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Methylphenidate ER CD 30mg 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
Aug 1955
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Methylphenidate ER CD is a stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in impulse control and hyperactivity. The 'ER CD' means it's an extended-release capsule designed to release the medication slowly throughout the day, usually taken once in the morning.
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How to Use This Medicine

Taking Your Medication Correctly

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

1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your prescription, and follow the instructions carefully.
2. Timing and Food: Typically, this medication should be taken in the morning. Some medications need to be taken with food, while others should be taken on an empty stomach. If you're unsure, consult your pharmacist for guidance on the best way to take your medication.
3. Swallowing Your Medication: Swallow the medication whole. Do not chew, break, or crush it.
4. Alternative Administration: If you have difficulty swallowing the capsule, you may sprinkle its contents onto 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 about the best way to take your medication, refer to the package insert or consult your pharmacist.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

1. Store at Room Temperature: Keep your medication at room temperature, away from direct light and moisture.
2. Secure Storage: Store your medication in a safe, dry place, such as a locked cabinet or drawer. This will help prevent accidental ingestion by children, pets, or unauthorized individuals.
3. Keep Out of Reach: Ensure your medication is out of sight and reach of children and pets.

Missing 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 continue with your regular dosing 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 dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Swallow the capsule whole. If unable to swallow, the capsule may be opened and the contents sprinkled over a small amount of applesauce and consumed immediately. Do not chew the beads.
  • Avoid taking the medication in the late afternoon or evening as it may cause sleep problems.
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
  • Avoid alcohol consumption, as it may affect the release of the medication.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 20 mg once daily in the morning; may increase by 10-20 mg weekly.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 20 mg once daily in the morning. May be titrated in 10-20 mg increments weekly. Max 60 mg/day. Administer orally once daily in the morning. Capsule may be swallowed whole or opened and sprinkled on applesauce.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6 years and older: Initial 20 mg once daily in the morning. May be titrated in 10-20 mg increments weekly. Max 60 mg/day.
Adolescent: Initial 20 mg once daily in the morning. May be titrated in 10-20 mg increments weekly. Max 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis: Not available; methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: 22-28% (oral)
Tmax: Biphasic: Initial peak ~1-2 hours, second peak ~4-5 hours (for ER formulations like CD)
FoodEffect: Food can delay Tmax but generally does not significantly affect AUC (total exposure) for ER CD formulations. Administer with or without food.

Distribution:

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

Elimination:

HalfLife: 2-3 hours (methylphenidate); 3-4 hours (ritalinic acid)
Clearance: Not readily available, but rapid metabolism and excretion.
ExcretionRoute: Renal (urine)
Unchanged: <1% (methylphenidate); ~80-90% (ritalinic acid)
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Pharmacodynamics

OnsetOfAction: Within 1 hour (for initial release)
PeakEffect: Biphasic: 1-2 hours and 4-5 hours
DurationOfAction: 8-10 hours (for ER CD 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 patients for signs of abuse and dependence while on 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
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ 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 eyesight or eye pain, swelling, or redness
Seizures
 Shakiness
Trouble 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 hands, feet, or other areas
 Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
 Muscle pain or weakness, dark urine, or difficulty urinating
Changes in sex drive
 Weakness on one side of the body, trouble speaking or thinking, changes in balance, 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 died suddenly, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, such as:

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 dysfunction if not treated promptly.
 New or worsening behavior and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, 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, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, 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. 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 do not go away:

Dizziness or headache
 Drowsiness
Dry mouth
 Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
 Weight loss
Feeling nervous and excitable
 Trouble 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
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New manic symptoms (e.g., extreme energy, racing thoughts)
  • Unexplained wounds on fingers or toes, or numbness/coolness in extremities
  • Blurred vision or other vision changes
  • Prolonged or painful erections (priapism)
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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. Be sure to describe the allergic reaction and its symptoms.
 Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
A 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 of specific medications for depression or Parkinson's disease within the last 14 days, including:
+ 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, such as:
+ 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, including:

 Prescription and over-the-counter (OTC) medications
Natural products
 Vitamins

Your doctor will assess the safety of taking this medication with your existing health conditions and medications. Do not start, stop, or change the dose 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. 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 other products) and chocolate, as combining these with the medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, it is crucial to discuss with your doctor before using any 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 use or high doses 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 notice that the medication is not working as well as it previously did, 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. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.

