Concerta 36mg ER Tablets
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.
Drug Class
Central Nervous System (CNS) Stimulant
Pharmacologic Class
Norepinephrine and Dopamine Reuptake Inhibitor
Pregnancy Category
Category C
FDA Approved
Aug 2000
DEA Schedule
Schedule II
Overview
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.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your dose in the morning.
Some medications need to be taken with food, while others should be taken on an empty stomach. Check with your pharmacist to determine the best way to take your specific medication.
Swallow your medication 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.
Keep it in a dry place, away from moisture.
Do not store 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.
Keep all medications out of reach of pets.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Skip the missed dose 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.
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your dose in the morning.
Some medications need to be taken with food, while others should be taken on an empty stomach. Check with your pharmacist to determine the best way to take your specific medication.
Swallow your medication 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.
Keep it in a dry place, away from moisture.
Do not store 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.
Keep all medications out of reach of pets.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Skip the missed dose 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.
Lifestyle & Tips
- Take Concerta once daily in the morning with or without food. Do not take it in the afternoon or evening as it may 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 increase side effects.
- 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 the medication to be released too quickly.
- 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.
- Maintain a healthy diet and regular exercise, especially for children, to support overall health and growth.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 18 mg or 36 mg orally once daily in the morning. May increase by 18 mg increments weekly.
Dose Range:
18 - 72 mg
Condition-Specific Dosing:
ADHD:
Maximum recommended dose is 72 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 18 mg orally once daily in the morning. May increase by 18 mg increments weekly to a maximum of 54 mg/day.
Adolescent:
13-17 years: Initial 18 mg orally once daily in the morning. May increase by 18 mg increments weekly to a maximum of 72 mg/day.
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 due to limited data.
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
Mechanism of Action
Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in Attention Deficit Hyperactivity Disorder (ADHD) are thought to be mediated through the blockade of dopamine and norepinephrine reuptake into the presynaptic neuron and the increase of monoamine release into the extraneuronal space. This leads to increased concentrations of dopamine and norepinephrine in the synaptic cleft.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 22% to 28% (due to first-pass metabolism)
Tmax:
Biphasic: Initial peak at 1-2 hours, second peak at 6-8 hours (for Concerta ER)
FoodEffect:
Food does not significantly affect the extent of absorption (AUC) of methylphenidate from Concerta, but Tmax may be slightly delayed.
Distribution:
Vd:
Approximately 2.6 L/kg
ProteinBinding:
Approximately 15% (to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 3.5 hours (methylphenidate); 8 hours (ritalinic acid)
Clearance:
Approximately 0.53 L/hr/kg
ExcretionRoute:
Primarily renal (90% as ritalinic acid, 1% as unchanged drug)
Unchanged:
Less than 1%
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour
PeakEffect:
Approximately 6-8 hours
DurationOfAction:
Approximately 10-12 hours
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including Concerta, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor patients for signs of abuse and dependence while on therapy.
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 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 defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly.
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
If you have 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, and if left untreated, may lead to lasting sexual problems.
New or worsening behavior and mood changes, such as changes in thinking, anger, or 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 disorder, or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
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, or severe headache.
Other Possible Side Effects
Many people taking this medication may not experience any side effects or only minor side effects. However, if you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
+ Dizziness or headache
+ Feeling sleepy
+ Dry mouth
+ Stomach pain, upset stomach, vomiting, or decreased appetite
+ Heartburn
+ Weight loss
+ Feeling nervous or excitable
+ Difficulty sleeping
+ Nose or throat irritation
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor.
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 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 defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly.
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
If you have 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, and if left untreated, may lead to lasting sexual problems.
New or worsening behavior and mood changes, such as changes in thinking, anger, or 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 disorder, or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
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, or severe headache.
Other Possible Side Effects
Many people taking this medication may not experience any side effects or only minor side effects. However, if you notice any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
+ Dizziness or headache
+ Feeling sleepy
+ Dry mouth
+ Stomach pain, upset stomach, vomiting, or decreased appetite
+ Heartburn
+ Weight loss
+ Feeling nervous or excitable
+ Difficulty sleeping
+ Nose or throat irritation
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor.
You can 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 agitation
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New or worsening tics (uncontrolled movements or sounds)
- Unexplained wounds on fingers or toes (Raynaud's phenomenon)
- Prolonged or painful erection (priapism, rare but serious)
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
If you have taken specific 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)
If you have difficulty swallowing this product whole
If you have a history of:
+ Cystic fibrosis
+ Narrowing of the gastrointestinal (GI) tract or other GI problems, such as:
- Bowel block
- Small bowel disease
- Short gut syndrome
- Slow-moving esophagus or bowel tract
+ Peritonitis
If you are currently taking:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins. Your doctor will help you determine if it is safe to take this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without consulting 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
If you have taken specific 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)
If you have difficulty swallowing this product whole
If you have a history of:
+ Cystic fibrosis
+ Narrowing of the gastrointestinal (GI) tract or other GI problems, such as:
- Bowel block
- Small bowel disease
- Short gut syndrome
- Slow-moving esophagus or bowel tract
+ Peritonitis
If you are currently taking:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins. Your doctor will help you determine if it is safe to take this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without consulting your doctor.
