Metadate ER 20mg Tablets
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 is used to treat narcolepsy.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
Mar 1999
DEA Schedule
Schedule II
Overview
What is this medicine?
Metadate ER 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 tablet is designed to release the medication slowly throughout the day, so it's usually 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 guidelines:
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.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, away from moisture.
Do not store your medication in a bathroom.
Keep your medication in a safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication.
Keep all medications out of reach of pets.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Skip the missed dose 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 dose.
To ensure you get the most benefit from your medication, follow these guidelines:
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.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, away from moisture.
Do not store your medication in a bathroom.
Keep your medication in a safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication.
Keep all medications out of reach of pets.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Skip the missed dose 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 dose.
Lifestyle & Tips
- Take Metadate ER exactly as prescribed, usually once daily in the morning. Do not take it in the afternoon or evening as it may cause sleep problems.
- Swallow the tablet whole with water. Do not crush, chew, or divide the tablet, as this will interfere with its extended-release properties and could lead to a sudden release of a large amount of medication.
- Avoid alcohol consumption, as it may cause the medication to be released too quickly.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially MAOIs, blood pressure medications, or antidepressants.
- Regularly monitor your blood pressure and heart rate as advised by your doctor.
- For children, monitor height and weight regularly, as this medication can sometimes affect growth.
- Store the medication securely to prevent misuse or abuse, as it has a high potential for dependence.
Available Forms & Alternatives
Dosing & Administration
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. May be increased in 10-20 mg increments weekly to a maximum of 60 mg/day. Doses should be individualized based on patient response and tolerability.
Narcolepsy:
Not a primary indication for Metadate ER, but methylphenidate immediate-release is used. If converting, careful titration is needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6 years and older: Initial dose 20 mg orally once daily in the morning. May be increased in 10-20 mg increments weekly to a maximum of 60 mg/day. Doses should be individualized.
Adolescent:
Initial dose 20 mg orally once daily in the morning. May be increased in 10-20 mg increments weekly to a maximum of 60 mg/day. Doses should be individualized.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended, but use with caution and monitor for adverse effects.
Severe:
No specific dose adjustment recommended, but use with caution and monitor for adverse effects. Methylphenidate is primarily metabolized by de-esterification, not renal excretion of the parent drug.
Dialysis:
Not available. Methylphenidate is not significantly dialyzable.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended, but use with caution and monitor for adverse effects.
Severe:
No specific dose adjustment recommended, but use with caution and monitor for adverse effects.
Pharmacology
Mechanism of Action
Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in ADHD are thought to be due to its ability to block the reuptake of norepinephrine and dopamine into the presynaptic neuron, thereby increasing the concentrations of these monoamines in the extraneuronal space of the frontal cortex and striatum. This action is believed to enhance neurotransmission in brain regions associated with attention, executive function, and impulse control.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30-50% (due to first-pass metabolism)
Tmax:
Biphasic release: Initial peak at 1.5 hours, second peak at 6.8 hours (for Metadate ER)
FoodEffect:
Food does not significantly affect the extent of absorption (AUC) of Metadate ER, but may delay the initial peak concentration (Tmax) by approximately 1 hour.
Distribution:
Vd:
Approximately 2.6 L/kg
ProteinBinding:
Approximately 15% (to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2-3 hours (for methylphenidate); ritalinic acid has a longer half-life (3-4 hours)
Clearance:
Approximately 0.5 L/hr/kg
ExcretionRoute:
Primarily renal (90% as ritalinic acid, <1% as unchanged drug)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for Metadate ER)
PeakEffect:
Approximately 6-8 hours (for Metadate ER)
DurationOfAction:
Approximately 6-8 hours (for Metadate ER)
Safety & Warnings
BLACK BOX WARNING
CNS STIMULANTS, INCLUDING METHYLPHENIDATE, HAVE A HIGH POTENTIAL FOR ABUSE AND DEPENDENCE. ASSESS THE RISK OF ABUSE PRIOR TO PRESCRIBING, AND MONITOR FOR SIGNS OF ABUSE AND DEPENDENCE WHILE ON THERAPY.
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 medical attention right away:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
Joint pain
Purple patches on the skin or mouth
Changes in vision or eye pain, swelling, or redness
Seizures
Shakiness or tremors
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
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.
Heart-Related Side Effects:
If you experience any of the following symptoms, seek medical help immediately:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Other Serious Side Effects:
Painful or prolonged erections (lasting more than 4 hours): Seek medical help right away to avoid long-term damage
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or behavior
+ Anger or hallucinations
+ Depression, suicidal thoughts, or anxiety
Serotonin syndrome, a potentially life-threatening condition that can occur when taking this medication with certain other drugs. Symptoms include:
+ Agitation
+ Balance problems
+ 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:
Many people experience no side effects or only mild side effects. However, if you notice any of the following symptoms, 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
Trouble sleeping
* 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.
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 medical attention right away:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
Joint pain
Purple patches on the skin or mouth
Changes in vision or eye pain, swelling, or redness
Seizures
Shakiness or tremors
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
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.
Heart-Related Side Effects:
If you experience any of the following symptoms, seek medical help immediately:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Other Serious Side Effects:
Painful or prolonged erections (lasting more than 4 hours): Seek medical help right away to avoid long-term damage
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or behavior
+ Anger or hallucinations
+ Depression, suicidal thoughts, or anxiety
Serotonin syndrome, a potentially life-threatening condition that can occur when taking this medication with certain other drugs. Symptoms include:
+ Agitation
+ Balance problems
+ 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:
Many people experience no side effects or only mild side effects. However, if you notice any of the following symptoms, 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
Trouble sleeping
* 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.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggression, hostility, or agitation
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- New or worsening tics (uncontrolled movements or sounds)
- Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes
- Severe headache
- Blurred vision
- Unusual sweating
- Muscle tremors or stiffness
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. Be sure to describe the allergic reaction you experienced.
