Focalin 5mg Tablets

Manufacturer NOVARTIS Active Ingredient Dexmethylphenidate Tablets(dex meth il FEN i date) Pronunciation DEX-meth-il-FEN-i-date
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Central Nervous System Stimulant
đŸ§Ŧ
Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
🤰
Pregnancy Category
Category C
✅
FDA Approved
Nov 2001
âš–ī¸
DEA Schedule
Schedule II

Overview

â„šī¸

What is this medicine?

Focalin is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. It can help improve focus, reduce hyperactivity, and control impulsive behavior.
📋

How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. If you are taking this medication twice a day, make sure to take the second dose at least 4 hours after the first dose, unless your doctor has given you different instructions. It's also important to avoid taking this medication too late in the day, as it may interfere with your sleep.

Storing and Disposing of Your Medication

To keep your medication safe and effective, store it at room temperature, away from light and moisture. Avoid storing it in a bathroom or any area where it may be exposed to excessive heat or humidity. Keep your medication in a secure location, out of the reach of children and pets, and where others cannot access it. Consider using a locked box or area to store your medication. This will help prevent accidental ingestion or misuse.

What to Do If You Miss a Dose

If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one. Sticking to your regular dosing schedule will help you get the most benefit from your medication.
💡

Lifestyle & Tips

  • Take exactly as prescribed by your doctor, usually twice a day, in the morning and at midday. Do not take late in the day to avoid sleep problems.
  • Do not crush, chew, or break the tablets.
  • Avoid alcohol, as it may increase side effects.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly to ensure proper growth.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 5 mg twice daily
Dose Range: 5 - 20 mg

Condition-Specific Dosing:

ADHD: Initial dose 5 mg twice daily, titrated weekly in 5 mg increments to a maximum of 20 mg twice daily.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial dose 2.5 mg twice daily, titrated weekly in 2.5-5 mg increments to a maximum of 10 mg twice daily.
Adolescent: 13-17 years: Initial dose 5 mg twice daily, titrated weekly in 5 mg increments to a maximum of 20 mg twice daily.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, monitor for adverse effects.
Moderate: No specific dose adjustment recommended, monitor for adverse effects.
Severe: No specific dose adjustment recommended, monitor for adverse effects. Use with caution.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific dose adjustment recommended, monitor for adverse effects.
Moderate: No specific dose adjustment recommended, monitor for adverse effects.
Severe: No specific dose adjustment recommended, monitor for adverse effects. Use with caution.
Confidence: Medium

Pharmacology

đŸ”Ŧ

Mechanism of Action

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 related to its ability to block the reuptake of norepinephrine and dopamine into presynaptic neurons and increase the release of these monoamines into the extraneuronal space.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but rapidly absorbed.
Tmax: 1-2 hours (immediate-release)
FoodEffect: High-fat meal may delay Tmax by approximately 1 hour and decrease Cmax by 20-30% for immediate-release formulations, but overall extent of absorption (AUC) is not significantly affected.

Distribution:

Vd: Not available
ProteinBinding: Approximately 15% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: 2.2 hours (immediate-release)
Clearance: Not available
ExcretionRoute: Renal (primarily as PPAA)
Unchanged: <1% (dexmethylphenidate) in urine
âąī¸

Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 1-2 hours
DurationOfAction: Approximately 4 hours (immediate-release)
Confidence: Medium

Safety & Warnings

âš ī¸

BLACK BOX WARNING

CNS stimulants, including FOCALIN, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
âš ī¸

Side Effects

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, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold feeling 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 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

Sudden deaths have occurred in people with certain heart problems or 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:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Mental Health Warning

New or worsening behavior 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 Side Effects

Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Dizziness or headache
Drowsiness
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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening aggression, hostility, or irritability
  • New psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • Manic symptoms (e.g., extreme energy, racing thoughts, unusual happiness or irritability)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained weight loss or lack of growth in children
  • Blurred vision or other vision changes
📋

Before Using This Medicine

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 family history of certain health conditions, such as:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
+ A history of stroke
Recent use of certain 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)
* 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 change the dose of any medication without consulting your doctor first.
âš ī¸

Precautions & Cautions

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.

Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you. If you experience any changes in your alertness or response time, consult your doctor for guidance.

Long-term use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not exceed the prescribed dose, as this can increase the risk of adverse effects.

