Home â€ē Medicine

Methylphenidate 15mg 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.
🏷ī¸
Drug Class
Central Nervous System Stimulant
đŸ§Ŧ
Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jun 2000
⚖ī¸
DEA Schedule
Schedule II

Overview

ℹī¸

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, so it's usually taken once a day in the morning.
📋

How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your prescription, and follow the instructions carefully.
2. Timing and Food: Take your medication 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.
3. Swallowing Your Medication: Swallow your medication whole. Do not chew, break, or crush it.
4. Alternative Administration: If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce. Do not chew the applesauce. Swallow it right away, and then drink 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.
5. Mixing 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

To keep your medication safe and effective:

1. Store at Room Temperature: Keep your medication at room temperature, away from light and moisture.
2. Protect from Children and Pets: Store your medication in a safe place where children and pets cannot access it. Consider using a locked box or secure area.
3. Keep Away from Others: Keep your medication away from other people to prevent accidental ingestion or misuse.

What to Do If You Miss a Dose

If you miss a dose, skip it and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
💡

Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening as it may cause sleep problems.
  • Swallow the capsule whole. Do not crush, chew, or divide the capsule. Some ER capsules can be opened and sprinkled on applesauce, but check specific product instructions.
  • Avoid alcohol, as it may affect the release of the medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly.
💊

Available Forms & Alternatives

Available Strengths:

Dosing & Administration

👨‍⚕ī¸

Adult Dosing

Standard Dose: Not typically initiated in adults; titration from lower doses is standard. For continued treatment, dosage is individualized.
Dose Range: 10 - 80 mg

Condition-Specific Dosing:

ADHD: Initial dose typically 20 mg once daily in the morning (for Ritalin LA equivalent). Dosage may be adjusted in 10 mg increments weekly. Max 60 mg/day for Ritalin LA, up to 80 mg/day for some other ER formulations.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial dose 10-20 mg once daily in the morning (for Ritalin LA equivalent) for children 6 years and older. Dosage may be adjusted in 10 mg increments weekly. Max 60 mg/day (for Ritalin LA).
Adolescent: Initial dose 10-20 mg once daily in the morning (for Ritalin LA equivalent). Dosage may be adjusted in 10 mg increments weekly. Max 60 mg/day (for Ritalin LA).
⚕ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dosage adjustment recommended.
Moderate: No specific dosage adjustment recommended.
Severe: No specific dosage adjustment recommended. Use with caution due to potential for accumulation of metabolites.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific dosage adjustment recommended.
Moderate: No specific dosage adjustment recommended.
Severe: No specific dosage adjustment recommended. Use with caution due to potential for altered metabolism.
Confidence: Medium

Pharmacology

đŸ”Ŧ

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 related to its ability to increase dopamine and norepinephrine levels in the prefrontal cortex, improving attention, focus, and impulse control.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-30% (oral)
Tmax: 1-3 hours (initial peak), 4-7 hours (second peak for ER formulations like Ritalin LA)
FoodEffect: Food may delay Tmax but generally does not significantly affect AUC or Cmax for ER capsules. Some formulations may be taken with or without food, while others may have specific recommendations.

Distribution:

Vd: 2.65 L/kg
ProteinBinding: 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: 3-4 hours (for methylphenidate, but ER formulations provide extended release)
Clearance: Not available
ExcretionRoute: Renal (primarily as PPAA)
Unchanged: <1% (methylphenidate), 80% (PPAA)
⏱ī¸

Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER capsules)
PeakEffect: Approximately 4-7 hours (for ER capsules)
DurationOfAction: Approximately 8-10 hours (for ER capsules like Ritalin LA)
Confidence: Medium

Safety & Warnings

⚠ī¸

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.
⚠ī¸

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, changes in balance, drooping on one side of the face, or blurred vision
Sudden deaths have occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly.

Heart Problems:

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

Erectile Dysfunction:

If you have a painful erection or an erection that lasts longer than 4 hours, seek medical attention right away. This can occur even when you are not having sex. If left untreated, it may lead to lasting sexual problems.

Mental Health:

New or worsening behavior and mood changes, such as changes in thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.

Serotonin Syndrome:

A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience agitation, changes in balance, confusion, hallucinations, fever, fast or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, upset stomach, or vomiting, or severe headache.

Other Side Effects:

Most people do not experience significant side effects or only have minor ones. However, if you notice any of the following side effects or if they bother you or do not go away, contact your doctor:

 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.
🚨

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
  • New psychotic symptoms (e.g., hallucinations, delusions)
  • New manic symptoms (e.g., extreme elation, racing thoughts)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Blurred vision or other vision changes
  • Prolonged or painful erections (priapism)
📋

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. 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 these medications with this drug can lead to very high blood pressure)
 Current use of:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dose of any medication without consulting your doctor.
⚠ī¸

Precautions & Cautions

Important Information to Share with Your Healthcare Providers

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial for ensuring your safety and proper care, especially if you are scheduled to have surgery. Be sure to discuss your treatment plan with your doctor before undergoing any surgical procedure.

Precautions to Take While Using This Medication

Until you know how this medication affects you, avoid driving and engaging in activities that require you to be alert. Regular monitoring of your blood work, blood pressure, and heart rate is essential, as directed by your doctor. You may also need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

Interactions with Other Substances

It is recommended that you avoid consuming alcohol while taking this medication. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and chocolate), as it may interact with this medication and cause nervousness, shakiness, and a rapid heartbeat.

