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Methylphenidate 20mg ER (la) Caps

Manufacturer SANDOZ 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?

Methylphenidate is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural substances in the brain that are involved in attention and impulse control. The 'ER' or 'LA' means it's an extended-release form, so it works over a longer period, usually once a 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:

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 can 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 first.
After mixing your medication with food, take your dose right away. Do not prepare a dose in advance or store it 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 to prevent accidental ingestion.
* Keep all medications out of reach of pets.

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. Do not crush, chew, or divide extended-release capsules.
  • Avoid alcohol, as it can cause the medication to be released too quickly.
  • Maintain a healthy diet and regular sleep schedule, as stimulants can affect appetite and sleep.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Store medication securely to prevent misuse or abuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

ADHD: Initial dose 20 mg once daily; may be titrated weekly in 10-20 mg increments 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 dose 20 mg orally once daily in the morning; may be titrated weekly in 10-20 mg increments to a maximum of 60 mg/day.
Adolescent: For adolescents 13-17 years: Initial dose 20 mg orally once daily in the morning; may be titrated weekly in 10-20 mg increments to a maximum of 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. Monitor for adverse effects.
Dialysis: Not available. Methylphenidate is not significantly dialyzable.

Hepatic Impairment:

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

Pharmacology

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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 exact mechanism by which it produces its therapeutic effects in ADHD is not fully understood but is thought to involve modulation of dopaminergic and noradrenergic pathways in the brain.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-28% (due to first-pass metabolism)
Tmax: Biphasic absorption for ER formulations: first peak at 1-2 hours, second peak at 4-7 hours.
FoodEffect: Food does not significantly affect the extent of absorption (AUC) but may delay Tmax by approximately 1 hour for some ER formulations.

Distribution:

Vd: Approximately 2.65 L/kg
ProteinBinding: Approximately 15% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for ER formulations, effective half-life may be longer due to extended release)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (90% as PPAA, 1% as unchanged drug)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER formulations)
PeakEffect: Approximately 4-7 hours (for ER formulations)
DurationOfAction: Approximately 8-10 hours (for Ritalin LA, other ER formulations may vary)

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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
 Joint pain
Purple patches on the skin or mouth
 Changes in eyesight 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 trouble urinating
Changes in sex interest
 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. If you have a heart condition or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, tell your doctor. 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 that lasts longer than 4 hours (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
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, inform your doctor. Seek medical help immediately 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 lack of interest in life
 Serotonin syndrome, a potentially life-threatening condition, may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache

Common Side Effects

Most people experience no side effects or only minor side effects. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Dizziness or headache
 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, 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, hostility, or irritability
  • New or worsening tics (uncontrolled movements or sounds)
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • Unexplained numbness, pain, or discoloration in fingers or toes
  • Prolonged or painful erections (priapism)
  • Blurred vision or other eye problems
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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 conditions and situations to ensure safe treatment:

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.
 Existing health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
Family medical history, particularly if you or a family member has:
+ 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 these medications with this drug 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 (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 existing treatments and health status. Never start, stop, or change 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. This is especially important if you are scheduled to have surgery, as your doctor may need to adjust your treatment plan.

Precautions to Take While Using This Medication

Until you know how this medication affects you, avoid driving and engaging in activities that require you to be alert. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may also 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. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and chocolate) as it may interact with this medication and 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 experience a decrease in the medication's effectiveness, 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 factors 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 Breastfeeding Women

This medication may affect growth in children and teens. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns.

If you are pregnant, plan to become pregnant, or are breastfeeding, 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)
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (very high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth and mucous membranes

What to Do:

Call 911 or your local poison control center (1-800-222-1222 in the US) immediately. Seek emergency medical attention. Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms.

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: May potentiate the pressor effect of vasopressors.
  • Halogenated Anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
  • Antipsychotics (e.g., risperidone, haloperidol): May antagonize the effects of methylphenidate or exacerbate tics.
  • Antidepressants (e.g., tricyclics, SSRIs): May increase plasma levels of antidepressants or methylphenidate; caution with serotonin syndrome risk.
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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 these drugs, requiring dose adjustment.
  • Antihypertensive drugs: May reduce the effectiveness of antihypertensive drugs.
  • Alcohol: May lead to dose dumping of methylphenidate from some ER formulations.
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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: Methylphenidate can cause dose-related increases in BP and HR. Baseline assessment is crucial.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Stimulants are associated with growth suppression in pediatric patients.

Timing: Prior to initiation of therapy.

Cardiac History (personal and family)

Rationale: To identify pre-existing cardiac conditions that may contraindicate or require caution with stimulant use (e.g., structural cardiac abnormalities, arrhythmias).

Timing: Prior to initiation of therapy.

Psychiatric History (personal and family)

Rationale: To identify risk factors for psychiatric adverse events (e.g., bipolar disorder, psychosis, tics).

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: Maintain within normal limits for age/sex.

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant investigation, dose reduction, or discontinuation.

Height and Weight

Frequency: Every 3-6 months in pediatric patients; annually in adults.

Target: Maintain normal growth trajectory in children; stable weight in adults.

Action Threshold: Significant growth deceleration or weight loss may require dose adjustment or drug holiday.

ADHD Symptom Control

Frequency: At each visit (e.g., every 1-3 months during titration, then every 3-6 months).

Target: Improved attention, reduced hyperactivity/impulsivity.

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

Emergence of Psychiatric Symptoms

Frequency: At each visit.

Target: Absence of new or worsening psychosis, mania, aggression, anxiety, or tics.

Action Threshold: New onset or worsening of these symptoms requires immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening tics
  • Hallucinations
  • Delusional thinking
  • Mania
  • Aggression
  • Severe anxiety
  • Unexplained weight loss
  • Sleep disturbances

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. Data from observational studies suggest a possible increased risk of cardiac malformations with first-trimester exposure, but these findings are inconsistent.

Trimester-Specific Risks:

First Trimester: Possible increased risk of cardiac malformations (e.g., ventricular septal defects) based on some observational studies, though data are conflicting and overall risk appears low.
Second Trimester: No specific data indicating increased risk.
Third Trimester: Risk of premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremor, poor feeding) have been reported following chronic maternal use.
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Lactation

L3 (Moderate risk). Methylphenidate is excreted into breast milk. Monitor breastfed infants for adverse effects such as agitation, insomnia, decreased appetite, or poor weight gain. Consider alternative therapies or discontinuing breastfeeding, especially for neonates or infants with cardiac conditions.

Infant Risk: Low to moderate. Potential for irritability, sleep disturbances, and decreased appetite in the infant. Long-term effects on neurodevelopment are unknown.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).

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Geriatric Use

Safety and efficacy have not been established in patients over 65 years of age. Use with caution due to increased sensitivity to stimulant effects, potential for cardiovascular events, and comorbidities. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Extended-release formulations are designed for once-daily dosing, providing symptom control throughout the school/work day.
  • Patients should be screened for cardiac disease and psychiatric comorbidities before initiating therapy.
  • Monitor blood pressure and heart rate regularly, as stimulants can cause clinically significant increases.
  • Growth suppression is a concern in pediatric patients; monitor height and weight and consider drug holidays if growth is affected.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., severe fatigue, depression).
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, transdermal patch, chewable tablets, oral suspension)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy, psychotherapy
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Cost & Coverage

Average Cost: Varies widely, e.g., $100-$400+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for generics); Tier 3 or Tier 4 (for brands)
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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 crucial 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. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.