Concerta 54mg ER Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
Major Interactions
- Halogenated Anesthetics (risk of sudden death)
- Vasopressor Agents (may potentiate pressor effects)
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
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To identify pre-existing cardiovascular conditions and establish baseline for monitoring stimulant-induced changes.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline for monitoring growth suppression, especially in pediatric patients.
Timing: Prior to initiation of therapy.
Rationale: To identify risk factors for psychiatric adverse events or unmasking of underlying conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
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.
Frequency: Every 3-6 months (pediatric), annually (adult)
Target: Normal growth trajectory (pediatric); stable weight (adult).
Action Threshold: Significant growth deceleration or weight loss.
Frequency: Regularly (e.g., at each visit)
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms.
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.
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
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:
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.
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.
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
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.
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
Cost & Coverage
General Drug Facts
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.