Special Considerations for Certain Medical Conditions

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 Use and Potential Side Effects

If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which can reduce its effectiveness. In this case, you may require higher doses to achieve the same effect. However, do not take more than the prescribed amount. If you notice that the medication is no longer working as well as it should, contact your doctor.

Seizure Risk and Allergic Reactions

This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk factors with your doctor to determine if you are more susceptible to seizures while taking this medication. Additionally, if you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products may contain this ingredient.

Effects on Growth and Pregnancy

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary to monitor any potential effects. If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the benefits and risks of this medication to you and your baby.
🆘

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:

Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Treatment is generally supportive, including gastric lavage, activated charcoal, and sedation for severe agitation or seizures.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
🔴

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.
  • Anticoagulants (e.g., warfarin) - may inhibit metabolism, increasing anticoagulant effect.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, increasing antidepressant levels; risk of serotonin syndrome with serotonergic agents.
🟡

Moderate Interactions

  • Antihypertensive agents - may reduce the hypotensive effect of these drugs.
  • Dopaminergic drugs (e.g., levodopa, bromocriptine) - potential for additive dopaminergic effects.
  • Alcohol - may accelerate the release of methylphenidate from some ER formulations, leading to a rapid increase in plasma levels.
đŸŸĸ

Minor Interactions

  • Caffeine - additive stimulant effects.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Timing: Prior to initiation of therapy.

Height and Weight (Pediatric)

Rationale: Stimulants have been associated with growth suppression in children.

Timing: Prior to initiation of therapy.

Psychiatric History (including family history of sudden death or serious cardiac disease)

Rationale: To assess risk of psychiatric adverse events or underlying cardiac conditions.

Timing: Prior to initiation of therapy.

ECG (if clinically indicated)

Rationale: For patients with pre-existing cardiac conditions or family history of sudden cardiac death.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each dose adjustment and at least every 3-6 months thereafter.

Target: Within normal limits for age.

Action Threshold: Significant or sustained increases warrant dose reduction or discontinuation.

Height and Weight (Pediatric)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration may warrant dose reduction, drug holiday, or alternative therapy.

ADHD Symptom Control

Frequency: Regularly, especially during titration and long-term therapy.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or re-evaluation of diagnosis.

Emergence or Worsening of Psychiatric Symptoms (e.g., psychosis, mania, aggression, anxiety)

Frequency: Regularly, at each visit.

Target: Absence of new or worsening symptoms.

Action Threshold: Prompt evaluation and potential discontinuation if symptoms emerge.

👁ī¸

Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Depressed mood
  • Tics or abnormal movements
  • Numbness, coolness, or pain in digits (Raynaud's phenomenon)

Special Patient Groups

🤰

Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Data from a meta-analysis of cohort studies and a case-control study suggest no association between methylphenidate use in the first trimester and major congenital malformations. However, some studies suggest a possible association with cardiac malformations.

Trimester-Specific Risks:

First Trimester: Possible small increased risk of cardiac malformations, but overall data are conflicting and largely reassuring for major malformations.
Second Trimester: Limited data, but generally considered lower risk for structural malformations.
Third Trimester: Potential for premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremor, poor feeding) have been reported with stimulant exposure near term.
🤱

Lactation

Methylphenidate is excreted into breast milk. The relative infant dose (RID) is generally low (around 0.2-2.1%). Monitor breastfed infants for adverse effects such as agitation, insomnia, decreased appetite, or poor weight gain. Use with caution, especially in neonates or preterm infants.

Infant Risk: L3 (Moderate risk - There are no controlled studies in breastfeeding women. The drug is present in breast milk. The risk of adverse effects to the infant should be weighed against the benefits of breastfeeding and the mother's need for the drug.)
đŸ‘ļ

Pediatric Use

Approved for 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.

👴

Geriatric Use

Use with caution in elderly patients. No specific studies in geriatric population. Start with lower doses and titrate slowly due to increased sensitivity to adverse effects, especially cardiovascular and psychiatric effects. Consider age-related decreases in renal and hepatic function.

Clinical Information

💎

Clinical Pearls

  • Methylphenidate ER capsules provide a smoother, longer-lasting effect compared to immediate-release formulations, reducing the need for multiple daily doses.
  • Different ER formulations (e.g., Ritalin LA, Concerta, Aptensio XR, Jornay PM) have distinct release profiles and dosing instructions (e.g., some can be sprinkled, some must be swallowed whole, some are dosed in the evening). Always verify specific product instructions.
  • Patients should be screened for cardiac conditions and psychiatric history before starting therapy.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Consider drug holidays for children during weekends or school breaks to assess baseline symptoms and potentially mitigate growth suppression, though this should be individualized and discussed with a physician.
🔄

Alternative Therapies

  • Other CNS Stimulants (e.g., Amphetamine salts (Adderall XR), Lisdexamfetamine (Vyvanse), Dextroamphetamine (Dexedrine))
  • Non-stimulants (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree))
  • Behavioral therapy
  • Cognitive Behavioral Therapy (CBT)
💰

Cost & Coverage

Average Cost: $150 - $400+ per 30 capsules (15mg ER)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generic often Tier 1 or 2, brand Tier 3)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 crucial information. 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, consult your doctor, pharmacist, or other healthcare provider for guidance.

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, including the name of the medication taken, the amount, and the time it occurred.