Focalin XR 10mg 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
Pregnancy Category
Category C
FDA Approved
May 2005
DEA Schedule
Schedule II
Overview
What is this medicine?
Focalin XR is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It 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 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 in a dry place. 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 pets' reach.
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 in a dry place. 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 pets' reach.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening as it may cause sleep problems.
- Swallow the capsule whole. Do not chew, crush, or divide the capsule. If unable to swallow, the capsule may be opened and the contents sprinkled over a small amount of applesauce and consumed immediately.
- Avoid alcohol, as it may affect the release of the medication.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Do not stop taking this medication suddenly without consulting your doctor, as it may lead to withdrawal symptoms.
- Store at room temperature away from moisture and heat. Keep out of reach of children and pets.
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. Max: 40 mg/day.
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. May increase by 5 mg increments weekly. Max: 30 mg/day.
Adolescent:
13-17 years: Initial: 10 mg orally once daily in the morning. May increase by 10 mg increments weekly. Max: 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.
Dialysis:
Not well-studied; use with caution and monitor for adverse effects.
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.
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, but well-absorbed.
Tmax:
Biphasic release: Initial peak at approximately 1.5 hours, second peak at approximately 4.5 hours.
FoodEffect:
High-fat meal may delay Tmax by approximately 1 hour and decrease Cmax by about 15%, but overall extent of absorption (AUC) is not significantly affected.
Distribution:
Vd:
Not extensively distributed; approximately 2.65 L/kg.
ProteinBinding:
Approximately 15% (low).
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2.2 hours (mean terminal half-life).
Clearance:
Approximately 0.40 L/hr/kg.
ExcretionRoute:
Renal (primarily as metabolites).
Unchanged:
Less than 1% of the dose is excreted in the urine as unchanged dexmethylphenidate.
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes.
PeakEffect:
Biphasic, corresponding to Tmax values (1.5 hours and 4.5 hours).
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
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 or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Fast heartbeat
Joint pain
Purple patches on the skin or mouth
Changes in eyesight or eye pain, swelling, or redness
Seizures
Shakiness
Trouble controlling body movements
Difficulty 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
Urination problems, such as inability to pass urine or changes in urine output
Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex interest
Painful erection (hard penis) or an erection lasting longer than 4 hours, which can occur even when not having sex (seek medical attention immediately to avoid potential long-term sexual problems)
Important Heart-Related Warnings
If you have a heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek medical help right away if you experience:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. 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 potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help right away 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 Possible Side Effects
While many people may not experience side effects or may only have minor side effects, some individuals may encounter:
Dizziness or headache
Drowsiness
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Trouble sleeping
Dry mouth
Upset stomach or vomiting
* Throat pain
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, consult your doctor for medical advice.
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 immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Fast heartbeat
Joint pain
Purple patches on the skin or mouth
Changes in eyesight or eye pain, swelling, or redness
Seizures
Shakiness
Trouble controlling body movements
Difficulty 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
Urination problems, such as inability to pass urine or changes in urine output
Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex interest
Painful erection (hard penis) or an erection lasting longer than 4 hours, which can occur even when not having sex (seek medical attention immediately to avoid potential long-term sexual problems)
Important Heart-Related Warnings
If you have a heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek medical help right away if you experience:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Mental Health and Mood Changes
New or worsening behavior and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. 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 potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help right away 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 Possible Side Effects
While many people may not experience side effects or may only have minor side effects, some individuals may encounter:
Dizziness or headache
Drowsiness
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Trouble sleeping
Dry mouth
Upset stomach or vomiting
* Throat pain
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, consult your doctor for medical advice.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention).
- New or worsening aggression, hostility, or agitation.
- New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true).
- New or worsening tics (uncontrolled repetitive movements or sounds).
- Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes (Raynaud's phenomenon).
- Blurred vision or other vision changes.
- Unusual changes in mood or behavior.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A family 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
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ A history of stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to very high blood pressure.
If you are currently taking:
+ Linezolid
+ Methylene blue
All your medications, including:
+ Prescription drugs
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
* All your health problems, as this medication may interact with other drugs or exacerbate certain conditions.
Remember, this list is not exhaustive, and it is crucial to consult your doctor and pharmacist about all your medications and health issues to ensure safe use of this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A family 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
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ A history of stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to very high blood pressure.
If you are currently taking:
+ Linezolid
+ Methylene blue
All your medications, including:
+ Prescription drugs
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
* All your health problems, as this medication may interact with other drugs or exacerbate certain conditions.
Remember, this list is not exhaustive, and it is crucial to consult your doctor and pharmacist about all your medications and health issues to ensure safe use of this medication. Never start, stop, or change the dose of any medication without first 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 or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be necessary to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Before starting this medication, your doctor may recommend heart tests. 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 seizures. Consult your doctor to determine if you are at a higher risk of experiencing 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 instructed by your doctor, and seek immediate medical attention if you experience severe headache, dizziness, fainting, or changes in vision.
