Metadate CD 30mg 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 containing methylphenidate, a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are important for attention and impulse control. The 'CD' means 'Controlled Delivery,' so the medicine is released slowly throughout the day, usually allowing for once-daily dosing.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your prescription, and follow the instructions carefully.
2. Timing and Food: Take your medication 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 medication.
3. Swallowing Your Medication: Swallow your medication whole. Do not chew, break, or crush it.
4. Alternative Administration: If you have trouble swallowing the capsule, you can sprinkle its contents on applesauce. Do not chew the mixture. Swallow it immediately, and then drink a glass of water or juice. Some products can also be mixed with yogurt. If you are unsure, consult the package insert or talk to your pharmacist.
Important Administration Reminders:
* After mixing your medication with food, take your dose immediately. Do not store the mixture for later use.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
1. Store at Room Temperature: Keep your medication at room temperature, away from light and moisture.
2. Protect from Children and Pets: Store your medication in a secure location where children and pets cannot access it. Consider using a locked box or area to prevent accidental ingestion.
3. Keep Away from Moisture: Do not store your medication in a bathroom or other humid environment.
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:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your prescription, and follow the instructions carefully.
2. Timing and Food: Take your medication 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 medication.
3. Swallowing Your Medication: Swallow your medication whole. Do not chew, break, or crush it.
4. Alternative Administration: If you have trouble swallowing the capsule, you can sprinkle its contents on applesauce. Do not chew the mixture. Swallow it immediately, and then drink a glass of water or juice. Some products can also be mixed with yogurt. If you are unsure, consult the package insert or talk to your pharmacist.
Important Administration Reminders:
* After mixing your medication with food, take your dose immediately. Do not store the mixture for later use.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
1. Store at Room Temperature: Keep your medication at room temperature, away from light and moisture.
2. Protect from Children and Pets: Store your medication in a secure location where children and pets cannot access it. Consider using a locked box or area to prevent accidental ingestion.
3. Keep Away from Moisture: Do not store your medication in a bathroom or other humid environment.
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 exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening as it may cause sleep problems.
- Swallow the capsule whole. Do not crush, chew, or divide the capsule. If unable to swallow, the capsule may be opened and the contents sprinkled on a small amount of applesauce and consumed immediately.
- Avoid alcohol, as it can cause the medication to be released too quickly.
- Maintain a healthy diet and regular exercise. Monitor growth in children.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Store safely to prevent misuse or abuse.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not typically indicated for adult ADHD as a first-line, but if used, initial dose is 20 mg once daily in the morning. May be titrated weekly.
Dose Range:
20 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial dose 20 mg once daily in the morning. May be increased in 10-20 mg increments weekly to a maximum of 60 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6 years and older: Initial dose 20 mg once daily in the morning. May be increased in 10-20 mg increments weekly to a maximum of 60 mg/day.
Adolescent:
Initial dose 20 mg once daily in the morning. May be increased in 10-20 mg increments weekly to a maximum of 60 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution. Monitor for adverse effects.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution. Monitor for adverse effects.
Confidence:
Medium
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 therapeutic effect in ADHD is thought to be related to increased dopamine and norepinephrine activity in the prefrontal cortex, improving attention, focus, and impulse control.
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:
High-fat meal may delay Tmax by approximately 1 hour and increase Cmax by 30% and AUC by 17% for Metadate CD. Can be taken with or without food.
Distribution:
Vd:
Not available (estimated to be large)
ProteinBinding:
Approximately 15% (to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 3.5 hours (for Metadate CD)
Clearance:
Not available
ExcretionRoute:
Primarily renal (90% as ritalinic acid, 1% as unchanged drug)
Unchanged:
Less than 1%
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours
PeakEffect:
Approximately 4-5 hours (for Metadate CD)
DurationOfAction:
Approximately 8-10 hours (for Metadate CD)
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 during therapy.
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 immediately or seek emergency medical attention:
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, 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. Seek medical help immediately if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
If you experience a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical attention immediately. This can occur even when not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or behavior
+ Anger or hallucinations
+ Inform your doctor if you or a family member has a history of mental health conditions, such as depression or bipolar disorder, or if a family member has committed suicide. Seek medical help immediately if you experience:
- Hallucinations
- Changes in behavior
- Signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience:
+ Agitation
+ Changes in balance or coordination
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:
Dizziness or headache
Drowsiness
Dry mouth
Stomach pain, nausea, 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, consult 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 immediately or seek emergency medical attention:
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, 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. Seek medical help immediately if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
If you experience a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical attention immediately. This can occur even when not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or behavior
+ Anger or hallucinations
+ Inform your doctor if you or a family member has a history of mental health conditions, such as depression or bipolar disorder, or if a family member has committed suicide. Seek medical help immediately if you experience:
- Hallucinations
- Changes in behavior
- Signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience:
+ Agitation
+ Changes in balance or coordination
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:
Dizziness or headache
Drowsiness
Dry mouth
Stomach pain, nausea, 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, consult 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
- New or worsening tics (uncontrolled movements or sounds)
- Seeing or hearing things that are not real (hallucinations)
- Unexplained numbness, pain, skin color changes (pale, blue, red), or unusual coldness in fingers or toes
- Significant unexplained weight loss or lack of growth in children
- Severe headache or blurred vision
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 specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Current use of certain medications, including:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, such as:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (note: some products contain sucrose)
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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 specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
Current use of certain medications, including:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, such as:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (note: some products contain sucrose)
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to undergo surgery, discuss this with your doctor beforehand.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult with your doctor.