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, so be sure to discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for 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:

Call 911 or your local emergency number immediately. Call a poison control center for advice (1-800-222-1222 in the US).

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
  • Antihypertensive drugs - methylphenidate may reduce their effectiveness
  • Coumarin anticoagulants (e.g., warfarin) - may inhibit metabolism, increasing anticoagulant effect
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels
  • Tricyclic antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, increasing TCA levels
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Moderate Interactions

  • Dopaminergic drugs (e.g., antipsychotics, dopamine agonists) - potential for pharmacodynamic antagonism or additive effects
  • Alcohol - may increase plasma levels of methylphenidate and lead to dose dumping with some ER formulations (though less common with bead-based CD)
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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: Risk of dose-related increases in BP and HR, which can be clinically significant.

Timing: Prior to initiation of therapy.

Height and Weight (Pediatric Patients)

Rationale: Risk of growth suppression.

Timing: Prior to initiation of therapy.

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 therapy.

Cardiac History (including family history of sudden death, arrhythmias, structural abnormalities)

Rationale: Risk of serious cardiovascular events.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Target: Within normal limits for age/individual baseline.

Action Threshold: Persistent elevation above baseline or age-appropriate norms; consider dose reduction or discontinuation.

Height and Weight (Pediatric Patients)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration; consider drug holiday or alternative treatment.

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

Frequency: At each visit.

Target: Absence of new or worsening symptoms.

Action Threshold: Emergence or worsening of symptoms; consider dose reduction, discontinuation, or psychiatric evaluation.

Abuse/Diversion Potential

Frequency: At each visit.

Target: No signs of abuse or diversion.

Action Threshold: Signs of abuse or diversion; implement appropriate strategies.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Depressed mood
  • Unexplained wounds on fingers/toes (Raynaud's phenomenon)
  • Numbness, coolness, or pain in extremities

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, and 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 limited.
Second Trimester: Limited data, but continued exposure may carry risks similar to first trimester or affect fetal growth.
Third Trimester: Potential for withdrawal symptoms in the neonate (e.g., agitation, tremors, feeding difficulties) if exposed late in pregnancy.
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Lactation

L3 (Moderately Safe). Methylphenidate is excreted into human milk. Monitor breastfed infants for agitation, insomnia, decreased weight gain, or decreased appetite. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for methylphenidate and any potential adverse effects on the breastfed infant.

Infant Risk: Low to moderate. Potential for irritability, poor feeding, and sleep disturbances in the 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. Monitor for emergence or worsening of psychiatric symptoms.

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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 higher prevalence of comorbidities. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Methylphenidate ER CD capsules are designed for once-daily dosing, providing extended release of the medication throughout the day.
  • The 'CD' formulation typically refers to a bead-based system (e.g., Ritalin LA, Aptensio XR) that allows for sprinkling on applesauce if swallowing capsules is difficult, but the beads must not be chewed.
  • Always assess for pre-existing cardiac conditions and psychiatric history before initiating therapy due to potential for serious adverse events.
  • 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.
  • Consider drug holidays for pediatric patients to assess growth and continued need for medication.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, transdermal patch, osmotic-release oral system)
  • Amphetamine-based stimulants (e.g., Adderall, Vyvanse)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
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Cost & Coverage

Average Cost: Varies widely, typically $100-$400+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (generic often Tier 1 or 2, brand Tier 3)
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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 safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial 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, consult 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, and the time it occurred.