Focalin XR 30mg Capsules
Overview
What is this medicine?
How to Use This Medicine
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. Swallow the tablet whole; do not chew or crush it. If you have difficulty swallowing the tablet whole, you can sprinkle its contents onto applesauce, but be sure to swallow the mixture immediately without chewing.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. Keep your medication in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. 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.
- Swallow the capsule whole; do not crush, chew, or divide. 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 affect the release of the medication.
- Maintain regular sleep patterns and healthy diet.
- Regular exercise can complement ADHD treatment.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Rapid 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
Uncontrollable 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 sensations 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
Prolonged or painful erections (lasting more than 4 hours), which can lead to permanent sexual dysfunction if left untreated
Important Heart-Related Warnings
If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heart rhythms or sudden death, notify your doctor. Seek immediate medical attention if you experience:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Mental Health and Mood Changes
This medication can cause changes in behavior and mood, including:
Hallucinations
Changes in thinking or behavior
Anger or aggression
Depression or suicidal thoughts
If you or a family member have a history of mental health conditions, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience any of these symptoms.
Serotonin Syndrome: A Potentially Life-Threatening Condition
Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. Seek immediate medical attention if you experience:
Agitation or restlessness
Changes in balance or coordination
Confusion or hallucinations
Fever
Rapid or abnormal heartbeat
Flushing or sweating
Muscle twitching or stiffness
Seizures
Shivering or shaking
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, some common side effects include:
Dizziness or headache
Drowsiness
Nervousness or excitability
Stomach pain or heartburn
Weight loss
Decreased appetite
Difficulty sleeping
Dry mouth
Upset stomach or vomiting
Throat pain
If you experience any of these side effects or have concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention).
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon).
- New or worsening aggression, hostility, or agitation.
- Seeing or hearing things that are not real (hallucinations), or believing things that are not true (delusions).
- New or worsening manic symptoms (e.g., extreme energy, racing thoughts, decreased need for sleep).
- Unexplained weight loss or slowed growth in children.
- Any signs of abuse or dependence (e.g., craving, taking more than prescribed).
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and signs.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Presence of specific health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever had a stroke
Use of certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may lead to very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Until you know how this medication affects you, avoid driving and other activities that require your full attention. If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. If you suspect you have developed tolerance, contact your doctor. Do not take more than the prescribed dose.
Before starting this medication, your doctor may recommend heart tests to ensure your safety. 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 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 side effects, 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 while on this medication.
If you have high blood pressure, consult your doctor before taking any 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:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, maintaining circulation and respiration, external cooling for hyperpyrexia, and benzodiazepines for severe agitation or convulsions.
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 (e.g., phenylephrine, pseudoephedrine): May potentiate the pressor effect.
- Halogenated Anesthetics (e.g., halothane, isoflurane): Risk of sudden blood pressure and heart rate increases during surgery.
- Antihypertensive drugs: May decrease the effectiveness of antihypertensive medications.
Moderate Interactions
- Coumarin anticoagulants (e.g., warfarin): May prolong prothrombin time; monitor coagulation parameters.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism, increasing plasma concentrations of anticonvulsants.
- Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine): May inhibit metabolism, increasing plasma concentrations of TCAs.
- Selective Serotonin Reuptake Inhibitors (SSRIs): Potential for additive serotonergic effects, though less common than with other stimulants.
Minor Interactions
- Alcohol: May alter the release profile of dexmethylphenidate from the extended-release capsule.
Monitoring
Baseline Monitoring
Rationale: CNS stimulants can cause increases in BP and HR.
Timing: Prior to initiating treatment.
Rationale: To screen for pre-existing cardiac conditions that may contraindicate stimulant use.
Timing: Prior to initiating treatment.
Rationale: To screen for bipolar disorder, psychosis, or other psychiatric comorbidities.
Timing: Prior to initiating treatment.
Rationale: To establish baseline for growth monitoring.
Timing: Prior to initiating treatment.
Routine Monitoring
Frequency: Regularly (e.g., at each dose adjustment, then every 3-6 months)
Target: Within normal limits for age/individual
Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant evaluation and potential dose adjustment or discontinuation.
Frequency: Every 3-6 months
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss warrants evaluation and potential treatment interruption.
Frequency: Regularly (e.g., at each visit)
Target: Stable mood, absence of new or worsening psychotic/manic symptoms
Action Threshold: Emergence or worsening of aggressive behavior, hostility, new psychotic or manic symptoms, or suicidal ideation warrants immediate evaluation and potential discontinuation.
Frequency: Regularly (e.g., at each visit)
Target: No signs of abuse or diversion
Action Threshold: Signs of abuse or diversion warrant intervention and potential discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression/hostility
- New psychotic symptoms (e.g., hallucinations, delusions)
- Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
- Suicidal ideation or behavior
- Unexplained weight loss
- Growth deceleration (in children)
- Peripheral vasculopathy (e.g., Raynaud's phenomenon)
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.
Trimester-Specific Risks:
Lactation
L3 (Moderate risk). Dexmethylphenidate and/or its metabolites are excreted in human milk. Monitor breastfed infants for agitation, insomnia, decreased appetite, and poor weight gain. Consider risks vs. benefits or alternative feeding methods.
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can be associated with growth suppression. Monitor for emergence of psychiatric symptoms.
Geriatric Use
Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to stimulant effects (e.g., cardiovascular effects, anxiety, insomnia). Generally not recommended unless benefits clearly outweigh risks.
Clinical Information
Clinical Pearls
- Focalin XR is the d-isomer of methylphenidate, meaning it contains the more pharmacologically active enantiomer, allowing for lower doses compared to racemic methylphenidate.
- The extended-release formulation provides a biphasic release, mimicking a twice-daily dosing of immediate-release dexmethylphenidate, but with once-daily administration.
- Counsel patients on the importance of taking the medication consistently in the morning to avoid insomnia.
- Educate patients and caregivers about the potential for abuse and diversion, and the importance of secure storage.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial due to potential cardiovascular and growth-related side effects.
- Patients should be screened for pre-existing cardiac conditions and psychiatric disorders (e.g., bipolar disorder, psychosis) before initiating treatment.
Alternative Therapies
- Other CNS Stimulants: Methylphenidate (e.g., Ritalin, Concerta, Daytrana), Amphetamine/Dextroamphetamine (e.g., Adderall, Vyvanse), Lisdexamfetamine (Vyvanse)
- Non-Stimulants: Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree)
- Behavioral therapy and psychotherapy for ADHD.
Cost & Coverage
General Drug Facts
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 whenever 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to facilitate prompt and appropriate treatment.