Home â€ē Medicine

Methylphenidate 10mg 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 (CNS) 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 stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in impulse control and hyperactivity. The extended-release form means the medication is released slowly over several hours, so it's usually taken once a day.
📋

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 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, 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.
💡

Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Do not crush, chew, or divide extended-release capsules. Swallow whole.
  • Avoid alcohol, as it may affect the release of the medication.
  • Maintain a healthy diet and regular exercise.
  • Report any changes in mood, behavior, or heart rate/blood pressure to your doctor.
  • Store safely to prevent misuse or diversion.
💊

Available Forms & Alternatives

Available Strengths:

Dosing & Administration

👨‍⚕ī¸

Adult Dosing

Standard Dose: Initial 20 mg once daily in the morning; may increase by 10-20 mg weekly.
Dose Range: 10 - 60 mg

Condition-Specific Dosing:

ADHD: Max 60 mg/day
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6 years and older: Initial 10-20 mg once daily in the morning; may increase by 10-20 mg weekly. Max 60 mg/day.
Adolescent: Initial 10-20 mg once daily in the morning; may increase by 10-20 mg weekly. Max 60 mg/day.
⚕ī¸

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 available; methylphenidate is not significantly dialyzable.

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

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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 30% (variable)
Tmax: Biphasic release: First peak 1-4 hours, second peak 4-8 hours (for ER formulations)
FoodEffect: Food may delay Tmax but generally does not affect the extent of absorption (AUC) for most ER formulations. Specific formulations may have different food effects.

Distribution:

Vd: Approximately 2.6 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: 2-3 hours (for methylphenidate); effective duration of action for ER is 8-12 hours.
Clearance: Not available
ExcretionRoute: Primarily renal (urine)
Unchanged: <1% (methylphenidate); ~90% excreted as ritalinic acid
⏱ī¸

Pharmacodynamics

OnsetOfAction: 1-2 hours (for ER formulations)
PeakEffect: 4-8 hours (for ER formulations)
DurationOfAction: 8-12 hours (for ER formulations)
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 or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
 Joint pain
Purple patches on the skin or mouth
 Changes in eyesight or eye pain, swelling, or redness
Seizures
 Shakiness
Trouble controlling body movements
 Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
 Restlessness
Changes in skin color, such as pale, blue, gray, purple, or red hands, feet, or other areas
 Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
 Muscle pain or weakness, dark urine, or trouble urinating
Changes in sex interest
 Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision

Heart Problems:

If you have a heart condition or defect, inform your doctor. Sudden deaths have occurred in people with certain heart problems. Tell your doctor if you or a family member have a history of abnormal heartbeats or sudden death. Seek medical help immediately if you experience:

Chest pain
 Abnormal heartbeat
Shortness of breath
 Severe dizziness or fainting

Other Serious Side Effects:

Painful erections (priapism) or erections lasting longer than 4 hours, which can occur even when not having sex. If left untreated, this can lead to permanent sexual problems.
 New or worsening behavior and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
Serotonin syndrome, a potentially life-threatening condition, can occur when taking 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
+ Severe headache

Common Side Effects:

Most people do not experience severe side effects, but some may occur. If you experience 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
Feeling sleepy
 Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
 Heartburn
Weight loss
 Feeling nervous and excitable
Trouble sleeping
 Nose or throat irritation

Reporting Side Effects:

If you have questions about side effects or want to report a side effect, 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 or hostility
  • Seeing or hearing things that are not real (psychosis)
  • Mania (unusual excitement, overactivity, or irritability)
  • Numbness, tingling, or color change 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. Be sure to describe the allergic reaction and its symptoms.
 Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever experienced a stroke
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: 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. Never start, stop, or change the dose of any medication without consulting your doctor.
⚠ī¸

Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

Caution with Daily Activities

Until you understand how this medication affects you, avoid driving and engaging in other activities that require your full attention. Your doctor will also instruct you to have regular blood tests, blood pressure checks, and heart rate monitoring.

Pre-Treatment Evaluations

You may need to undergo certain heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor.

Interactions with Other Substances

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

Special Considerations for High Blood Pressure

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 Tolerance

If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same effect. This is known as tolerance. If you notice that the medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose.

Seizure Risk

This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.

Allergies and Sensitivities

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

Effects on Growth in Children and Teens

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

Pregnancy and Breast-Feeding

If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both 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 (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 cardiovascular and CNS effects.

