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Methylphenidate 60mg 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
Not available
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FDA Approved
Jan 1970
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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 means the medication is released 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 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 applesauce. Swallow it right away and follow with a glass of water or juice.
Some products can also be sprinkled on 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 immediately. Do not store the mixture for later use.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture.
 Keep your medication in a dry place, such as a closet or drawer. Avoid storing it in a bathroom.
Keep your medication out of reach of children and pets. Store it in a safe, secure location, such as a locked box or cabinet.

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.
  • Avoid alcohol, as it can affect the release of the medication.
  • Maintain a healthy diet and regular sleep schedule.
  • 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: Initial: 20 mg once daily in the morning; Titrate weekly by 10-20 mg/day. Maintenance: 20-80 mg once daily. Max: 100 mg/day (depending on specific ER formulation).
Dose Range: 20 - 100 mg

Condition-Specific Dosing:

ADHD: Initial: 20 mg once daily; Titrate weekly by 10-20 mg/day based on response and tolerability. Max: 100 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial: 10-20 mg once daily in the morning; Titrate weekly by 10-20 mg/day. Max: 60 mg/day (for some formulations, up to 80 mg/day).
Adolescent: 13-17 years: Initial: 20 mg once daily in the morning; Titrate weekly by 10-20 mg/day. Max: 100 mg/day (depending on specific ER formulation).
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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 significantly dialyzable; use with caution, monitor for adverse effects.

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. The therapeutic effect in ADHD is believed to be mediated through the potentiation of dopaminergic and noradrenergic neurotransmission in the prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: 20-60% (highly variable due to first-pass metabolism)
Tmax: Biphasic for ER formulations, typically 1-2 hours (first peak) and 4-6 hours (second peak).
FoodEffect: Varies by specific ER formulation. Some formulations (e.g., Concerta) are not significantly affected by food, while others (e.g., Aptensio XR) may have altered absorption with high-fat meals.

Distribution:

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

Elimination:

HalfLife: Approximately 3-4 hours (for methylphenidate itself; effective duration of ER formulations is 8-12 hours)
Clearance: Not available
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes (for the initial release of ER formulations)
PeakEffect: Biphasic, corresponding to Tmax values (e.g., 1-2 hours and 4-6 hours)
DurationOfAction: 8-12 hours (for extended-release 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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
 Joint pain
Purple patches on the skin or mouth
 Changes in vision or eye pain, swelling, or redness
Seizures
 Shakiness or tremors
Difficulty 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, balance problems, drooping on one side of the face, or blurred vision
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. If a family member has an abnormal heartbeat or died suddenly, also notify your doctor. Seek medical help immediately if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
 If you experience a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical attention right away. This can occur even when not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or behavior
+ Anger or hallucinations
+ If you or a family member have a history of mental or mood disorders (e.g., depression, 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, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life
 A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience:
+ Agitation
+ Changes in balance or coordination
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 agitation
  • 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, rare but serious)
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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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, other drugs, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
 Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
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 experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
 Current use of certain medications, such as:
+ Linezolid
+ Methylene blue
* Rare hereditary health problems, including:
+ 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 (prescription, over-the-counter, natural products, and vitamins) and health conditions. This will help ensure your safety while taking this medication. Never 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. 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.

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 with this medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.

This medication may increase the risk of seizures in some individuals, particularly 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 any concerns.

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:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for agitation, hyperthermia, and cardiovascular effects.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or use within 14 days of discontinuing an MAOI due to risk of hypertensive crisis.
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Major Interactions

  • Vasopressor Agents: May potentiate the pressor effect of vasopressor agents.
  • Halogenated Anesthetics: Risk of sudden increases in blood pressure and heart rate during surgery.
  • Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Potential for serotonin syndrome, though less direct for methylphenidate compared to other stimulants.
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Moderate Interactions

  • Anticoagulants (e.g., coumarin): May inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of these drugs, requiring dose adjustment.
  • Antihypertensive Drugs: May reduce the effectiveness of drugs used to treat hypertension.
  • Tricyclic Antidepressants (TCAs): May increase plasma concentrations of TCAs, requiring dose adjustment.
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Minor Interactions

  • Alcohol: May alter the release profile of some ER formulations, leading to dose dumping.

