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Methylphenidate CD 50mg Capsules

Manufacturer MALLINCKRODT 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 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
Jun 2000
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Methylphenidate CD is an extended-release capsule 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. Taking it once a day in the morning helps improve focus, reduce hyperactivity, and control impulsive behaviors throughout the day.
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How to Use This Medicine

Taking Your Medication Correctly

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

Take your medication exactly as directed by your doctor.
 Read all the information provided with your medication and follow the instructions carefully.
Take your dose in the morning.
 Some medications 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.

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're 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 future 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 return to your regular dosing schedule.
 Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening as it may cause sleep problems.
  • Swallow the capsule whole with water. Do not crush, chew, or divide the capsule, as this will release all the medication at once and increase the risk of side effects.
  • Methylphenidate CD capsules can be opened and the beads sprinkled onto a small amount of applesauce and consumed immediately, without chewing.
  • Avoid alcohol consumption, as it may increase the release of the medication.
  • Maintain a healthy diet and regular exercise, as stimulants can sometimes affect appetite and growth in children.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not share this medication with others, as it is a controlled substance.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg once daily in the morning, may be titrated
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

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

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

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; consider lower doses and monitor for adverse effects due to potential for increased exposure. Not extensively studied.
Dialysis: Not available; methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; consider lower doses and monitor for adverse effects. Not extensively studied.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. It is believed to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. This leads to increased concentrations of dopamine and norepinephrine in the synaptic cleft, particularly in the prefrontal cortex, which is thought to mediate its therapeutic effects in ADHD.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-25% (due to first-pass metabolism)
Tmax: Biphasic absorption: Initial peak at 1-2 hours, second peak at 4-5 hours (for CD formulation)
FoodEffect: Food does not significantly affect the extent of absorption (AUC) but may delay Tmax by approximately 1 hour.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate CD)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (90% as PPAA, 1% as unchanged drug)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Approximately 4-5 hours (for CD formulation)
DurationOfAction: Approximately 8-10 hours (for CD formulation)

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, 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, difficulty speaking or thinking, balance problems, 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 a family history of abnormal heart rhythms or sudden death, inform your doctor.

Heart-Related Side Effects:

If you experience any of the following symptoms, seek immediate medical attention:

 Chest pain
Abnormal heartbeat
 Shortness of breath
Severe dizziness or fainting

Other Serious Side Effects:

 Painful or prolonged erections (lasting more than 4 hours). If left untreated, this can lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or behavior
+ Anger or hallucinations
+ Depression, suicidal thoughts, or nervousness
+ Emotional instability, anxiety, or loss of interest in life

Serotonin Syndrome:

A potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. If you experience any of the following symptoms, seek immediate medical attention:

 Agitation
Changes in balance or coordination
 Confusion
Hallucinations
 Fever
Abnormal heartbeat or 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 notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

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

Reporting Side Effects:

If you have questions 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:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening aggression, hostility, or irritability
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New or worsening manic symptoms (e.g., extreme high mood, racing thoughts, decreased need for sleep)
  • Unexplained numbness, tingling, or coldness in fingers or toes
  • Prolonged or painful erection (priapism)
  • Blurred vision
  • 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:

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)
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, such as:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (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. Ensure that 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

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before undergoing surgery, discuss this with your doctor.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. Regularly monitor your blood work, blood pressure, and heart rate as advised by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult your doctor.

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

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

Long-term or high-dose use of this medication may lead to tolerance, reducing its effectiveness and potentially requiring higher doses to achieve the same effect. If you notice the medication is not working as well, contact your doctor. Do not exceed 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. 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 your doctor to discuss this further.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to weigh the benefits and risks of this medication for 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)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth

What to Do:

Seek immediate medical attention or call 911. Contact a poison control center (1-800-222-1222). Management includes supportive care, maintaining circulation and respiration, external cooling for hyperpyrexia, and benzodiazepines for severe agitation or convulsions.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
  • Known hypersensitivity to methylphenidate or other components
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Major Interactions

