Focalin XR 35mg Capsules

Dexmethylphenidate is the d-threo-enantiomer of methylphenidate. It is a central nervous system (CNS) stimulant. Its therapeutic efficacy in 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.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or 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
Depression
Thoughts of suicide
Anxiety or mood swings
Lack of interest in life

If you or a family member has 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 Rare but Life-Threatening Condition

Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a potentially fatal condition. Seek immediate medical attention if you experience:

Agitation
Changes in balance or coordination
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Common Side Effects

While many people may not experience any side effects or only minor ones, some common side effects of this medication include:

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

If any of these side effects bother you or persist, 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.

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 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 the following health conditions:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever had a stroke
Use of specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
Concurrent use of:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine 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.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Long-term use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you experience decreased effectiveness, contact your doctor. Do not exceed the prescribed dose.

Prior to starting this medication, your doctor may recommend heart tests. If you have questions or concerns, discuss them with your doctor.

This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this 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), as it may cause nervousness, shakiness, and rapid heartbeat when combined with this medication. Avoid consuming alcohol while taking this medication.

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, requiring regular growth checks. Discuss any concerns 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.

• Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.

• Vasopressors (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.
• Antihypertensive drugs - may reduce the effectiveness of antihypertensive agents.
• Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.

• Coumarin anticoagulants (e.g., warfarin) - may inhibit metabolism, requiring dose adjustment of anticoagulant.
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, requiring dose adjustment of anticonvulsant.
• Tricyclic Antidepressants (e.g., imipramine, desipramine) - may inhibit metabolism, requiring dose adjustment of antidepressant.

• Alcohol - may alter release profile of extended-release formulation.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hostility
• Psychotic symptoms (e.g., hallucinations, delusions)
• Manic symptoms (e.g., elevated mood, grandiosity, decreased need for sleep)
• Motor or verbal tics
• Blurred vision
• Persistent priapism
• Unexplained weight loss
• Insomnia
• Anorexia

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.

L3 (Moderate Risk). Dexmethylphenidate and/or its metabolites are excreted in human milk. Monitor breastfed infants for agitation, insomnia, anorexia, and reduced weight gain.

Safety and effectiveness established in pediatric patients 6 to 17 years of age. Monitor growth (height and weight) regularly due to potential for growth suppression. Long-term effects on growth are not fully established.

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Use with caution in elderly patients, generally starting at the low end of the dosing range, due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Focalin XR is the extended-release formulation of dexmethylphenidate, providing once-daily dosing convenience.
• It is the more potent d-isomer of methylphenidate, meaning lower doses are typically used compared to racemic methylphenidate.
• Counsel patients not to crush or chew the capsules, as this will lead to immediate release of the entire dose and potential for adverse effects.
• Consider a drug holiday periodically to assess the need for continued therapy and to mitigate potential growth suppression in children.
• Careful cardiac screening is important before initiating therapy, especially in patients with pre-existing cardiac conditions or a family history of sudden cardiac death.
• Monitor for the emergence or worsening of psychiatric symptoms, including psychosis or mania, particularly in patients with a history of bipolar disorder or psychosis.

• Methylphenidate (e.g., Ritalin, Concerta, Daytrana, Quillivant XR)
• Amphetamine/Dextroamphetamine (e.g., Adderall, Vyvanse, Dexedrine)
• Lisdexamfetamine (Vyvanse)
• Atomoxetine (Strattera)
• Guanfacine extended-release (Intuniv)
• Clonidine extended-release (Kapvay)
• Bupropion (Wellbutrin - off-label for ADHD)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.