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Methylphenidate CD 10mg 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
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Not available
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FDA Approved
Mar 1999
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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 works by affecting certain natural substances in the brain that help with focus and impulse control. The 'CD' means it's a 'Controlled Delivery' capsule, designed to release the medicine over several hours, so you usually only 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:

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. If you're unsure, consult with your pharmacist for guidance.
3. Swallowing Your Medication: Swallow the medication whole. Do not chew, break, or crush it.
4. Alternative Administration: If you have trouble swallowing the capsule, you can sprinkle the 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 with your pharmacist.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

1. Store at Room Temperature: Keep your medication at room temperature, away from direct light and moisture.
2. Secure Storage: Store your medication in a safe place where children and pets cannot access it. Consider using a locked box or secure area to prevent accidental ingestion or misuse.
3. Keep Away from Pets: Keep all medications out of reach of pets to avoid accidental ingestion.

What to Do If You Miss a Dose

If you miss a dose, follow these steps:

1. Skip the Missed Dose: If you miss a dose, skip it and take your next dose at the scheduled time.
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. Do not crush, chew, or divide the capsule.
  • Avoid alcohol, as it can affect the release of the medication.
  • Maintain good sleep hygiene, as stimulants can cause insomnia if taken too late in the day.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Store safely 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: 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. Max 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6-12 years: Initial 20 mg once daily in the morning. May increase by 10-20 mg weekly to a maximum of 60 mg/day.
Adolescent: For adolescents 13-17 years: Initial 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, use with caution.
Severe: Use with caution; consider lower doses and monitor for adverse effects due to potential accumulation of ritalinic acid.
Dialysis: Not available; methylphenidate is extensively metabolized, and only a small fraction is excreted unchanged.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: Use with caution; consider lower doses and monitor for adverse effects due to potential altered metabolism.
Confidence: Medium

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: Approximately 22-25% (oral)
Tmax: Bimodal release: First peak ~1.5 hours, second peak ~4.5 hours (for CD formulation)
FoodEffect: High-fat meal can delay Tmax and slightly increase AUC, but generally not clinically significant for overall efficacy.

Distribution:

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

Elimination:

HalfLife: Approximately 3.4 hours (for the extended-release component)
Clearance: Not readily available for total body clearance, but rapid metabolism.
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for initial release)
PeakEffect: Bimodal: First peak ~1.5 hours, second peak ~4.5 hours
DurationOfAction: Approximately 6-8 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 medical attention immediately:

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 (hands, feet, or other areas may turn pale, blue, gray, purple, or red)
 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 interest
 Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision

Important Heart-Related Warnings

If you have a heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or has died suddenly, notify your doctor. Seek medical help immediately 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

If you experience a painful erection (hard penis) or an erection that lasts longer than 4 hours, seek medical help right away. This can occur even when you are not having sex, and if left untreated, may lead to lasting sexual problems.
 New or worsening behavior and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems (e.g., depression, bipolar illness), or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life
A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help immediately 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 occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

 Dizziness or headache
Feeling sleepy
 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 about side effects or would like to report any, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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 psychiatric symptoms like hallucinations, delusions, or mania.
  • Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
  • New or worsening tics (uncontrolled movements or sounds).
  • 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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
 Certain health conditions, such as:
+ 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
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
 Current use of:
+ Linezolid
+ Methylene blue
* Presence of 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. They will help determine the safety of taking this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

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

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these with this 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 this medication is no longer working as well as it should, 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, inform your doctor. It is essential to discuss the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Vomiting
  • Agitation
  • Tremors
  • Hyperreflexia
  • Muscle twitching
  • Convulsions
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dry mouth

What to Do:

Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention.

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

  • Halogenated Anesthetics (e.g., halothane, isoflurane, enflurane) - risk of sudden increases in blood pressure and heart rate during surgery.
  • Vasopressors (e.g., phenylephrine, pseudoephedrine) - potentiates pressor effects.
  • Antihypertensive drugs - may reduce the hypotensive effect of these drugs.
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Moderate Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - theoretical risk of serotonin syndrome, though less common than with amphetamines.
  • Coumarin anticoagulants (e.g., warfarin) - may inhibit metabolism, requiring dose adjustment.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, requiring dose adjustment.
  • Tricyclic antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, requiring dose adjustment.
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Minor Interactions

  • Alcohol - may increase plasma levels of methylphenidate and lead to dose dumping with some extended-release formulations (though less of an issue with CD).

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: CNS stimulants can cause increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Monitor for potential growth suppression in pediatric patients.

Timing: Prior to initiation of therapy.

Psychiatric History (including family history of sudden death or serious cardiac disease)

Rationale: Assess for pre-existing psychiatric conditions (e.g., psychosis, bipolar disorder, tics) or cardiac risk factors.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At least annually, or more frequently if clinically indicated.

Target: Within normal limits for age.

Action Threshold: Significant or sustained elevations warrant dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months in pediatric patients.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration may warrant drug holiday or alternative therapy.

ADHD Symptom Control

Frequency: Regularly, at each follow-up visit.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or re-evaluation.

Psychiatric Symptoms (e.g., emergence/worsening of psychosis, mania, aggression, tics)

Frequency: Regularly, at each follow-up visit.

Target: Absence of new or worsening symptoms.

Action Threshold: Emergence of severe symptoms warrants immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening tics
  • Hallucinations
  • Delusions
  • Mania
  • Aggression
  • Severe headache
  • Unexplained fever
  • Muscle rigidity

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. Human data suggest a potential for increased risk of cardiac malformations, pre-eclampsia, and preterm birth/low birth weight.

Trimester-Specific Risks:

First Trimester: Potential increased risk of cardiac malformations (e.g., ventricular septal defect) based on some observational studies.
Second Trimester: Limited data, but potential for pre-eclampsia and preterm birth/low birth weight.
Third Trimester: Potential for pre-eclampsia and preterm birth/low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremor, poor feeding) have been reported.
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Lactation

Methylphenidate is excreted into breast milk in low amounts. Monitor breastfed infants for agitation, insomnia, decreased appetite, or poor weight gain. Use with caution, weighing benefits to mother and risks to infant.

Infant Risk: L3 (Moderately Safe) - Low levels in milk, but monitor infant for adverse effects.
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Pediatric Use

Regular monitoring of height and weight is crucial due to the potential for growth suppression. Cardiovascular and psychiatric monitoring are also important. Not recommended for children under 6 years of age.

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Geriatric Use

Limited data in geriatric patients. Use with caution, generally starting with lower doses and titrating slowly due to potential for increased sensitivity to adverse effects and comorbidities.

Clinical Information

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Clinical Pearls

  • Methylphenidate CD has a bimodal release, providing initial rapid effect and sustained action for 6-8 hours, making it suitable for once-daily dosing.
  • Capsules can often be opened and sprinkled on applesauce for patients who have difficulty swallowing, but ensure the beads are not chewed.
  • Monitor for signs of abuse or diversion, especially in patients with a history of substance use disorder.
  • Consider drug holidays (e.g., weekends or school breaks) to assess ongoing need for medication and to potentially mitigate growth suppression, though this should be discussed with the prescribing physician.
  • Educate patients and caregivers on the importance of consistent dosing and potential side effects like insomnia and appetite suppression.
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Alternative Therapies

  • Other stimulant medications (e.g., amphetamine salts, dexmethylphenidate)
  • Non-stimulant medications (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
  • Parent training
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Cost & Coverage

Average Cost: Varies widely, typically $100-$400+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
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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. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.