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Methylphenidate 54mg ER Tb (bx) 24h

Manufacturer KREMERS 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 important for 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 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 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 resume 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 medication exactly as prescribed, usually once daily in the morning. Do not take it in the afternoon or evening as it may cause sleep problems.
  • Swallow the extended-release tablet 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 or overdose risk.
  • You may notice a tablet shell in your stool; this is normal and means the medication has been released.
  • Avoid alcohol, as it may cause the medication to be released too quickly.
  • Maintain a healthy diet and regular exercise. Monitor food intake, especially in children, as appetite suppression can occur.
  • 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.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 18 mg once daily in the morning. Titrate weekly in 18 mg increments.
Dose Range: 18 - 72 mg

Condition-Specific Dosing:

ADHD: Max 72 mg/day
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Pediatric Dosing

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

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis: Not well studied. Use with caution and monitor closely.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic efficacy in ADHD is thought to be related 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, particularly in the prefrontal cortex, which are believed to improve attention, focus, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22% (oral)
Tmax: Biphasic release for Concerta: Initial peak at 1-2 hours, second peak at 6-8 hours.
FoodEffect: Food does not significantly affect the extent of absorption (AUC) of methylphenidate ER, but may delay Tmax by approximately 1 hour.

Distribution:

Vd: 2.65 L/kg
ProteinBinding: 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate), PPAA half-life is about 2.5 hours.
Clearance: Not available
ExcretionRoute: Renal (primarily as PPAA)
Unchanged: <1% (methylphenidate), 80% (PPAA)
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: Approximately 6-8 hours (for the second peak of ER formulations)
DurationOfAction: Approximately 10-12 hours (for 24h ER formulations)
Confidence: High

Safety & Warnings

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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 immediate medical attention:

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 vision 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, including pale, blue, gray, purple, or red discoloration of 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, trouble 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. Seek immediate medical attention 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 help right away. This can occur even when not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ 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, including 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 right away 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

While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following:

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

If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention.

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening tics (uncontrolled movements or sounds)
  • New or worsening aggressive behavior or hostility
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • Manic symptoms (e.g., extreme high mood, increased energy, racing thoughts)
  • Numbness, tingling, or color change in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Blurred vision or other vision changes
  • Prolonged or painful erection (priapism)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
 Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever experienced a stroke
Recent use of 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)
 Difficulty swallowing this product whole
Presence of certain gastrointestinal conditions, such as:
+ Cystic fibrosis
+ Narrowing of the GI (gastrointestinal) tract
+ Bowel block or other GI problems (e.g., short gut syndrome, slow-moving esophagus or bowel tract)
+ Peritonitis
 Concurrent use of:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is essential 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 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. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may also need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

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

If you have high blood pressure, consult 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 this medication is no longer working as well as it should, 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. Discuss your risk of seizures with your doctor.

For some formulations of this medication, you may notice the tablet shell in your stool. This is a normal occurrence and not a cause for concern. However, if you have any questions, consult with your doctor.

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

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary. Consult with your doctor to discuss any potential risks.

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 (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 supportive and may include 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 due to risk of hypertensive crisis.
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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.
  • Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, requiring dose adjustment.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, requiring dose adjustment.
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Moderate Interactions

  • Antihypertensive drugs - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., antipsychotics, levodopa) - potential for additive effects or antagonism.
  • Alcohol - may accelerate the release of methylphenidate from some ER formulations, leading to a more rapid increase in plasma levels.
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Minor Interactions

  • Caffeine - additive stimulant effects.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause increases in BP and HR. Baseline assessment is crucial to identify pre-existing cardiovascular risk.

Timing: Prior to initiation

Height and Weight

Rationale: Stimulants can cause growth suppression in children. Baseline measurements are needed for ongoing monitoring.

Timing: Prior to initiation (especially in pediatric patients)

Psychiatric History and Symptoms

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

Timing: Prior to initiation

Cardiac History and Physical Exam

Rationale: To screen for structural cardiac abnormalities or other serious heart problems that could contraindicate stimulant use.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly (e.g., at each visit or every 3-6 months)

Target: Within normal limits for age and clinical status

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

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative treatment.

ADHD Symptom Control and Adverse Effects

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

Target: Improved attention, reduced hyperactivity/impulsivity; minimal side effects

Action Threshold: Lack of efficacy, intolerable side effects (e.g., insomnia, anorexia, anxiety, tics, mood changes); consider dose adjustment or alternative.

Psychiatric Symptoms

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

Target: Stable mood, absence of psychotic symptoms or severe anxiety

Action Threshold: Emergence or worsening of psychotic or manic symptoms, severe anxiety, aggression; consider discontinuation.

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Symptom Monitoring

  • Increased heart rate
  • Elevated blood pressure
  • Insomnia
  • Decreased appetite/weight loss
  • Anxiety
  • Nervousness
  • Irritability
  • Headache
  • Stomach ache
  • Nausea
  • Dry mouth
  • Dizziness
  • Tics (new or worsening)
  • Mood changes (e.g., agitation, aggression, mania)
  • Psychotic symptoms (e.g., hallucinations, delusions)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of teratogenicity at high doses. Limited human data suggest no major increase in birth defects, but some studies indicate a possible association with cardiac malformations when used in the first trimester.

Trimester-Specific Risks:

First Trimester: Possible 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 well studied, but generally considered lower risk than first trimester for structural malformations.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms (e.g., tremors, irritability) in the neonate if used close to 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 such as irritability, insomnia, or poor feeding.

Infant Risk: L3 (Moderate risk). Monitor for irritability, insomnia, poor feeding, and weight gain. Consider using the lowest effective dose and observing the infant closely.
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Pediatric Use

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

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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 (e.g., cardiovascular, psychiatric) and higher prevalence of comorbidities. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Methylphenidate ER formulations are designed for once-daily dosing, typically in the morning, to provide symptom control throughout the school/work day.
  • Patients should be instructed to swallow the tablet whole; crushing or chewing can lead to rapid release and increased side effects.
  • The tablet shell may be visible in the stool, which is a normal occurrence and does not indicate that the medication was not absorbed.
  • Careful cardiovascular assessment, including blood pressure and heart rate, should be performed at baseline and periodically during treatment.
  • Monitor for psychiatric adverse events, including new or worsening psychosis, mania, or aggression, especially in patients with pre-existing psychiatric conditions.
  • In children, regular monitoring of height and weight is crucial due to the potential for growth suppression. Drug holidays may be considered if growth is significantly affected.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of storing the medication securely.
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Alternative Therapies

  • Other stimulant medications (e.g., amphetamine salts, lisdexamfetamine)
  • Non-stimulant medications (e.g., atomoxetine, guanfacine ER, clonidine ER)
  • Behavioral therapy
  • Cognitive Behavioral Therapy (CBT)
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Cost & Coverage

Average Cost: $150 - $400 per 30 tablets (for 54mg ER)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generics often Tier 1 or 2, brands Tier 2 or 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 use, 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 important information. 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, consult 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, and the time it occurred.