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Methylphenidate 20mg Tablets

Manufacturer MALLINCKRODT Active Ingredient Methylphenidate 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 1955
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Methylphenidate is a stimulant medication used to help people, especially children and adolescents, with Attention-Deficit/Hyperactivity Disorder (ADHD) to improve their ability to focus, pay attention, and control impulsive behaviors. It is also used to treat narcolepsy, a condition causing excessive daytime sleepiness. It works by increasing the levels of certain natural substances in the brain that are important for attention and impulse control.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose 30 to 45 minutes before meals. If you take this medication more than once a day, be sure to take your last dose before 6 PM.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. To prevent accidental ingestion, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or area to keep your medication out of reach. When you're finished with your medication or it expires, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about potential drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, do not take a missed dose after 6 PM. If it's close to the time for your next scheduled dose, 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 a missed one.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less, or more often than directed.
  • Avoid alcohol consumption while taking this medication, as it can increase side effects.
  • Maintain a healthy diet and regular exercise routine.
  • Ensure adequate sleep, as stimulants can sometimes interfere with sleep.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not share this medication with others, as it is a controlled substance.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 10-20 mg orally 2-3 times daily (immediate-release)
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 5-10 mg twice daily, titrate weekly by 5-10 mg/day up to 60 mg/day.
Narcolepsy: 10 mg 2-3 times daily, titrate up to 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For ADHD (6 years and older): Initial 5 mg orally twice daily before breakfast and lunch. Increase dosage gradually, in increments of 5-10 mg weekly. Max 60 mg/day.
Adolescent: For ADHD: Initial 5 mg orally twice daily before breakfast and lunch. Increase dosage gradually, in increments of 5-10 mg weekly. Max 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended, monitor for adverse effects.
Severe: Use with caution; monitor for adverse effects due to potential accumulation of inactive metabolites. No specific dose adjustment guidelines.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.

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 by inhibiting the norepinephrine transporter (NET) and dopamine transporter (DAT). This increases the concentration of these monoamines in the extraneuronal space, particularly in the prefrontal cortex, enhancing neurotransmission.
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Pharmacokinetics

Absorption:

Bioavailability: 22-65%
Tmax: 1-2 hours (immediate-release)
FoodEffect: Food may delay Tmax and slightly decrease Cmax, but overall extent of absorption is not significantly affected.

Distribution:

Vd: 2.6 L/kg
ProteinBinding: 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: 2-3 hours (immediate-release)
Clearance: 10 L/hr/kg
ExcretionRoute: Primarily renal (approximately 90% as ritalinic acid)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (immediate-release)
PeakEffect: 1-2 hours (immediate-release)
DurationOfAction: 3-5 hours (immediate-release)

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 medical attention immediately:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or 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 (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, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Sudden deaths have occurred in people with certain heart problems or defects; if you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor and seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting

Additional Important Warnings

 If you experience a painful erection (hard penis) or an erection lasting longer than 4 hours, seek medical help right away to prevent long-term sexual dysfunction
New or worsening behavioral and mood changes, such as changes in thinking, anger, and hallucinations, have been reported; if you or a family member have a history of mental health conditions, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor and seek help immediately if you experience hallucinations, changes in behavior, or mood changes like depression, thoughts of suicide, nervousness, emotional ups and downs, 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, or severe headache

Common Side Effects

Not everyone experiences side effects, but if you do, they may be mild or severe. Contact your doctor or seek medical help if you experience any of the following:

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 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 (syncope)
  • Palpitations or irregular heartbeat
  • Numbness, tingling, or coldness in fingers or toes, or unexplained wounds on fingers/toes
  • New or worsening psychiatric symptoms such as hallucinations (seeing or hearing things that are not real), paranoia, or mania (unusual excitement, irritability, or extreme mood swings)
  • New or worsening tics (uncontrolled repetitive movements or sounds)
  • Severe headache or blurred vision
  • Seizures
  • Prolonged or painful erections (priapism)
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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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
 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 had a stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
 If you are currently taking:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) drugs
 Natural products
* Vitamins

Your doctor needs to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without first 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. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. 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 exceed 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.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult your doctor to discuss this potential effect.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Agitation
  • Tremors
  • Hyperreflexia
  • Muscle twitching
  • Convulsions (may be followed by coma)
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (very high fever)
  • Tachycardia (rapid heart rate)
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension (high blood pressure)
  • Mydriasis (dilated pupils)
  • Dry mouth
  • Nausea
  • Vomiting

What to Do:

If you suspect an overdose, seek immediate medical attention or call your local poison control center (e.g., 1-800-222-1222 in the US).

