Focalin XR 5mg 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 an extended-release capsule containing dexmethylphenidate, a stimulant medication. It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. It is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to improve focus, reduce hyperactivity, and control impulsive behavior.
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 effects. 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 effects. 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 to avoid sleep problems.
- Capsules can be swallowed whole or opened and sprinkled over a small amount of applesauce and consumed immediately. Do not chew the beads.
- Avoid alcohol, as it can cause the medication to be released too quickly.
- Maintain a regular sleep schedule.
- Eat a balanced diet, especially if appetite suppression occurs.
- Regular exercise can complement treatment for ADHD.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 10 mg orally once daily in the morning. Titrate weekly by 10 mg increments.
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
ADHD:
Initial: 10 mg orally once daily in the morning. Max: 40 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial: 5 mg orally once daily in the morning. Titrate weekly by 5 mg increments. Max: 30 mg/day.
Adolescent:
13-17 years: Initial: 10 mg orally once daily in the morning. Titrate weekly by 10 mg increments. Max: 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, monitor for adverse effects.
Moderate:
No specific dose adjustment recommended, monitor for adverse effects.
Severe:
No specific dose adjustment recommended, monitor for adverse effects.
Dialysis:
Not well studied; caution and close monitoring recommended.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, monitor for adverse effects.
Moderate:
No specific dose adjustment recommended, monitor for adverse effects.
Severe:
No specific dose adjustment recommended, 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 of action in ADHD is not fully known, but it is thought to involve modulation of dopaminergic and noradrenergic neurotransmission in the frontal cortex and subcortical regions.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified for dexmethylphenidate, but methylphenidate has low oral bioavailability (22-30%) due to first-pass metabolism.
Tmax:
Biphasic release: Initial peak at 1.5 hours, second peak at 4.5 hours (for XR formulation).
FoodEffect:
High-fat meal delays Tmax by approximately 1.5 hours and increases Cmax by about 30% for the second peak, but overall exposure (AUC) is not significantly affected.
Distribution:
Vd:
Not explicitly reported for dexmethylphenidate, but methylphenidate has a large volume of distribution (2.65 L/kg).
ProteinBinding:
Approximately 15% (for methylphenidate).
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2.2 hours (for XR formulation).
Clearance:
Not explicitly reported for dexmethylphenidate, but methylphenidate clearance is high (0.53 L/hr/kg).
ExcretionRoute:
Renal (approximately 90% as metabolites, 1% unchanged drug).
Unchanged:
Less than 1%
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes (for XR formulation).
PeakEffect:
Biphasic: 1.5 hours and 4.5 hours (for XR formulation).
DurationOfAction:
Approximately 8-12 hours (for XR formulation).
Safety & Warnings
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
+ 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 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
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex drive
Erectile Dysfunction Warning
If you experience a painful erection (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.
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 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, such as depression, 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, upset stomach, or vomiting
Severe headache
Other Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, 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 potential 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
+ 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 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
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex drive
Erectile Dysfunction Warning
If you experience a painful erection (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.
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 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, such as depression, 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, upset stomach, or vomiting
Severe headache
Other Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, 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 potential 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 irritability.
- New psychotic symptoms (e.g., hearing voices, believing things that are not true).
- New manic symptoms (e.g., extreme high mood, increased energy, racing thoughts).
- Unexplained wounds on fingers or toes (Raynaud's phenomenon).
- Prolonged or painful erections (priapism, rare but serious).
- 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. 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 conditions
+ Tourette's syndrome or tics (you or a family member)
Presence of other health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever experienced a stroke
Recent use (within the last 14 days) of 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 inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. This will help ensure your safety while taking this medication. Never start, stop, or change 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. 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 conditions
+ Tourette's syndrome or tics (you or a family member)
Presence of other health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever experienced a stroke
Recent use (within the last 14 days) of 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 inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. This will help ensure your safety while taking this medication. Never start, stop, or change 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 alertness, wait until you understand how this medication affects you. If you experience drowsiness or other side effects, avoid tasks that may put you or others at risk.
Long-term use or high doses of this medication can lead to tolerance, reducing its effectiveness. If you notice that the medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose, as this can increase the risk of adverse effects.
Your doctor may recommend heart tests before starting this medication, especially if you have pre-existing heart conditions. 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 seizure disorders. Consult your doctor to determine if you are at higher risk and discuss strategies to minimize this risk.
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. Avoid drinking alcohol, as it can exacerbate these effects.
