Ritalin LA 60mg ER 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
Jun 2000
DEA Schedule
Schedule II
Overview
What is this medicine?
Ritalin LA is an extended-release capsule that helps improve focus, attention, and control impulsive behaviors in people with Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain. The 'LA' means 'long-acting', so you usually take it once a day in the morning.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
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 capsules, you can sprinkle the 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're unsure, read the package insert or consult with your pharmacist.
5. Mixing and Taking Your Dose: After mixing your medication, take your dose right away. Do not store the mixture for later use.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
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 safe place where children and pets cannot see or reach it. Consider using a locked box or secure area.
3. Keep Away from Others: Keep your medication away from other people to prevent accidental ingestion or misuse.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular 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 capsules, you can sprinkle the 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're unsure, read the package insert or consult with your pharmacist.
5. Mixing and Taking Your Dose: After mixing your medication, take your dose right away. Do not store the mixture for later use.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
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 safe place where children and pets cannot see or reach it. Consider using a locked box or secure area.
3. Keep Away from Others: Keep your medication away from other people to prevent accidental ingestion or misuse.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular 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 beads sprinkled onto a small amount of applesauce and consumed immediately.
- Avoid alcohol, as it may increase the release of methylphenidate from the capsule.
- Maintain a healthy diet and regular exercise, as appetite suppression and weight loss can occur.
- Report any new or worsening psychiatric symptoms (e.g., hallucinations, paranoia, aggression, severe anxiety) immediately.
- Report any signs of heart problems (e.g., chest pain, shortness of breath, fainting) immediately.
- Keep out of reach of children and store in a safe place due to its potential for abuse.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not typically initiated in adults; generally for continuation from pediatric use or specific adult ADHD diagnosis. Max 60 mg once daily.
Dose Range:
20 - 60 mg
Condition-Specific Dosing:
ADHD:
Initial dose 20 mg once daily in the morning. May increase by 10-20 mg weekly to a maximum of 60 mg once daily.
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 increase by 10-20 mg weekly to a maximum of 60 mg once daily.
Adolescent:
Initial dose 20 mg once daily in the morning. May increase by 10-20 mg weekly to a maximum of 60 mg once daily.
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 and monitor.
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 ADHD are thought to be due to its ability to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. This leads to increased concentrations of dopamine and norepinephrine in the synaptic cleft, enhancing neurotransmission in brain regions associated with attention and impulse control.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 22-25% (due to first-pass metabolism)
Tmax:
Biphasic release: First peak at 1-2 hours, second peak at approximately 6.8 hours (for Ritalin LA)
FoodEffect:
Food (high-fat meal) can delay Tmax by approximately 1 hour and increase Cmax by about 30% for Ritalin LA, but overall extent of absorption (AUC) is not significantly affected.
Distribution:
Vd:
Approximately 2.65 L/kg
ProteinBinding:
Approximately 10-15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 3.5 hours (for Ritalin LA)
Clearance:
Approximately 0.53 L/hr/kg
ExcretionRoute:
Primarily renal (urine)
Unchanged:
<1% (as unchanged drug in urine)
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (for Ritalin LA)
PeakEffect:
Biphasic: First peak at 1-2 hours, second peak at approximately 6.8 hours (for Ritalin LA)
DurationOfAction:
Approximately 8 hours (for Ritalin LA)
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ 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
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of 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, changes in balance, 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 defect, inform your doctor. If a family member has an abnormal heartbeat or died suddenly, also 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 help right away. This can occur even when not having sex, and if left untreated, may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
+ Depression
+ Thoughts of suicide
+ Nervousness
+ Emotional instability
+ Abnormal thinking
+ Anxiety
+ 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
+ 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
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ 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
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of 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, changes in balance, 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 defect, inform your doctor. If a family member has an abnormal heartbeat or died suddenly, also 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 help right away. This can occur even when not having sex, and if left untreated, may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
+ Depression
+ Thoughts of suicide
+ Nervousness
+ Emotional instability
+ Abnormal thinking
+ Anxiety
+ 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
+ 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
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (signs of heart problems)
- Numbness, coldness, or pain in fingers or toes, or skin color changes (signs of circulation problems)
- Unexplained wounds on fingers or toes
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- Feeling unusually suspicious or paranoid
- New or worsening aggressive behavior or hostility
- New or worsening anxiety or depression
- New or worsening tics (uncontrolled movements or sounds)
- Prolonged or painful erections (priapism, rare but serious)
- 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 certain medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue
* 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. Ensure that it is safe to take this medication with your existing treatments and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your treatment regimen.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced a stroke
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue
* 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. Ensure that it is safe to take this medication with your existing treatments and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your treatment regimen.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.
