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Methylphenidate 40mg 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 assigned (Risk Summary available)
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FDA Approved
Jun 2002
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Methylphenidate is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by helping to balance certain natural chemicals in the brain, which can improve attention, focus, and control over impulsive behaviors. The 'ER' or 'XR' means it's an extended-release form, so it works throughout the day with one 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 should 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 are 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, 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 once 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 open extended-release capsules unless specifically instructed by your doctor for sprinkle formulations.
  • Avoid alcohol, as it can affect how the medication is released and increase side effects.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Report any new or worsening heart problems (e.g., chest pain, shortness of breath, fainting), psychiatric symptoms (e.g., hallucinations, paranoia, aggression), or unexplained weight loss.
  • Store medication securely to prevent misuse or abuse.
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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. May increase by 10-20 mg weekly. Max: 80 mg/day.
Dose Range: 20 - 80 mg

Condition-Specific Dosing:

ADHD: Initial: 20 mg once daily in the morning. May increase by 10-20 mg weekly. Max: 80 mg/day. The 40mg dose is a common therapeutic dose.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial (6-12 years): 10-20 mg once daily in the morning. May increase by 10 mg weekly. Max: 60 mg/day.
Adolescent: Initial (13-17 years): 20 mg once daily in the morning. May increase by 10-20 mg weekly. Max: 80 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended, but use with caution. Monitor for adverse effects.
Severe: Use with caution; consider lower starting doses and careful titration. Monitor for adverse effects. Data limited.
Dialysis: Not available; methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended, but use with caution. Monitor for adverse effects.
Severe: Use with caution; consider lower starting doses and careful titration. Monitor for adverse effects. Data limited.

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 due to increased dopamine and norepinephrine activity in the prefrontal cortex, improving attention, focus, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-30% (due to first-pass metabolism)
Tmax: For extended-release capsules, typically biphasic: initial peak at 1-2 hours, second peak at 4-8 hours (varies by specific ER formulation).
FoodEffect: Food may delay Tmax but generally does not significantly affect AUC or Cmax for most ER formulations. Some formulations may have specific food instructions (e.g., take with or without food).

Distribution:

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

Elimination:

HalfLife: Approximately 3-4 hours (for the active drug, methylphenidate, from ER formulations)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (90% as PPAA, <1% as unchanged drug)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for initial release)
PeakEffect: Approximately 4-8 hours (for second peak of ER formulations)
DurationOfAction: Approximately 8-12 hours (varies by specific ER formulation)

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, 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 immediate medical attention if you experience any signs of heart problems, such as:

Chest pain
 Abnormal heartbeat
Shortness of breath
 Severe dizziness or fainting

Other Serious Side Effects

Painful erection (hard penis) or an erection lasting longer than 4 hours (even when not having sex). If left untreated, this can 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 immediate medical attention 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 serious side effects, but some may occur. If you notice any of the following symptoms, 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, 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)
  • Numbness, tingling, or coldness in fingers or toes
  • Unexplained wounds on fingers or toes
  • New or worsening aggressive behavior or hostility
  • New psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New manic symptoms (e.g., extreme elation, racing thoughts, unusual energy)
  • Severe headache
  • Blurred vision or other vision changes
  • Uncontrolled muscle movements or tics
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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
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 these medications with this drug can lead to very high blood pressure)
 If you are currently taking:
+ Linezolid
+ Methylene blue
* If you have 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 drugs, natural products, and vitamins, as well as any health problems you may have. 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

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. As directed by your doctor, undergo regular blood tests, blood pressure checks, and heart rate monitoring. 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, 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 some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult 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 (fast heart rate)
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension (high blood pressure)
  • Mydriasis (dilated pupils)
  • Dryness of mucous membranes

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of MAOI use due to risk of hypertensive crisis.
  • Severe anxiety, tension, or agitation: May exacerbate these conditions.
  • Glaucoma: May increase intraocular pressure.
  • Tics or Tourette's syndrome: May exacerbate motor and phonic tics.
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Major Interactions

  • Vasopressors (e.g., phenylephrine, pseudoephedrine): May potentiate pressor effects, leading to severe hypertension.
  • 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): Potential for serotonin syndrome, though methylphenidate's serotonergic activity is minor.
  • Antihypertensive Drugs: May reduce the effectiveness of antihypertensive medications.
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Moderate Interactions

  • Coumarin Anticoagulants (e.g., warfarin): May prolong prothrombin time; monitor INR.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of these drugs, increasing their plasma concentrations.
  • Tricyclic Antidepressants (TCAs): May inhibit metabolism of TCAs, increasing their plasma concentrations and potential for adverse effects.
  • Dopaminergic Drugs (e.g., antipsychotics, levodopa): May antagonize effects of antipsychotics or potentiate effects of levodopa.
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Minor Interactions

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

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 of therapy.

