry mouth and mucous membranes
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Seek immediate medical attention. Treatment is supportive and may include 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 due to risk of hypertensive crisis.
Major Interactions
- Pressor agents (e.g., decongestants, tricyclic antidepressants) - risk of increased blood pressure.
- Halogenated anesthetics - risk of sudden blood pressure and heart rate increases during surgery.
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans) - theoretical risk of serotonin syndrome, though less common than with amphetamines.
Moderate Interactions
- Antihypertensive drugs - may reduce the effectiveness of antihypertensive medications.
- Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of these drugs, requiring dose adjustment.
- Tricyclic antidepressants (TCAs) - may inhibit metabolism of TCAs, requiring dose adjustment.
Minor Interactions
- Alcohol - may alter the release profile of extended-release formulations, leading to dose dumping.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Stimulants can cause dose-related increases in BP and HR.
Timing: Prior to initiation of treatment.
Height and Weight (Pediatric)
Rationale: Stimulants have been associated with growth suppression in pediatric patients.
Timing: Prior to initiation of treatment.
Psychiatric History and Symptoms
Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated by stimulants.
Timing: Prior to initiation of treatment.
Cardiac History (ECG if indicated)
Rationale: To screen for pre-existing cardiac conditions that may increase risk of sudden death.
Timing: Prior to initiation of treatment, especially if family history of sudden death or cardiac abnormalities.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or at least every 3-6 months.
Target: Within normal limits for age.
Action Threshold: Significant or sustained increases warrant dose reduction or discontinuation.
Height and Weight (Pediatric)
Frequency: Every 3-6 months.
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration may warrant dose reduction or drug holiday.
Psychiatric Symptoms
Frequency: At each visit.
Target: Stable mood, absence of new or worsening psychotic or manic symptoms.
Action Threshold: Emergence of new or worsening psychiatric symptoms (e.g., aggression, hallucinations, mania) warrants evaluation and potential discontinuation.
ADHD Symptom Control
Frequency: At each visit.
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or intolerable side effects warrants dose adjustment or alternative treatment.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Anxiety
- Insomnia
- Tics or dyskinesias
- Numbness, coolness, or pain in digits (Raynaud's phenomenon)
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 no increased risk of major congenital malformations with methylphenidate exposure during the first trimester.
Trimester-Specific Risks:
First Trimester:
Limited data, but some studies suggest a small increased risk of cardiac malformations (e.g., atrial septal defects) with methylphenidate exposure, though overall risk remains low. Dexmethylphenidate is the d-isomer of methylphenidate.
Second Trimester:
Potential for fetal growth restriction and premature birth, though data are limited and confounded by underlying maternal conditions.
Third Trimester:
Potential for withdrawal symptoms (e.g., tremors, irritability) in neonates exposed to stimulants late in pregnancy.
Lactation
Dexmethylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate (and by extension, dexmethylphenidate) to be compatible with breastfeeding, but caution is advised. Monitor the infant for adverse effects.
Infant Risk:
Low to moderate. Potential for irritability, poor feeding, or sleep disturbances in the infant. Monitor infant for changes in feeding, sleep patterns, and weight gain.
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., aggression, psychosis, mania).
Geriatric Use
Safety and efficacy in patients over 65 years have not been established. Use with caution due to increased likelihood of comorbidities, polypharmacy, and age-related decline in renal/hepatic function. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Focalin XR is an extended-release formulation designed for once-daily dosing, providing symptom control throughout the school or workday.
- The capsule can be opened and sprinkled on applesauce for patients who have difficulty swallowing pills, but the beads should not be chewed.
- Patients should be advised to avoid alcohol, as it can cause dose dumping from the extended-release formulation.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
- Educate patients and caregivers about the potential for psychiatric side effects, including new or worsening aggression, psychosis, or mania.
- Consider drug holidays (e.g., weekends or school breaks) in pediatric patients to assess the need for continued treatment and to potentially mitigate growth suppression, though this should be discussed with a healthcare provider.
Alternative Therapies
- Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Daytrana, Quillivant XR, Adhansia XR)
- Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Mydayis, Dexedrine)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy and psychotherapy for ADHD.
Cost & Coverage
Average Cost:
Varies widely, typically $200-$500+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand, or generic equivalent)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns regarding this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns regarding this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.