Concerta 27mg ER Tablets

Manufacturer JANSSEN Active Ingredient Methylphenidate Extended- Release Tablets(meth il FEN i date) Pronunciation kon-SER-tuh (for Concerta); meth-il-FEN-i-date (for Methylphenidate)
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 Stimulant
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Pharmacologic Class
Dopamine and Norepinephrine Reuptake Inhibitor
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Pregnancy Category
Not 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 medication 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, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. Take your medication in the morning.

Some medications are taken with food, while others are taken on an empty stomach. It's crucial to check with your pharmacist to determine the best way to take your specific medication. When taking your medication, swallow the tablet whole - do not chew, break, or crush it.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication in a bathroom. Keep your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or 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 or 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. Taking it too late in the day can cause sleep problems.
  • Swallow the tablet whole with water. Do NOT chew, crush, or divide the tablet, as this will release all the medication at once and can lead to serious side effects.
  • You may notice a tablet shell in your stool. This is normal and means the medication has been released.
  • Avoid alcohol, as it can cause the medication to be released too quickly.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor your blood pressure and heart rate as advised by your doctor.
  • Maintain a healthy diet and regular exercise, especially for children, as appetite suppression and growth effects can occur.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose 18 mg or 36 mg once daily in the morning. Titrate in 18 mg increments weekly. Max 72 mg/day.
Dose Range: 18 - 72 mg

Condition-Specific Dosing:

ADHD: Initial dose 18 mg or 36 mg once daily in the morning. Titrate in 18 mg increments weekly. Max 72 mg/day.
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Pediatric Dosing

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

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution. Monitor for adverse effects due to potential accumulation of metabolites.
Dialysis: Considerations: Not dialyzable. Use with caution, monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in ADHD are 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. This leads to increased concentrations of dopamine and norepinephrine in the synaptic cleft, enhancing neurotransmission in brain regions associated with attention and behavior.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified for Concerta due to extended release, but well absorbed.
Tmax: Biphasic release: Initial peak at 1-2 hours, second peak at 6-10 hours.
FoodEffect: High-fat meal can delay Tmax by approximately 1 hour and increase Cmax by 15-30%.

Distribution:

Vd: 2.65 L/kg (for d-methylphenidate)
ProteinBinding: 10-33%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate), 2.9 hours (for d-methylphenidate), 6.8 hours (for l-methylphenidate).
Clearance: Not precisely quantified, but rapid.
ExcretionRoute: Renal (primarily as ritalinic acid).
Unchanged: <1% (methylphenidate), 80% (ritalinic acid)
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour (initial release).
PeakEffect: 6-10 hours (second peak).
DurationOfAction: Approximately 12 hours.

Safety & Warnings

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Side Effects

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: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and 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
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 deaths have 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 and seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting

Additional Warnings

If you experience a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical help immediately to avoid potential long-term damage
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations, have been reported; if you or a family member have a history of mental health conditions, such as depression or bipolar disorder, or a family history of suicide, inform your doctor and seek help if you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, or anxiety
A 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, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache

Common Side Effects

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

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

Reporting Side Effects

This is not an exhaustive list of potential 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.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (syncope)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • New or worsening tics (uncontrolled movements or sounds)
  • Changes in vision
  • New or worsening aggressive behavior, hostility, or agitation
  • New psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New manic symptoms (e.g., extreme high mood, increased energy, racing thoughts)
  • Prolonged or painful erections (priapism)
  • Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
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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:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced a 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 these medications with this drug can lead to very high blood pressure)
Difficulty swallowing this product whole
Presence of certain gastrointestinal conditions, such as:
+ Cystic fibrosis
+ Narrowing of the GI tract or other GI problems (e.g., bowel block, small bowel disease, short gut syndrome, slow-moving esophagus or bowel tract)
+ Peritonitis
Concurrent use of certain medications, including:
+ 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 conditions with your doctor and pharmacist to ensure safe use of this medication. Do not initiate, terminate, or modify any medication regimen without consulting your doctor.
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Precautions & Cautions

It is essential to inform all 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.

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may also need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

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

If you have high blood pressure, it is crucial to discuss with your doctor before using 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.

Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not take more than the prescribed dose.

