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Methylphenidate CD 20mg 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
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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 a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It is a stimulant that works by affecting certain natural chemicals in the brain to help improve attention, focus, and control over impulsive behavior.
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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. If you have trouble swallowing, you can sprinkle the contents of the capsule on applesauce. Do not chew the applesauce; swallow it immediately, and then drink a glass of water or juice. Some products can also be mixed with yogurt; check the package insert or consult with your pharmacist if you're unsure.
4. Mixing 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

To keep your medication safe and effective:

1. Store at Room Temperature: Keep your medication at room temperature, away from light and moisture.
2. Protect from Children and Pets: Store your medication in a safe place where children cannot see or reach it, and where other people cannot access it. Consider using a locked box or secure area.
3. Keep Away from Pets: Keep all medications out of reach of pets.

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. Do not crush, chew, or open the capsule; swallow it whole.
  • Avoid taking the medication late in the day to prevent sleep problems.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • Maintain a healthy diet and regular exercise. For children, monitor growth and weight.
  • Avoid alcohol, as it can increase the release of methylphenidate from the capsule.
  • Store safely to prevent misuse or abuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Methylphenidate CD is generally not indicated for adults who have not been previously treated with methylphenidate. For adults continuing treatment, the dose should be individualized. Typical adult doses range from 20 mg to 60 mg once daily.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Initial dose 20 mg once daily in the morning. May be titrated in 10-20 mg increments weekly to a maximum of 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6-12 years: Initial dose 20 mg once daily in the morning. May be titrated in 10-20 mg increments weekly to a maximum of 60 mg/day.
Adolescent: For adolescents 13-17 years: Initial dose 20 mg once daily in the morning. May be titrated in 10-20 mg increments 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, use with caution and 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. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) are thought to be mediated through the blockade of dopamine and norepinephrine reuptake transporters in the presynaptic neuron, thereby increasing the extracellular concentrations of these monoamines in the striatum and prefrontal cortex. This leads to enhanced neurotransmission in brain regions associated with attention, executive function, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (variable, generally good)
Tmax: Biphasic release: Initial peak at 1.5-2.5 hours, second peak at 6.5-8.5 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: Not available (estimated to be large, indicating extensive tissue distribution)
ProteinBinding: 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: 3.5 hours (for CD formulation, reflecting the extended release)
Clearance: Not available
ExcretionRoute: Renal (primarily as PPAA)
Unchanged: <1% (as unchanged methylphenidate)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for CD formulation)
PeakEffect: Biphasic: 1.5-2.5 hours and 6.5-8.5 hours (for CD formulation)
DurationOfAction: Approximately 8-10 hours (for CD formulation)
Confidence: Medium

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 immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 or tremors
Difficulty controlling body movements
 Uncontrollable sounds, such as humming, throat clearing, yelling, or 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 sensations 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 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, irregular heartbeat, shortness of breath, or severe dizziness, seek medical help immediately.

Additional Urgent Side Effects:

 Prolonged or painful erections (lasting more than 4 hours); if not treated promptly, this can lead to lasting sexual problems
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations; if you or a family member has 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 if this medication is taken with certain other drugs; seek medical help immediately if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering, excessive sweating, severe diarrhea, stomach upset, or vomiting

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
Nervousness or excitement
 Sleep disturbances
* Nose or throat irritation

If any of these side effects bother you or persist, contact your doctor for advice. 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)
  • Manic symptoms (e.g., feeling unusually excited, overactive, or uninhibited)
  • Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes
  • Prolonged or painful erection (priapism)
  • Blurred vision
  • Unexplained weight loss or growth slowing in children
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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)
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
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
 If you are currently taking:
+ Linezolid
+ Methylene blue
* If you have a rare hereditary condition, 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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Precautions

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. 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 questions or concerns, consult with your doctor.

While taking this medication, it is recommended that you avoid consuming alcohol and limit your intake of caffeine (found in tea, coffee, cola, and chocolate), as combining these substances may cause 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, 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 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 this further.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks 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 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Treatment is supportive and may include 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) - 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 anticoagulants, increasing bleeding risk.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of anticonvulsants, increasing serum levels.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism of antidepressants, increasing serum levels; risk of serotonin syndrome with SSRIs.
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Moderate Interactions

  • Antihypertensive drugs - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., bromocriptine, levodopa) - potential for additive dopaminergic effects.
  • Alcohol - may increase plasma levels of methylphenidate and lead to more rapid absorption of the immediate-release component.
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Minor Interactions

  • Caffeine - additive stimulant effects, increased risk of adverse cardiovascular effects.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Timing: Prior to initiation of therapy.

Height and Weight

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

Timing: Prior to initiation of therapy.

Psychiatric History (personal and family)

Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis, tics) that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy.

Cardiovascular History (personal and family)

Rationale: To screen for structural cardiac abnormalities or other serious heart problems.

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 thereafter.

Target: Within normal limits for age/sex.

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

Height and Weight

Frequency: Every 3-6 months in pediatric patients.

Target: Normal growth trajectory.

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

ADHD Symptom Assessment

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

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms warrants dose adjustment or re-evaluation of diagnosis/treatment plan.

Psychiatric Status (mood, anxiety, psychosis, tics)

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

Target: Stable mood, absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence or worsening of 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 aggression
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
  • New or worsening tics
  • Unexplained weight loss
  • Blurred vision
  • Priapism (rare, but serious)

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. Studies in animals have shown some evidence of developmental toxicity. There are limited data from human observational studies, which have not established a clear association with major birth defects. However, some studies suggest a possible increased risk of cardiac malformations.

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest a possible small increased risk of cardiac malformations.
Second Trimester: Not well-studied, but generally considered less critical for major organogenesis.
Third Trimester: Potential for premature birth and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms (e.g., agitation, feeding difficulties).
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for adverse reactions such as agitation, insomnia, or decreased weight gain.

Infant Risk: L3 (Moderate risk - use with caution. Monitor infant for irritability, poor feeding, and sleep disturbances.)
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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. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, tics).

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Geriatric Use

Safety and efficacy have not been established in geriatric patients. Use with caution in elderly patients due to potential for increased sensitivity to stimulant effects, particularly cardiovascular effects. Consider lower initial doses and slower titration.

Clinical Information

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Clinical Pearls

  • Methylphenidate CD is an extended-release formulation designed for once-daily dosing, providing symptom control throughout the school or workday.
  • The 'CD' (Controlled Delivery) formulation provides an initial rapid release (30%) followed by a slower, extended release (70%), mimicking a twice-daily dosing regimen of immediate-release methylphenidate.
  • Capsules should be swallowed whole; they should not be crushed, chewed, or divided, as this will alter the extended-release properties.
  • Patients should be screened for cardiac disease and psychiatric conditions prior to initiation due to potential cardiovascular and psychiatric adverse effects.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Avoid concomitant use with MAOIs due to the risk of hypertensive crisis.
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Alternative Therapies

  • Other stimulant medications (e.g., amphetamines like Adderall XR, Vyvanse; other methylphenidate formulations like Concerta, Ritalin LA, Focalin XR)
  • Non-stimulant medications (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
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Cost & Coverage

Average Cost: $100 - $300 per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (depending on specific plan and generic vs. 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 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, 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 details about the overdose, including the medication taken, the amount, and the time it occurred.