Ritalin LA 10mg ER Capsules

Manufacturer NOVARTIS Active Ingredient Methylphenidate Extended- Release Capsules(meth il FEN i date) Pronunciation METH-il-FEN-i-date
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.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Category C
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FDA Approved
Jun 2000
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Ritalin LA is an extended-release capsule containing methylphenidate, a stimulant medication. It works by affecting certain natural substances in the brain that are important for attention and impulse control. It is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) by helping to improve focus, reduce impulsivity, and control hyperactivity.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your dose in the morning.
Some medications need to be taken with food, while others should be taken on an empty stomach. Check with your pharmacist to determine the best way to take your specific medication.

Swallowing Your Medication

Swallow your medication whole, without chewing, breaking, or crushing it.
If you have trouble swallowing the capsule, you can sprinkle the contents onto applesauce. Do not chew the mixture, and swallow it immediately. Follow with a glass of water or juice.
Some products can also be mixed with yogurt. If you're unsure, consult the package insert or talk to your pharmacist.

Preparing and Taking Your Dose

After mixing your medication with food, take your dose right away. Do not store the mixture for later use.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture.
Keep your medication in a dry place, such as a closet or drawer. Avoid storing it in a bathroom.
Keep your medication out of reach of children and pets, and store it in a secure location where others cannot access it. Consider using a locked box or area to keep your medication safe.

Missing a Dose

If you miss a dose, skip it and take your next dose at the usual time.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Swallow the capsule whole or sprinkle the contents onto a small amount of applesauce or other soft food and consume immediately. Do not chew or crush the beads.
  • Avoid alcohol, as it can cause the medication to be released too quickly.
  • Maintain a healthy diet and regular exercise, as stimulants can sometimes affect appetite and growth in children.
  • Store in a safe place to prevent misuse or abuse.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max: 60 mg/day.
Dose Range: 10 - 60 mg

Condition-Specific Dosing:

ADHD: Initial: 20 mg once daily. Max: 60 mg/day.
Narcolepsy: Not typically used for narcolepsy in extended-release form; immediate-release is preferred for titration.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6 years and older: Initial: 10-20 mg orally once daily in the morning. May increase by 10 mg weekly. Max: 60 mg/day.
Adolescent: Initial: 10-20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max: 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis: Not extensively studied. Methylphenidate is not significantly dialyzable. Use with caution.

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution. Monitor for adverse effects.

Pharmacology

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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 precise mechanism by which methylphenidate produces its therapeutic effects in ADHD is not fully understood.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 30-50%
Tmax: Biphasic: Initial peak at 1-2 hours, second peak at 4-5 hours (for ER formulation)
FoodEffect: Food can delay Tmax by approximately 1 hour but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 2.6 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for Ritalin LA)
Clearance: Not readily available for specific rate, but rapid elimination.
ExcretionRoute: Renal (urine)
Unchanged: <1% (as unchanged methylphenidate)
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes
PeakEffect: Approximately 4-5 hours
DurationOfAction: Approximately 8 hours

Safety & Warnings

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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. Misuse of CNS stimulants can cause sudden death and serious cardiovascular adverse events.
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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 medical attention immediately:

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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or 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 (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold feeling 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

Heart Problems: Important Warning

Sudden deaths have occurred in people with certain heart problems or defects. Inform your doctor if you have any heart condition or defect. Also, tell your doctor if a family member has an abnormal heartbeat or died suddenly. Seek medical help immediately if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Other Serious Side Effects

Painful erection (hard penis) or an erection lasting longer than 4 hours (even when not having sex). If not treated promptly, this may lead to lasting sexual problems.
New or worsening behavior and mood changes, such as changes in thinking, anger, or hallucinations. Inform your doctor if you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide.

Serotonin Syndrome: A Potentially Life-Threatening Condition

This medication can cause a severe and potentially deadly problem called serotonin syndrome when taken with certain other medications. Seek medical help immediately if you experience any of the following symptoms:

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

Common Side Effects

Not everyone experiences side effects, and many people have only minor or no side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention:

Dizziness or headache
Feeling sleepy
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous and excitable
Trouble sleeping
Nose or throat irritation

Reporting Side Effects

If you have questions about side effects or experience any side effects that bother you or do not go away, 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.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening aggression or hostility
  • Seeing or hearing things that are not real (psychosis)
  • New or worsening tics (uncontrolled movements or sounds)
  • Numbness, pain, or discoloration in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Prolonged or painful erection (priapism, rare but serious)
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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)
A 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 (as this may lead to very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, including:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (note that 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 problems with your doctor and pharmacist. Ensure that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor.
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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. If you are scheduled to have surgery, be sure to discuss this with your doctor.

