Metadate CD 50mg 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 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 a medication 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 extended-release capsule is designed to release medication throughout the day, typically taken once in the morning.
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.
Swallowing Your Medication
Swallow your medication whole. Do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can sprinkle the contents on 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. If you're unsure, read the package insert or consult with your pharmacist.
Preparing 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
Store your medication at room temperature, protected from light and moisture.
Keep your medication in a dry place, away from the bathroom.
Store your medication in a safe and secure location, out of reach of children and pets. Consider using a locked box or area to prevent accidental ingestion.
Keep all medications away from pets.
Missing a Dose
If you miss a dose, skip it and take your next dose at the usual time.
Do not take two doses at the same time or take extra doses to make up for the missed dose.
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.
Swallowing Your Medication
Swallow your medication whole. Do not chew, break, or crush it.
If you have trouble swallowing the capsule, you can sprinkle the contents on 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. If you're unsure, read the package insert or consult with your pharmacist.
Preparing 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
Store your medication at room temperature, protected from light and moisture.
Keep your medication in a dry place, away from the bathroom.
Store your medication in a safe and secure location, out of reach of children and pets. Consider using a locked box or area to prevent accidental ingestion.
Keep all medications away from pets.
Missing a Dose
If you miss a dose, skip it and take your next dose at the usual time.
Do not take two doses at the same time or take extra doses to make up for the missed dose.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening to avoid sleep problems.
- Swallow the capsule whole. Do not chew, crush, or divide the capsule. If unable to swallow whole, the capsule may be opened and the contents sprinkled on a small amount of applesauce and consumed immediately.
- Avoid alcohol, as it may cause the medication to be released too quickly.
- 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.
- Report any changes in mood, behavior, or new physical symptoms to your doctor immediately.
- Store in a safe place to prevent misuse or diversion, as it is a controlled substance.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not typically initiated in adults; dosage is usually continued from adolescence or titrated based on individual response and tolerability.
Dose Range:
20 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial dose: 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:
Initial dose (6-12 years): 20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max: 60 mg/day.
Adolescent:
Initial dose (13-17 years): 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.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; monitor for adverse effects. No specific dose adjustment recommended due to limited data.
Dialysis:
Not available; caution advised.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; monitor for adverse effects. No specific dose adjustment recommended due to limited data.
Confidence:
Medium
Pharmacology
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.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 22-25% (due to first-pass metabolism)
Tmax:
Biphasic release: Initial peak at 1.5 hours, second peak at 4.5 hours (for Metadate CD)
FoodEffect:
Food (high-fat meal) may delay Tmax and increase Cmax slightly, but overall exposure (AUC) is not significantly affected. Can be taken with or without food.
Distribution:
Vd:
2.65 L/kg
ProteinBinding:
10-15%
CnssPenetration:
Yes
Elimination:
HalfLife:
3.4 hours (for Metadate CD)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as PPAA)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours
PeakEffect:
Approximately 4-5 hours (for Metadate CD)
DurationOfAction:
Approximately 6-8 hours (for Metadate CD)
Confidence:
Medium
Safety & Warnings
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 sensations 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 deaths have 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.
Additional Urgent Side Effects
If you have a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical attention right away to prevent long-term sexual dysfunction
If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor; if you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, or anxiety, contact your doctor immediately
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
Common Side Effects
Not everyone will experience side effects, but if you do, they may be mild or moderate. If any of the following side effects bother you or 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
Reporting Side Effects
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, 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 sensations 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 deaths have 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.
Additional Urgent Side Effects
If you have a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical attention right away to prevent long-term sexual dysfunction
If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor; if you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, or anxiety, contact your doctor immediately
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
Common Side Effects
Not everyone will experience side effects, but if you do, they may be mild or moderate. If any of the following side effects bother you or 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
Reporting Side Effects
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 (especially with exercise)
- 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 numbness, pain, or discoloration in fingers or toes
- Prolonged or painful erections (priapism)
- Blurred vision or other vision changes
- Unexplained tics or involuntary movements
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
* Presence of 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 to ensure safe use. Do not initiate, stop, or adjust the dosage 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)
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
* Presence of 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 to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Information to Share with Your Healthcare Team
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 it may cause nervousness, shakiness, and a rapid heartbeat when combined with this medication. 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
Potential Risks and Side Effects
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 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 with your doctor.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products may contain this ingredient.