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

  • Vasopressors (e.g., phenylephrine, epinephrine) - risk of additive pressor effects, severe hypertension.
  • Halogenated Anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery.
  • Coumarin Anticoagulants (e.g., warfarin) - methylphenidate may inhibit their metabolism, increasing prothrombin time and bleeding risk.
  • Anticonvulsants (e.g., phenytoin, phenobarbital, primidone) - methylphenidate may inhibit their metabolism, increasing serum levels and toxicity risk.
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Moderate Interactions

  • Antidepressants (e.g., TCAs, SSRIs) - potential for additive sympathomimetic effects, increased risk of serotonin syndrome with SSRIs, or increased TCA levels.
  • Antipsychotics (e.g., haloperidol, risperidone) - methylphenidate may antagonize the effects of antipsychotics or exacerbate psychotic symptoms.
  • Clonidine - potential for serious adverse events, including sudden death, though some clinicians use this combination cautiously.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To assess for pre-existing cardiovascular conditions and establish baseline for stimulant effects.

Timing: Prior to initiation.

Height and Weight

Rationale: To establish baseline for growth monitoring, especially in children and adolescents.

Timing: Prior to initiation.

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

Rationale: To assess for risk of exacerbation of psychiatric conditions or emergence of new symptoms.

Timing: Prior to initiation.

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To identify individuals at higher risk for serious cardiovascular events.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit (e.g., every 3-6 months)

Target: Maintain within normal limits or no significant increase from baseline.

Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex or significant increase from baseline) warrants further evaluation and potential dose adjustment/discontinuation.

Height and Weight

Frequency: Every 3-6 months in children/adolescents; annually in adults.

Target: Maintain normal growth trajectory in children; stable weight in adults.

Action Threshold: Significant growth deceleration or weight loss warrants evaluation and potential dose adjustment/drug holiday.

ADHD Symptom Control

Frequency: At each visit

Target: Improved focus, attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.

Emergence of New Psychiatric Symptoms

Frequency: At each visit

Target: Absence of new or worsening psychosis, mania, aggression, or tics.

Action Threshold: Development of new or worsening psychiatric symptoms warrants immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope (fainting)
  • Palpitations
  • Numbness, tingling, or coldness in fingers/toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers/toes
  • Hallucinations
  • Paranoia
  • Mania
  • Severe headache
  • Blurred vision
  • Seizures
  • Prolonged or painful erections (priapism)

Special Patient Groups

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Pregnancy

Methylphenidate is classified as Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Animal studies have shown evidence of teratogenicity (e.g., skeletal abnormalities, fetal death) at doses higher than human therapeutic doses. Human data are limited but do not conclusively demonstrate a risk of major birth defects.
Second Trimester: Not specifically studied, but continued exposure carries potential risks observed in animal models.
Third Trimester: Neonates exposed to amphetamines (a class of stimulants similar to methylphenidate) during the third trimester have experienced withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremors) and premature delivery. Monitor neonates for these effects.
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Lactation

Methylphenidate is excreted into breast milk. The American Academy of Pediatrics considers methylphenidate to be a drug for which the effect on a nursing infant is unknown but may be of concern. The Lactation Risk Category is L3 (Moderately Safe).

Infant Risk: Monitor breastfed infants for signs of agitation, insomnia, decreased weight gain, or other adverse effects. Consider alternatives or pumping and discarding milk if concerns arise, especially with higher doses or in very young infants.
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Pediatric Use

Approved for children 6 years and older for ADHD. Long-term use in children has been associated with growth suppression (weight and height). Growth should be monitored regularly. Use with caution in children with pre-existing cardiac conditions or psychiatric disorders.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to stimulant effects and a higher prevalence of cardiovascular disease. Start with lower doses and titrate slowly. Monitor cardiovascular parameters closely.

Clinical Information

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Clinical Pearls

  • Immediate-release methylphenidate requires multiple daily doses (typically 2-3 times/day) due to its short half-life. Extended-release formulations are available for once-daily dosing.
  • Regular monitoring of blood pressure, heart rate, height, and weight is crucial, especially in children and adolescents.
  • Assess for pre-existing cardiac conditions (e.g., structural heart abnormalities, arrhythmias) and psychiatric disorders (e.g., bipolar disorder, psychosis) before initiating treatment.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of proper storage and disposal.
  • Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., severe fatigue, depression).
  • Consider drug holidays (e.g., weekends, school breaks) in children to assess for continued need and to potentially mitigate growth suppression, though this practice is debated and should be individualized.
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Alternative Therapies

  • Other CNS Stimulants: Amphetamine (e.g., Adderall, Vyvanse), Dexmethylphenidate (e.g., Focalin)
  • Non-Stimulants: Atomoxetine (Strattera), Guanfacine extended-release (Intuniv), Clonidine extended-release (Kapvay), Viloxazine (Qelbree)
  • Behavioral therapy, psychotherapy, cognitive behavioral therapy (CBT) for ADHD.
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Cost & Coverage

Average Cost: Varies widely, generally low for generic formulations per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to 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. This information will help healthcare professionals provide you with the most effective treatment.