Focalin XR 20mg Capsules
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System 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 used to treat Attention Deficit Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. The 'XR' means it's designed to release medicine slowly throughout the day, so you usually only need to take it once in the morning.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. 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 crush, chew, or divide the capsule. Swallow whole. If unable to swallow, the capsule may be opened and the entire contents sprinkled onto a small amount of applesauce and consumed immediately.
- Avoid alcohol, as it may cause the medication to be released too quickly.
- Inform your doctor about all other medications you are taking, especially MAOIs, blood pressure medications, and antidepressants.
- Monitor for changes in mood, behavior, or heart rate/blood pressure.
- Maintain regular sleep patterns and healthy diet.
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 increments 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 increments weekly. Maximum recommended dose is 30 mg/day.
Adolescent:
For adolescents 13-17 years: Initial 5 mg orally once daily in the morning. May increase by 5 mg increments weekly. Maximum recommended dose is 30 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. Consider lower initial doses and careful monitoring.
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. Consider lower initial doses and careful monitoring.
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.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified for oral dexmethylphenidate, but well absorbed.
Tmax:
Biphasic release: First peak at approximately 1.5 hours, second peak at approximately 4.5 hours.
FoodEffect:
High-fat meal delays Tmax by approximately 1.5 hours and decreases Cmax by approximately 20%, but does not affect AUC.
Distribution:
Vd:
Not available
ProteinBinding:
Approximately 15% (to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2.2 hours (for the d-threo-methylphenidate component)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 90% excreted in urine as metabolites and unchanged drug)
Unchanged:
Less than 1% of the dose is excreted in the urine as unchanged dexmethylphenidate.
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes (for initial release)
PeakEffect:
Approximately 1.5 hours (first peak) and 4.5 hours (second peak)
DurationOfAction:
Approximately 10-12 hours
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 therapy.
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 or hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Fast heartbeat
Joint pain
Purple patches on the skin or mouth
Changes in vision or eye pain, swelling, or redness
Seizures
Shakiness
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex drive
Erectile Dysfunction Warning
If you experience a painful erection or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
Cardiac 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 any signs of heart problems, including:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Mental Health Warning
New or worsening behavioral and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. Inform your doctor if you or a family member have a history of mental or mood 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
Signs of mood changes, including 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 medications. 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 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 go away:
Dizziness or headache
Drowsiness
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Difficulty sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Fast heartbeat
Joint pain
Purple patches on the skin or mouth
Changes in vision or eye pain, swelling, or redness
Seizures
Shakiness
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex drive
Erectile Dysfunction Warning
If you experience a painful erection or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
Cardiac 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 any signs of heart problems, including:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Mental Health Warning
New or worsening behavioral and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. Inform your doctor if you or a family member have a history of mental or mood 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
Signs of mood changes, including 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 medications. 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 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 go away:
Dizziness or headache
Drowsiness
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Difficulty sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, anxiety, or depression
- Seeing or hearing things that are not real (psychosis)
- New tics or worsening of existing tics
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained weight loss or slowed growth in children
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Existing health problems, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ History of stroke
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Current use of certain medications, including:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Your doctor will assess the safety of taking this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
A family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Existing health problems, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ History of stroke
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Current use of certain medications, including:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Your doctor will assess the safety of taking this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you. If you experience any changes in your alertness or reaction time, consult your doctor for guidance.
Long-term use or high doses of this medication can lead to tolerance, reducing its effectiveness. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not exceed the prescribed dose, as this can increase the risk of adverse effects.
Prior to 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 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.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you. If you experience any changes in your alertness or reaction time, consult your doctor for guidance.
Long-term use or high doses of this medication can lead to tolerance, reducing its effectiveness. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not exceed the prescribed dose, as this can increase the risk of adverse effects.
Prior to 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 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
- Tachycardia
- Palpitations
- Cardiac arrhythmias
- Hypertension
- Mydriasis
- Dry mouth
What to Do:
Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of discontinuing an MAOI due to risk of hypertensive crisis.
Major Interactions
- Vasopressor Agents: May enhance the pressor effect of vasopressor agents.
