Ritalin LA 40mg 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 2002
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Ritalin LA is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural substances in the brain that help with focus and impulse control. It's an extended-release capsule, meaning it releases the medicine slowly throughout the day.
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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:

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 specific 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 may be able to sprinkle the contents on applesauce or yogurt. However, do not chew the mixture. Swallow it immediately, and then drink a glass of water or juice. Be sure to check the package insert or consult with your pharmacist to confirm the best approach for your specific medication.
5. Mixing and Taking Your Dose: If you need to mix your medication with food or liquid, take your dose immediately after mixing. 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 cabinet to prevent accidental ingestion.
3. Keep Away from Others: Keep your medication in a safe place where others cannot find or take it.

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.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning to avoid sleep problems.
  • Do not crush, chew, or divide the capsule. It can be opened and 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 ensure adequate sleep.
  • Regularly monitor height and weight in children.
  • Store in a safe place to prevent misuse or abuse.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically first-line for adults; individualized. Max 60 mg/day.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 20 mg orally once daily in the morning. May increase by 10-20 mg weekly to a maximum of 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 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.
Adolescent: For adolescents 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.
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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 well studied; use with caution. Methylphenidate is not significantly dialyzable.

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.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 30-50%
Tmax: Biphasic: 1-2 hours and 4-6 hours (for Ritalin LA)
FoodEffect: Food can delay Tmax by approximately 1 hour but does not significantly affect AUC or Cmax.

Distribution:

Vd: Approximately 2.65 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for Ritalin LA)
Clearance: Not precisely quantified for methylphenidate, but rapid metabolism and excretion.
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: Less than 1% of the dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes
PeakEffect: Biphasic: 1-2 hours and 4-6 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.
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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 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.
Difficulty 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 deaths have 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 immediate medical attention if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting.

Additional Urgent Side Effects:

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 changes in 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 immediate medical attention if you experience hallucinations, changes in behavior, or signs of mood changes like depression, suicidal thoughts, nervousness, emotional ups and downs, 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 immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, fast or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.

Common Side Effects:

Not all medications cause side effects, and many people experience only minor or no side effects. However, if you experience any of the following side effects or if they bother you or persist, contact your doctor or seek medical attention:

Dizziness or headache.
Drowsiness.
Dry mouth.
Stomach pain, upset stomach, vomiting, or decreased appetite.
Heartburn.
Weight loss.
Feeling nervous or excitable.
Difficulty sleeping.
* Nose or throat irritation.

Reporting Side Effects:

This is not an exhaustive list of potential 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.
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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 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 movements or sounds)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Blurred vision or other vision changes
  • Seizures
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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 you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever had a stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
If you are currently taking:
+ Linezolid
+ Methylene blue
* If you have a rare hereditary condition, 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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without consulting your doctor.
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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 have surgery, be sure to discuss this with your doctor.

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, do not take more than the prescribed dose; instead, consult with your doctor.

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 teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary; consult with your doctor to discuss this further.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks 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 (very high fever)
  • Tachycardia (fast heart rate)
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension (high blood pressure)
  • Mydriasis (dilated pupils)
  • Dry mouth and 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.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or use within 14 days of discontinuing an MAOI is contraindicated due to risk of hypertensive crisis.
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Major Interactions

  • Vasopressor Agents: Methylphenidate may potentiate the pressor effect of vasopressor agents.
  • Halogenated Anesthetics: Risk of sudden death when used concomitantly with methylphenidate during surgery.
  • Anticoagulants (e.g., coumarin), Anticonvulsants (e.g., phenobarbital, phenytoin, primidone), Antidepressants (e.g., tricyclic antidepressants, SSRIs): Methylphenidate may inhibit the metabolism of these drugs, requiring dose adjustments.
  • Antihypertensive Drugs: Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
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Moderate Interactions

  • Alcohol: Avoid alcohol due to potential for dose dumping with extended-release formulations.
  • Dopaminergic Drugs (e.g., antipsychotics, dopamine agonists): Potential for additive effects or antagonism.
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Minor Interactions

  • Caffeine: May increase stimulant effects and adverse reactions.

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR, ECG if indicated)

Rationale: To identify pre-existing cardiac conditions or risk factors for adverse cardiovascular events.

Timing: Prior to initiation of therapy

Height and Weight

Rationale: To establish baseline for monitoring growth, especially in pediatric patients.

Timing: Prior to initiation of therapy

Psychiatric history and evaluation

Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis, tics) that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or at least every 3-6 months

Target: Within normal limits for age; monitor for sustained increases

Action Threshold: Sustained clinically significant increases (e.g., >10-20 mmHg systolic/diastolic or >15-20 bpm HR) warrant investigation and potential dose adjustment or discontinuation.

Height and Weight

Frequency: Every 3-6 months in children; annually in adults

Target: Maintain age-appropriate growth trajectory

Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines) warrants investigation and potential drug holiday or alternative therapy.

ADHD symptom control and functional improvement

Frequency: At each visit

Target: Improved attention, reduced impulsivity/hyperactivity, improved academic/social functioning

Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.

Emergence of psychiatric symptoms (e.g., tics, agitation, psychosis, mania, anxiety)

Frequency: At each visit

Target: Absence of new or worsening symptoms

Action Threshold: New onset or worsening of psychiatric symptoms warrants immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope (fainting)
  • Palpitations
  • Hallucinations (visual, tactile, auditory)
  • Paranoia
  • Mania or hypomania
  • Aggression or hostility
  • New or worsening tics
  • Unexplained wounds on fingers or toes (peripheral vasculopathy)
  • Numbness, coolness, or pain in extremities
  • Severe headache
  • Blurred vision
  • Seizures

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. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations, though data are conflicting and limited.
Second Trimester: Limited data; monitor for fetal growth.
Third Trimester: Limited data; monitor for signs of withdrawal in neonate if used close to delivery.
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for agitation, insomnia, decreased weight gain, or poor feeding.

Infant Risk: Low to Moderate (L3)
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) carefully, as stimulants have been associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.

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Geriatric Use

Use with caution in elderly patients, as they may be more sensitive to the effects of stimulants, particularly cardiovascular effects. Start with lower doses and titrate slowly. Monitor blood pressure and heart rate closely.

Clinical Information

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Clinical Pearls

  • Ritalin LA capsules can be opened and the beads sprinkled onto a small amount of applesauce for patients who have difficulty swallowing capsules. The mixture should be consumed immediately without chewing the beads.
  • Administer in the morning to minimize the risk of insomnia.
  • Patients should be advised to avoid alcohol, as it can lead to a rapid release of methylphenidate from the extended-release formulation.
  • 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 storing the medication securely.
  • Consider drug holidays or dose adjustments if growth suppression is observed in children.
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Alternative Therapies

  • Non-stimulant medications for ADHD (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
  • Behavioral therapy
  • Cognitive Behavioral Therapy (CBT)
  • Lifestyle modifications (e.g., exercise, diet, sleep hygiene)
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Cost & Coverage

Average Cost: $150 - $400 per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand)
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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. It is vital to read this guide carefully and review it again whenever your prescription is refilled. 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 the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.