Metadate CD 10mg 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 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 slowly throughout the day, so it's usually taken once in the morning.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication in the morning, as directed.
Special Instructions for Taking Your Medication
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.
When taking your medication:
Swallow the capsule whole; do not chew, break, or crush it.
If you have trouble swallowing the capsule, you may sprinkle its contents onto applesauce. Do not chew the mixture; swallow it immediately and follow with a glass of water or juice.
Some products can also be mixed with yogurt. If you are unsure, consult the package insert or speak with your pharmacist.
After mixing your medication with food, take your dose right away. Do not store the mixture for later use.
Storing and Disposing of Your Medication
To keep your medication effective and safe:
Store it at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area.
* Keep all medications out of reach of pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication in the morning, as directed.
Special Instructions for Taking Your Medication
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.
When taking your medication:
Swallow the capsule whole; do not chew, break, or crush it.
If you have trouble swallowing the capsule, you may sprinkle its contents onto applesauce. Do not chew the mixture; swallow it immediately and follow with a glass of water or juice.
Some products can also be mixed with yogurt. If you are unsure, consult the package insert or speak with your pharmacist.
After mixing your medication with food, take your dose right away. Do not store the mixture for later use.
Storing and Disposing of Your Medication
To keep your medication effective and safe:
Store it at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area.
* Keep all medications out of reach of pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take Metadate CD once daily in the morning, with or without food. Do not take it in the afternoon or evening as it may cause sleep problems.
- Swallow the capsule whole. Do not crush, chew, or divide the capsule. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a small amount of applesauce and consume immediately.
- Store at room temperature away from moisture and heat.
- Keep out of reach of children and pets.
- Do not share your medication with others, as it has a high potential for abuse.
- Avoid alcohol consumption, as it may cause the medication to be released too quickly.
- Maintain a healthy diet and regular exercise, as appetite suppression and weight loss can occur, especially in children.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 20 mg orally once daily in the morning. Titrate weekly by 10-20 mg/day.
Dose Range:
20 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial 20 mg once daily in the morning. May increase by 10-20 mg weekly to a maximum of 60 mg/day. Doses above 60 mg/day are not recommended.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: Initial 20 mg orally once daily in the morning. May increase by 10-20 mg weekly to a maximum of 60 mg/day. Doses above 60 mg/day are not recommended.
Adolescent:
13-17 years: Initial 20 mg orally once daily in the morning. May increase by 10-20 mg weekly to a maximum of 60 mg/day. Doses above 60 mg/day are not recommended.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis:
Not well studied. Methylphenidate is not significantly dialyzable. Use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Pharmacology
Mechanism of Action
Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) are thought to be mediated through the blockade of dopamine and norepinephrine reuptake into the presynaptic neuron and the inhibition of monoamine oxidase, thereby increasing the extracellular levels of these monoamines in the striatum and prefrontal cortex.
Pharmacokinetics
Absorption:
Bioavailability:
22-30% (due to first-pass metabolism)
Tmax:
Initial peak: ~1.5 hours; Second peak: ~4.5 hours (for extended-release formulation)
FoodEffect:
A high-fat meal can delay Tmax by approximately 1 hour and increase Cmax by about 30% for the initial release, and delay the second peak by about 1.5 hours and increase Cmax by about 15% for the extended release. Overall AUC is not significantly affected.
Distribution:
Vd:
~2.6 L/kg
ProteinBinding:
~15%
CnssPenetration:
Yes
Elimination:
HalfLife:
~3.5 hours (for Metadate CD)
Clearance:
Not readily available, but rapid metabolism and excretion.
ExcretionRoute:
Primarily renal (urine), with a small amount in feces.
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
~1-2 hours
PeakEffect:
~4-7 hours
DurationOfAction:
~8-10 hours
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 or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Severe headache, dizziness, or fainting.
Joint pain.
Purple patches on the skin or mouth.
Changes in vision or eye pain, swelling, or redness.
Seizures.
Shakiness.
Difficulty controlling body movements.
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises.
Excessive sweating.
Restlessness.
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas.
Numbness, pain, tingling, or cold sensation in hands or feet.
