Concerta 54mg ER Tablets

Manufacturer JANSSEN Active Ingredient Methylphenidate Extended- Release Tablets(meth il FEN i date) Pronunciation 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 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.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Not assigned (Risk Summary available)
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FDA Approved
Aug 2000
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Concerta is an extended-release tablet used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It helps improve focus, attention, and control over impulsive behavior by affecting certain natural chemicals in the brain.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's recommended to take this medication in the morning.

Some medications require specific administration with regard to food intake. Your pharmacist can advise you on whether to take this medication with food, on an empty stomach, or if it doesn't matter.

Important Administration Instructions

- Swallow the medication whole.
- Do not chew, break, or crush the medication.

Storing and Disposing of Your Medication

To maintain the medication's effectiveness and safety:

- Store it at room temperature, protected from light.
- Keep it in a dry place.
- Avoid storing it in a bathroom.

Safe Storage and Handling

Keep your medication in a secure location where:

- Children cannot see or reach it.
- Other individuals cannot access it.

Consider using a locked box or secure area to store your medication. Remember to keep all medications out of reach of pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and resume your regular dosing schedule. Do not:

- Take two doses at the same time.
- Take extra doses to make up for the missed dose.
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Lifestyle & Tips

  • Take Concerta once daily in the morning with or without food. Do not chew, crush, or divide the tablet, as this will affect its extended-release properties.
  • Swallow the tablet whole with water.
  • The tablet shell may appear in your stool; this is normal and does not mean the medication was not absorbed.
  • Avoid alcohol, as it can cause a rapid release of the medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not stop taking Concerta suddenly without consulting your doctor, as withdrawal symptoms may occur.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 18-36 mg orally once daily in the morning. Maintenance: 54 mg orally once daily in the morning.
Dose Range: 18 - 72 mg

Condition-Specific Dosing:

ADHD: Titrate weekly in 18 mg increments based on response and tolerability. Max 72 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial 18 mg orally once daily in the morning. Titrate weekly by 18 mg. Max 54 mg/day.
Adolescent: 13-17 years: Initial 18 mg orally once daily in the morning. Titrate weekly by 18 mg. Max 72 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.
Dialysis: Not available, use with caution.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The therapeutic effect in ADHD is believed to be related to increased dopamine and norepinephrine activity in the prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: 22% (oral)
Tmax: Biphasic: Initial peak ~1-2 hours, second peak ~6-8 hours
FoodEffect: High-fat meal can delay Tmax and slightly increase AUC, but overall absorption is not significantly affected to warrant dosing changes.

Distribution:

Vd: 2.65 L/kg
ProteinBinding: 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: 3.5 hours (methylphenidate), 8 hours (ritalinic acid)
Clearance: 0.53 L/hr/kg
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour (initial release)
PeakEffect: Biphasic: ~1-2 hours and ~6-8 hours
DurationOfAction: Approximately 10-12 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 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
Severe headache, dizziness, or fainting
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
Trouble controlling 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 sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Changes in sex drive
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor.
If you experience any signs of heart problems, such as chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting, seek medical help immediately.

Additional Serious Side Effects

Prolonged or painful erections (lasting more than 4 hours) can lead to permanent sexual dysfunction if not treated promptly. Seek medical help right away if you experience this symptom.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or behavior
+ Anger or hallucinations
+ Depression, thoughts of suicide, nervousness, emotional instability, or lack of interest in life
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 committed suicide, inform your doctor.
A potentially life-threatening condition called serotonin syndrome can occur when taking this medication with certain other drugs. Seek medical help immediately if you experience:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, stomach upset, 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
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous or excitable
Difficulty sleeping
* Nose or throat irritation

If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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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
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New or worsening manic symptoms (e.g., extreme energy, racing thoughts)
  • Unexplained wounds on fingers or toes, or changes in skin color (Raynaud's phenomenon)
  • Prolonged or painful erection (priapism)
  • Blurred vision or other vision changes
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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 conditions and circumstances to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
Family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
Personal history of:
+ Stroke
+ Use of specific medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure
Difficulty swallowing this product whole
History of gastrointestinal (GI) problems, including:
+ Cystic fibrosis
+ Narrowing of the GI tract or other GI issues like bowel block, small bowel disease, short gut syndrome, or slow-moving esophagus or bowel tract
+ Peritonitis
* Current use of certain medications, such as linezolid or 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 conditions with your doctor and pharmacist to ensure safe use of this medication. Do not initiate, stop, or modify the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

Precautions and Warnings

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. In some cases, you may need to undergo heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

Additionally, it is recommended that you avoid consuming alcohol while taking this medication. Limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these with your medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, it is essential to discuss the use of over-the-counter (OTC) products with your doctor before taking them. These products, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids, may increase your blood pressure.