Height and Weight

Rationale: Stimulants can be associated with growth suppression in pediatric patients.

Timing: Prior to initiation of therapy.

Cardiac History (personal and family)

Rationale: To identify pre-existing cardiac conditions that may contraindicate stimulant use or require further evaluation.

Timing: Prior to initiation of therapy.

Psychiatric History (personal and family)

Rationale: To identify pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis, tics) that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each dose adjustment and at least every 6 months thereafter.

Target: Within normal limits for age/sex.

Action Threshold: Persistent elevation above normal range; consider dose reduction, discontinuation, or referral to cardiology.

Height and Weight

Frequency: Every 3-6 months in pediatric patients; annually in adults.

Target: Normal growth trajectory for age; stable weight.

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

ADHD Symptom Control

Frequency: Regularly (e.g., monthly initially, then every 3-6 months) using validated scales (e.g., Vanderbilt, Conners).

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative therapy.

Emergence/Worsening of Psychiatric Symptoms

Frequency: At each visit.

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

Action Threshold: New onset or worsening of symptoms; consider dose reduction, discontinuation, or psychiatric consultation.

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Symptom Monitoring

  • Appetite suppression/weight loss
  • Insomnia/sleep disturbances
  • Anxiety/nervousness
  • Irritability/mood lability
  • Headache
  • Stomach ache/nausea
  • Dizziness
  • New or worsening tics
  • Hallucinations, delusions, or manic symptoms
  • Chest pain, shortness of breath, syncope (report immediately)

Special Patient Groups

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Pregnancy

Data from observational studies and registries have not identified a clear association between methylphenidate use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are potential risks, including premature birth and low birth weight. Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry is available.

Trimester-Specific Risks:

First Trimester: Limited data, but no consistent pattern of major birth defects observed.
Second Trimester: Not specifically studied for trimester-specific risks, but generally considered lower risk than first trimester for structural anomalies.
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. Limited data suggest that infant exposure is low, and adverse effects in breastfed infants are generally not reported. However, monitor breastfed infants for agitation, insomnia, decreased appetite, or poor 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: Low to moderate risk (L3).
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Pediatric Use

Methylphenidate ER is approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly, as stimulants can be associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).

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Geriatric Use

Safety and efficacy in patients over 65 years have not been established. Use with caution due to potential for increased sensitivity to stimulant effects (e.g., cardiovascular, psychiatric) and higher likelihood of comorbidities and polypharmacy. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Extended-release methylphenidate capsules are designed for once-daily dosing, typically in the morning, to provide symptom control throughout the school/work day.
  • Some ER formulations (e.g., Aptensio XR, Ritalin LA) can be opened and sprinkled on applesauce for patients who have difficulty swallowing capsules, but ensure the beads are not chewed.
  • Monitor for 'rebound' symptoms in the late afternoon/evening as the medication wears off, which may indicate a need for dose adjustment or a different formulation.
  • Educate patients and caregivers about the potential for abuse and the importance of secure storage.
  • Regularly assess for cardiovascular and psychiatric side effects, especially during dose titration.
  • Consider drug holidays (e.g., weekends, school breaks) for some patients to assess baseline symptoms, reduce tolerance, and potentially mitigate growth suppression, but this should be discussed with a healthcare provider.
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Alternative Therapies

  • Other CNS Stimulants: Amphetamine (e.g., Adderall XR, Vyvanse), Dexmethylphenidate (e.g., Focalin XR)
  • Non-Stimulants: Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree)
  • Behavioral therapy and psychotherapy (often used in conjunction with pharmacotherapy for ADHD)
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Cost & Coverage

Average Cost: Varies widely by specific ER formulation and pharmacy; typically $150-$400+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for generics); Tier 3 or Tier 4 (for brands), often requires prior authorization.
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them 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 detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.