Focalin 10mg 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 of action in ADHD is not fully understood.

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
Trouble 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 help right away. 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 certain heart problems or defects are at risk of sudden death. 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:

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 right away 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 lack 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 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 Side Effects

Most people do not experience side effects or only have minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention:

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 about side effects, 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. Be sure to describe the allergic reaction and its symptoms.
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 other health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever experienced a stroke
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of very high blood pressure)
Current use of certain medications, such as:
+ 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, 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 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 headache, dizziness, fainting, or changes in vision.

To minimize potential interactions, limit your consumption of caffeine (found in tea, coffee, cola) and chocolate, as combining these with this medication may cause nervousness, shakiness, and rapid heartbeat. 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, 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.

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

• Vasopressor agents (may potentiate pressor effects)
• Halogenated anesthetics (risk of sudden death due to acute increases in heart rate and blood pressure)
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) (risk of serotonin syndrome)

• Antihypertensive drugs (may reduce the effectiveness of antihypertensive agents)
• Coumarin anticoagulants (may prolong prothrombin time)
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) (may alter plasma concentrations of these drugs)
• Tricyclic antidepressants (TCAs) (may inhibit metabolism of TCAs, leading to increased plasma levels)

• Not available (most interactions are moderate to major due to CNS effects)

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusions
• Mania
• Severe anxiety
• Depression
• Unexplained wounds or skin changes (due to picking)
• Tics or dyskinesias
• Blurred vision
• Priapism (rare, but serious)

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 and/or its metabolites are excreted into human milk. The American Academy of Pediatrics considers methylphenidate (the racemic mixture) to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for adverse reactions such as agitation, insomnia, or decreased weight gain.

Approved for children 6 years and older. Safety and efficacy in children younger than 6 years have not been established. Monitor growth (height and weight) regularly due to potential for growth suppression.

Safety and efficacy in geriatric patients have not been established. Use with caution in elderly patients due to potential for increased sensitivity to stimulant effects and higher prevalence of cardiovascular disease.

• Dexmethylphenidate is the more potent d-isomer of methylphenidate, meaning lower doses are typically used compared to racemic methylphenidate.
• Immediate-release formulations like Focalin 10mg are typically dosed twice daily, with the second dose given in the early afternoon to avoid interference with sleep.
• Patients should be screened for cardiac abnormalities and psychiatric conditions prior to initiation due to potential risks.
• Growth suppression is a known side effect in children; regular monitoring of height and weight is crucial. Drug holidays (e.g., weekends, school breaks) may be considered to mitigate this.
• High potential for abuse and dependence; careful prescribing and monitoring are essential. Store securely to prevent diversion.

• Other methylphenidate formulations (e.g., methylphenidate HCl, methylphenidate extended-release, transdermal methylphenidate)
• Amphetamine-based stimulants (e.g., mixed amphetamine salts, lisdexamfetamine, dextroamphetamine)
• Non-stimulants (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
• Behavioral therapy and psychotherapy for ADHD

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. 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, consult 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.