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. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult with your doctor.
While taking this medication, it is recommended that you avoid consuming alcohol and limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, it is crucial to discuss with your doctor the potential risks of 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.
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 this medication is no longer working as well as it should, contact your doctor. Do not exceed 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 certain brands of this medication, you may notice the tablet shell in your stool; however, this is a normal occurrence and not a cause for concern. 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.
It is essential to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication to both you and your baby.
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. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult with your doctor.
While taking this medication, it is recommended that you avoid consuming alcohol and limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, it is crucial to discuss with your doctor the potential risks of 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.
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 this medication is no longer working as well as it should, contact your doctor. Do not exceed 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 certain brands of this medication, you may notice the tablet shell in your stool; however, this is a normal occurrence and not a cause for concern. 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.
It is essential to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication to both 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
- Dryness of mucous membranes
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, maintaining circulation and respiration, external cooling for hyperpyrexia, and gastric lavage if recent ingestion.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.
Major Interactions
- Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - risk of increased blood pressure.
- Halogenated anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery.
- Alcohol - may increase the rate of drug release from Concerta, leading to higher peak plasma concentrations.
Moderate Interactions
- Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of these drugs, requiring dose adjustment.
- Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism of these drugs, requiring dose adjustment.
- Dopaminergic drugs (e.g., antipsychotics, levodopa) - potential for pharmacodynamic antagonism or potentiation.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Risk of dose-related increases in BP and HR.
Timing: Prior to initiation of treatment.
Height and Weight
Rationale: Risk of growth suppression in pediatric patients.
Timing: Prior to initiation of treatment (pediatric).
Cardiac history and family history of sudden death/arrhythmias
Rationale: To identify patients at risk for serious cardiovascular events.
Timing: Prior to initiation of treatment.
Psychiatric history (e.g., bipolar disorder, psychosis, tics)
Rationale: Risk of exacerbation of pre-existing psychiatric conditions or emergence of new symptoms.
Timing: Prior to initiation of treatment.
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
Action Threshold: Persistent elevation requiring intervention or dose reduction/discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric)
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration requiring intervention (e.g., drug holiday, alternative treatment).
Psychiatric symptoms (e.g., agitation, aggression, hallucinations, mania, tics)
Frequency: Regularly (e.g., at each visit)
Target: Stable or improved
Action Threshold: Emergence or worsening of symptoms requiring intervention or discontinuation.
ADHD symptom control
Frequency: Regularly (e.g., at each visit)
Target: Improved attention, reduced hyperactivity/impulsivity
Action Threshold: Lack of efficacy or intolerable side effects requiring dose adjustment or alternative treatment.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hostility
- Psychotic symptoms (e.g., hallucinations, delusions)
- Manic symptoms
- New or worsening tics
- Blurred vision
- Priapism (rare)
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 limited human data.
Trimester-Specific Risks:
First Trimester:
Limited data; potential for increased risk of cardiac malformations based on some studies, though overall evidence is inconsistent.
Second Trimester:
Not available
Third Trimester:
Not available; potential for withdrawal symptoms in neonates if exposed late in pregnancy.
Lactation
Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor the infant for adverse effects such as agitation, insomnia, or poor weight gain.
Infant Risk:
Low to moderate risk (L3). Monitor for irritability, poor feeding, and sleep disturbances.
Pediatric Use
Concerta is approved for children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Assess for emergence or worsening of psychiatric symptoms.
Geriatric Use
Safety and efficacy in patients over 65 years have not been established. Use with caution due to potential for increased sensitivity to stimulant effects and higher prevalence of cardiovascular conditions. Start with lower doses and titrate slowly.
Clinical Information
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 twice-daily dosing regimen.
- Patients should be advised that the tablet shell may be visible in their stool, which is normal and does not indicate that the medication was not absorbed.
- Due to its extended-release profile, Concerta should be taken once daily in the morning to avoid interference with sleep.
- Careful cardiovascular assessment, including family history, is crucial before initiating treatment due to the risk of sudden cardiac death in patients with pre-existing structural cardiac abnormalities or other serious heart problems.
- Concerta is a Schedule II controlled substance, emphasizing the importance of proper prescribing, storage, and disposal to prevent abuse and diversion.
Alternative Therapies
- Other methylphenidate formulations (e.g., Ritalin, Focalin, Quillivant XR, Aptensio XR, Jornay PM, Daytrana patch)
- Amphetamine-based stimulants (e.g., Adderall, Vyvanse, Dexedrine)
- Non-stimulants (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree))
- Behavioral therapy, psychotherapy, parent training
Cost & Coverage
Average Cost:
$300 - $500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.