Ritalin LA 20mg 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 used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural substances in the brain that are important for attention and impulse control. The 'LA' means 'long-acting,' so it's usually taken once a day in the morning.
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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 is Important: Take your medication in the morning.
3. Food and Drug Interactions: 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.
4. Swallowing Your Medication: Swallow your medication whole. Do not chew, break, or crush it.
5. Alternative Administration: If you have trouble swallowing capsules, you may sprinkle the contents on 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're unsure, consult the package insert or talk to your pharmacist.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

1. Store at Room Temperature: Keep your medication at room temperature, away from light and moisture.
2. Protect from Children and Pets: Store your medication in a secure location where children and pets cannot access it. Consider using a locked box or area to prevent accidental ingestion.
3. Keep it Dry: Store your medication in a dry place, away from bathrooms and other areas prone to moisture.

What to Do if You Miss a Dose

If you miss a dose, skip it and resume your regular dosing 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. Taking it later in the day may cause sleep problems.
  • Swallow the capsule whole. Do not crush, chew, or divide the capsule. If swallowing is difficult, the capsule may be opened and the entire contents sprinkled on a small amount of applesauce and consumed immediately.
  • Avoid alcohol, as it can cause the medication to be released too quickly.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • For children, monitor height and weight regularly to ensure proper growth.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg once daily in the morning
Dose Range: 10 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 20 mg once daily in the morning. May increase by 10-20 mg weekly. Max 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6 years and older: Initial 20 mg once daily in the morning. May increase by 10-20 mg weekly. Max 60 mg/day.
Adolescent: Initial 20 mg 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 dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.
Dialysis: Not available

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.

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: Not available (relative bioavailability compared to immediate-release is similar)
Tmax: Biphasic: First peak ~1-2 hours, second peak ~4-6 hours
FoodEffect: Food can delay Tmax but does not significantly affect AUC (total exposure).

Distribution:

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

Elimination:

HalfLife: Approximately 3-4 hours (for extended-release formulation)
Clearance: Not available
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1% (methylphenidate) and ~80% (ritalinic acid) in urine
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Approximately 4-6 hours (second peak)
DurationOfAction: Approximately 8 hours

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Ritalin LA, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor patients for signs of abuse and dependence while on therapy. Serious cardiovascular reactions, including sudden death, have been reported in association with CNS stimulant treatment in patients with pre-existing structural cardiac abnormalities or other serious heart problems. Psychiatric adverse reactions, including exacerbation of pre-existing psychosis, induction of manic episodes, and new psychotic or manic symptoms, have been reported.
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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, 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
Difficulty 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, balance problems, drooping on one side of the face, or blurred vision

Heart Problems:

If you have a heart condition or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or has died suddenly, notify your doctor. Seek medical help immediately if you experience:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Other Serious Side Effects:

Prolonged or painful erections (lasting more than 4 hours) can lead to permanent sexual dysfunction if not treated promptly.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life

Serotonin Syndrome:

A potentially life-threatening condition called serotonin syndrome can occur when taking 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

Common Side Effects:

Many people may not experience any side effects or only minor ones. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Dizziness or headache
Drowsiness
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 want to report any, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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 aggressive behavior or hostility
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • New manic symptoms (e.g., extreme elation, irritability, racing thoughts)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Blurred vision
  • Prolonged or painful erections (priapism)
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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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. 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 beforehand.

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult with your doctor.

While taking this medication, it is recommended that you avoid consuming alcohol and limit your intake of caffeine (found in tea, coffee, cola, and chocolate), as combining these substances may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, it is crucial to discuss the use of over-the-counter (OTC) products with your doctor before taking them, as some may increase blood pressure. These products include cough and 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 and potentially requiring higher doses to achieve the same effect. If you notice that the medication is no longer working as well, contact your doctor. Do not exceed the prescribed dose.

This medication may increase the risk of seizures in certain 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.

If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.