To minimize potential interactions, limit your consumption of caffeine (found in tea, coffee, cola, and chocolate), as it may cause nervousness, shakiness, and rapid heartbeat when combined with this medication. Avoid consuming alcohol while taking this drug.
If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
This medication may cause changes in behavior and mood, including altered thinking, anger, and hallucinations. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
In some cases, this medication may affect growth in children and adolescents, and regular growth checks may be necessary. 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 or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be necessary to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.
Before starting this medication, your doctor may recommend heart tests. 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 seizures. Consult your doctor to determine if you are at a higher risk of experiencing 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 instructed by your doctor, and seek immediate medical attention if you experience severe headache, dizziness, fainting, or changes in vision.
To minimize potential interactions, limit your consumption of caffeine (found in tea, coffee, cola, and chocolate), as it may cause nervousness, shakiness, and rapid heartbeat when combined with this medication. Avoid consuming alcohol while taking this drug.
If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
This medication may cause changes in behavior and mood, including altered thinking, anger, and hallucinations. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
In some cases, this medication may affect growth in children and adolescents, and regular growth checks may be necessary. 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:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose management typically involves supportive care, including maintaining an open airway, monitoring vital signs, and managing 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
- 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, though less pronounced than with other stimulants.
Moderate Interactions
- Antihypertensive drugs - may reduce the hypotensive effect of these drugs.
- Anticoagulants (e.g., warfarin) - may inhibit metabolism, increasing anticoagulant effect (monitor INR).
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels.
- Tricyclic Antidepressants (TCAs) - may inhibit metabolism, increasing TCA levels.
Minor Interactions
- Alcohol - may alter release rate of dexmethylphenidate from the extended-release formulation.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: To identify pre-existing cardiovascular conditions and monitor for stimulant-induced increases.
Timing: Prior to initiation of therapy.
Height and Weight
Rationale: To establish baseline for growth monitoring, especially in pediatric patients.
Timing: Prior to initiation of therapy.
Psychiatric History (including family history of sudden death or serious cardiac disease)
Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) or cardiac risks.
Timing: Prior to initiation of therapy.
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; significant increases should prompt evaluation.
Action Threshold: Sustained elevation above baseline or age-appropriate norms (e.g., >95th percentile for BP) warrants investigation and potential dose adjustment or discontinuation.
Height and Weight
Frequency: Every 3-6 months in children and adolescents.
Target: Consistent growth along established growth curves.
Action Threshold: Significant growth deceleration or weight loss warrants nutritional assessment and potential dose adjustment or drug holiday.
ADHD Symptom Control
Frequency: At each visit.
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Psychiatric Status (e.g., emergence of new psychotic symptoms, mania, aggression, tics)
Frequency: At each visit.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Emergence of new or worsening psychiatric symptoms warrants immediate evaluation and potential discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Unexplained sudden death (in family history)
- New or worsening aggression or hostility
- New or worsening psychotic or manic symptoms (e.g., hallucinations, delusions)
- New or worsening tics or Tourette's syndrome
- Severe anxiety or agitation
- Growth suppression (in children)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Neonates exposed to amphetamines during pregnancy may be at increased risk of premature delivery and low birth weight. Withdrawal symptoms have been observed in neonates.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are conflicting and limited.
Second Trimester:
Potential for growth restriction and premature birth.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., agitation, feeding difficulties, tremors) if used close to delivery.
Lactation
Dexmethylphenidate and its metabolites are excreted into human milk. The American Academy of Pediatrics considers methylphenidate (parent compound) to be compatible with breastfeeding. However, monitor breastfed infants for agitation, insomnia, decreased weight gain, or other adverse effects. Weigh the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for irritability, poor feeding, and sleep disturbances.
Pediatric Use
Safety and efficacy established in children 6 years and older. Monitor growth (height and weight) regularly, as stimulants can cause modest growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).
Geriatric Use
Safety and efficacy not established in geriatric patients. Use with caution due to increased sensitivity to stimulant effects, potential for cardiovascular events, and comorbidities. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Focalin XR is the extended-release formulation of dexmethylphenidate, providing a longer duration of action (up to 12 hours) compared to immediate-release formulations.
- The biphasic release profile aims to provide rapid onset and sustained effect throughout the day.
- Counsel patients on the importance of taking the medication in the morning to avoid sleep disturbances.
- Monitor for cardiovascular side effects (BP, HR) and psychiatric side effects (new psychosis, mania, aggression, tics) at each visit.
- Growth monitoring is crucial for pediatric patients on long-term stimulant therapy.
- Educate patients and families about the potential for abuse and dependence, and the importance of secure storage.
- Consider drug holidays for growth monitoring or to assess continued need for medication, especially in children.
Alternative Therapies
- Other CNS Stimulants (e.g., methylphenidate, amphetamine salts, lisdexamfetamine)
- Non-stimulants (e.g., atomoxetine, guanfacine ER, clonidine ER)
- Behavioral therapy
- Cognitive Behavioral Therapy (CBT)
Cost & Coverage
Average Cost:
Varies widely, typically $200-$400+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand); generic typically Tier 1.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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, we encourage you to discuss them 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.