Metadate CD 40mg Capsules
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.
Drug Class
Central Nervous System (CNS) Stimulant
Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
Pregnancy Category
Category C
FDA Approved
Feb 2001
DEA Schedule
Schedule II
Overview
What is this medicine?
Metadate CD is an extended-release capsule used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. This medicine helps improve focus, reduce hyperactivity, and control impulsive behaviors.
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.
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 specific medication.
Swallow your medication whole; do not chew, break, or crush it.
If you have a capsule, you can sprinkle the contents onto applesauce, but do not chew. Swallow the mixture immediately and follow with a glass of water or juice. Some products can also be mixed with yogurt; check the package insert or consult with your pharmacist if you are 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 your medication 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.
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.
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 specific medication.
Swallow your medication whole; do not chew, break, or crush it.
If you have a capsule, you can sprinkle the contents onto applesauce, but do not chew. Swallow the mixture immediately and follow with a glass of water or juice. Some products can also be mixed with yogurt; check the package insert or consult with your pharmacist if you are 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 your medication 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.
Lifestyle & Tips
- Take Metadate CD once daily in the morning, with or without food. Swallow the capsule whole; do not crush, chew, or divide it. 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 can cause the medication to be released too quickly.
- Maintain a regular sleep schedule, as this medication can cause insomnia.
- Eat regular, healthy meals, as appetite suppression can occur.
- Store in a safe place to prevent misuse or diversion, as it is a controlled substance.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max: 60 mg/day.
Dose Range:
20 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial: 20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max: 60 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial: 20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max: 60 mg/day.
Adolescent:
13-17 years: Initial: 20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max: 60 mg/day.
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.
Pharmacology
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 by which methylphenidate produces its therapeutic effects in ADHD is not fully known.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 22-25% (due to first-pass metabolism)
Tmax:
Biphasic absorption: Initial peak at 1.5 hours, second peak at 4.5 hours (for Metadate CD)
FoodEffect:
High-fat meal may delay Tmax and slightly increase AUC, but does not significantly affect Cmax.
Distribution:
Vd:
2.65 L/kg
ProteinBinding:
Approximately 15% (to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 3.5 hours (for Metadate CD, parent drug)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as ritalinic acid)
Unchanged:
Less than 1% (parent drug)
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for extended-release effect)
PeakEffect:
Approximately 4-5 hours (for extended-release effect)
DurationOfAction:
Approximately 8 hours (for Metadate CD)
Safety & Warnings
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 treatment.
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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 yellowing of the 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
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, difficulty 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 a family history of abnormal heart rhythms or sudden death, inform your doctor
If you experience any signs of heart problems, such as chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting, seek medical help immediately.
Erectile Dysfunction: If you experience a painful erection or an erection lasting longer than 4 hours, seek medical attention right away. If left untreated, this can lead to permanent sexual dysfunction.
Mental Health: New or worsening behavioral and mood changes, such as changes in thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental health conditions, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or signs of mood changes (e.g., depression, suicidal thoughts, nervousness, emotional instability, or loss of interest in life), contact your doctor immediately.
Serotonin Syndrome: A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. 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, stomach upset, or vomiting, or severe headache, seek medical help right away.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by 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
Difficulty sleeping
Nose or throat irritation
This is not an exhaustive list of possible 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.
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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 yellowing of the 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
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, difficulty 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 a family history of abnormal heart rhythms or sudden death, inform your doctor
If you experience any signs of heart problems, such as chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting, seek medical help immediately.
Erectile Dysfunction: If you experience a painful erection or an erection lasting longer than 4 hours, seek medical attention right away. If left untreated, this can lead to permanent sexual dysfunction.
Mental Health: New or worsening behavioral and mood changes, such as changes in thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental health conditions, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or signs of mood changes (e.g., depression, suicidal thoughts, nervousness, emotional instability, or loss of interest in life), contact your doctor immediately.
Serotonin Syndrome: A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. 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, stomach upset, or vomiting, or severe headache, seek medical help right away.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by 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
Difficulty sleeping
Nose or throat irritation
This is not an exhaustive list of possible 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.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, or irritability
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New manic symptoms (e.g., extreme excitement, racing thoughts)
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
- Blurred vision or other vision changes
- Prolonged or painful erections (priapism)
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)
A family 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 (within the last 14 days) of specific medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (as this may lead to very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, including:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (as 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 problems with your doctor and pharmacist. Ensure that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting 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)
A family 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 (within the last 14 days) of specific medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (as this may lead to very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, including:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (as 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 problems with your doctor and pharmacist. Ensure that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Information to Share with Your Healthcare Providers
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial to ensure your safety and proper care. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.