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 had a stroke
If you have taken specific 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)
If you are currently taking:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Your doctor needs to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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. Be sure to describe the allergic reaction you experienced.
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 had a stroke
If you have taken specific 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)
If you are currently taking:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Your doctor needs to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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 undergo surgery, be sure to discuss this with your doctor beforehand.
To ensure your safety, avoid operating a vehicle or engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, regularly monitor your blood work, blood pressure, and heart rate. You may 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 beverages such as tea, coffee, and cola) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, it is crucial to discuss with your doctor the potential risks of 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 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, particularly those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of experiencing seizures while taking this medication.
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary; discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is essential to weigh the benefits and risks of this medication for both you and your baby.
To ensure your safety, avoid operating a vehicle or engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, regularly monitor your blood work, blood pressure, and heart rate. You may 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 beverages such as tea, coffee, and cola) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, it is crucial to discuss with your doctor the potential risks of 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 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, particularly those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of experiencing seizures while taking this medication.
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary; discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is essential to weigh the benefits and risks of this medication for 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 your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
- Halogenated Anesthetics (during surgery) - risk of sudden blood pressure and heart rate increases.
Major Interactions
- Vasopressor Agents (e.g., phenylephrine, pseudoephedrine) - risk of increased blood pressure.
- Antihypertensive Drugs (e.g., guanethidine, clonidine, reserpine) - methylphenidate may reduce their effectiveness.
- 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 serum levels.
- Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) - methylphenidate may inhibit their metabolism, increasing serum levels and potential for adverse effects.
- Selective Serotonin Reuptake Inhibitors (SSRIs) - potential for serotonin syndrome, though less common than with other stimulants.
Moderate Interactions
- Alcohol - may alter the release profile of extended-release methylphenidate formulations, leading to dose dumping.
- Caffeine - additive stimulant effects, increased risk of anxiety, insomnia, and cardiovascular effects.
- Dopaminergic Drugs (e.g., levodopa, bromocriptine) - potential for additive dopaminergic effects.
Minor Interactions
- Antacids - may affect absorption of some formulations, but generally not significant for Metadate ER.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Methylphenidate can cause dose-related increases in BP and HR. Baseline assessment is crucial to identify pre-existing cardiovascular conditions or risks.
Timing: Prior to initiation of therapy
Height and Weight (Pediatric Patients)
Rationale: Stimulants have been associated with modest growth suppression in children. Baseline measurements are needed to monitor growth over time.
Timing: Prior to initiation of therapy
Psychiatric History and Symptoms
Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis, tics) that may be exacerbated by stimulants or require alternative treatment.
Timing: Prior to initiation of therapy
Electrocardiogram (ECG)
Rationale: Consider for patients with pre-existing cardiac conditions, family history of sudden cardiac death, or other cardiovascular risk factors, as recommended by clinical guidelines.
Timing: Prior to initiation of therapy (if indicated)
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or at least every 3-6 months
Target: Within normal limits for age; monitor for sustained increases
Action Threshold: Sustained clinically significant increases (e.g., >10-20 mmHg systolic/diastolic or >10-20 bpm HR) warrant dose reduction, discontinuation, or further cardiovascular evaluation.
Height and Weight (Pediatric Patients)
Frequency: Every 3-6 months
Target: Maintain normal growth trajectory
Action Threshold: Significant deviation from expected growth curve (e.g., persistent decline in growth velocity or crossing major percentile lines) warrants consideration of drug holiday or alternative therapy.
Psychiatric Symptoms (e.g., mood changes, agitation, psychosis, tics)
Frequency: At each visit
Target: Stable or improved
Action Threshold: Emergence or worsening of psychotic or manic symptoms, severe anxiety, agitation, or new/worsening tics warrant dose adjustment or discontinuation.
ADHD Symptom Control and Functional Improvement
Frequency: At each visit
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning
Action Threshold: Lack of efficacy or intolerable side effects warrant dose adjustment or consideration of alternative therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hallucinations
- Delusions
- Mania
- Severe anxiety
- Agitation
- New or worsening tics
- Unexplained weight loss
- Insomnia
- Anorexia
Special Patient Groups
Pregnancy
Methylphenidate is 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., atrial septal defect) 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 (e.g., tremors, irritability) in the neonate if used close to delivery.
Lactation
Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor the infant for adverse effects such as irritability, poor feeding, or sleep disturbances.
Infant Risk:
L3 (Moderate risk). Monitor for irritability, poor feeding, insomnia, and weight loss in the infant. Consider using the lowest effective dose and monitoring infant plasma levels if concerns arise.
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) regularly due to potential for modest growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, tics). Cardiovascular monitoring is also important.
Geriatric Use
Safety and efficacy in patients over 65 years have not been established. Use with caution in elderly patients due to increased sensitivity to sympathomimetic effects, potential for cardiovascular events, and higher likelihood of comorbidities and polypharmacy. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Metadate ER is an extended-release formulation designed for once-daily dosing, providing symptom control for approximately 6-8 hours.
- Patients should be instructed to swallow the tablet whole; crushing or chewing will lead to immediate release of the entire dose and potential for adverse effects.
- Careful titration is essential to find the optimal dose that balances efficacy and tolerability.
- 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 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 individualized and discussed with the prescriber.
Alternative Therapies
- Other methylphenidate formulations (e.g., Ritalin LA, Concerta, Daytrana, Quillivant XR, Aptensio XR, Jornay PM)
- Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy and psychotherapy
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (brand name); Tier 1 (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.