Prior to starting this medication, your doctor may recommend heart tests to assess your cardiovascular health. 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 experiencing 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 medical attention immediately 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) 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 activities.

In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary to monitor their development. Discuss any concerns with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential 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:

Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Treatment is generally supportive, including gastric lavage, activated charcoal, and sedation for severe agitation or seizures.

Drug Interactions

đŸšĢ

Contraindicated Interactions

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

Major Interactions

  • Vasopressor Agents: May potentiate the pressor effect of vasopressor agents.
  • Halogenated Anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
🟡

Moderate Interactions

  • Antihypertensive Drugs: May reduce the effectiveness of drugs used to treat hypertension.
  • Anticoagulants (e.g., coumarin), Anticonvulsants (e.g., phenobarbital, phenytoin, primidone), Tricyclic Antidepressants (TCAs): May inhibit the metabolism of these drugs, requiring dose adjustment and monitoring.
  • Dopaminergic Drugs (e.g., antipsychotics, levodopa): Potential for pharmacodynamic interactions; monitor for altered effects.
đŸŸĸ

Minor Interactions

  • Alcohol: May lead to faster release of drug from extended-release formulations (not applicable to immediate-release tablets, but generally relevant for methylphenidate products).

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: CNS stimulants can cause increases in BP and HR.

Timing: Prior to initiation of therapy.

Cardiac History and Physical Exam

Rationale: To screen for pre-existing cardiac conditions that may contraindicate stimulant use.

Timing: Prior to initiation of therapy.

Psychiatric History

Rationale: To screen for bipolar disorder, psychosis, or other psychiatric conditions.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: To establish baseline for growth monitoring, especially in pediatric patients.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly (e.g., at each visit or every 3-6 months)

Target: Within normal limits for age/patient

Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative treatment.

Psychiatric Symptoms (e.g., agitation, psychosis, mania, aggression)

Frequency: Regularly (e.g., at each visit)

Target: Absence of new or worsening symptoms

Action Threshold: Emergence or worsening of psychiatric symptoms; consider discontinuation.

ADHD Symptom Control

Frequency: Regularly (e.g., at each visit)

Target: Improved attention, reduced hyperactivity/impulsivity

Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative treatment.

đŸ‘ī¸

Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • New psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., euphoria, irritability, racing thoughts)
  • Unexplained weight loss
  • Growth deceleration
  • Peripheral vasculopathy (e.g., Raynaud's phenomenon)

Special Patient Groups

🤰

Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, and there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations based on some studies of methylphenidate, though data are conflicting and limited.
Second Trimester: Not well studied, but continued exposure could affect fetal growth and development.
Third Trimester: Potential for premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremors) have been reported with stimulant use near term.
🤱

Lactation

Dexmethylphenidate and its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, reduced weight gain), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Risk L3 (Moderate Concern) - Monitor infant for irritability, poor feeding, and sleep disturbances.
đŸ‘ļ

Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly. Long-term effects on growth are not fully established. Psychiatric and cardiovascular monitoring is crucial.

👴

Geriatric Use

Safety and efficacy have not been established in patients over 65 years of age. Use with caution due to increased sensitivity to adverse effects (e.g., cardiovascular, psychiatric) and potential for comorbidities and polypharmacy. Start with lower doses and titrate slowly.

Clinical Information

💎

Clinical Pearls

  • 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 Focalin (dexmethylphenidate) has a short duration of action (approx. 4 hours), requiring multiple daily doses. Focalin XR is available for once-daily dosing.
  • Counsel patients on the importance of taking the last dose early enough in the day to avoid insomnia.
  • Emphasize the potential for abuse and dependence, and the importance of storing the medication securely.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is essential.
  • Patients should be screened for pre-existing cardiac conditions and psychiatric disorders before starting stimulant therapy.
🔄

Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Daytrana)
  • Amphetamine/Dextroamphetamine (e.g., Adderall)
  • Lisdexamfetamine (Vyvanse)
  • Atomoxetine (Strattera) - non-stimulant
  • Guanfacine (Intuniv) - non-stimulant
  • Clonidine (Kapvay) - non-stimulant
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
💰

Cost & Coverage

Average Cost: $100 - $300 per 30 tablets (5mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generic often Tier 1 or 2)
📚

General Drug Facts

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 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, 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.