In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks. Discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, 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.
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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
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dryness of mucous membranes

What to Do:

Call 1-800-222-1222 (Poison Control) or seek emergency medical attention immediately.

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 increases in blood pressure and heart rate during surgery)
  • Vasopressors (may potentiate pressor effects)
  • Coumarin Anticoagulants (may increase prothrombin time)
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone - may alter their plasma concentrations)
  • Tricyclic Antidepressants (TCAs) and Selective Serotonin Reuptake Inhibitors (SSRIs) (may inhibit metabolism of TCAs/SSRIs, increasing their levels; potential for serotonin syndrome with SSRIs)
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Moderate Interactions

  • Antihypertensive Drugs (may reduce the effectiveness of antihypertensives)
  • Alcohol (risk of 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 (additive stimulant effects)

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To identify pre-existing cardiovascular conditions and monitor for stimulant-induced increases.

Timing: Prior to initiation

Height and Weight (Pediatric Patients)

Rationale: To establish baseline growth parameters and monitor for growth suppression.

Timing: Prior to initiation

Psychiatric History (including family history of sudden death, ventricular arrhythmia, or psychiatric disorders)

Rationale: To assess risk for serious cardiovascular or psychiatric adverse events.

Timing: Prior to initiation

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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/sex

Action Threshold: Persistent elevation requiring intervention or dose adjustment.

Height and Weight (Pediatric Patients)

Frequency: Every 3-6 months

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric Symptoms (e.g., new or worsening psychosis, mania, aggression, anxiety)

Frequency: Regularly at follow-up visits

Target: Absence of new or worsening symptoms

Action Threshold: Emergence of new psychotic/manic symptoms, severe anxiety, or aggression requiring intervention.

CBC with differential (for long-term therapy)

Frequency: Periodically (e.g., annually)

Target: Within normal limits

Action Threshold: Significant abnormalities (e.g., leukopenia, thrombocytopenia) requiring investigation.

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Symptom Monitoring

  • Insomnia
  • Decreased appetite/weight loss
  • Nervousness/agitation
  • Headache
  • Abdominal pain
  • Palpitations
  • Chest pain
  • Shortness of breath
  • Fainting
  • New or worsening tics
  • Blurred vision
  • Peripheral vasculopathy (e.g., Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown some evidence of developmental toxicity at doses higher than therapeutic human doses.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations (e.g., ventricular septal defects) based on some observational studies, though data are conflicting and limited.
Second Trimester: Not specifically studied, but general risks of stimulant exposure may apply.
Third Trimester: Potential for premature delivery and low birth weight. Neonates exposed to amphetamines during pregnancy may experience withdrawal symptoms (e.g., dysphoria, agitation) post-delivery.
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Lactation

Methylphenidate is excreted into human milk. Monitor breastfed infants for signs of adverse reactions such as agitation, insomnia, anorexia, or decreased weight gain. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Ritalin LA, and any potential adverse effects on the breastfed infant from Ritalin LA or from the underlying maternal condition.

Infant Risk: Low to moderate risk. Monitor for irritability, poor feeding, and sleep disturbances.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) and cardiovascular parameters. Long-term safety and efficacy in children younger than 6 years have not been established.

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Geriatric Use

Clinical studies of Ritalin LA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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.
  • The capsule can be opened and sprinkled on applesauce for patients who have difficulty swallowing pills, but the entire contents must be consumed immediately without chewing.
  • Patients should be advised to take the medication in the morning to avoid insomnia.
  • Regular monitoring of blood pressure and heart rate is crucial due to the cardiovascular effects of stimulants.
  • In pediatric patients, growth (height and weight) should be monitored regularly due to the potential for growth suppression.
  • Patients should be screened for pre-existing cardiac conditions and psychiatric disorders before initiating therapy.
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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)
  • Behavioral therapy and psychotherapy
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Cost & Coverage

Average Cost: $200 - $400 per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand), Tier 1 (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, a patient fact sheet that provides important information. 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.