  • Vasopressors (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 (tricyclic antidepressants, SSRIs) - may inhibit metabolism, increasing antidepressant levels; risk of serotonin syndrome with serotonergic agents
  • Dopaminergic drugs (e.g., bromocriptine, levodopa) - risk of additive dopaminergic effects
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Moderate Interactions

  • Antihypertensive agents - methylphenidate may reduce the effectiveness of drugs used to treat hypertension
  • Alcohol - may increase plasma levels of methylphenidate and lead to more rapid absorption of the active ingredient from the extended-release formulation
  • Acidifying agents (e.g., ascorbic acid, ammonium chloride) - may decrease methylphenidate levels
  • Alkalinizing agents (e.g., sodium bicarbonate, acetazolamide) - may increase methylphenidate levels
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Timing: Prior to initiation of therapy.

Height and Weight

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

Timing: Prior to initiation of therapy.

Cardiac history (personal and family)

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

Timing: Prior to initiation of therapy.

Psychiatric history (personal and family)

Rationale: To assess for risk of psychiatric adverse events (e.g., psychosis, mania, aggression).

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 3-6 months.

Target: Within normal limits for age.

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg SBP/DBP or >10-20 bpm HR) warrant further evaluation and potential dose adjustment or discontinuation.

Height and Weight

Frequency: Every 3 months for children/adolescents; periodically for adults.

Target: Normal growth trajectory for age.

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

ADHD symptom control and adverse effects

Frequency: Regularly (e.g., monthly initially, then every 3-6 months).

Target: Improved ADHD symptoms with tolerable side effects.

Action Threshold: Lack of efficacy, emergence of new or worsening psychiatric symptoms (e.g., agitation, anxiety, psychosis, mania), or severe side effects.

Diversion/Abuse potential

Frequency: Ongoing assessment.

Target: Not applicable.

Action Threshold: Signs of drug-seeking behavior, misuse, or diversion.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • New or worsening manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
  • Severe anxiety or agitation
  • Unexplained weight loss
  • Growth deceleration (in children)
  • Blurred vision
  • Priapism (rare, but serious)

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 only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations (e.g., atrial septal defects) based on some observational studies, though data are conflicting and overall risk appears low.
Second Trimester: No specific risks identified beyond general stimulant effects.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms (e.g., tremors, irritability) in the neonate if used close to delivery.
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Lactation

Methylphenidate is excreted into human 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 along with the mother’s clinical need for methylphenidate and any potential adverse effects on the breastfed infant.

Infant Risk: L3 (Moderate risk - limited data, potential for adverse effects in infant, monitor closely).
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Assess for emergence of psychiatric symptoms. Long-term safety and efficacy in children under 6 years have not been established.

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Geriatric Use

Safety and efficacy in patients over 65 years have not been established. Use with caution due to increased likelihood of cardiovascular disease and other comorbidities. Start with lower doses and titrate slowly, monitoring for adverse effects.

Clinical Information

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Clinical Pearls

  • Methylphenidate CD (Ritalin LA) uses a SODAS® (Spheroidal Oral Drug Absorption System) technology, providing an immediate release component and an extended-release component, resulting in a biphasic plasma concentration profile.
  • Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing pills, but the beads should not be chewed.
  • Patients should be advised to take the medication in the morning to avoid insomnia.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and diversion, and the importance of secure storage.
  • Consider drug holidays periodically to assess the need for continued therapy and to mitigate potential growth suppression in children.
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Alternative Therapies

  • Atomoxetine (Strattera) - non-stimulant
  • Guanfacine extended-release (Intuniv) - non-stimulant
  • Clonidine extended-release (Kapvay) - non-stimulant
  • Bupropion (Wellbutrin) - off-label for ADHD
  • Cognitive Behavioral Therapy (CBT)
  • Behavioral therapy
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Cost & Coverage

Average Cost: $200 - $500+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand); Tier 1 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 resource that provides important information. 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, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the amount taken and the time it occurred.