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Methylphenidate CD 40mg Capsules

Manufacturer SPECGX 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
Category C
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FDA Approved
May 2002
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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 substances in the brain to help improve focus, attention, 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 this 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 medication.
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 on 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, consult the package insert or talk to your pharmacist.
5. 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 secure location where children and pets cannot access it. Consider using a locked box or area to prevent accidental ingestion.
3. Keep Away from Others: Keep your medication in a safe place where others cannot find or take it.

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 the capsule whole with water in the morning, usually before breakfast. Do not crush, chew, or divide the capsule.
  • If you cannot swallow the capsule whole, you may open it and sprinkle the entire contents over a small amount of applesauce. Swallow the mixture immediately without chewing.
  • Avoid taking the medication in the late afternoon or evening to prevent sleep problems (insomnia).
  • Avoid alcohol consumption, as it may affect the release of the medication.
  • Maintain a healthy diet and regular exercise. For children, monitor height and weight regularly as growth suppression can occur.
  • Store the medication securely to prevent misuse or abuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 20 mg orally once daily in the morning; may be titrated in 10-20 mg increments weekly.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Maximum recommended dose is 60 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6-12 years: Initial 20 mg orally once daily in the morning; may be titrated in 10-20 mg increments weekly up to a maximum of 60 mg once daily.
Adolescent: For adolescents 13-17 years: Initial 20 mg orally once daily in the morning; may be titrated in 10-20 mg increments weekly up to a maximum of 60 mg once daily.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific dose adjustment recommended, monitor for adverse effects.
Moderate: No specific dose adjustment recommended, monitor for adverse effects.
Severe: Use with caution; consider lower doses and close monitoring due to potential for increased exposure.

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: 22-65%
Tmax: Bimodal: First peak ~1.5 hours, second peak ~4.5 hours (for CD formulation)
FoodEffect: Food can delay Tmax but generally does not significantly affect AUC or Cmax.

Distribution:

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

Elimination:

HalfLife: 3-4 hours (for ER formulations)
Clearance: High (systemic clearance ~10 L/hr/kg)
ExcretionRoute: Renal (approximately 90% as ritalinic acid)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 1-2 hours
PeakEffect: 4-6 hours
DurationOfAction: 8-10 hours

Safety & Warnings

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BLACK BOX WARNING

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

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash
+ 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 vision or eye pain, swelling, or redness
Seizures
 Shakiness
Trouble controlling body movements
 Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
 Restlessness
Changes in skin color, including 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, trouble 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 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:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
 If you experience a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical help right away. This can occur even when not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
+ Depression
+ Thoughts of suicide
+ Nervousness
+ Emotional instability
+ Abnormal thinking
+ Anxiety
+ Loss of interest in life
 A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical attention if you experience:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are concerned about any of the following side effects or if they persist, contact your doctor:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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 (syncope)
  • Numbness, coolness, or pain in fingers or toes, or skin color changes (Raynaud's phenomenon)
  • New or worsening mental problems such as hallucinations (seeing or hearing things that are not real), delusions (believing things that are not true), or mania (unusually excited mood, racing thoughts)
  • New or worsening aggressive behavior or hostility
  • New or worsening tics (uncontrolled repetitive movements or sounds)
  • Blurred vision or other changes in eyesight
  • Unexplained wounds on fingers or toes
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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)
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 certain medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs 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 (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 (OTC) drugs
Natural products
 Vitamins

Your doctor will help you determine if it is safe to take 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

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 have 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. 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 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 (overactive reflexes)
  • Muscle twitching
  • Convulsions (may be followed by coma)
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (very high fever)
  • Tachycardia (fast heart rate)
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension (high blood pressure)
  • Mydriasis (dilated pupils)
  • Dry mucous membranes

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, maintaining circulation and respiration, and external cooling for hyperpyrexia. Gastric lavage and activated charcoal may be considered.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or use within 14 days of discontinuing an MAOI is contraindicated due to risk of hypertensive crisis.
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Major Interactions

  • Halogenated Anesthetics: Risk of sudden increases in blood pressure and heart rate during surgery.
  • Vasopressors: May potentiate the pressor effect of vasopressors.
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Moderate Interactions

