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Methylphenidate 10mg 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 Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor
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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 medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and narcolepsy. 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 several hours, providing a longer-lasting effect with a single daily 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 in a dry place. Avoid storing it in a bathroom. Keep your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication. Remember to keep all medications out of reach of pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning. Do not crush, chew, or divide extended-release tablets.
  • Avoid taking doses late in the day to prevent sleep problems.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Limit or avoid alcohol consumption, as it can affect the release of the medication and increase side effects.
  • Maintain regular sleep patterns and a healthy diet.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor growth and weight regularly.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose of 10-20 mg once daily in the morning, titrated weekly by 10-20 mg.
Dose Range: 10 - 60 mg
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial dose of 10-20 mg once daily in the morning for children 6 years and older, titrated weekly by 10-20 mg. Max 60 mg/day.
Adolescent: Initial dose of 10-20 mg once daily in the morning, titrated weekly by 10-20 mg. Max 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.
Dialysis: Not well-studied; caution advised.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-25% (due to first-pass metabolism)
Tmax: Approximately 6-8 hours (for ER formulations)
FoodEffect: Food may delay Tmax but does not significantly affect AUC or Cmax for ER formulations.

Distribution:

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

Elimination:

HalfLife: Approximately 3-4 hours (for ER formulations)
Clearance: Not readily available as a single rate; primarily hepatic metabolism.
ExcretionRoute: Renal (90% as r-PPAA, 1% as unchanged drug)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER formulations)
PeakEffect: Approximately 6-8 hours (for ER formulations)
DurationOfAction: Approximately 8-12 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

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: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
 Liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellowing of the 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 sensations 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 a family history of abnormal heart rhythms or sudden death, inform your doctor

If you experience any signs of heart problems, such as chest pain, irregular heartbeat, shortness of breath, or severe dizziness, seek medical help immediately.

Additional Urgent Side Effects:

 Prolonged or painful erections (lasting more than 4 hours); if not treated promptly, this may lead to lasting sexual dysfunction
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations; if you or a family member have a history of mental health conditions (e.g., depression, bipolar disorder) or suicidal tendencies, inform your doctor
 Serotonin syndrome, a potentially life-threatening condition, may occur if you take this medication with certain other drugs; seek medical help if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering, excessive sweating, severe diarrhea, stomach upset, or vomiting

Common Side Effects:

While many people may not experience side effects or only have mild ones, some common side effects include:

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

If these or any other side effects bother you or persist, contact your doctor for advice. 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
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New or worsening manic symptoms (e.g., feeling overly excited, unusually high energy, decreased need for sleep)
  • Unexplained wounds on fingers or hands (from picking)
  • Blurred vision or other vision changes
  • Prolonged or painful erection (priapism)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
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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. 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 certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
 Current 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, including:

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

Your doctor needs to verify that it is safe for you to take this medication with your existing medications and health conditions. 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, it is crucial to discuss with your doctor the potential risks of 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. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so be sure to discuss this with your doctor.

If you are pregnant, planning to become pregnant, or 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)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dry mouth

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222.

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 hypertensive crisis.
  • Halogenated Anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery.
  • 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) - potential for serotonin syndrome, though less common than with amphetamines.
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Moderate Interactions

  • Antihypertensives - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., bupropion, levodopa) - potential for additive dopaminergic effects.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: CNS stimulants can cause dose-related increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Monitor for growth suppression in pediatric patients.

Timing: Prior to initiation of therapy.

Psychiatric History (personal and family)

Rationale: Assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis, tics) that may be exacerbated.

Timing: Prior to initiation of therapy.

Cardiac History (personal and family)

Rationale: Assess for structural cardiac abnormalities or other serious heart problems.

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

Height and Weight

Frequency: Every 3-6 months in pediatric patients.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration; consider drug holiday or alternative therapy.

Psychiatric Status

Frequency: At each visit.

Target: Stable mood, absence of new or worsening psychotic/manic symptoms, tics.

Action Threshold: Emergence or worsening of psychiatric symptoms; consider dose adjustment or discontinuation.

ADHD Symptom Control

Frequency: At each visit.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hostility
  • Psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, grandiosity, decreased need for sleep)
  • Motor or verbal tics
  • Unexplained wounds on fingers/hands (from picking)
  • Blurred vision
  • Priapism (rare)

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 developmental toxicity at high doses. Human data are limited but do not suggest a major teratogenic risk.

Trimester-Specific Risks:

First Trimester: Limited human data, no clear pattern of major birth defects identified. Animal studies show some risk at high doses.
Second Trimester: No specific data indicating unique risks during this trimester.
Third Trimester: Potential for premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremors) have been reported with stimulant exposure late in pregnancy.
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Lactation

Methylphenidate is excreted into breast milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding. Monitor breastfed infants for agitation, insomnia, and reduced weight gain.

Infant Risk: Low to moderate risk (L3). Monitor for irritability, poor feeding, and sleep disturbances.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) carefully due to potential for growth suppression. Assess for emergence or worsening of psychiatric symptoms and tics.

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Geriatric Use

Use with caution in elderly patients, as they may be more sensitive to the effects of stimulants, particularly cardiovascular effects. 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 extended-release tablets as this can lead to rapid release of the entire dose and increased side effects.
  • Monitor for cardiovascular side effects (BP, HR) and psychiatric adverse events (e.g., psychosis, mania, aggression) throughout treatment.
  • Growth suppression is a concern in pediatric patients; regular height and weight monitoring is crucial. Consider drug holidays if growth is significantly affected.
  • Patients with pre-existing cardiac conditions or structural heart abnormalities should generally not use methylphenidate.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
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Alternative Therapies

  • Other CNS Stimulants (e.g., Amphetamine salts, Lisdexamfetamine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
  • Cognitive behavioral therapy
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Cost & Coverage

Average Cost: $50 - $200 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, contact your doctor immediately. It's essential to keep your medication to yourself and not take anyone else's prescription. This medication includes a Medication Guide, which provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, promptly call the poison control center or seek immediate medical attention. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.