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 hallucinations, anger, and altered thinking patterns. 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 attempted suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, anxiety, or loss of interest in activities.
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary to monitor potential effects. Discuss any concerns 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 alertness, wait until you understand how this medication affects you. If you experience drowsiness or other side effects, avoid tasks that may put you or others at risk.
Long-term use or high doses of this medication can lead to tolerance, reducing its effectiveness. If you notice that the medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose, as this can increase the risk of adverse effects.
Your doctor may recommend heart tests before starting this medication, especially if you have pre-existing heart conditions. 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 seizure disorders. Consult your doctor to determine if you are at higher risk and discuss strategies to minimize this risk.
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. Avoid drinking alcohol, as it can exacerbate these effects.
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 hallucinations, anger, and altered thinking patterns. 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 attempted suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, anxiety, or loss of interest in activities.
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary to monitor potential effects. Discuss any concerns 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)
- Euphoria
- Confusion
- Hallucinations
- Delirium
- Sweating
- Flushing
- Headache
- Hyperpyrexia (very high fever)
- Tachycardia
- Palpitations
- Cardiac arrhythmias
- Hypertension
- Mydriasis (dilated pupils)
- Dry mouth and mucous membranes
What to Do:
Call 911 or your local emergency number immediately. Contact a poison control center at 1-800-222-1222. Medical management typically involves supportive care, including gastric lavage, activated charcoal, and sedation for severe agitation or seizures. Monitor vital signs and cardiac rhythm.
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) - theoretical risk of serotonin syndrome.
- Antihypertensive drugs - may reduce the effectiveness of antihypertensives.
Moderate Interactions
- Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, requiring dose adjustment.
- Tricyclic antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, requiring dose adjustment.
Minor Interactions
- Alcohol - may accelerate the release of dexmethylphenidate from the extended-release formulation, leading to a more rapid increase in plasma levels.
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.
Height and Weight
Rationale: Monitor for growth suppression in pediatric patients.
Timing: Prior to initiation.
Cardiac history (personal and family)
Rationale: Assess for pre-existing cardiac conditions that may contraindicate stimulant use.
Timing: Prior to initiation.
Psychiatric history (personal and family)
Rationale: Assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated.
Timing: Prior to initiation.
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
Frequency: Every 3 months for pediatric patients.
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration; consider drug holiday or alternative treatment.
ADHD symptom control
Frequency: Regularly, at each follow-up visit.
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative.
Emergence of new psychiatric symptoms (e.g., psychosis, mania, aggression)
Frequency: At each follow-up visit.
Target: Absence of new symptoms.
Action Threshold: New or worsening symptoms; discontinue treatment and evaluate.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- Unexplained fainting
- New or worsening aggression
- Hallucinations
- Delusional thinking
- Mania
- Severe anxiety
- Persistent insomnia
- Tics or dyskinesias
- Blurred vision
- Priapism (rare)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of developmental toxicity at high doses. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cardiac malformations (based on some studies with methylphenidate, though data are conflicting).
Second Trimester:
Limited data, general stimulant risks apply.
Third Trimester:
Potential for premature delivery and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremor, poor feeding) have been reported with stimulant use near term.
Lactation
Dexmethylphenidate and/or its metabolites are excreted into human 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) - Monitor infant for irritability, poor feeding, and sleep disturbances.
Pediatric Use
Safety and efficacy established in pediatric patients 6 years and older. Long-term effects on growth (weight and height) should be monitored. Growth suppression has been observed with long-term stimulant use.
Geriatric Use
Safety and efficacy have not been established in patients over 65 years of age. Generally not recommended due to increased risk of cardiovascular adverse events and other comorbidities. If used, start with lower doses and titrate slowly with close monitoring.
Clinical Information
Clinical Pearls
- Focalin XR is the d-isomer of methylphenidate, meaning it is the more active enantiomer, allowing for lower doses compared to racemic methylphenidate.
- The extended-release formulation provides a biphasic release, aiming for once-daily dosing convenience and sustained effect throughout the school/work day.
- Counsel patients to take it in the morning to avoid insomnia.
- Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing pills, but the beads should not be crushed or chewed.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
- Be vigilant for new or worsening psychiatric symptoms, especially in patients with a history of bipolar disorder or psychosis.
Alternative Therapies
- Other methylphenidate formulations (e.g., Ritalin LA, Concerta, Daytrana, Quillivant XR, Adhansia XR)
- Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Mydayis)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy
Cost & Coverage
Average Cost:
Not available per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.