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Methylphenidate 27mg ER Tb (24h)

Manufacturer KREMERS URBAN Active Ingredient Methylphenidate Extended- Release Tablets(meth il FEN i date) Pronunciation meth il FEN i date
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
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 helping to increase the levels of certain natural substances in the brain that are important for attention and focus. The extended-release tablet is designed to release the medication slowly over 24 hours, so it's usually taken once a day in the morning.
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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 must 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 the bathroom.
 Store 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.
Keep all medications out of reach of pets.

What to Do If You Miss a Dose

If you miss a dose, follow these steps:

 Skip the missed dose and return to your regular 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 tablet whole with water in the morning. Do not crush, chew, or divide the tablet, as this will cause the medication to be released too quickly.
  • Take consistently at the same time each day.
  • Avoid alcohol, as it can cause the medication to be released too quickly.
  • Maintain a healthy diet and regular sleep schedule, as stimulants can affect appetite and sleep.
  • Store medication securely to prevent misuse or abuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 18-36 mg orally once daily in the morning
Dose Range: 18 - 72 mg

Condition-Specific Dosing:

ADHD: Initial dose 18-36 mg once daily in the morning. May increase by 18 mg increments weekly to a maximum of 72 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6-12 years: Initial dose 18 mg orally once daily in the morning. May increase by 18 mg increments weekly to a maximum of 54 mg/day.
Adolescent: For adolescents 13-17 years: Initial dose 18 mg orally once daily in the morning. May increase by 18 mg increments weekly to a maximum of 72 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution due to limited data.
Moderate: No specific dose adjustment recommended, use with caution due to limited data.
Severe: No specific dose adjustment recommended, use with caution due to limited data.
Dialysis: Not available; methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution due to limited data.
Moderate: No specific dose adjustment recommended, use with caution due to limited data.
Severe: No specific dose adjustment recommended, use with caution due to limited data.

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: Approximately 22% (oral, due to first-pass metabolism)
Tmax: For Concerta (27mg ER Tb): Bimodal/trimodal release with initial peak at 1-2 hours and a second/third peak at 6-8 hours.
FoodEffect: Food does not significantly affect the extent of absorption (AUC) of methylphenidate ER, but may delay Tmax.

Distribution:

Vd: Approximately 2.6 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for Concerta, due to extended release, duration of action is 10-12 hours)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: Less than 1% (as unchanged methylphenidate)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for initial release)
PeakEffect: Approximately 6-8 hours (for second/third release)
DurationOfAction: Approximately 10-12 hours

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 notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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
 Uncontrollable 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. If a family member has an abnormal heartbeat or died suddenly, also notify your doctor. Seek medical help immediately if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
 If you experience a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical attention immediately. This can occur even when not engaging in sexual activity. Untreated, it may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or anger
+ Hallucinations
+ Inform your doctor if you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide. Seek medical help immediately if you experience:
- Hallucinations
- Changes in behavior
- Signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life
 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
+ 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
+ Severe headache

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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 (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 numbness, weakness, or coldness in fingers or toes
  • Severe headache or blurred vision
  • Unusual changes in mood or behavior
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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, such as foods or drugs. Describe the allergic reaction and its symptoms.
 Certain health conditions, including:
+ 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, such as:
+ 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, including:
+ 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, such as:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use of this medication. Do not initiate, stop, or modify the dosage of any medication 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. 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.

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 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 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 no longer working as well, 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, you may notice the tablet shell in your stool, which 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 teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary, so discuss this with your doctor.

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.
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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. Call 911 or 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) (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
  • Antihypertensive drugs (may reduce effectiveness of antihypertensives)
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Moderate Interactions

  • Coumarin anticoagulants (e.g., warfarin) - may inhibit metabolism, increasing anticoagulant effect
  • Anticonvulsants (e.g., phenytoin, phenobarbital, primidone) - may inhibit metabolism, increasing serum levels
  • Tricyclic antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, increasing serum levels
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - theoretical risk of serotonin syndrome, though less common than with amphetamines
  • Dopaminergic drugs (e.g., bromocriptine, levodopa) - may potentiate effects
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Minor Interactions

  • Alcohol (may accelerate release of methylphenidate from ER formulations, leading to dose dumping)

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR)

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

Timing: Prior to initiation of therapy.

Height and Weight (pediatric patients)

Rationale: To establish baseline for monitoring potential growth suppression.

Timing: Prior to initiation of therapy.

Psychiatric history and current symptoms

Rationale: To assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or at least every 3-6 months

Target: Within normal limits for age/sex; significant increases should prompt evaluation.

Action Threshold: Sustained increase in BP (>10-20 mmHg systolic/diastolic) or HR (>10-20 bpm) above baseline, or development of symptoms (e.g., palpitations, chest pain).

Height and Weight (pediatric patients)

Frequency: Every 3-6 months

Target: Consistent growth along established growth curves.

Action Threshold: Significant deviation from expected growth curve or growth deceleration.

Psychiatric status (mood, anxiety, agitation, emergence of psychotic symptoms)

Frequency: At each visit or at least every 3-6 months

Target: Stable mood, absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence of new psychotic symptoms, mania, severe anxiety, or agitation.

ADHD symptom control and functional improvement

Frequency: At each visit

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

Action Threshold: Lack of efficacy or worsening of symptoms.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • Unexplained weakness or numbness
  • New or worsening aggression
  • Hostility
  • Agitation
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Persistent insomnia
  • Significant appetite suppression
  • Tics or abnormal movements

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. There are limited data on methylphenidate use in pregnant women. Studies in animals have shown some evidence of developmental toxicity at high doses.

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: No specific risks identified beyond general stimulant effects.
Third Trimester: Potential for premature delivery and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, feeding difficulties) have been reported with stimulant use near term.
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Lactation

Methylphenidate is excreted into breast milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor the infant for adverse effects.

Infant Risk: L3 (Moderately Safe). Monitor for irritability, poor feeding, insomnia, or weight loss in the infant. Consider using the lowest effective dose and observing infant closely.
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Pediatric Use

Methylphenidate ER is approved for children 6 years and older. Monitor growth (height and weight) due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression). Cardiovascular assessment is crucial.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • The 27mg ER tablet is designed for 24-hour release, typically taken once daily in the morning. It should be swallowed whole and not crushed, chewed, or divided.
  • Patients may notice the 'ghost tablet' (empty shell) in their stool, which is normal and indicates the medication has been released.
  • Monitor blood pressure and heart rate regularly, especially in patients with pre-existing cardiovascular conditions.
  • Counsel patients and caregivers on the potential for growth suppression in children and the importance of monitoring height and weight.
  • Educate on the high potential for abuse and dependence, and the importance of secure storage.
  • Avoid concomitant use with MAOIs due to the risk of hypertensive crisis.
  • Consider a 'drug holiday' if clinically appropriate, especially during school breaks, to assess ongoing need and potentially mitigate growth suppression or tolerance.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, other extended-release formulations like Aptensio XR, Jornay PM, Quillivant XR)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulant medications (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy and psychotherapy
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Cost & Coverage

Average Cost: $150 - $400 per 30 tablets (generic 27mg ER)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generic often Tier 1 or 2, brand Tier 3)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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, to facilitate prompt and appropriate treatment.