Metadate CD 60mg Capsules

Manufacturer AYTU BIOPHARMA Active Ingredient Methylphenidate Extended- Release Capsules(meth il FEN i date) Pronunciation METH-uh-date See-Dee (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
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 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.
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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 keep it safe.
* Keep all medications out of reach of pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and return to 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 Metadate CD once daily in the morning, with or without food. Do not take it in the late afternoon or evening as it may cause sleep problems.
  • 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 while taking this medication, as it may increase the side effects.
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically initiated in adults. If continued from childhood, individualize dose. Max 60 mg/day.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Individualize dosage according to the therapeutic needs and response of the patient. Doses above 60 mg/day are not recommended.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial 20 mg once daily in the morning for children 6-12 years. May increase by 10-20 mg weekly. Max 60 mg/day.
Adolescent: Initial 20 mg once daily in the morning for adolescents 13-17 years. May increase by 10-20 mg 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.
Dialysis: Not available, likely not dialyzable due to high protein binding and metabolism.

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.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in Attention Deficit Hyperactivity Disorder (ADHD) are thought to be mediated through the blockade of dopamine and norepinephrine reuptake transporters in the presynaptic neuron, thereby increasing the extracellular concentrations of these monoamines in the striatum and prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: Not explicitly stated for Metadate CD, but generally high for methylphenidate.
Tmax: Biphasic release: Initial peak at approximately 1.5 hours, second peak at approximately 4.5 hours.
FoodEffect: A 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 extent of absorption (AUC).

Distribution:

Vd: Approximately 2.6 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for Metadate CD)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1% (as unchanged methylphenidate)
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Pharmacodynamics

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

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 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Severe headache, dizziness, or fainting.
Joint pain.
Purple patches on the skin or mouth.
Changes in vision or eye pain, swelling, or redness.
Seizures.
Shakiness.
Difficulty controlling body movements.
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises.
Excessive sweating.
Restlessness.
Changes in skin color (pale, blue, gray, purple, or red) on 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.

Important Heart-Related Information

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): seek medical attention immediately to avoid potential long-term damage.
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations. If you or a family member have a history of mental health conditions (e.g., depression, bipolar disorder) or suicidal tendencies, inform your doctor. Seek help if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
Serotonin syndrome: a potentially life-threatening condition that may occur when taking this medication with certain other drugs. Seek immediate medical attention if you experience:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, stomach upset, or vomiting
+ Severe headache

Common Side Effects

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

Dizziness or headache
Drowsiness
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous or excitable
Sleep disturbances
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)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • New or worsening aggression, hostility, or irritability
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • New manic symptoms (e.g., extreme energy, racing thoughts)
  • Unexplained tics or muscle twitching
  • Blurred vision or other vision changes
  • 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 conditions 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: taking these medications with this drug can lead to very high blood pressure)
Current use of certain medications, such as:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, including:
+ 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 drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never 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
  • Muscle twitching
  • Convulsions (may be followed by coma)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dryness of mucous membranes

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
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Major Interactions

  • Vasopressors (e.g., phenylephrine, epinephrine) - risk of hypertensive crisis
  • Halogenated Anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery
  • Alcohol - may increase plasma levels of methylphenidate
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Moderate Interactions

  • Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of these drugs
  • Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism of TCAs
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - caution with co-administration due to potential for serotonin syndrome, though less common than with other stimulants
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Minor Interactions

  • Antihypertensive drugs - may decrease the hypotensive effect of these drugs

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular effects (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.

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

Rationale: To identify pre-existing psychiatric conditions or cardiac risks.

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 elevation requiring intervention or dose adjustment.

Height and Weight

Frequency: Every 3-6 months in pediatric patients.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric Status (e.g., emergence or worsening of psychotic or manic symptoms, aggression, anxiety)

Frequency: Regularly throughout treatment.

Target: Stable or improved psychiatric symptoms.

Action Threshold: New or worsening psychiatric symptoms requiring evaluation or dose adjustment.

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Symptom Monitoring

  • Insomnia
  • Anorexia/decreased appetite
  • Nervousness
  • Headache
  • Abdominal pain
  • Dizziness
  • Palpitations
  • Chest pain
  • Shortness of breath
  • Syncope
  • Unexplained wounds on fingers/toes (Raynaud's phenomenon)
  • Changes in mood or behavior (e.g., agitation, aggression, hallucinations, mania)
  • Tics or worsening of Tourette's syndrome

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations (e.g., atrial septal defects) based on some observational studies, though data is conflicting and overall risk appears low.
Second Trimester: Limited data, but generally considered lower risk for major malformations compared to first trimester.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms in the neonate if used close to delivery.
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for adverse reactions such as agitation, insomnia, or decreased weight gain.

Infant Risk: L3 (Moderate risk) - Monitor infant for irritability, poor feeding, and sleep disturbances. Consider alternative if infant is premature or has underlying health issues.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) carefully. Long-term effects on growth are a concern. Cardiovascular monitoring is essential.

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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 and higher prevalence of cardiovascular disease.

Clinical Information

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Clinical Pearls

  • Metadate CD uses a biphasic release system, providing an immediate release component and an extended-release component, designed for once-daily dosing.
  • Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules, but the beads should not be chewed.
  • Patients should be screened for cardiac disease and psychiatric conditions prior to initiation.
  • Abrupt discontinuation after prolonged high-dose use can lead to severe fatigue and depression.
  • Consider a drug holiday (e.g., weekends or school breaks) to assess the need for continued therapy and to mitigate potential growth suppression, though this should be discussed with a healthcare provider.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Focalin XR, Quillivant XR)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulant medications for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy and psychotherapy
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Cost & Coverage

Average Cost: Varies widely, typically $200-$400+ per 30 capsules (60mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand), Tier 1 (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 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. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.