Sores or wounds on fingers or toes.
Muscle pain or weakness, dark urine, or difficulty urinating.
Changes in sex drive.
Weakness on one side of the body, 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 defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly. Seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting.
Additional Urgent Conditions
If you experience a painful erection (hard penis) or an erection lasting longer than 4 hours, seek medical help right away. This can occur even when not having sex, and if left untreated, may lead to lasting sexual problems.
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems (e.g., depression, bipolar illness) or a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience hallucinations, changes in behavior, or signs of mood changes like depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
A severe and 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, 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.
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:
Dizziness or headache.
Drowsiness.
Dry mouth.
Stomach pain, upset stomach, vomiting, or decreased appetite.
Heartburn.
Weight loss.
Feeling nervous and excitable.
Difficulty sleeping.
* Nose or throat irritation.
If any of these side effects or other concerns bother you or persist, contact your doctor for guidance. 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 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 defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly. Seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting.
Additional Urgent Conditions
If you experience a painful erection (hard penis) or an erection lasting longer than 4 hours, seek medical help right away. This can occur even when not having sex, and if left untreated, may lead to lasting sexual problems.
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems (e.g., depression, bipolar illness) or a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience hallucinations, changes in behavior, or signs of mood changes like depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
A severe and 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, 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.
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:
Dizziness or headache.
Drowsiness.
Dry mouth.
Stomach pain, upset stomach, vomiting, or decreased appetite.
Heartburn.
Weight loss.
Feeling nervous and excitable.
Difficulty sleeping.
* Nose or throat irritation.
If any of these side effects or other concerns bother you or persist, contact your doctor for guidance. 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 heart problems (e.g., palpitations, irregular heartbeat)
- New or worsening mental problems (e.g., seeing or hearing things that are not real, believing things that are not true, suspiciousness, mania, aggression)
- New or worsening tics (uncontrolled repetitive movements or sounds)
- Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
- Blurred vision or other eye problems
- Severe headache
- Seizures
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
Family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, including:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (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 conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
Family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, including:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (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 Providers
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial for ensuring 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 you to be alert. 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 interact with this medication and cause nervousness, shakiness, and a rapid heartbeat. If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
* Certain natural products or aids
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.
Additional Warnings
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. In children and teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of this medication to both you and your baby.
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial for ensuring 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 you to be alert. 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 interact with this medication and cause nervousness, shakiness, and a rapid heartbeat. If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
* Certain natural products or aids
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.
Additional Warnings
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. In children and teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Vomiting
- Agitation
- Tremors
- Hyperreflexia
- Muscle twitching
- Convulsions (may be followed by coma)
- Euphoria
- Confusion
- Hallucinations
- Delirium
- Sweating
- Flushing
- Headache
- Hyperpyrexia (very high fever)
- Tachycardia
- Palpitations
- Cardiac arrhythmias
- Hypertension
- Mydriasis (dilated pupils)
- Dryness of mucous membranes
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US). Treatment is generally supportive, including gastric lavage, activated charcoal, and sedation for severe agitation or seizures.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis)
Major Interactions
- Halogenated Anesthetics (risk of sudden death due to acute increases in heart rate and blood pressure)
- Vasopressors (may potentiate pressor effects)
- Warfarin (may increase prothrombin time)
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone - may alter plasma concentrations)
- Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine - may increase plasma concentrations)
- Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., fluoxetine, paroxetine - may increase plasma concentrations)
Moderate Interactions
- Antihypertensives (may reduce the hypotensive effect of these drugs)
- Alcohol (may lead to dose dumping of methylphenidate from extended-release formulations)
- Dopaminergic drugs (e.g., antipsychotics, levodopa - potential for additive effects or antagonism)
Minor Interactions
- Caffeine (additive stimulant effects)
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Methylphenidate can cause dose-related increases in BP and HR. Baseline assessment is crucial to identify pre-existing cardiovascular risk.
Timing: Prior to initiation of therapy.
Height and Weight
Rationale: To monitor for potential growth suppression in pediatric patients and general nutritional status.
