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Methylphenidate CD 60mg 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 (CNS) Stimulant
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Pharmacologic Class
Dopamine and Norepinephrine Reuptake Inhibitor
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Pregnancy Category
Category C
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FDA Approved
May 2001
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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. The 'CD' means it releases some medicine right away and the rest slowly throughout the day, so you only need to take it once a 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 applesauce. Swallow it right away and follow with a glass of water or juice.
Some products can also be mixed with yogurt. If you are unsure, read the package insert or consult with your pharmacist.

Preparing and Taking Your Dose

 After mixing your medication with food, take your dose immediately. Do not store the mixture for later use.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture.
 Keep your medication in a dry place, such as a closet or drawer. Avoid storing it in a bathroom.
Keep your medication out of reach of children and pets. Store it in a safe, secure location, such as a locked box or cabinet.

Missing a Dose

 If you miss a dose, skip it and take your next dose at the usual time.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
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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; do not crush, chew, or divide. If unable to swallow whole, the capsule may be opened and the contents sprinkled over a small amount of applesauce and consumed immediately.
  • Avoid alcohol, as it may cause the medication to be released too quickly.
  • 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.
  • Store in a safe place to prevent misuse or diversion, 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: Methylphenidate CD 60mg once daily in the morning. Doses should be individualized.
Dose Range: 10 - 80 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 80 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial dose 20 mg 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 once daily in the morning. May increase by 10-20 mg weekly to a maximum of 80 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended. Use with caution due to limited data.
Dialysis: Not available. Methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended. Use with caution due to limited data.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic efficacy in ADHD is 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 areas of the brain associated with attention, executive function, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (variable, but generally good)
Tmax: Biphasic: Initial peak at 1-2 hours, second peak at 4-5 hours (for CD formulation)
FoodEffect: Food (high-fat meal) may delay Tmax and slightly increase AUC, but does not significantly affect Cmax. Can be taken with or without food.

Distribution:

Vd: 2.65 L/kg
ProteinBinding: 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3-4 hours (for CD formulation)
Clearance: Not available
ExcretionRoute: Renal (approximately 90% as ritalinic acid)
Unchanged: <1% (as unchanged drug)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (initial release)
PeakEffect: Approximately 4-5 hours (second peak)
DurationOfAction: Approximately 8-10 hours

Safety & Warnings

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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
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
 Joint pain
Purple patches on the skin or mouth
 Changes in vision or eye pain, swelling, or redness
Seizures
 Shakiness
Difficulty controlling body movements
 Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
 Restlessness
Changes in skin color, such as pale, blue, gray, purple, or red discoloration of 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

Heart Problems:

If you have a heart condition or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience:

Chest pain
 Abnormal heartbeat
Shortness of breath
 Severe dizziness or fainting

Other Serious Side Effects:

Prolonged or painful erections (lasting more than 4 hours) can lead to permanent sexual problems if not treated promptly.
 New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek immediate medical attention if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life
 Serotonin syndrome, a potentially life-threatening condition, can occur when taking this medication with certain other drugs. Seek immediate medical attention if you experience:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache

Common Side Effects:

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

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 agitation.
  • Seeing or hearing things that are not real (hallucinations).
  • Believing things that are not true (delusions).
  • New or worsening tics (uncontrolled movements or sounds).
  • Unexplained numbness, pain, or discoloration in fingers or toes.
  • Prolonged or painful erection (priapism, rare but serious).
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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)
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 (note: taking these medications with this drug 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 (some products contain sucrose)

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. Verify that it is safe to take this medication with your existing medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and 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 undergo surgery, be sure to discuss this with your doctor.

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 with this medication 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 and potentially requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed 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 adolescents, 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
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dryness of mucous membranes

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for agitation, hyperthermia, and cardiovascular effects.

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

  • 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.
  • Antihypertensive Drugs (e.g., guanethidine, clonidine) - methylphenidate may reduce their effectiveness.
  • Coumarin Anticoagulants (e.g., warfarin) - may prolong prothrombin time.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit their metabolism, increasing serum concentrations.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit their metabolism, increasing serum concentrations.
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Moderate Interactions

  • Alcohol - may accelerate the release of methylphenidate from extended-release formulations, leading to a more rapid absorption of a larger amount of methylphenidate.
  • Dopaminergic drugs (e.g., levodopa, bromocriptine) - potential for additive dopaminergic effects.
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Minor Interactions

  • Caffeine - potential for additive stimulant effects.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of dose-related increases in BP and HR.

Timing: Prior to initiation of treatment.

Height and Weight (Pediatric Patients)

Rationale: Risk of growth suppression.

Timing: Prior to initiation of treatment.

Psychiatric History (including family history of suicide, bipolar disorder, depression)

Rationale: Risk of new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression).

Timing: Prior to initiation of treatment.

Cardiac History (including family history of sudden death or ventricular arrhythmia)

Rationale: Risk of serious cardiovascular events.

Timing: Prior to initiation of treatment.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Target: Within normal limits for age/baseline

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

Height and Weight (Pediatric Patients)

Frequency: Every 3-6 months

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss may require dose interruption or discontinuation.

Psychiatric Symptoms (e.g., agitation, aggression, hallucinations, mania, depression)

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

Target: Absence of new or worsening symptoms

Action Threshold: Emergence or worsening of symptoms warrants evaluation and potential discontinuation.

Abuse/Diversion Potential

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

Target: No signs of abuse or diversion

Action Threshold: Signs of abuse or diversion require intervention and re-evaluation of treatment plan.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusional thinking
  • Mania
  • Severe anxiety
  • Agitation
  • Unexplained weight loss
  • Tics or dyskinesias
  • Priapism (rare)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.

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: Not specifically studied, but continued exposure could theoretically impact fetal growth.
Third Trimester: Potential for withdrawal symptoms (e.g., tremors, irritability) in neonates if exposed late in pregnancy.
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Lactation

L3 (Moderate risk). Methylphenidate is excreted into human milk. Monitor breastfed infants for agitation, insomnia, anorexia, or reduced weight gain. Consider alternative treatments or temporary discontinuation of breastfeeding, especially for neonates or infants with underlying health issues.

Infant Risk: Risk of irritability, poor feeding, and sleep disturbances in the infant. Long-term effects on neurodevelopment are unknown.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly. Risk of growth suppression should be weighed against clinical benefits. Psychiatric and cardiovascular monitoring is crucial.

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Geriatric Use

Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to stimulant effects (e.g., cardiovascular, psychiatric) and comorbidities. Start with lower doses and titrate slowly.

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/work day.
  • The capsule 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 essential.
  • Educate patients and caregivers about the potential for abuse and diversion, and the importance of secure storage.
  • Assess for pre-existing cardiac conditions or family history of sudden cardiac death before initiating treatment.
  • Be vigilant for new or worsening psychiatric symptoms, including psychosis, mania, or aggression.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, transdermal patch, other extended-release formulations like Concerta, Ritalin LA, Aptensio XR, Jornay PM, Quillivant XR, Quillichew ER, Daytrana)
  • Amphetamine-based stimulants (e.g., Adderall, Vyvanse, Dexedrine)
  • Non-stimulant medications (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy and psychotherapy
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Cost & Coverage

Average Cost: $200 - $400 per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand-name, generic often Tier 1)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your 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 reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.