Precautions to Take While Using This Medication
Until you know how this medication affects you, avoid driving and engaging in activities that require your full attention. 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 any questions or concerns, consult with your doctor.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. 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
* Certain natural products or aids
Long-Term Use and Potential Risks
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same effect. This is known as tolerance. 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.
Seizure Risk
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.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Effects on Children and Teens
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to discuss any potential risks.
Pregnancy and Breast-Feeding
If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the benefits and risks of this medication to both you and your baby.
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial to ensure your safety and proper care. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.
Precautions to Take While Using This Medication
Until you know how this medication affects you, avoid driving and engaging in activities that require your full attention. 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 any questions or concerns, consult with your doctor.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. 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
* Certain natural products or aids
Long-Term Use and Potential Risks
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same effect. This is known as tolerance. 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.
Seizure Risk
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.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Effects on Children and Teens
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to discuss any potential risks.
Pregnancy and Breast-Feeding
If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the benefits and risks of this medication to both you and your baby.
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
- Dry mouth
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
Major Interactions
- Vasopressors (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.
- Anticoagulants (e.g., warfarin) - may inhibit metabolism, increasing anticoagulant effect.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels.
- Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, increasing antidepressant levels.
Moderate Interactions
- Alcohol - may accelerate the release of methylphenidate from extended-release formulations, leading to a rapid increase in plasma levels.
- Antihypertensives - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
Minor Interactions
- Caffeine - additive stimulant effects.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Methylphenidate can cause dose-related increases in BP and HR.
Timing: Prior to initiation of treatment.
Height and Weight
Rationale: Monitor for growth suppression in pediatric patients.
Timing: Prior to initiation of treatment.
Cardiac History (personal and family)
Rationale: Assess for pre-existing cardiac conditions that may contraindicate stimulant use.
Timing: Prior to initiation of treatment.
Psychiatric History (personal and family)
Rationale: Assess for risk of psychiatric adverse events (e.g., psychosis, mania, aggression).
Timing: Prior to initiation of treatment.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each dose adjustment and at least every 3-6 months thereafter.
Target: Within normal limits for age.
Action Threshold: Significant or sustained increases warrant dose reduction or discontinuation.
Height and Weight
Frequency: Every 3 months for pediatric patients.
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration may warrant dose interruption or discontinuation.
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 alternative therapy.
Emergence of Psychiatric Symptoms
Frequency: Regularly, at each follow-up visit.
Target: Absence of new or worsening psychotic, manic, or aggressive symptoms.
Action Threshold: New onset or worsening of such symptoms warrants immediate evaluation and potential discontinuation.
Abuse/Diversion Potential
Frequency: Regularly, at each follow-up visit.
Target: No signs of misuse or diversion.
Action Threshold: Signs of abuse or diversion require intervention and potential discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Persistent insomnia
- Loss of appetite
- Numbness, coolness, or pain in fingers/toes (Raynaud's phenomenon)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of teratogenicity at high doses.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cardiac malformations (e.g., ventricular septal defects) based on some observational studies, though data are conflicting and overall risk appears low.
Second Trimester:
No specific risks identified beyond general stimulant effects.
Third Trimester:
Potential for premature birth, low birth weight, and withdrawal symptoms in the neonate if used close to delivery.
Lactation
L3 (Moderately Safe). Methylphenidate is excreted into human milk. Monitor breastfed infants for agitation, insomnia, and decreased weight gain. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for the drug and any potential adverse effects on the breastfed infant.
Infant Risk:
Low to moderate risk. Potential for irritability, poor feeding, and sleep disturbances in the infant. Monitor infant growth and development.
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) carefully, as long-term use has been associated with growth suppression. Monitor for emergence of psychiatric symptoms (e.g., psychosis, mania).
Geriatric Use
Safety and efficacy have not been established in geriatric patients. Use with caution due to increased sensitivity to stimulant effects, potential for cardiovascular events, and comorbidities. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Metadate CD uses a SODAS (Spheroidal Oral Drug Absorption System) technology, providing an immediate release component (30%) and an extended-release component (70%) for once-daily dosing.
- Patients should be advised to take the medication in the morning to avoid insomnia.
- Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules, but the beads should not be chewed.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
- Educate patients and caregivers about the potential for abuse and diversion, and the importance of secure storage.
- Consider a drug holiday periodically, especially in children, to assess the need for continued therapy and to mitigate potential growth suppression.
Alternative Therapies
- Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Focalin XR, Daytrana patch)
- Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy, psychotherapy, educational interventions
Cost & Coverage
Average Cost:
Varies widely, typically $150-$400 per 30 capsules (40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand name); Tier 1 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not 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 detailed information, including the name of the medication taken, the quantity, and the time it was taken.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not 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 detailed information, including the name of the medication taken, the quantity, and the time it was taken.