Ritalin LA 30mg 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 an extended-release capsule used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It helps improve focus, reduce impulsivity, and control hyperactivity by affecting certain natural chemicals in the brain.
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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.
Check with your pharmacist to determine if your medication should be taken with food, on an empty stomach, or if it doesn't matter.
Swallow your medication whole; do not chew, break, or crush it.
If you have trouble swallowing the capsule, you may sprinkle its contents onto applesauce. Do not chew the mixture; swallow it immediately and follow with a glass of water or juice. Some products can also be mixed with yogurt, but be sure to check the package insert or consult with your pharmacist if you're unsure.
After mixing your medication with food, take your dose right away; do not store the mixture for later use.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

Store it at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Store your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area.
* Keep all medications out of reach of pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and return to your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning. Do not take in the late afternoon or evening to avoid 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 contents sprinkled over 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 normal 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 dose 20 mg once daily in the morning. May be titrated in 10-20 mg increments weekly to a maximum of 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6 years and older: Initial dose 10-20 mg once daily in the morning. May be titrated in 10 mg increments weekly to a maximum of 60 mg/day.
Adolescent: Initial dose 10-20 mg once daily in the morning. May be titrated in 10-20 mg increments weekly to a maximum of 60 mg/day.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.

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 therapeutic effect in ADHD is believed to be related to the increased availability of dopamine and norepinephrine in the prefrontal cortex, which improves attention, impulse control, and hyperactivity.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (relative bioavailability compared to immediate-release is similar)
Tmax: Biphasic: First peak at approximately 1.5 hours, second peak at approximately 4.5 hours.
FoodEffect: Food does not significantly affect the extent of absorption (AUC) but may delay Tmax by approximately 1 hour.

Distribution:

Vd: Not available (estimated 2.65 L/kg)
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate), 2.4 hours (for ritalinic acid)
Clearance: Not available
ExcretionRoute: Renal (approximately 90% as ritalinic acid, <1% as unchanged drug)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes
PeakEffect: Approximately 4-5 hours (for the second peak of extended release)
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 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, 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, such as pale, blue, gray, purple, or red hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the 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 heart 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 immediate medical attention 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, which can occur even when not having sex. If left untreated, this may lead to lasting sexual problems.
New or worsening behavior and mood changes, such as:
+ Changes in thinking
+ Anger
+ 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. Seek immediate medical attention if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life
Serotonin syndrome, a potentially life-threatening condition, may occur when taking this medication with certain other drugs. Seek immediate medical attention 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

Most people do not experience serious side effects, but some may occur. 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
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 want to report any side effects, contact your doctor or 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 aggression, hostility, or irritability
  • New psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • Manic symptoms (e.g., feeling overly excited, racing thoughts, decreased need for sleep)
  • Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes
  • Blurred vision or other vision changes
  • Severe headache
  • Unexplained weight loss or loss of appetite that is concerning
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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. Be sure to 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 inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins

Your doctor needs to be aware of all your medications and health conditions to ensure it is safe for you to take 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 the 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, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.

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 (high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dryness of mucous membranes

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. 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): Concomitant use or within 14 days of discontinuing an MAOI due to risk of hypertensive crisis.
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Major Interactions

  • Vasopressors (e.g., phenylephrine, epinephrine): May potentiate the pressor effect of vasopressors.
  • Halogenated Anesthetics (e.g., halothane, isoflurane): Risk of sudden blood pressure and heart rate increases during surgery.
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Moderate Interactions

  • Anticoagulants (e.g., warfarin): May inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of certain anticonvulsants, requiring dose adjustment.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs): May inhibit metabolism of certain antidepressants, requiring dose adjustment. Increased risk of serotonin syndrome with serotonergic agents.
  • Dopaminergic drugs (e.g., bupropion, levodopa): Increased risk of dopaminergic adverse effects.
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Minor Interactions

  • Alcohol: May accelerate the release of methylphenidate from the extended-release formulation, leading to a more rapid absorption and higher peak plasma concentrations.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: CNS stimulants can cause increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Monitor for potential growth suppression in pediatric patients.

Timing: Prior to initiation of therapy.

Cardiac History (personal and family)

Rationale: Assess for pre-existing cardiac conditions that may contraindicate stimulant use.

Timing: Prior to initiation of therapy.

Psychiatric History (personal and family)

Rationale: Assess for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) 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: Regularly (e.g., at each visit or every 3-6 months)

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 (pediatric patients)

Target: Normal growth trajectory

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

ADHD Symptom Control

Frequency: Regularly (e.g., at each visit)

Target: Improved attention, reduced hyperactivity/impulsivity

Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative therapy.

Emergence/Worsening of Psychiatric Symptoms

Frequency: Regularly (e.g., at each visit)

Target: Absence of new or worsening psychosis, mania, aggression, or suicidal ideation.

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

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • New psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
  • Severe anxiety or agitation
  • Unexplained weight loss
  • Insomnia
  • Anorexia

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of developmental toxicity at high doses. Limited human data suggest no increased risk of major congenital malformations, but some studies suggest a small increased risk of cardiac malformations.

Trimester-Specific Risks:

First Trimester: Potential small increased risk of cardiac malformations, though data are conflicting and limited.
Second Trimester: Not well-studied, but generally considered lower risk for structural malformations compared to first trimester.
Third Trimester: Potential for premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremors) have been reported with chronic maternal use near term.
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Lactation

Methylphenidate is excreted into human milk. Monitor breastfed infants for adverse reactions such as agitation, insomnia, anorexia, or reduced weight gain. Weigh the developmental and health benefits of breastfeeding against the mother's clinical need for Ritalin LA and any potential adverse effects on the breastfed infant.

Infant Risk: L3 (Moderately Safe). Low levels in milk, but potential for infant effects. Monitor infant closely.
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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.

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Geriatric Use

Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to stimulant effects (e.g., cardiovascular effects, anxiety, insomnia). Start with lower doses and titrate slowly.

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 whole capsules.
  • Counsel patients on the importance of taking the medication in the morning to avoid insomnia.
  • 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 safe storage.
  • Consider drug holidays (e.g., weekends, school breaks) for pediatric patients to assess ongoing need and potentially mitigate growth suppression, under physician guidance.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., Concerta, Daytrana, Quillivant XR, Aptensio XR, Jornay PM, immediate-release methylphenidate)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy, psychotherapy, educational interventions
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Cost & Coverage

Average Cost: Varies widely (e.g., $200-$400+) 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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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 detailed information, including the substance taken, the amount, and the time it occurred.