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Methylphenidate 27mg ER Tb (bx)

Manufacturer MALLINCKRODT PHARM 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 Stimulant
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Pharmacologic Class
Dopamine and Norepinephrine Reuptake Inhibitor
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Pregnancy Category
Category C
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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?

Methylphenidate extended-release is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. The extended-release form means the medication is released slowly over the day, so you usually only need to take it once in the morning.
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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. However, some medications may need to be taken with food or on an empty stomach, while others may not have specific requirements. Consult your pharmacist to determine the best way to take this medication. When taking your dose, swallow the 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, and in a dry place. Avoid storing it 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 normal dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, usually once daily in the morning. Do not take it in the afternoon or evening as it can cause sleep problems.
  • Swallow the extended-release tablets whole with water. Do not crush, chew, or divide the tablet, as this will release all the medication at once and can increase side effects and abuse potential.
  • 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 blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly.
  • Store the medication securely to prevent misuse or diversion, as it has a high potential for abuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

ADHD: Initial: 18-36 mg orally once daily in the morning. Titrate weekly by 18 mg increments based on response and tolerability. Max: 72 mg/day.
Narcolepsy: Not a primary indication for extended-release formulations; immediate-release is typically used. If used, individualized titration from 10-60 mg/day in divided doses, but ER is once daily.
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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 increments. Max: 54 mg/day.
Adolescent: 13-17 years: Initial 18 mg orally once daily in the morning. Titrate weekly by 18 mg increments. Max: 72 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; monitor for adverse effects. No specific dose adjustment recommended due to minimal renal excretion of parent drug.
Dialysis: Not available

Hepatic Impairment:

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

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 the increased availability of dopamine and norepinephrine in the prefrontal cortex, improving attention and executive function.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-28% (due to first-pass metabolism)
Tmax: Biphasic release: First peak ~1-2 hours, second peak ~6-8 hours (for OROS formulations like Concerta)
FoodEffect: High-fat meal may delay Tmax by approximately 1 hour and increase Cmax by 15-20% for some ER formulations, but overall extent of absorption (AUC) is not significantly affected. Should be taken with or without food consistently.

Distribution:

Vd: Approximately 2.65 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate), PPAA half-life is longer (~7-8 hours)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (90% as PPAA, <1% as unchanged drug)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (initial release)
PeakEffect: Approximately 6-8 hours (second release peak)
DurationOfAction: Approximately 10-12 hours (for 27mg ER formulation like Concerta)

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
 Joint pain
Purple patches on the skin or mouth
 Changes in eyesight or eye pain, swelling, or redness
Seizures
 Shakiness
Trouble controlling body movements
 Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
 Restlessness
Changes in skin color, such as pale, blue, gray, purple, or red hands, feet, or other areas
 Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
 Muscle pain or weakness, dark urine, or difficulty urinating
Changes in sex drive
 Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision

Heart Problems:

If you have a heart condition or defect, inform your doctor. Sudden deaths have occurred in people with certain heart problems. 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.

Erectile Dysfunction:

If you experience a painful erection or an erection that lasts longer than 4 hours, seek medical help right away. This can occur even when you are not having sex. If left untreated, it may lead to lasting sexual problems.

Mental Health:

New or worsening behavior and mood changes, such as changes in thinking, anger, and 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. 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, seek medical help immediately.

Serotonin Syndrome:

A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. 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, seek medical help immediately.

Other Side Effects:

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

Dizziness or headache
 Drowsiness
Dry mouth
 Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
 Weight loss
Feeling nervous and excitable
 Trouble sleeping
* Nose or throat irritation

Reporting Side Effects:

If you have questions about side effects or want to report a side effect, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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 tics (uncontrolled movements or sounds)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Prolonged or painful erections (priapism)
  • Unexplained fever, muscle stiffness, or confusion (signs of neuroleptic malignant syndrome-like reaction, though rare)
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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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
 Existing health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
 If you have ever experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure
 Difficulty swallowing this product whole
History 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
 Current use of linezolid or methylene blue, as these medications may interact with this drug

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. Do not initiate, stop, 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. Before undergoing surgery, discuss this with your doctor.

To ensure your safety, avoid driving and other 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 need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult your doctor.

While taking this medication, it is recommended to 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, consult your doctor before 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, reducing its effectiveness. If you experience a decrease in the medication's effectiveness, 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. Discuss your risk with your doctor.

