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Methylphenidate 20mg ER (xr) Caps

Manufacturer RHODES PHARMACEUTICAL Active Ingredient Methylphenidate Extended- Release Capsules(meth il FEN i date) Pronunciation meth il FEN i date
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Category C
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FDA Approved
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 stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. The extended-release form releases medication slowly throughout the day, so it's usually taken once in the morning.
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How to Use This Medicine

Taking Your Medication Correctly

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

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 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 mixture. Swallow it immediately, and then drink a glass of water or juice. Some products can also be mixed with yogurt. If you're unsure, consult the package insert or talk to your pharmacist.

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 secure location where children and pets cannot access it. Consider using a locked box or area to prevent accidental ingestion.
3. Keep Away from Moisture: Do not store your medication in a bathroom or other humid environment.

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.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning to avoid sleep problems.
  • Do not crush, chew, or divide the extended-release capsules. Swallow them whole.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Avoid alcohol, as it can affect the release of the medication and increase side effects.
  • Maintain regular sleep patterns and a healthy diet.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg orally once daily in the morning
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Initial dose 20 mg once daily in the morning; may increase by 10-20 mg weekly to a maximum of 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial dose 20 mg orally once daily in the morning; may increase by 10-20 mg weekly to a maximum of 60 mg/day.
Adolescent: 13-17 years: Initial dose 20 mg orally once daily in the morning; may increase by 10-20 mg weekly to a maximum of 60 mg/day.
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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; monitor for adverse effects.
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; monitor for adverse effects.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: 20-65% (highly variable due to first-pass metabolism)
Tmax: 1-2 hours (initial peak), 4-5 hours (second peak for ER formulations)
FoodEffect: Food may delay Tmax and slightly increase Cmax for some ER formulations, but overall absorption is not significantly affected for most ER capsules and can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: 3-4 hours (for extended-release formulations, effective duration is longer due to controlled release)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (for initial release)
PeakEffect: 1-2 hours (initial peak), 4-5 hours (second peak)
DurationOfAction: 8-12 hours (for extended-release capsules)

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. Misuse of CNS stimulants can cause sudden death and serious cardiovascular adverse events.
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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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, 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
Trouble 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, 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 a family history of abnormal heart rhythms or sudden death, inform your doctor

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.

Additional Serious Side Effects

 Prolonged or painful erections (lasting more than 4 hours); if not treated promptly, this can lead to permanent sexual dysfunction
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations; if you or a family member have a history of mental health conditions (e.g., depression, bipolar disorder) or suicidal tendencies, inform your doctor
 Serotonin syndrome, a potentially life-threatening condition, can occur when taking this medication with certain other drugs; seek medical help if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache

Common Side Effects

While many people may not experience side effects or only have mild ones, some common side effects include:

Dizziness or headache
 Drowsiness
Dry mouth
 Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
 Weight loss
Feeling nervous or excitable
 Trouble sleeping
* Nose or throat irritation

If any of these side effects or other concerns bother you or persist, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or 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 heart problems (e.g., palpitations, irregular heartbeat)
  • New or worsening mental problems (e.g., seeing or hearing things that are not real, believing things that are not true, suspiciousness, mania, aggression)
  • New or worsening tics or Tourette's syndrome
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained fever, rash, or joint pain (signs of allergic reaction or vasculitis)
  • Blurred vision or other eye problems
  • Priapism (prolonged and painful erections)
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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)
A family 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 (within the last 14 days) of specific medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
 Current use of:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, including:
+ 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 whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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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 to ensure your safety and proper care. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

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. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

Interactions with Other Substances

Avoid consuming alcohol while taking this medication. 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. 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
* Certain natural products or aids

Potential Risks and Side Effects

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 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 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.

