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Methylphenidate 50mg ER (xr) Caps

Manufacturer RHODES Active Ingredient Methylphenidate Extended- Release Capsules(meth il FEN i date) Pronunciation meth il FEN i date
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Category C
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FDA Approved
Aug 2000
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Methylphenidate extended-release capsules are 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 form releases the medicine slowly over the day, so it's usually taken 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 steps:

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 specific medication.

Swallowing Your Medication

Swallow your medication whole. Do not chew, break, or crush it.
 If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce. Do not chew the mixture. Swallow it immediately and follow with a glass of water or juice.
Some products can also be mixed with yogurt. If you're unsure, read the package insert or consult with your pharmacist.

Preparing and Taking Your Dose

 After mixing your medication with food, take your dose right away. Do not store the mixture for later use.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture.
 Keep your medication in a dry place, away from the bathroom.
Store your medication in a safe and secure location, out of reach of children and pets. Consider using a locked box or area to prevent accidental ingestion.
 Keep all medications away from pets.

Missing a Dose

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

  • Take exactly as prescribed, usually once daily in the morning.
  • Do not crush, chew, or divide the extended-release capsules; swallow them whole.
  • Avoid alcohol, as it can cause the medication to be released too quickly.
  • Maintain a regular sleep schedule, as this medication can cause insomnia.
  • Eat regular, healthy meals, as this medication can decrease appetite.
  • Store safely to prevent misuse or abuse, 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: Initial dose 18-20 mg once daily in the morning, titrated weekly. 50mg ER is a specific strength, not a standard starting dose.
Dose Range: 18 - 72 mg

Condition-Specific Dosing:

ADHD: Titrate in 18-20 mg increments weekly to a maximum of 72 mg/day.
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Pediatric Dosing

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

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis: Not available. Methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose 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 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 6-10 hours (for ER formulations)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC) for most ER formulations.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate acid, the active moiety, from ER formulations)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Renal (primarily as PPAA)
Unchanged: Less than 1% (of parent drug)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER formulations)
PeakEffect: Approximately 6-10 hours (for ER formulations)
DurationOfAction: Approximately 10-12 hours (for ER formulations)

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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, 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
Difficulty controlling body movements
 Difficulty 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, difficulty speaking or thinking, balance problems, 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 defects. Inform your doctor if you have any heart condition or defect. Also, tell your doctor if a family member has an abnormal heartbeat or died suddenly. 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 Urgent Side Effects

Painful erection (hard penis) or an erection lasting longer than 4 hours (even when not having sex). If left untreated, this may lead to lasting sexual problems.
 New or worsening behavior and mood changes, such as changes in thinking, anger, or hallucinations. Inform your doctor 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.

Serotonin Syndrome: A Potentially Life-Threatening Condition

This condition may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience any of the following symptoms:

Agitation
 Changes in balance
Confusion
 Hallucinations
Fever
 Fast or abnormal heartbeat
Flushing
 Muscle twitching or stiffness
Seizures
 Shivering or shaking
Excessive sweating
 Severe diarrhea, stomach upset, or vomiting
Severe headache

Common Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

 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

Reporting Side Effects

If you have questions about side effects or want to report any side effects, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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, tingling, or coldness in fingers or toes
  • Significant unexplained weight loss or slowed growth in children
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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 and its symptoms.
 Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever experienced a stroke
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
 Current use of:
+ Linezolid
+ Methylene blue
A rare hereditary condition, such as:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (note: some products contain sucrose)

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 consulting your doctor.
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Precautions & Cautions

Important Warnings and 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.

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult with your doctor.

While taking this medication, it is recommended that you avoid consuming alcohol and limit your intake of caffeine (found in tea, coffee, cola, and chocolate), as combining these substances 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, reducing its effectiveness and requiring higher doses to achieve the same effect. If you notice this medication is no longer working as well, 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.

If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.

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

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to 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 management of symptoms like hypertension, hyperthermia, and convulsions.

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.
  • Known hypersensitivity to methylphenidate or other components of the formulation.
  • Glaucoma.
  • Tics or Tourette's syndrome (or family history of Tourette's syndrome).
  • Severe anxiety, tension, or agitation.
  • Symptomatic cardiovascular disease (e.g., severe hypertension, advanced arteriosclerosis, heart failure, arrhythmias).
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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.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - theoretical risk of serotonin syndrome, though less common than with amphetamines.
  • Antihypertensive drugs - methylphenidate may reduce the effectiveness of these drugs.
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Moderate Interactions

  • Coumarin anticoagulants (e.g., warfarin) - methylphenidate may inhibit their metabolism, increasing bleeding risk.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - methylphenidate may inhibit their metabolism, increasing serum levels.
  • Tricyclic antidepressants (TCAs) - methylphenidate may inhibit their metabolism, increasing serum levels and potential for adverse effects.
  • Alcohol - may increase the rate of drug release from some ER formulations, leading to dose dumping.
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Minor Interactions

  • Caffeine - additive stimulant effects, increased risk of nervousness, insomnia.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Timing: Prior to initiation

Height and Weight

Rationale: Stimulants can cause growth suppression in pediatric patients.

Timing: Prior to initiation

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

Rationale: Stimulants can exacerbate pre-existing psychiatric conditions or induce new ones.

Timing: Prior to initiation

Cardiac History (e.g., structural heart abnormalities, family history of sudden death)

Rationale: To identify patients at increased 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 or at least every 3-6 months

Target: Within normal limits for age

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; consider drug holiday or alternative treatment.

Psychiatric Status (e.g., emergence of psychotic symptoms, mania, aggression, tics)

Frequency: At each visit

Target: Stable mental state

Action Threshold: New or worsening psychiatric symptoms; consider dose reduction or discontinuation.

ADHD Symptom Control and Functional Improvement

Frequency: At each visit

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

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

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • New or worsening tics
  • Unexplained weight loss
  • Insomnia
  • Anxiety
  • Nervousness

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 doses higher than typical human doses. Human data are limited but do not suggest a major teratogenic risk.

Trimester-Specific Risks:

First Trimester: Limited human data, but no clear pattern of major birth defects identified. Animal studies show some risk.
Second Trimester: Not well-studied, but generally considered less critical for major organogenesis than the first trimester.
Third Trimester: Potential for premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, feeding difficulties) have been reported with stimulant exposure late in pregnancy.
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Lactation

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

Infant Risk: L3 (Moderate risk). Potential for irritability, insomnia, decreased weight gain in the infant. Monitor for these effects.
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can cause growth suppression. Psychiatric adverse events (e.g., psychosis, mania, aggression) can occur. Cardiovascular monitoring is essential.

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Geriatric Use

Safety and efficacy have not been established in geriatric patients. Use with caution due to increased likelihood of comorbidities (e.g., cardiovascular disease) and polypharmacy. Start with lower doses and titrate slowly, monitoring for adverse effects.

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.
  • Patients should be advised not to crush, chew, or divide the capsules to avoid dose dumping and ensure proper extended release.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for psychiatric side effects (e.g., new or worsening aggression, hallucinations) and the importance of reporting them immediately.
  • Consider drug holidays (e.g., weekends, school breaks) for some patients to assess baseline symptoms, reduce tolerance, and potentially mitigate growth suppression, though this should be discussed with a healthcare provider.
  • Abuse potential exists; store medication securely and dispose of unused medication properly.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, transdermal patch, chewable tablets, oral suspension)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
  • Parent training
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Cost & Coverage

Average Cost: Varies widely, typically $100-$400+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization)
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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. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.