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Methylphenidate 30mg 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
C
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FDA Approved
Jun 2000
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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 affecting certain natural chemicals in the brain that are involved in attention and impulse control. The extended-release (ER or XR) capsule releases the medication slowly over the day to provide a long-lasting effect.
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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 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 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, follow these steps:

1. Skip the Missed Dose: If you forget to take a dose, skip it and return to your regular schedule.
2. Do Not Double Up: 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 the medication exactly as prescribed, usually once daily in the morning. Do not crush, chew, or divide extended-release capsules.
  • Avoid alcohol, as it can affect the release of the medication and increase side effects.
  • Maintain a healthy diet and regular exercise. For children, monitor growth and weight regularly.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not share this medication with others, as it has a high potential for abuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 20 mg orally once daily in the morning. May increase by 10-20 mg weekly.
Dose Range: 20 - 80 mg

Condition-Specific Dosing:

ADHD: Typically 20-80 mg once daily in the morning. Max 80 mg/day for most formulations, some up to 100 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial (6-12 years): 10-20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max 60 mg/day.
Adolescent: Initial (13-17 years): 20 mg orally 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, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.
Dialysis: Not well studied; use with caution, monitor for adverse effects.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The therapeutic effect in ADHD is thought to be related to increased dopamine and norepinephrine activity in the prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-25% (due to first-pass metabolism)
Tmax: Extended-release formulations typically 6-10 hours (biphasic release can lead to earlier peaks as well)
FoodEffect: Food may delay Tmax but generally does not significantly affect the extent of absorption (AUC) for ER formulations.

Distribution:

Vd: Approximately 2.65 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3-4 hours (for ER formulations, effective half-life can be longer due to extended release)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Renal (primarily as PPAA)
Unchanged: Less than 1% (as unchanged drug)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER formulations)
PeakEffect: Approximately 6-10 hours (for ER formulations)
DurationOfAction: Approximately 10-12 hours (for ER formulations)

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.
 Liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and 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.
 Uncontrollable 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.
Sudden death has 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. Seek immediate medical attention if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting.

Additional Urgent Side Effects:

 Prolonged or painful erections (lasting more than 4 hours) can lead to permanent sexual problems if not treated promptly. Seek medical help right away if you experience this symptom.
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations, have been reported. If you or a family member have a history of mental or mood disorders (e.g., depression, bipolar illness), or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience hallucinations, changes in behavior, or signs of mood changes like depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
 A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help right away 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:

Most people do not experience severe side effects, but some may encounter mild or moderate symptoms. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:

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:

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • New or worsening chest pain, shortness of breath, or fainting (seek immediate medical attention).
  • New or worsening mental problems such as hallucinations (seeing or hearing things that are not real), delusions (believing things that are not real), paranoia, or mania.
  • Aggressive behavior or hostility.
  • Numbness, tingling, or coldness in fingers or toes, or unexplained wounds on fingers or toes.
  • Unexplained weight loss or slowed growth in children.
  • Blurred vision or other vision changes.
  • Severe headache.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, 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)
Family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (as this may 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 that 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 the safety of taking this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may also need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

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

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

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

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

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

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

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 both 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)
  • Dry mouth

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) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.
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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 of coumarin anticoagulants, requiring dose adjustment.
  • 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 and toxicity.
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - caution due to potential for serotonin syndrome, though less common than with other stimulants.
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Moderate Interactions

  • Antihypertensive agents - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., bupropion, levodopa) - potential for additive dopaminergic effects.
  • Alcohol - may increase the rate of drug release from some ER formulations, leading to dose dumping and increased adverse effects.
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Minor Interactions

  • Caffeine - additive stimulant effects.

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. Baseline assessment is crucial to identify pre-existing cardiovascular risk.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Stimulants can cause growth suppression in pediatric patients. Baseline measurements are needed for growth monitoring.

Timing: Prior to initiation of therapy.

Psychiatric History and Family History of Psychiatric Disorders

Rationale: To assess risk for new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression) and to identify pre-existing conditions.

Timing: Prior to initiation of therapy.

Cardiac History and Family History of Sudden Cardiac Death/Arrhythmias

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

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 during stable therapy.

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

Action Threshold: Sustained increase >10-20 mmHg systolic/diastolic or HR >20 bpm above baseline; new onset hypertension.

Height and Weight

Frequency: Every 3-6 months in pediatric patients.

Target: Normal growth trajectory for age.

Action Threshold: Significant growth deceleration or weight loss.

ADHD Symptom Control

Frequency: Regularly, at each visit or as needed.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms.

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

Frequency: Regularly, at each visit or as needed.

Target: Absence of new or worsening symptoms.

Action Threshold: New onset or significant worsening of psychiatric symptoms.

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Symptom Monitoring

  • Chest pain, shortness of breath, syncope (cardiovascular symptoms)
  • Hallucinations, delusions, mania, severe anxiety, aggression, suicidal ideation (psychiatric symptoms)
  • Persistent headaches, blurred vision (potential for increased intracranial pressure, though rare)
  • Numbness, tingling, or color change in fingers or toes (peripheral vasculopathy, e.g., Raynaud's phenomenon)
  • Unexplained weight loss or growth deceleration (especially in children)

Special Patient Groups

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Pregnancy

Methylphenidate is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Untreated ADHD may also pose risks to pregnancy outcomes.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations, though data are conflicting and limited. Discuss risks vs. benefits.
Second Trimester: Limited data, generally considered lower risk than first trimester for structural anomalies.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms in the neonate (e.g., agitation, tremors, feeding difficulties) if used close to delivery.
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Lactation

Methylphenidate is excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for irritability, poor feeding, and sleep disturbances. Weigh the developmental and health benefits of breastfeeding against the mother's clinical need for methylphenidate and any potential adverse effects on the breastfed infant.

Infant Risk: L3 (Moderate risk) - Monitor for irritability, poor feeding, insomnia, and weight loss. Consider using the lowest effective dose and taking immediately after nursing.
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Pediatric Use

Closely monitor growth (height and weight) and cardiovascular parameters. Assess for emergence or worsening of psychiatric symptoms. Long-term safety and efficacy in children under 6 years of age have not been established.

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Geriatric Use

Use with caution in elderly patients, generally starting with lower doses and titrating slowly, due to increased sensitivity to stimulant effects and higher prevalence of cardiovascular conditions. Monitor for cardiovascular and psychiatric adverse effects.

Clinical Information

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Clinical Pearls

  • Extended-release formulations are designed for once-daily dosing, typically in the morning, to provide symptom control throughout the school or workday.
  • Advise patients not to crush, chew, or open ER capsules, as this can lead to rapid release of the entire dose (dose dumping) and increased side effects.
  • Methylphenidate ER capsules may contain non-absorbable components (e.g., ghost shell) that can be seen in the stool; this is normal and does not mean the medication was not absorbed.
  • Regularly assess for signs of abuse or diversion, as methylphenidate is a Schedule II controlled substance.
  • Consider a 'drug holiday' (e.g., weekends or school breaks) for some patients to assess baseline ADHD symptoms, minimize growth suppression, and reduce tolerance, but this should be discussed with the prescribing physician.
  • Educate patients and caregivers on the importance of monitoring blood pressure, heart rate, and growth, and reporting any new or worsening psychiatric symptoms.
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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, psychotherapy, educational interventions (often used in conjunction with pharmacotherapy for ADHD)
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Cost & Coverage

Average Cost: $100 - $400 per 30 capsules (30mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic, Tier 3 or higher for brand-name formulations. Coverage varies widely by insurance plan.
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General Drug Facts

If your symptoms or health problems 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 valuable 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it occurred.