Long-Term Use and Potential Risks

If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not work as effectively. In this case, you may require higher doses to achieve the same effect. If you notice that the medication is no longer working well, contact your doctor. Do not take more than the prescribed dose.

This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.

Additional Information

For certain brands of this medication, you may notice the tablet shell in your stool. This is a normal occurrence and not a cause for concern. However, if you have any questions or concerns, discuss them with your doctor.

If you are undergoing x-rays near the abdominal area, inform your doctor that you are taking this medication. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss any potential risks.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor.
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Overdose Information

Overdose Symptoms:

  • Vomiting
  • Agitation
  • Tremors
  • Hyperreflexia
  • Muscle twitching
  • Convulsions (may be followed by coma)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (very high fever)
  • Tachycardia (fast heart rate)
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension (high blood pressure)
  • Mydriasis (dilated pupils)
  • Dry mouth

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, maintaining airway, monitoring vital signs, and managing symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).

Drug Interactions

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Contraindicated Interactions

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

  • Halogenated Anesthetics (risk of sudden death)
  • Vasopressor Agents (may potentiate pressor effects)
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Moderate Interactions

  • Anticoagulants (e.g., coumarin) - may inhibit metabolism, requiring dose adjustment
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may alter plasma concentrations, requiring dose adjustment
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may increase plasma levels of antidepressants or lead to additive serotonergic effects; caution and monitoring advised
  • Dopaminergic drugs (e.g., antipsychotics, dopamine agonists) - potential for additive effects or antagonism
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To identify pre-existing cardiovascular conditions and establish baseline for monitoring stimulant-induced changes.

Timing: Prior to initiation of therapy.

Height and Weight

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

Timing: Prior to initiation of therapy.

Psychiatric History (including family history of sudden death, bipolar disorder, psychosis, tics)

Rationale: To identify risk factors for psychiatric adverse events or unmasking of underlying conditions.

Timing: Prior to initiation of therapy.

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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/sex; significant sustained increases should prompt evaluation.

Action Threshold: Sustained increase in BP (>10-20 mmHg) or HR (>10-20 bpm) above baseline, or development of hypertension/tachycardia.

Height and Weight

Frequency: Every 3-6 months (pediatric), annually (adult)

Target: Normal growth trajectory (pediatric); stable weight (adult).

Action Threshold: Significant growth deceleration or weight loss.

ADHD Symptom Control

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

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms.

Psychiatric Symptoms (e.g., agitation, psychosis, mania, tics, anxiety, depression)

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

Target: Absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence or worsening of psychiatric symptoms, especially psychosis or mania.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Agitation
  • New or worsening tics
  • Blurred vision
  • Priapism
  • Peripheral vasculopathy (e.g., Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Based on animal reproduction studies, methylphenidate may cause fetal harm. 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.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data (e.g., skeletal abnormalities, increased fetal deaths). Human data are limited and inconclusive.
Second Trimester: Limited human data, animal data suggest potential for harm.
Third Trimester: Limited human data, animal data suggest potential for harm. Risk of withdrawal symptoms in neonate if exposed late in pregnancy.
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Lactation

Methylphenidate is excreted into human milk. Monitor breastfed infants for agitation, insomnia, decreased weight gain. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Concerta and any potential adverse effects on the breastfed infant from Concerta or from the underlying maternal condition.

Infant Risk: L3 (Moderate risk) - Potential for irritability, poor feeding, and sleep disturbances in the infant. Monitor infant closely.
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Pediatric Use

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 and cardiovascular effects.

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Geriatric Use

Safety and efficacy in patients over 65 years have not been established. Use with caution due to potential for increased sensitivity to adverse effects, particularly cardiovascular and psychiatric effects. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Concerta utilizes an OROS (Osmotic Release Oral System) delivery system, which allows for a controlled, ascending release of methylphenidate over 10-12 hours, mimicking a multiple-dose regimen.
  • The tablet shell is designed to remain intact and may be visible in the stool; this is normal and does not indicate lack of absorption.
  • Patients should be advised to take Concerta in the morning to avoid insomnia.
  • Regular monitoring of blood pressure, heart rate, height, and weight is crucial, especially in pediatric patients.
  • Educate patients and caregivers about the signs of serious cardiovascular or psychiatric adverse events and when to seek medical attention.
  • Concerta should not be used in patients with marked anxiety, tension, agitation, glaucoma, tics, or Tourette's syndrome, or severe cardiovascular disease.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., Ritalin, Focalin, Daytrana, Quillivant XR, Adhansia XR)
  • Amphetamine-based stimulants (e.g., Adderall, Vyvanse, Dexedrine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
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Cost & Coverage

Average Cost: $300 - $450+ per 30 tablets (brand Concerta 54mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 for brand; Tier 1 for generic methylphenidate ER
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about its use. 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 this medication, don't hesitate 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 details about the medication taken, the amount consumed, and the time it occurred.