Precautions to Take While Using This Medication

Until you know how this medication affects you, avoid driving and other activities that require you to be alert. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may need to undergo certain heart tests before starting this medication. If you have any questions or concerns, discuss them 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 other products) 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
* 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 find that this medication is no longer working as well as it should, 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 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.

Special Considerations for Children, Teens, and Pregnant or Breast-feeding Women

In some cases, this medication may affect growth in children and teens. Regular growth checks may be necessary. Discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Vomiting
  • Agitation
  • Tremors
  • Hyperreflexia
  • Muscle twitching
  • Convulsions (may be followed by coma)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth

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. Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis)
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Major Interactions

  • Halogenated Anesthetics (risk of sudden death due to acute increases in heart rate and blood pressure)
  • Vasopressors (potentiates pressor effects)
  • Warfarin (may increase prothrombin time, monitor INR)
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone - may alter plasma concentrations, monitor levels)
  • Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine - may increase plasma concentrations of TCAs, monitor for toxicity)
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Moderate Interactions

  • Antihypertensives (may reduce the effectiveness of antihypertensive drugs)
  • Alcohol (may lead to more rapid release of methylphenidate from extended-release formulations, increasing peak plasma levels)
  • Dopaminergic drugs (e.g., antipsychotics, levodopa - may antagonize effects)
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Minor Interactions

  • Caffeine (additive stimulant effects)

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Stimulants have been associated with growth suppression in children.

Timing: Prior to initiation of therapy.

Psychiatric History (e.g., tics, bipolar disorder, psychosis)

Rationale: Stimulants can exacerbate or unmask psychiatric conditions.

Timing: Prior to initiation of therapy.

Cardiac History and ECG (if indicated)

Rationale: To screen for underlying cardiac conditions that may contraindicate stimulant use.

Timing: Prior to initiation of therapy, especially if cardiac risk factors are present.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At least annually, or more frequently if clinically indicated.

Target: Within normal limits for age/individual.

Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months in children and adolescents.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative therapy.

Psychiatric Symptoms (e.g., agitation, psychosis, tics, mood changes)

Frequency: Regularly at follow-up visits.

Target: Absence of new or worsening symptoms.

Action Threshold: Emergence or worsening of symptoms; consider dose adjustment or discontinuation.

ADHD Symptom Control

Frequency: Regularly at follow-up visits.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hostility
  • Psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, grandiosity)
  • Motor or verbal tics
  • Blurred vision
  • Priapism (rare, but serious)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Data from a pregnancy registry did not show an increased risk of major congenital malformations.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations, though data are conflicting and overall risk appears low.
Second Trimester: No specific data on unique risks.
Third Trimester: Potential for premature birth and low birth weight; withdrawal symptoms in neonates if used late in pregnancy.
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Lactation

L3 (Moderate concern). Methylphenidate is excreted into human milk. Monitor breastfed infants for signs of agitation, insomnia, decreased appetite, or poor weight gain. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for the drug and any potential adverse effects on the breastfed infant.

Infant Risk: Low to moderate. Potential for irritability, poor feeding, and sleep disturbances. Long-term effects are unknown.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly. Long-term effects on growth are not fully established, but some studies suggest a temporary slowing of growth rate. Monitor for emergence or worsening of psychiatric symptoms.

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Geriatric Use

Use with caution in elderly patients. Start with lower doses and titrate slowly. Elderly patients may be more sensitive to the cardiovascular and CNS stimulant effects. Monitor blood pressure and heart rate closely.

Clinical Information

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Clinical Pearls

  • Ritalin LA is an extended-release formulation designed for once-daily dosing, providing approximately 8 hours of effect.
  • Capsules can be swallowed whole or opened and sprinkled on applesauce for patients who have difficulty swallowing pills.
  • Patients should be screened for cardiac abnormalities and psychiatric conditions before starting therapy.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Avoid late afternoon or evening dosing to prevent insomnia.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., Concerta, Daytrana, Quillivant XR, Focalin XR)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulant medications (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy and psychotherapy for ADHD
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Cost & Coverage

Average Cost: Varies widely, typically $50-$300+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (for brand), Tier 1 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.