While taking this medication, it is recommended that you avoid consuming alcohol and limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Long-term or high-dose use of this medication may lead to tolerance, reducing its effectiveness. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.
This medication may increase the risk of seizures in certain individuals, including those with a history of seizures. Discuss your risk of seizures with your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary; consult with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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, discuss this with your doctor beforehand.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult with your doctor.
While taking this medication, it is recommended that you avoid consuming alcohol and limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Long-term or high-dose use of this medication may lead to tolerance, reducing its effectiveness. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.
This medication may increase the risk of seizures in certain individuals, including those with a history of seizures. Discuss your risk of seizures with your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary; consult with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Vomiting
- Agitation
- Tremors
- Hyperreflexia (overactive reflexes)
- Muscle twitching
- Convulsions (seizures)
- Euphoria
- Confusion
- Hallucinations
- Delirium
- Sweating
- Flushing
- Headache
- Hyperpyrexia (very high fever)
- Tachycardia (fast heart rate)
- Palpitations
- Cardiac arrhythmias
- Hypertension (high blood pressure)
- Mydriasis (dilated pupils)
- Dryness of mucous membranes
What to Do:
Call 911 or your local poison control center immediately (e.g., 1-800-222-1222 in the US). Seek emergency medical attention. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for agitation, hyperthermia, and cardiovascular effects.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of discontinuing an MAOI due to risk of hypertensive crisis.
Major Interactions
- Vasopressors (e.g., phenylephrine, pseudoephedrine): May potentiate the pressor effect, leading to severe hypertension.
- Halogenated Anesthetics (e.g., halothane, isoflurane): Risk of sudden blood pressure and heart rate increases during surgery.
- Anticoagulants (e.g., warfarin): May inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of these drugs, requiring dose adjustment.
- Antidepressants (e.g., tricyclic antidepressants, SSRIs): May inhibit metabolism of some antidepressants, requiring dose adjustment and monitoring for increased adverse effects.
Moderate Interactions
- Dopaminergic drugs (e.g., bupropion, levodopa): Potential for additive dopaminergic effects.
- Antihypertensive drugs: May reduce the effectiveness of antihypertensive medications.
- Alcohol: May increase the rate of drug release from extended-release formulations, leading to a more rapid absorption and higher peak plasma concentrations (dose dumping).
Minor Interactions
- Caffeine: May have additive stimulant effects.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: CNS stimulants can cause dose-related increases in BP and HR.
Timing: Prior to initiation of therapy.
Height and Weight
Rationale: Stimulants have been associated with modest weight loss and growth suppression in pediatric patients.
Timing: Prior to initiation of therapy (especially in pediatric patients).
Cardiac History and Family History of Sudden Death/Arrhythmias
Rationale: To identify pre-existing cardiac conditions that may contraindicate stimulant use.
Timing: Prior to initiation of therapy.
Psychiatric History (e.g., bipolar disorder, psychosis, tics)
Rationale: Stimulants can exacerbate psychotic symptoms, mania, or tics.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or every 3-6 months, or as clinically indicated.
Target: Within normal limits for age/individual.
Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant investigation and potential dose adjustment or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric patients).
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration or weight loss warrants investigation and potential drug holiday or alternative therapy.
ADHD Symptom Control and Functional Improvement
Frequency: Regularly (e.g., monthly initially, then every 3-6 months).
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning.
Action Threshold: Lack of efficacy or worsening symptoms warrants dose adjustment or re-evaluation of diagnosis/treatment plan.
Emergence of Psychiatric Symptoms (e.g., psychosis, mania, aggression, tics)
Frequency: At each visit.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: New onset or worsening of these symptoms requires immediate evaluation and potential discontinuation.
Symptom Monitoring
- Changes in mood or behavior (e.g., agitation, irritability, aggression, anxiety, depression)
- New or worsening tics
- Hallucinations or delusional thinking
- Chest pain, shortness of breath, syncope (fainting)
- Numbness, pain, skin color change, or temperature sensitivity in fingers or toes (Raynaud's phenomenon)
- Unexplained weight loss or appetite suppression
- Sleep disturbances
Special Patient Groups
Pregnancy
Methylphenidate is classified as 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 defects) based on some observational studies, though data are conflicting and limited. 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, insomnia, decreased weight gain, or other signs of stimulant effects in the infant. Consider using the lowest effective dose and observing infant closely.
Pediatric Use
Approved for children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, tics).
Geriatric Use
Safety and efficacy in patients over 65 years have not been established. Use with caution due to increased sensitivity to stimulant effects (e.g., cardiovascular effects, anxiety, insomnia). Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Metadate CD uses a 'Controlled Delivery' system with 30% immediate release and 70% extended release beads, providing a biphasic release profile.
- Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules. The entire contents should be consumed immediately without chewing.
- Patients should be advised to avoid alcohol due to the risk of dose dumping with extended-release formulations.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
- Consider drug holidays (e.g., weekends, school breaks) for pediatric patients to assess ongoing need for medication and potentially mitigate growth suppression, though this should be discussed with a healthcare provider.
- Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
Alternative Therapies
- Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Focalin XR, Daytrana patch)
- Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
- Non-stimulant medications (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay))
- Behavioral therapy, psychotherapy, parent training
Cost & Coverage
Average Cost:
$200 - $400+ per 30 capsules (30mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 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 your safety, 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, we encourage you to discuss them 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.