Focalin 2.5mg Tablets

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.

Urgent 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
+ 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, which may turn pale, blue, gray, purple, or red
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the 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.

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. If a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:

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 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, such as 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 Possible Side Effects

While many people may not experience any side effects or only minor ones, it is essential to be aware of the following possible side effects:

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

If any of these side effects or other symptoms bother you or do not go away, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can 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 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
Recent use (within the last 14 days) of specific 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
All your medications, including prescription and over-the-counter drugs, natural products, and vitamins, to ensure safe use with this medication.

Remember, this list is not exhaustive, and it is crucial to consult your doctor and pharmacist about all your medications and health conditions to confirm the 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 all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.

Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you. This is crucial to prevent accidents and ensure your safety.

Long-term use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose, as this can lead to adverse effects.

Your doctor may recommend heart tests before starting this medication, especially if you have pre-existing heart conditions. 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 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 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 and 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 health conditions, such as depression or bipolar disorder, or if a family member has attempted 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.

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

• Pressor Agents (e.g., phenylephrine, pseudoephedrine): May potentiate the pressor effect, leading to severe hypertension.
• Halogenated Anesthetics: Risk of sudden blood pressure and heart rate increases during surgery; discontinue on the day of surgery.
• Alcohol: May increase plasma levels of dexmethylphenidate and exacerbate adverse effects.

• Anticoagulants (e.g., warfarin): May decrease the metabolism of coumarin anticoagulants, requiring dose adjustment.
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit the metabolism of these drugs, requiring dose adjustment.
• Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine): May inhibit the metabolism of TCAs, requiring dose adjustment and monitoring for increased TCA levels.
• Selective Serotonin Reuptake Inhibitors (SSRIs): Caution due to potential for serotonin syndrome, though less common than with other stimulants.

• Caffeine: May increase stimulant effects and adverse reactions.

• Chest pain
• Shortness of breath
• Syncope
• Unexplained exertion intolerance
• New or worsening psychiatric symptoms (e.g., hallucinations, delusions, mania, aggression, agitation)
• Tics or abnormal movements
• Blurred vision
• Priapism (rare, but serious)

There are no adequate and well-controlled studies of dexmethylphenidate in pregnant women. Data from a pregnancy registry of methylphenidate (racemic mixture) did not show an increased risk of major congenital malformations. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Dexmethylphenidate and/or its metabolites are excreted in human milk. The effects on the breastfed infant are unknown. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Focalin and any potential adverse effects on the breastfed infant from Focalin or from the underlying maternal condition.

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

Safety and effectiveness in patients over 65 years have not been established. Use with caution due to potential for increased sensitivity to adverse effects, especially cardiovascular effects. Consider lower initial doses and slower titration.

• Focalin is the d-isomer of methylphenidate, meaning it is the more pharmacologically active enantiomer, allowing for lower doses compared to racemic methylphenidate.
• Immediate-release formulation requires twice-daily dosing for sustained effect throughout the day.
• Patients should be screened for cardiac abnormalities and psychiatric conditions (e.g., bipolar disorder, psychosis) before initiating treatment.
• Growth monitoring is crucial in pediatric patients; consider drug holidays if growth suppression is significant.
• Educate patients and caregivers about the potential for abuse and the importance of secure storage.
• Avoid late afternoon/evening dosing to prevent insomnia.

• Other CNS Stimulants (e.g., methylphenidate, amphetamine, lisdexamfetamine)
• Non-stimulants (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
• Behavioral therapy
• Cognitive behavioral therapy (CBT)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will enable healthcare professionals to provide you with the most appropriate and timely care.