  • Antihypertensive Drugs: May reduce the effectiveness of drugs used to treat hypertension.
  • Coumarin Anticoagulants: May prolong prothrombin time; dose adjustment of anticoagulant may be needed.
  • Anticonvulsants (e.g., Phenobarbital, Phenytoin, Primidone): May inhibit metabolism of these drugs, leading to increased plasma concentrations.
  • Tricyclic Antidepressants (TCAs): May inhibit metabolism of TCAs, leading to increased plasma concentrations of TCAs or methylphenidate.
  • Serotonergic Drugs (e.g., SSRIs, SNRIs, Triptans): Potential for serotonin syndrome, though less common than with amphetamines.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation of therapy (pediatric patients).

Psychiatric History and Status

Rationale: Assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis, tics) that may be exacerbated or new symptoms that may emerge.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: Consider if patient has pre-existing cardiac conditions or family history of sudden cardiac death/arrhythmias.

Timing: Prior to initiation of therapy (if indicated).

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit (e.g., every 3-6 months or as clinically indicated).

Target: Within normal limits for age.

Action Threshold: Sustained elevation requiring intervention or dose adjustment.

Height and Weight

Frequency: Every 3-6 months (pediatric patients).

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric Status

Frequency: At each visit.

Target: Stable mood, absence of new or worsening psychotic/manic symptoms, tics, or aggression.

Action Threshold: Emergence or worsening of agitation, psychosis, mania, tics, severe anxiety, or aggression.

ADHD Symptom Control

Frequency: At each visit.

Target: Improved focus, reduced impulsivity/hyperactivity.

Action Threshold: Lack of efficacy or worsening symptoms.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope (fainting)
  • Unexplained wounds on fingers or toes (Raynaud's phenomenon)
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • New or worsening manic symptoms (e.g., elevated mood, increased energy, racing thoughts)
  • New or worsening tics (motor or vocal)
  • Aggression or hostility
  • Severe anxiety or agitation
  • Blurred vision or other visual disturbances

Special Patient Groups

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Pregnancy

Category C. Limited data from pregnancy registries and epidemiological studies have not identified a clear association between methylphenidate use during pregnancy and major congenital malformations, miscarriage, or adverse maternal or fetal outcomes. However, some studies suggest a small increased risk of cardiac malformations. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for small increased risk of cardiac malformations, though overall risk remains low.
Second Trimester: Not specifically studied for unique risks.
Third Trimester: Not specifically studied for unique risks. Neonatal withdrawal symptoms (e.g., agitation, tremors, poor feeding) have been reported with stimulant use near term.
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Lactation

L3 (Moderately safe). Methylphenidate is excreted into breast milk. Monitor breastfed infants for signs of adverse reactions such as agitation, insomnia, poor feeding, or weight loss. 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 risk. Monitor for irritability, sleep disturbances, and poor weight gain. Consider using the lowest effective dose and avoiding breastfeeding during peak plasma concentrations.
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Pediatric Use

Safety and efficacy established in children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Closely monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, tics, aggression).

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Geriatric Use

Limited data in patients over 65 years. Use with caution, generally starting with lower doses and titrating slowly, due to increased sensitivity to adverse effects, particularly cardiovascular and psychiatric effects. Monitor closely for blood pressure, heart rate, and psychiatric changes.

Clinical Information

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Clinical Pearls

  • Methylphenidate CD is an extended-release formulation designed for once-daily dosing, providing symptom control for approximately 8-10 hours.
  • The capsule can be opened and sprinkled on applesauce for patients who have difficulty swallowing, but the beads should not be crushed or chewed.
  • Always assess for a history of substance abuse before initiating therapy due to the high potential for abuse and dependence.
  • Regularly monitor blood pressure and heart rate, especially in patients with pre-existing cardiovascular conditions.
  • In children, monitor height and weight periodically to detect potential growth suppression.
  • Educate patients and caregivers about the signs of psychiatric adverse events (e.g., hallucinations, paranoia, mania) and the importance of reporting them immediately.
  • Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., severe fatigue, depression).
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Alternative Therapies

  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy and psychotherapy
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Cost & Coverage

Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization for brand, generic may be Tier 1 or 2)
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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. 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 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.