Precautions and Warnings
To ensure your safety, avoid driving and engaging in activities that require alertness until you are aware of how this medication affects you. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. In some cases, you may need to undergo heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.
Additionally, it is recommended that you avoid consuming alcohol while taking this medication. Limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these with your medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, it is essential to discuss the use of over-the-counter (OTC) products with your doctor before taking them. Certain OTC products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, may increase your blood pressure.
Long-Term Use and Potential Risks
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not be as effective. In this case, you may require higher doses to achieve the same effect. However, do not take more than the prescribed amount. If you notice that the medication is no longer working as well, contact your doctor.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.
Allergies and Interactions
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Special Considerations for Children and Teens
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this with your doctor to determine the best course of action.
Pregnancy and Breast-Feeding
If you are pregnant, plan to become pregnant, or are breast-feeding, it is essential to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.
Precautions and Warnings
To ensure your safety, avoid driving and engaging in activities that require alertness until you are aware of how this medication affects you. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. In some cases, you may need to undergo heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.
Additionally, it is recommended that you avoid consuming alcohol while taking this medication. Limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these with your medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, it is essential to discuss the use of over-the-counter (OTC) products with your doctor before taking them. Certain OTC products, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids, may increase your blood pressure.
Long-Term Use and Potential Risks
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not be as effective. In this case, you may require higher doses to achieve the same effect. However, do not take more than the prescribed amount. If you notice that the medication is no longer working as well, contact your doctor.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.
Allergies and Interactions
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Special Considerations for Children and Teens
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this with your doctor to determine the best course of action.
Pregnancy and Breast-Feeding
If you are pregnant, plan to become pregnant, or are breast-feeding, it is essential to 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
- Muscle twitching
- Convulsions (may be followed by coma)
- 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:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and sedation for severe agitation or seizures.
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
- Vasopressor Agents: May potentiate the pressor effect of vasopressor agents.
- Halogenated Anesthetics: Risk of sudden blood pressure and heart rate increases during surgery; avoid use on day of surgery.
- Anticoagulants (e.g., coumarin): May decrease metabolism of coumarin anticoagulants, requiring dose adjustment.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of these drugs, requiring dose adjustment.
- Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine): May inhibit metabolism of TCAs, requiring dose adjustment.
Moderate Interactions
- Selective Serotonin Reuptake Inhibitors (SSRIs): Potential for additive serotonergic effects, monitor for serotonin syndrome.
- Dopaminergic Drugs (e.g., antipsychotics, levodopa): May antagonize effects of antipsychotics or potentiate effects of dopaminergic drugs.
- Alcohol: May increase plasma levels of methylphenidate and lead to more rapid absorption of the active ingredient from Ritalin LA.
Minor Interactions
- Antihypertensive Drugs: May reduce the effectiveness of drugs used to treat hypertension.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: CNS stimulants can cause 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
Rationale: Stimulants have been associated with growth suppression in pediatric patients.
Timing: Prior to initiation of therapy (pediatric patients)
Psychiatric History (including family history of suicide, bipolar disorder, depression)
Rationale: Stimulants can exacerbate pre-existing psychiatric conditions or induce new psychotic or manic symptoms.
Timing: Prior to initiation of therapy
ECG (Electrocardiogram)
Rationale: Consider if patient has pre-existing cardiac conditions, family history of sudden cardiac death, or other cardiovascular risk factors.
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: Maintain within normal limits for age/sex; significant sustained increases should prompt evaluation.