Special Considerations for Children and Teens

This medication may affect growth in children and teens. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of this medication 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)
  • 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:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

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

  • Halogenated Anesthetics (risk of sudden death due to acute increases in heart rate and blood pressure)
  • Vasopressors (may potentiate pressor effects)
  • Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans - theoretical risk of serotonin syndrome, though less common than with amphetamines)
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Moderate Interactions

  • Antihypertensives (may reduce the hypotensive effect of these drugs)
  • Coumarin Anticoagulants (may prolong prothrombin time)
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone - may inhibit metabolism, requiring dose adjustment)
  • Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine - may inhibit metabolism, requiring dose adjustment)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To identify pre-existing cardiovascular conditions and monitor for stimulant-induced increases.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: To monitor for potential growth suppression, especially in pediatric patients.

Timing: Prior to initiation of therapy.

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

Rationale: To assess risk for stimulant-induced psychiatric adverse events or exacerbation of underlying conditions.

Timing: Prior to initiation of therapy.

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

Rationale: To assess risk for serious cardiovascular events. ECG may be considered if clinically indicated.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or at least every 3-6 months.

Target: Within normal limits for age; significant increases should prompt evaluation.

Action Threshold: Sustained clinically significant increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant dose reduction or discontinuation.

Height and Weight

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

Target: Normal growth trajectory for age (pediatric); stable weight (adults).

Action Threshold: Significant growth deceleration or weight loss in children warrants evaluation and potential dose adjustment or drug holiday.

ADHD Symptom Control

Frequency: 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.

Psychiatric Status (e.g., mood, anxiety, tics, psychosis, aggression)

Frequency: At each visit.

Target: Stable mood, absence of new or worsening tics, psychotic symptoms, or aggressive behavior.

Action Threshold: Emergence of new psychotic symptoms, mania, severe anxiety, or tics warrants immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening tics
  • Hallucinations
  • Delusional thinking
  • Mania
  • Aggressive behavior
  • Severe anxiety
  • Unexplained weight loss
  • Sleep disturbances

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 observational studies suggest a possible increased risk of cardiac malformations and fetal growth restriction with first-trimester exposure.

Trimester-Specific Risks:

First Trimester: Possible increased risk of cardiac malformations (e.g., atrial septal defects) and fetal growth restriction.
Second Trimester: Limited data, but continued monitoring for fetal growth is advised.
Third Trimester: Limited data. Neonates exposed to CNS stimulants during the third trimester may experience withdrawal symptoms (e.g., feeding difficulties, irritability, poor muscle tone).
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Lactation

Methylphenidate is excreted into breast milk. Monitor breastfed infants for adverse reactions such as agitation, insomnia, decreased weight gain, or poor feeding. 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: Low to moderate risk. Monitor for irritability, sleep disturbances, and poor weight gain.
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Pediatric Use

Safety and efficacy established in children 6 years and older. Long-term effects on growth (weight and height) should be monitored. Psychiatric adverse events (e.g., psychosis, mania, tics) can occur. Cardiovascular monitoring is essential.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to stimulant effects and higher prevalence of cardiovascular disease. Start with lower doses and titrate slowly. Not routinely studied in this population for ADHD.

Clinical Information

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Clinical Pearls

  • Methylphenidate ER capsules should be taken once daily in the morning to maximize therapeutic effect during the day and minimize insomnia at night.
  • Advise patients not to crush, chew, or open extended-release capsules, as this can lead to rapid release of the entire dose and increased risk of side effects.
  • Monitor for signs of diversion or abuse, especially in patients with a history of substance use disorder.
  • Regularly assess for emergence of new psychiatric symptoms (e.g., psychosis, mania, severe anxiety, aggression) or tics.
  • Consider drug holidays (e.g., weekends or school breaks) in pediatric patients to assess for continued need for medication and to potentially mitigate growth suppression, though this should be discussed with a healthcare provider.
  • Patients should be advised to report any signs of circulatory problems in fingers or toes (e.g., numbness, pain, skin color change) as Raynaud's phenomenon can occur.
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Alternative Therapies

  • Other CNS Stimulants (e.g., Amphetamine, Lisdexamfetamine, Dexmethylphenidate)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
  • Cognitive Behavioral Therapy (CBT)
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Cost & Coverage

Average Cost: $50 - $200 per 30 capsules (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic); Tier 3 or higher (brand)
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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 your safety, 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, we encourage you 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, including the substance taken, the amount, and the time it occurred.