Special Considerations for Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential 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 it may cause nervousness, shakiness, and a rapid heartbeat when combined with this medication. 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
Potential Risks and Side Effects
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 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 with your doctor.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products may contain this ingredient.
Special Considerations for Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential 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 (very high fever)
- Tachycardia
- Palpitations
- Cardiac arrhythmias
- Hypertension
- Mydriasis (dilated pupils)
- 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 like hypertension, arrhythmias, and seizures.
Drug Interactions
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.
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.
- Anticoagulants (e.g., warfarin) - methylphenidate may inhibit metabolism, increasing anticoagulant effect.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - methylphenidate may inhibit metabolism, increasing anticonvulsant levels.
- Antidepressants (e.g., tricyclic antidepressants, SSRIs) - methylphenidate may inhibit metabolism, increasing antidepressant levels.
Moderate Interactions
- Alcohol - may accelerate the release of methylphenidate from extended-release formulations, leading to a more rapid absorption and higher peak plasma concentrations.
- Antihypertensive drugs - methylphenidate may reduce the effectiveness of these drugs.
- Dopaminergic drugs (e.g., levodopa, bromocriptine) - potential for additive dopaminergic effects.
Minor Interactions
- Caffeine - potential for additive stimulant effects.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Stimulants can cause dose-related increases in BP and HR.
Timing: Prior to initiation of treatment.
Height and Weight
Rationale: Stimulants can be associated with growth suppression in pediatric patients.
Timing: Prior to initiation of treatment (especially in pediatric patients).
Psychiatric History (including family history of sudden death, ventricular arrhythmia)
Rationale: To identify pre-existing cardiac conditions or psychiatric disorders that may be exacerbated.
Timing: Prior to initiation of treatment.
Electrocardiogram (ECG)
Rationale: Consider for patients with pre-existing cardiac conditions or family history of sudden cardiac death.
Timing: Prior to initiation, if indicated.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or at least every 3-6 months.
Target: Maintain within normal limits for age.
Action Threshold: Significant or sustained increases warrant dose reduction or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric patients).
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration may warrant dose reduction or drug holiday.
ADHD Symptoms and Functional Impairment
Frequency: Regularly, at each visit.
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Emergence or Worsening of Psychiatric Symptoms (e.g., psychosis, mania, aggression, anxiety, depression)
Frequency: Regularly, at each visit.
Target: Absence of new or worsening symptoms.
Action Threshold: Prompt evaluation and potential discontinuation.
Signs of Drug Abuse/Diversion
Frequency: Regularly, at each visit.
Target: Absence of signs.
Action Threshold: Address immediately, consider discontinuation or referral for substance abuse treatment.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Depressed mood
- Unexplained wounds or sores (from picking)
- Tics or abnormal movements
- Blurred vision
- Priapism (rare)
Special Patient Groups
Pregnancy
Methylphenidate is classified as Pregnancy Category C. Studies in animals have shown adverse effects on fetal development at doses higher than typical human doses. 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.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cardiac malformations (e.g., atrial septal defects) based on some observational studies, though data are conflicting and limited.
Second Trimester:
No specific data indicating unique risks during this trimester, but general risks of stimulant exposure apply.
Third Trimester:
Potential for premature birth, low birth weight, and withdrawal symptoms (e.g., agitation, tremor, poor feeding) in the neonate if used late in pregnancy.
Lactation
Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for agitation, insomnia, and reduced weight gain. Weigh 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 from the drug or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk; use with caution). Potential for irritability, poor feeding, and sleep disturbances in the infant. Long-term effects on neurodevelopment are unknown.
Pediatric Use
Approved for ADHD in children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can be associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms. Long-term safety and efficacy in children under 6 years have not been established.
Geriatric Use
Safety and efficacy in patients over 65 years have not been established. Use with caution due to increased likelihood of cardiovascular disease, other comorbidities, and polypharmacy. Start with lower doses and titrate slowly, monitoring for adverse effects.
Clinical Information
Clinical Pearls
- Metadate CD uses a SODAS (Spheroidal Oral Drug Absorption System) technology for biphasic release, providing an immediate release component and an extended-release component.
- 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.
- 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 drug holidays in pediatric patients to assess growth and continued need for medication, though this should be discussed with a healthcare provider.
Alternative Therapies
- Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Daytrana patch, Quillivant XR, Jornay PM, Aptensio XR, Adhansia XR)
- 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
Cost & Coverage
Average Cost:
Price varies widely by pharmacy and insurance plan. per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 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 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 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.