Action Threshold: Sustained increase >10-20 mmHg systolic/diastolic or HR >10-20 bpm above baseline; consider dose reduction or discontinuation.
Height and Weight
Frequency: Every 3-6 months (pediatric patients)
Target: Maintain expected growth trajectory.
Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines); consider drug holiday or alternative therapy.
ADHD Symptoms and Treatment Response
Frequency: Regularly (e.g., monthly initially, then every 3-6 months)
Target: Improvement in core ADHD symptoms (inattention, hyperactivity, impulsivity) with minimal side effects.
Action Threshold: Lack of efficacy, intolerable side effects, or emergence of new symptoms; consider dose adjustment or alternative.
Emergence of Psychiatric Symptoms (e.g., psychosis, mania, aggression, anxiety, depression)
Frequency: At each visit
Target: Absence of new or exacerbated psychiatric symptoms.
Action Threshold: New onset or worsening of psychiatric symptoms; discontinue therapy and evaluate.
Peripheral Vasculopathy (e.g., Raynaud's phenomenon)
Frequency: Periodically, inquire about coldness, numbness, or pain in digits.
Target: Absence of symptoms.
Action Threshold: Development of symptoms; consider discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- Numbness or tingling in fingers/toes
- Skin color changes in fingers/toes
- Unexplained wounds on fingers/toes
- Hallucinations
- Delusional thinking
- Mania
- Aggression
- Anxiety
- Depression
- Suicidal ideation
- Tics or abnormal movements
- Blurred vision
- Priapism (rare, prolonged erections)
Special Patient Groups
Pregnancy
Methylphenidate is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but 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. Consider risks of untreated ADHD during pregnancy.
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 overall risk appears low.
Second Trimester:
Limited data, but generally considered lower risk for major malformations compared to first trimester. Potential for growth restriction.
Third Trimester:
Potential for withdrawal symptoms in the neonate (e.g., agitation, tremors, feeding difficulties) if used late in pregnancy. Risk of premature birth and low birth weight.
Lactation
Methylphenidate is excreted into human milk. The relative infant dose is low (0.2-0.7% of maternal weight-adjusted dose). Monitor breastfed infants for agitation, insomnia, decreased appetite, or poor weight gain. Use with caution, weighing benefits of breastfeeding against potential infant exposure.
Infant Risk:
Low to moderate risk. Most infants show no adverse effects, but some may experience irritability, poor feeding, or sleep disturbances. Long-term effects on neurodevelopment are unknown.
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. Cardiovascular monitoring is important.
Geriatric Use
Safety and efficacy in patients over 65 years have not been established. Use with caution due to increased likelihood of cardiovascular disease, other comorbidities, and polypharmacy. Start with lower doses and titrate slowly, monitoring closely for adverse effects.
Clinical Information
Clinical Pearls
- Ritalin LA is an extended-release formulation designed for once-daily dosing, providing effects for approximately 8 hours. It has a biphasic release profile.
- Counsel patients to swallow the capsule whole. If swallowing is difficult, the capsule can be opened and the beads sprinkled on applesauce, but the beads should not be chewed or crushed.
- Methylphenidate is a Schedule II controlled substance due to its high potential for abuse and dependence. Prescribers should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence during treatment.
- Monitor blood pressure and heart rate at baseline and periodically during treatment, as stimulants can cause modest increases. Consider ECG if cardiac risk factors are present.
- Be vigilant for the emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, anxiety) during treatment, especially in patients with a history of psychiatric illness.
- Growth suppression is a concern in pediatric patients; monitor height and weight regularly. Drug holidays may be considered, but their impact on long-term growth is not fully established.
- Avoid concomitant use with MAOIs due to the risk of hypertensive crisis.
Alternative Therapies
- Other methylphenidate formulations (e.g., Concerta, Daytrana, Quillivant XR, Aptensio XR, Jornay PM, Focalin XR)
- Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER, Viloxazine ER)
- Behavioral therapy and psychotherapy (often used in conjunction with pharmacotherapy for ADHD)
Cost & Coverage
Average Cost:
$200 - $400+ per 30 capsules (60mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand name); Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.