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Methylphenidate 20mg ER Tablets

Manufacturer MALLINCKRODT Active Ingredient Methylphenidate Controlled- 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 is used to treat narcolepsy.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 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 (ER) tablet is designed to release the medication slowly over the day, providing a longer-lasting effect with a single morning dose.
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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.

Some medications are taken with food, while others should be taken on an empty stomach. To determine the best approach for your specific medication, consult with your pharmacist. When taking your medication, swallow the tablet 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 moisture. Avoid storing it in a bathroom. Keep your medication in a secure location where children cannot see or access it, and where others cannot easily get to it. Consider using a locked box or designated 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 or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning. Do not crush, chew, or divide extended-release tablets.
  • May be taken with or without food, but consistency is key.
  • Avoid alcohol, as it can cause rapid release of the medication.
  • Store at room temperature, away from moisture and heat.
  • Keep out of reach of children and pets.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor blood pressure, heart rate, and weight as advised by your doctor.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 18-20 mg orally once daily in the morning. May increase weekly by 18-20 mg increments. Max 72-80 mg/day.
Dose Range: 18 - 80 mg

Condition-Specific Dosing:

ADHD: Initial 18-20 mg once daily, titrate to effect, max 72-80 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For ADHD (6-12 years): Initial 18 mg orally once daily in the morning. May increase weekly by 18 mg increments. Max 54 mg/day.
Adolescent: For ADHD (13-17 years): Initial 18 mg orally once daily in the morning. May increase weekly by 18 mg increments. Max 72 mg/day.
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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 for adverse effects.

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. It is believed to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. This action is thought to increase the levels of these neurotransmitters in the synaptic cleft, particularly in the prefrontal cortex, which is associated with attention and executive function.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-30% (due to first-pass metabolism)
Tmax: Biphasic for ER formulations: Initial peak at 1-2 hours, second peak at 5-9 hours.
FoodEffect: Food generally delays Tmax but does not significantly affect AUC or Cmax for ER formulations.

Distribution:

Vd: Approximately 2.65 L/kg
ProteinBinding: Approximately 15% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3-4 hours (for methylphenidate), ritalinic acid half-life is longer (approx. 8 hours).
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: Less than 1% (as unchanged drug in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER formulations)
PeakEffect: Approximately 5-9 hours (for ER formulations)
DurationOfAction: Approximately 10-12 hours (for ER formulations)

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

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 medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or 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 skin
 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 trouble urinating
Changes in sex interest
 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: Important Warning

Sudden deaths have occurred in people with certain heart problems or heart defects. If you have a heart condition or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, tell your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:

Chest pain
 Abnormal heartbeat
Shortness of breath
 Severe dizziness or fainting

Other Serious Side Effects

Painful erection (hard penis) or an erection lasting longer than 4 hours (even when not having sex). If not treated promptly, this may lead to lasting sexual problems.
 New or worsening behavior and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life
 Serotonin syndrome, a potentially life-threatening condition, may occur when taking 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

Common Side Effects

While many people may not experience side effects, some may have minor or bothersome side effects. If you experience any of the following, contact your doctor or seek medical attention:

Dizziness or headache
 Feeling sleepy
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 experience any side effects not listed here, 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 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)
  • Unexplained numbness, pain, or discoloration in fingers or toes
  • Prolonged or painful erection (priapism)
  • Blurred vision
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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 you experienced.
 Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
A family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever had a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (as this may lead to very high blood pressure)
 Current use of certain medications, such as:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is essential to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

Important Information to Share with Your Healthcare Team

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial for ensuring your safety and proper care. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

Precautions to Take While on This Medication

Until you know how this medication affects you, avoid driving and engaging in activities that require your full attention. 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.

Interactions with Other Substances

Avoid consuming alcohol while taking this medication. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and chocolate) as it may cause nervousness, shakiness, and a rapid heartbeat when combined with this drug. 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
* Certain natural products or aids

Potential Risks and Side Effects

Long-term or high-dose use of this medication may lead to tolerance, reducing its effectiveness. If you find 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, particularly in individuals with a history of seizures. Discuss your risk with your doctor.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to determine the best course of action.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the potential 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)
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (very high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth and mucous membranes

What to Do:

Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Treatment is generally supportive, including gastric lavage, activated charcoal, and sedation for severe agitation or seizures.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (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, 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; risk of serotonin syndrome with serotonergic agents
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Moderate Interactions

  • Antihypertensive drugs - methylphenidate may reduce the effectiveness of antihypertensives
  • Dopaminergic drugs (e.g., antipsychotics, levodopa) - potential for additive dopaminergic effects or antagonism
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Minor Interactions

  • Alcohol - may increase the rate of drug release from some ER formulations (dose dumping)

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation of therapy.

Psychiatric History (e.g., bipolar disorder, psychosis, tics)

Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new ones.

Timing: Prior to initiation of therapy.

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To assess cardiovascular risk.

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.

Action Threshold: Sustained elevation requiring intervention (e.g., >95th percentile for age/sex or significant increase from baseline).

Height and Weight

Frequency: Every 3-6 months (pediatric patients).

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric Status (e.g., mood, anxiety, psychotic symptoms, tics)

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

Target: Stable, absence of new or worsening symptoms.

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

ADHD Symptom Control and Functional Improvement

Frequency: Regularly, as clinically indicated.

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

Action Threshold: Lack of efficacy or intolerable side effects.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • New or worsening tics
  • Unexplained weight loss
  • Blurred vision
  • 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 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 limited.
Second Trimester: Limited data, but continued exposure may be associated with growth restriction.
Third Trimester: Potential for neonatal withdrawal symptoms (e.g., agitation, tremors, poor feeding) if used close to delivery.
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Lactation

Methylphenidate is excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for irritability, poor feeding, and sleep disturbances. Weigh the developmental and health benefits of breastfeeding against the mother's clinical need for methylphenidate and any potential adverse effects on the breastfed infant.

Infant Risk: L3 (Moderate risk) - Monitor for irritability, poor feeding, insomnia, and weight gain.
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully, as long-term use has been associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.

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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 and higher prevalence of cardiovascular disease. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Extended-release formulations are designed for once-daily dosing, typically in the morning, to provide symptom control throughout the school/work day.
  • Do not crush, chew, or divide ER tablets, as this can lead to rapid release of the entire dose (dose dumping) and increased side effects.
  • Monitor cardiovascular parameters (BP, HR) regularly, especially in patients with pre-existing cardiac conditions.
  • Assess for psychiatric comorbidities (e.g., bipolar disorder, psychosis) before initiating therapy, as stimulants can exacerbate these conditions.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Consider drug holidays or dose adjustments if growth suppression is observed in pediatric patients.
  • Some ER formulations (e.g., Concerta) may appear in the stool as a ghost tablet; this is normal and indicates the medication has been released.
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Alternative Therapies

  • Other CNS Stimulants (e.g., Amphetamine salts, Lisdexamfetamine, Dexmethylphenidate)
  • Non-stimulant medications (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
  • Lifestyle modifications (e.g., exercise, diet, sleep hygiene)
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Cost & Coverage

Average Cost: $50 - $200+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generics), Tier 3 or higher (for brands)
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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, which provides crucial information for patients. Please 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. 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 quantity, and the time it occurred.