Focalin XR 15mg Capsules

Dexmethylphenidate is the d-threo enantiomer of methylphenidate. It is a central nervous system (CNS) stimulant. Its therapeutic effect 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 or seek immediate medical attention:

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
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or trouble passing urine
Changes in sex interest

Erectile Dysfunction Warning

If you experience a painful erection (hard penis) 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 lasting sexual problems and impotence.

Heart Problems and Sudden Death

People with pre-existing heart problems or heart defects are at risk of sudden death. 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 and Mood Changes

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 problems, 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 drugs. 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 or any other symptoms that bother you or do not go away, contact your doctor:

Dizziness or headache
Feeling sleepy
Feeling nervous and excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Trouble 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, 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. Be sure to describe the allergic reaction you experienced, including any 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
Any personal history of:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ Previous stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ 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 health conditions.

Remember, this is not an exhaustive list of potential interactions. It is crucial to consult with your doctor and pharmacist to ensure it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

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.

Until you know how this medication affects you, avoid driving and other activities that require you to be alert. 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 some 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 who have 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 possibility that this medication may cause high blood pressure. Monitor your blood pressure and heart rate as instructed by your doctor, and seek medical attention immediately if you experience severe headache, 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 a rapid heartbeat. Additionally, avoid drinking 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 problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical attention immediately 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 teenagers. Regular growth checks may be necessary, so discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of discontinuing MAOIs due to risk of hypertensive crisis.

• Halogenated Anesthetics: Risk of sudden increases in blood pressure and heart rate during surgery.
• Vasopressors: May potentiate the pressor effects of vasopressors.
• Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort): Increased risk of serotonin syndrome.
• Antihypertensive Drugs: May reduce the effectiveness of drugs used to treat hypertension.

• Antacids/H2 Blockers/PPIs: While the dissolution profile of Focalin XR is pH-independent, changes in gastric pH could theoretically alter absorption of some extended-release formulations, though not a significant interaction for Focalin XR based on label.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening psychotic symptoms (e.g., hallucinations, delusions)
• New or worsening manic symptoms
• Aggressive behavior
• Suicidal ideation
• Unexplained numbness, coolness, or pain in extremities (Raynaud's phenomenon)
• Blurred vision
• Persistent priapism (rare)

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. Data from a pregnancy registry suggest no increased risk of major congenital malformations with methylphenidate exposure during the first trimester.

Dexmethylphenidate (d-methylphenidate) is excreted into human milk. Monitor breastfed infants for adverse reactions such as agitation, insomnia, anorexia, or reduced weight gain. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Focalin XR and any potential adverse effects on the breastfed infant from Focalin XR or from the underlying maternal condition.

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully, as long-term stimulant use has been associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms.

Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to adverse effects, particularly cardiovascular effects. Start with lower doses and titrate slowly.

• Focalin XR is the extended-release formulation of dexmethylphenidate, providing a longer duration of action (up to 12 hours) compared to immediate-release formulations.
• It is the d-isomer of methylphenidate, which is considered the more pharmacologically active enantiomer.
• Advise patients to take Focalin XR in the morning to avoid insomnia.
• Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules, but the entire contents must be consumed immediately without chewing.
• Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
• Educate patients and caregivers about the signs of serious cardiovascular and psychiatric adverse events and when to seek medical attention.

• Other methylphenidate formulations (e.g., Ritalin, Concerta, Daytrana, Quillivant XR, Adhansia XR)
• Amphetamine formulations (e.g., Adderall XR, Vyvanse, Dexedrine, Mydayis)
• Non-stimulants (e.g., Atomoxetine (Strattera), Guanfacine extended-release (Intuniv), Clonidine extended-release (Kapvay))
• Behavioral therapy and psychotherapy

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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 detailed information about the medication taken, the quantity, and the time it occurred.