- Halogenated Anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, Triptans, Fentanyl, Tramadol, Tryptophan, St. John's Wort): Increased risk of serotonin syndrome.
- Antihypertensive Drugs: May reduce the effectiveness of drugs used to treat hypertension.
Moderate Interactions
- Alcohol: May lead to a more rapid release of dexmethylphenidate from the extended-release capsule.
- Antacids/H2 Blockers/PPIs: No significant interaction expected as release is pH-independent.
- Warfarin, Phenytoin, Phenobarbital, Primidone: May inhibit the metabolism of these drugs, requiring dose adjustment and monitoring.
Confidence Interactions
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.
Height and Weight
Rationale: CNS stimulants are associated with weight loss and growth suppression in pediatric patients.
Timing: Prior to initiation of treatment (especially in pediatric patients).
Psychiatric History (including family history of suicide, bipolar disorder, depression)
Rationale: To assess risk of psychiatric adverse events.
Timing: Prior to initiation of treatment.
Cardiac History (including family history of sudden death or ventricular arrhythmia)
Rationale: To assess risk of serious cardiovascular events.
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
Action Threshold: Persistent elevation requiring intervention or dose adjustment.
Height and Weight
Frequency: Regularly (e.g., every 3 months for pediatric patients)
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss.
Psychiatric Symptoms (e.g., emergence or worsening of aggression, hostility, anxiety, depression, mania, psychosis)
Frequency: Regularly (at each visit)
Target: Stable or improved
Action Threshold: New or worsening symptoms requiring intervention or discontinuation.
Abuse/Diversion Potential
Frequency: Regularly (at each visit)
Target: No signs of abuse or diversion
Action Threshold: Signs of abuse or diversion requiring intervention.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hostility
- Anxiety
- Depression
- Mania
- Psychotic symptoms (e.g., hallucinations, delusions)
- Tics or exacerbation of pre-existing tics
- 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. Studies in animals have shown adverse effects.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity based on animal studies.
Second Trimester:
Not specifically studied, but continued exposure carries potential risks.
Third Trimester:
Not specifically studied, but continued exposure carries potential risks.
Lactation
L3 (Moderately Safe). Dexmethylphenidate and/or its metabolites are excreted in human milk. The American Academy of Pediatrics considers methylphenidate (racemic mixture) to be compatible with breastfeeding. Monitor breastfed infants for agitation, insomnia, anorexia, or poor weight gain.
Infant Risk:
Low to moderate risk. Monitor for irritability, poor feeding, or sleep disturbances.
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) and cardiovascular parameters. Assess for emergence or worsening of psychiatric symptoms. Long-term safety and efficacy in children under 6 years have not been established.
Geriatric Use
Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to stimulant effects, especially cardiovascular effects. Consider lower initial doses and careful titration.
Clinical Information
Clinical Pearls
- Focalin XR is the d-threo-enantiomer of methylphenidate, meaning it's the more active component, allowing for lower doses compared to racemic methylphenidate.
- The extended-release formulation provides a biphasic release, aiming for once-daily dosing and sustained effect throughout the school/work day.
- Patients should be advised to take Focalin XR in the morning to avoid insomnia.
- Due to its Schedule II classification, strict prescribing regulations apply, including no refills and specific prescription requirements.
- Careful monitoring for cardiovascular and psychiatric adverse effects is crucial, especially during dose titration and long-term therapy.
- Patients and caregivers should be educated on the potential for abuse and diversion.
Alternative Therapies
- Methylphenidate (e.g., Ritalin, Concerta, Daytrana, Quillivant XR)
- Amphetamine/Dextroamphetamine (e.g., Adderall, Vyvanse, Dexedrine)
- Lisdexamfetamine (Vyvanse)
- Atomoxetine (Strattera) - non-stimulant
- Guanfacine extended-release (Intuniv) - non-stimulant
- Clonidine extended-release (Kapvay) - non-stimulant
- Behavioral therapy for ADHD
Cost & Coverage
Average Cost:
$200 - $400 per 30 capsules (20mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand), Tier 1 (for generic)
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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.