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; risk of serious cardiovascular events.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Stimulants have been associated with growth suppression in pediatric patients.

Timing: Prior to initiation of therapy (especially in pediatric patients).

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

Rationale: Stimulants can exacerbate pre-existing psychiatric conditions or induce new psychotic/manic symptoms or tics.

Timing: Prior to initiation of therapy.

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To identify patients at higher risk for cardiovascular events.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Target: Within normal limits for age/baseline

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic or >10-20 bpm HR) warrant further evaluation and potential dose adjustment or discontinuation.

Height and Weight

Frequency: Regularly (e.g., every 3-6 months in pediatric patients, annually in adults)

Target: Normal growth trajectory for age

Action Threshold: Significant growth deceleration or weight loss warrants evaluation and potential treatment interruption.

ADHD Symptom Control

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

Target: Improved attention, reduced hyperactivity/impulsivity

Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.

Emergence of Psychiatric Symptoms (e.g., agitation, aggression, psychosis, mania, tics)

Frequency: Regularly (at each visit)

Target: Absence of new or worsening symptoms

Action Threshold: Any new or worsening psychiatric symptoms warrant immediate evaluation and potential discontinuation.

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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, increased energy, decreased need for sleep)
  • New or worsening tics
  • Blurred vision
  • Priapism (rare, but serious)

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. Data from published observational studies and registries have not established a clear association between methylphenidate use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, some studies suggest a possible increased risk of cardiac malformations and growth restriction.

Trimester-Specific Risks:

First Trimester: Some studies suggest a small increased risk of cardiac malformations (e.g., atrial septal defects) with first-trimester exposure, but data are inconsistent.
Second Trimester: Potential for fetal growth restriction.
Third Trimester: Potential for fetal growth restriction; risk of withdrawal symptoms in the neonate (e.g., agitation, tremors, poor feeding) if exposed late in pregnancy.
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Lactation

Methylphenidate is excreted into human milk. Monitor breastfed infants for adverse reactions such as agitation, insomnia, anorexia, or reduced weight gain. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for methylphenidate, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Infant Risk: Moderate risk (L3). Monitor for irritability, poor feeding, sleep disturbances, and weight loss.
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Pediatric Use

Methylphenidate ER is approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, tics).

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Geriatric Use

Clinical studies of methylphenidate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Monitor closely for cardiovascular and psychiatric adverse effects.

Clinical Information

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Clinical Pearls

  • Methylphenidate ER capsules should be swallowed whole; they should not be crushed, chewed, or divided, as this can lead to rapid release of the entire dose and increased risk of side effects.
  • Different extended-release formulations of methylphenidate (e.g., Concerta, Ritalin LA, Aptensio XR, Adhansia XR, Jornay PM) have distinct release profiles and may not be interchangeable on a milligram-for-milligram basis. Always specify the brand or generic formulation.
  • Patients should be screened for cardiac disease and psychiatric conditions (e.g., bipolar disorder, psychosis, tics) prior to initiation of therapy.
  • Stimulants carry a risk of abuse and dependence, especially in individuals with a history of substance abuse. Prescribe with caution and monitor for signs of misuse.
  • Growth suppression has been observed in children treated with stimulants; regular monitoring of height and weight is crucial.
  • Rare cases of priapism (prolonged and painful erections) have been reported with methylphenidate; patients should seek immediate medical attention if this occurs.
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Alternative Therapies

  • Other CNS Stimulants: Amphetamine (e.g., Adderall, Vyvanse), Dexmethylphenidate (e.g., Focalin)
  • Non-Stimulants: Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree)
  • Behavioral Therapy
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Cost & Coverage

Average Cost: Price varies widely by brand and generic. For 60mg ER capsules, it can range from $100 to $400+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generics; Tier 3 or higher for brand names. Coverage varies by insurance plan.
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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, which is a crucial patient fact sheet. 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 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.