Metadate CD 20mg Capsules

Manufacturer AYTU BIOPHARMA Active Ingredient Methylphenidate Extended- Release Capsules(meth il FEN i date) Pronunciation MET-uh-date SEE-DEE
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
FDA Approved
Feb 2001
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Metadate CD is an extended-release capsule containing methylphenidate, a stimulant medication. It is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to 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:

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.
Check with your pharmacist to determine if your medication should be taken with food, on an empty stomach, or if it doesn't matter.
Swallow your medication whole; do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce. Do not chew the mixture; swallow it immediately and follow with a glass of water or juice. Some products can also be mixed with yogurt, but be sure to check the package insert or consult with your pharmacist if you're unsure.
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:

Store it at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to prevent accidental ingestion.
* Keep all medications out of reach of pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Swallow the capsule whole. Do not crush, chew, or divide the capsule.
  • 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 affect the release of the medication.
  • Maintain a healthy diet and regular sleep schedule.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not share this medication with others, as it is a controlled substance.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg orally once daily in the morning
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: Children 6-12 years: Initial dose 20 mg orally once daily in the morning. May be titrated in 10-20 mg increments weekly to a maximum of 60 mg/day.
Adolescent: Adolescents 13-17 years: Initial dose 20 mg orally once daily in the morning. May be titrated in 10-20 mg increments weekly to a maximum of 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis: Not available

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.
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. The precise mechanism of action in ADHD is not fully understood.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (relative bioavailability compared to immediate-release is approximately 90%)
Tmax: Biphasic release: Initial peak at approximately 1.5 hours, second peak at approximately 4.5 hours.
FoodEffect: High-fat meal can delay the initial peak (Tmax1) by approximately 1 hour and the second peak (Tmax2) by approximately 1.5 hours, but does not significantly affect the overall extent of absorption (AUC).

Distribution:

Vd: Not available (estimated 2.65 L/kg for immediate-release)
ProteinBinding: Approximately 15% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.4 hours (for Metadate CD)
Clearance: Not available
ExcretionRoute: Primarily renal (90% as ritalinic acid)
Unchanged: Less than 1% (as unchanged drug in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Approximately 4-5 hours (second peak)
DurationOfAction: Approximately 8 hours
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Metadate CD, 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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or 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

Heart Problems: Important Warning

Sudden deaths have occurred in people with certain heart problems or defects. Inform your doctor if you have any heart condition or defect. Also, tell your doctor if a family member has an abnormal heartbeat or died suddenly. Seek immediate medical help 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

Painful erection (hard penis) or an erection lasting longer than 4 hours (even when not having sex). If not treated promptly, this may lead to lasting sexual problems.
New or worsening behavior and mood changes, such as changes in thinking, anger, or hallucinations. Inform your doctor if you or a family member have a history of mental or mood problems, such as depression or bipolar illness.
Serotonin syndrome, a potentially life-threatening condition, may occur if you take this medication with certain other drugs. Seek immediate medical help if you experience any of the following symptoms:
+ 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 serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical help 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 want to report any side effects, 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 aggression, hostility, anxiety, depression, or unusual changes in behavior or mood
  • Hallucinations or delusions
  • Numbness, pain, or discoloration of fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Prolonged or painful erections (priapism)
  • Blurred vision
  • Uncontrolled muscle movements or tics
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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 and circumstances to ensure safe treatment:

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
Previous medical events, such as a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health status. 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 other products) and chocolate, as combining these 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, 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 some individuals, particularly 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, so be sure to discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to weigh 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 (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 1-800-222-1222 (Poison Control Center) immediately or 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
  • Known hypersensitivity to methylphenidate or other components of the formulation
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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 the effectiveness of these drugs
  • Coumarin anticoagulants (e.g., warfarin) - methylphenidate may inhibit their metabolism, increasing bleeding risk
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - methylphenidate may inhibit their metabolism, increasing plasma concentrations
  • Tricyclic antidepressants (TCAs) (e.g., imipramine, desipramine) - methylphenidate may inhibit their metabolism, increasing plasma concentrations and potential for adverse effects
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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 extended-release formulations (though less common with Metadate CD)
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Minor Interactions

  • Caffeine - additive stimulant effects

Monitoring

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Baseline Monitoring

Cardiovascular assessment (heart rate, blood pressure)

Rationale: To identify pre-existing cardiovascular conditions or risk factors that may be exacerbated by stimulant use.

Timing: Prior to initiation of therapy

Height and Weight

Rationale: To establish baseline for monitoring growth in pediatric patients.

Timing: Prior to initiation of therapy

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

Rationale: To assess risk of psychiatric adverse events or cardiac issues.

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood Pressure and Heart Rate

Frequency: At least every 3-6 months, or more frequently if clinically indicated

Target: Within normal limits for age

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm heart rate) 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 or weight loss may require dose adjustment, drug holiday, or alternative therapy.

Psychiatric symptoms (e.g., emergence or worsening of aggression, hostility, anxiety, depression, mania, psychosis)

Frequency: Regularly, at each follow-up visit

Target: Stable or improved

Action Threshold: New or worsening symptoms warrant immediate evaluation and potential discontinuation.

ADHD symptom control and functional improvement

Frequency: Regularly, at each follow-up visit

Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning

Action Threshold: Lack of efficacy or intolerable side effects may require dose adjustment or change in therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • Unexplained fainting
  • New or worsening aggression
  • Hostility
  • Anxiety
  • Depression
  • Mania
  • Psychotic symptoms (e.g., hallucinations, delusions)
  • Tics or Tourette's syndrome exacerbation
  • Blurred vision
  • Priapism (rare, but serious)

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. Data from a meta-analysis of cohort studies and a case-control study did not suggest an increase in the overall rate of major congenital malformations or cardiac malformations with methylphenidate exposure during the first trimester. However, some studies suggest a possible association with cardiac malformations.

Trimester-Specific Risks:

First Trimester: Possible small increased risk of cardiac malformations, though overall data are conflicting and largely reassuring for major malformations.
Second Trimester: Not well-studied, but generally considered lower risk for structural malformations.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms (e.g., agitation, tremor, poor feeding) in neonates if exposed near term.
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Lactation

L3 (Moderate risk). Methylphenidate is excreted into breast milk in small amounts. Monitor breastfed infants for agitation, insomnia, anorexia, or poor weight gain. Consider alternative therapies or close monitoring.

Infant Risk: Low to moderate. Potential for irritability, insomnia, decreased appetite, or weight loss in the infant. Long-term effects are unknown.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly, as stimulants can be associated with modest 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 increased risk of cardiovascular adverse events (e.g., hypertension, tachycardia) and potential for drug interactions. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Metadate CD uses a Diffucaps® bead technology for biphasic release, providing an initial rapid release followed by a sustained release, aiming for an 8-hour duration of action.
  • Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules. The beads should not be chewed.
  • Patients should be advised to take Metadate CD in the morning to avoid insomnia.
  • 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 if growth suppression or other side effects become problematic, under medical supervision.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Daytrana, Quillivant XR, Aptensio XR, Jornay PM)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulant medications (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy and psychotherapy for ADHD
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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 (for brand name); Tier 1 (for generic)
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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 use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. 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 consumed, and the time it occurred.