Drug Interactions

đŸšĢ

Contraindicated Interactions

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

Major Interactions

  • Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - risk of hypertensive crisis.
  • Halogenated anesthetics (e.g., halothane, isoflurane) - risk of sudden death due to acute increases in heart rate and blood pressure.
  • Coumarin anticoagulants (e.g., warfarin) - may increase prothrombin time.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of these drugs, requiring dose adjustment.
  • Tricyclic Antidepressants (TCAs) - may inhibit metabolism of TCAs, increasing plasma levels.
🟡

Moderate Interactions

  • Antihypertensive drugs - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - theoretical risk of serotonin syndrome, though less common than with other stimulants.
  • Dopamine agonists (e.g., bromocriptine, pergolide) - potential for additive dopaminergic effects.
  • Alcohol - may increase the rate of drug release from some ER formulations.
đŸŸĸ

Minor Interactions

  • Caffeine - additive stimulant effects.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular events, including hypertension and tachycardia.

Timing: Prior to initiation and at each dose adjustment.

Height and Weight (Pediatric patients)

Rationale: Risk of growth suppression.

Timing: Prior to initiation.

Psychiatric history and current symptoms

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

Timing: Prior to initiation.

Cardiac history (personal and family)

Rationale: Identify risk factors for sudden cardiac death or other serious cardiovascular events.

Timing: Prior to initiation.

📊

Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Target: Within normal limits for age/individual

Action Threshold: Sustained elevation requiring intervention or dose adjustment.

Height and Weight (Pediatric patients)

Frequency: Every 3-6 months

Target: Normal growth trajectory

Action Threshold: Significant deviation from expected growth curve.

Psychiatric symptoms (e.g., mood changes, anxiety, agitation, emergence of psychotic symptoms)

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

Target: Stable or improved

Action Threshold: New or worsening psychiatric symptoms, especially psychosis or mania.

ADHD symptom control

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

Target: Improved attention, reduced hyperactivity/impulsivity

Action Threshold: Lack of efficacy or worsening symptoms.

👁ī¸

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, decreased need for sleep, racing thoughts)
  • Severe anxiety or agitation
  • Unexplained weight loss
  • Blurred vision
  • Prolonged or painful erections (priapism)

Special Patient Groups

🤰

Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data from a pregnancy registry suggest no increased risk of major congenital malformations, but some studies suggest a small increased risk of cardiac malformations. There are reports of fetal growth restriction and premature birth.

Trimester-Specific Risks:

First Trimester: Small potential increased risk of cardiac malformations (e.g., atrial septal defects) based on some epidemiological studies, though overall risk of major malformations not consistently increased.
Second Trimester: Potential for fetal growth restriction.
Third Trimester: Potential for premature birth; neonatal withdrawal symptoms (e.g., agitation, tremor, poor feeding) if used late in pregnancy.
🤱

Lactation

Methylphenidate is excreted into human milk. Monitor breastfed infants for signs of adverse reactions such as agitation, insomnia, poor feeding, or decreased weight gain. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for methylphenidate and any potential adverse effects on the breastfed infant.

Infant Risk: Moderate risk (L3). Potential for irritability, sleep disturbances, and decreased weight gain in the infant. Long-term effects are unknown.
đŸ‘ļ

Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly. Cardiovascular and psychiatric monitoring as in adults. Not recommended for children under 6 years due to insufficient data.

👴

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, higher prevalence of cardiovascular disease, and polypharmacy. Start with lower doses and titrate slowly.

Clinical Information

💎

Clinical Pearls

  • Methylphenidate ER capsules should be taken once daily in the morning to avoid interference with sleep.
  • Instruct patients not to crush, chew, or open extended-release capsules, as this can lead to rapid release of the entire dose and potential overdose.
  • Monitor for signs of abuse and diversion, especially in adolescents and young adults.
  • Educate patients and caregivers about the importance of regular blood pressure and heart rate monitoring.
  • Consider a drug holiday periodically to assess the need for continued therapy and to mitigate potential growth suppression in children.
  • Some ER formulations may have a ghost tablet (empty shell) that passes in the stool, which is normal and does not mean the medication was not absorbed.
🔄

Alternative Therapies

  • Other CNS stimulants (e.g., Amphetamine/dextroamphetamine, Lisdexamfetamine, Dexmethylphenidate)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy and psychotherapy for ADHD.
💰

Cost & Coverage

Average Cost: Varies widely by formulation and pharmacy per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic; Tier 2 or 3 for brand-name ER formulations, often requiring prior authorization.
📚

General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. This medication is accompanied by a Medication Guide, which is a crucial resource for patients. 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. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.