Timing: Prior to initiation of therapy.
Psychiatric History (e.g., bipolar disorder, psychosis, tics, substance abuse)
Rationale: To identify pre-existing psychiatric conditions that may be exacerbated by stimulant therapy or contraindicate its use.
Timing: Prior to initiation of therapy.
Cardiovascular History (e.g., structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease)
Rationale: To identify patients at increased risk for sudden death or other serious cardiovascular events.
Timing: Prior to initiation of therapy.
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 and clinical status.
Action Threshold: Persistent elevation above normal range; consider dose reduction, discontinuation, or referral to cardiology.
Height and Weight
Frequency: Every 3-6 months for pediatric patients; annually for adults.
Target: Normal growth trajectory for children; stable weight for adults.
Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative therapy.
ADHD Symptom Control and Functional Improvement
Frequency: Regularly (e.g., monthly initially, then every 3-6 months once stable).
Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning.
Action Threshold: Lack of efficacy, worsening symptoms, or emergence of new symptoms; consider dose adjustment or alternative therapy.
Emergence of Psychiatric Symptoms (e.g., psychosis, mania, aggression, tics, anxiety)
Frequency: At each visit.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: New onset or worsening of symptoms; consider dose reduction, discontinuation, or psychiatric consultation.
Signs of Abuse/Diversion
Frequency: At each visit.
Target: No signs of drug-seeking behavior or misuse.
Action Threshold: Suspicion of abuse/diversion; consider discontinuation, referral to addiction specialist, or alternative treatment.
Symptom Monitoring
- Increased blood pressure
- Increased heart rate
- Insomnia
- Decreased appetite/weight loss
- Nervousness
- Headache
- Abdominal pain
- Nausea
- Vomiting
- Dizziness
- Dry mouth
- Mood changes (irritability, anxiety)
- New or worsening tics
- Psychotic symptoms (hallucinations, delusions)
- Manic symptoms (euphoria, grandiosity, increased energy)
- Aggression
- Growth deceleration (in children)
Special Patient Groups
Pregnancy
Methylphenidate is classified as Pregnancy Category C. This means that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data. Animal studies show developmental toxicity (e.g., skeletal variations, increased fetal deaths) at doses higher than human therapeutic doses.
Second Trimester:
Limited human data. Continue to monitor for potential risks.
Third Trimester:
Limited human data. Neonates exposed to amphetamines during the third trimester have experienced withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremors, hypertonia, somnolence). Monitor neonates for these symptoms.
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 breastfed infants for signs of adverse reactions (e.g., agitation, insomnia, decreased 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 methylphenidate or from the underlying maternal condition.
Infant Risk:
L3 (Moderately Safe - limited controlled studies show no adverse effects, or risk is minimal; however, controlled studies are lacking, or adverse effects are possible but minor).
Pediatric Use
Approved for children 6 years of age and older. Monitor growth (height and weight) regularly, as long-term use has been associated with growth suppression. Cardiovascular and psychiatric adverse events should also be closely monitored.
Geriatric Use
Safety and efficacy in patients over 65 years of age have not been established. Use with caution due to potential for increased sensitivity to adverse effects, particularly cardiovascular effects. Start with lower doses and titrate slowly with careful monitoring.
Clinical Information
Clinical Pearls
- Metadate CD is an extended-release formulation designed for once-daily dosing, typically providing 8-10 hours of symptom control.
- Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules, but the beads should not be chewed or crushed.
- Patients should be advised to take the medication in the morning to avoid insomnia.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial due to potential cardiovascular effects and growth suppression.
- Educate patients and caregivers about the high potential for abuse and dependence, and the importance of proper storage and disposal.
- Screen for pre-existing cardiac conditions and psychiatric disorders before initiating therapy, as stimulants can exacerbate these conditions.
- Consider drug holidays (e.g., weekends or 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.
Alternative Therapies
- Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Aptensio XR, Jornay PM, Quillivant XR, Quillichew ER, Adhansia XR)
- Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy (often used in conjunction with pharmacotherapy for ADHD)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and dosage; typically $100-$400+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand name); Tier 1 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.