This medication may increase the risk of seizures in certain individuals, including 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.

For some formulations 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, consult with your doctor.

If you are undergoing x-rays near the abdominal area, inform your doctor that you are taking this medication.

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary. Discuss this with your doctor.

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 to ensure the best possible outcome for you and your baby.
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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)
  • Dryness of mucous membranes

What to Do:

Seek immediate medical attention or call a poison control center. Call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

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

  • Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - risk of hypertensive crisis
  • Halogenated anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery
  • Anticoagulants (e.g., warfarin) - may inhibit metabolism, increasing anticoagulant effect
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, increasing antidepressant levels or risk of serotonin syndrome
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Moderate Interactions

  • Antihypertensive agents - may reduce the hypotensive effect of these drugs
  • Dopaminergic drugs (e.g., bupropion, levodopa) - increased risk of dopaminergic adverse effects
  • Alcohol - may increase the rate of drug release from Concerta
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Minor Interactions

  • Caffeine - additive stimulant effects

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Stimulants can cause growth suppression in pediatric patients.

Timing: Prior to initiation of therapy (especially in children/adolescents).

Cardiac history (personal and family)

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

Timing: Prior to initiation of therapy.

Psychiatric history (personal and family)

Rationale: To identify risk factors for psychiatric adverse events (e.g., psychosis, mania).

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.

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

Height and Weight

Frequency: Regularly (e.g., every 3-6 months in children/adolescents).

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration; consider drug holiday or alternative therapy.

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 therapy.

Emergence of new psychiatric symptoms (e.g., psychosis, mania, aggression, suicidal ideation)

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

Target: Absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence of such symptoms; discontinue therapy immediately.

Signs of abuse or dependence

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

Target: Absence of drug-seeking behavior or signs of misuse.

Action Threshold: Signs of abuse; reassess treatment plan and consider referral for substance use disorder.

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Symptom Monitoring

  • Changes in mood or behavior (e.g., agitation, anxiety, depression, aggression)
  • New or worsening tics
  • Hallucinations or delusions
  • Chest pain, shortness of breath, or syncope
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Data from observational studies have not shown an increase in the overall rate of major birth defects or the rate of cardiovascular malformations with methylphenidate exposure during the first trimester. However, some studies suggest a possible association with specific malformations or adverse pregnancy outcomes.

Trimester-Specific Risks:

First Trimester: Some studies suggest a small increased risk of cardiac malformations, but overall data are conflicting and do not consistently show an increased risk of major birth defects.
Second Trimester: Potential for fetal growth restriction and premature birth.
Third Trimester: Potential for withdrawal symptoms in the neonate (e.g., agitation, tremors, poor feeding) if used late in pregnancy.
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for adverse reactions such as agitation, insomnia, or decreased weight gain.

Infant Risk: Low to moderate risk. Monitor for irritability, poor feeding, and sleep disturbances.
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Pediatric Use

Concerta is approved for use in children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Assess for emergence of new psychiatric symptoms or tics.

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Geriatric Use

Clinical studies of Concerta did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Clinical Information

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Clinical Pearls

  • Concerta utilizes an OROS (Osmotic-controlled Release Oral Delivery System) technology, which provides a biphasic release profile, mimicking a twice-daily dosing of immediate-release methylphenidate but with once-daily administration.
  • The outer layer of the tablet dissolves quickly, providing an initial dose, while the remaining medication is released slowly over 10-12 hours through a small hole in the tablet shell.
  • Patients should be advised that the tablet shell may appear in their stool, which is normal and does not mean the medication was not absorbed.
  • Concerta should be taken in the morning to avoid sleep disturbances.
  • Careful titration is essential to find the optimal dose for each patient, balancing efficacy with tolerability.
  • Regular monitoring of cardiovascular parameters (BP, HR) and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of proper storage.
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Alternative Therapies

  • Other long-acting methylphenidate formulations (e.g., Jornay PM, Adhansia XR, Aptensio XR, Quillivant XR, Quillichew ER, Daytrana patch)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Mydayis)
  • Non-stimulant medications (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree))
  • Behavioral therapy and psychotherapy
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Cost & Coverage

Average Cost: $300 - $600 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand name), Tier 1 (Generic)
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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, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.