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, consult 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. Regular growth checks may be necessary. Discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of this medication to both 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 (high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dryness of mucous membranes

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis. Do not use within 14 days of MAOI discontinuation.
  • Pressor agents (e.g., dopamine, epinephrine, norepinephrine) - risk of hypertensive crisis.
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Major Interactions

  • Antihypertensives (e.g., guanethidine, clonidine, reserpine) - methylphenidate may reduce their effectiveness.
  • 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 with SSRIs/SNRIs.
  • Dopaminergic drugs (e.g., levodopa, bromocriptine) - may potentiate adverse effects.
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Moderate Interactions

  • Alcohol - may accelerate the release rate of methylphenidate from some ER formulations, leading to a rapid increase in plasma levels.
  • Caffeine - additive stimulant effects, increased risk of adverse cardiovascular or CNS effects.
  • Acidifying agents (e.g., ammonium chloride, ascorbic acid) - may increase renal excretion, decreasing methylphenidate levels.
  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - may decrease renal excretion, increasing methylphenidate levels.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Methylphenidate can cause dose-related increases in BP and HR. Baseline assessment is crucial to identify pre-existing cardiovascular conditions or risk factors.

Timing: Prior to initiation of therapy

Height and Weight

Rationale: Especially in pediatric patients, stimulants can cause growth suppression. Baseline measurements are needed for ongoing monitoring.

Timing: Prior to initiation of therapy

Psychiatric History (including family history of suicide, bipolar disorder, depression)

Rationale: Stimulants can exacerbate pre-existing psychiatric conditions or unmask new ones (e.g., psychosis, mania).

Timing: Prior to initiation of therapy

Cardiac History (including family history of sudden cardiac death, arrhythmias)

Rationale: To identify patients at risk for serious cardiovascular events.

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each dose adjustment and at least every 3-6 months thereafter

Target: Within normal limits for age and clinical status

Action Threshold: Persistent elevation outside normal range, or symptomatic changes (e.g., palpitations, chest pain) warrant further cardiovascular evaluation and potential dose adjustment/discontinuation.

Height and Weight

Frequency: Every 3-6 months in pediatric patients

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines) warrants evaluation of dose, drug holiday, or alternative therapy.

ADHD Symptom Control and Functional Improvement

Frequency: Regularly (e.g., monthly initially, then every 3-6 months)

Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning

Action Threshold: Lack of efficacy, worsening symptoms, or emergence of new symptoms warrants dose adjustment or re-evaluation of diagnosis/treatment plan.

Emergence of Psychiatric Symptoms (e.g., psychosis, mania, aggression, anxiety, depression, tics)

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

Target: Absence of new or worsening psychiatric symptoms

Action Threshold: Any new or worsening psychiatric symptoms warrant immediate evaluation and potential discontinuation.

Abuse/Diversion Potential

Frequency: At each visit

Target: No signs of abuse or diversion

Action Threshold: Signs of abuse or diversion warrant intervention, including potential discontinuation and referral for substance abuse treatment.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Depressed mood
  • Suicidal ideation
  • Unexplained tics or dyskinesias
  • Blurred vision
  • Numbness, coolness, or pain in digits (Raynaud's phenomenon)
  • Priapism (rare)

Special Patient Groups

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Pregnancy

Methylphenidate is Pregnancy Category C. Studies in animals have shown adverse effects on fetal development at doses several times the maximum recommended human dose. 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 increased risk of cardiac malformations (e.g., atrial septal defects) based on some observational studies, though data are conflicting and overall risk appears low.
Second Trimester: Not specifically studied, but continued exposure could theoretically impact fetal growth.
Third Trimester: Potential for withdrawal symptoms in the neonate if exposed late in pregnancy (e.g., tremors, irritability, feeding difficulties).
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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 signs of adverse effects such as irritability, insomnia, or poor weight gain.

Infant Risk: Low to moderate. Monitor for irritability, insomnia, decreased appetite, or poor weight gain. Consider using the lowest effective dose and taking the dose immediately after a feeding.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly. Assess for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression). High potential for abuse and dependence.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • The 27mg ER tablet (e.g., Concerta) utilizes an OROS (Osmotic Release Oral System) delivery system, which allows for a biphasic release of methylphenidate, providing an initial rapid release followed by a prolonged release over 10-12 hours. The tablet shell may be visible in stool.
  • Methylphenidate ER should be taken once daily in the morning to avoid sleep disturbances.
  • Patients should be screened for cardiac abnormalities and psychiatric conditions prior to initiation.
  • Growth suppression is a concern in pediatric patients; regular monitoring of height and weight is essential.
  • High potential for abuse and dependence; careful prescribing practices and monitoring for signs of abuse are critical.
  • Avoid abrupt discontinuation after prolonged high-dose therapy to prevent severe depression and fatigue.
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Alternative Therapies

  • Other CNS stimulants (e.g., amphetamine, lisdexamfetamine, dexmethylphenidate)
  • Non-stimulants (e.g., atomoxetine, guanfacine ER, clonidine ER)
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
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Cost & Coverage

Average Cost: $100 - $400+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generic often Tier 2, brand Tier 3)
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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 is a valuable resource that provides important information about your treatment. 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 your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, seek immediate medical attention or call your local poison control center. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to help healthcare professionals provide the best possible care.