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Methylphenidate 10mg 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 Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor
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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 stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals 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 for a longer period throughout the day, usually taken once 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:

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 a capsule, you can sprinkle the contents onto applesauce, but 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; consult the package insert or speak with your pharmacist if you're unsure.
After mixing your medication with food, take your dose right away and 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 afternoon or evening as it may cause sleep problems.
  • Swallow capsules whole; do not crush, chew, or divide the capsule contents, as this will destroy the extended-release properties.
  • Avoid alcohol, as it may increase side effects and alter drug release.
  • Maintain a healthy diet and regular exercise, as appetite suppression and weight loss can occur.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Store safely to prevent misuse or abuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

ADHD: Initial: 20 mg once daily in the morning. Max: 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial (6-12 years): 10-20 mg once daily in the morning. May increase by 10 mg weekly. Max: 60 mg/day.
Adolescent: Initial (13-17 years): 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 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, monitor for adverse effects.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The precise mechanism of action in ADHD is not fully understood.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-25% (due to first-pass metabolism)
Tmax: Bimodal: First peak ~1-2 hours, second peak ~4-5 hours (for extended-release formulations)
FoodEffect: Food does not significantly alter the extent of absorption but may delay the first peak Tmax by approximately 1 hour.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for extended-release formulations)
Clearance: Approximately 9.9 L/hr/kg
ExcretionRoute: Renal (approximately 78-97% as ritalinic acid, <1% as unchanged drug)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Bimodal: First peak ~1-2 hours, second peak ~4-5 hours
DurationOfAction: Approximately 8 hours

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, 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 death has occurred in people with certain heart problems or defects; if you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor

If you experience any signs of heart problems, such as chest pain, irregular heartbeat, shortness of breath, or severe dizziness, seek medical help immediately.

Additional Urgent Side Effects:

 Prolonged or painful erections (lasting more than 4 hours); if left untreated, this can lead to permanent sexual dysfunction
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations; if you or a family member have a history of mental health conditions (e.g., depression, bipolar disorder) or suicidal tendencies, inform your doctor
 Serotonin syndrome, a potentially life-threatening condition, can occur when taking this medication with certain other drugs; seek medical help immediately if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or irregular heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache

Common Side Effects:

While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience 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 or excitable
 Difficulty sleeping
* Nose or throat irritation

Reporting 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 aggression, hostility, or irritability
  • New psychotic symptoms (e.g., hallucinations, delusions)
  • New manic symptoms (e.g., extreme elation, racing thoughts)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Blurred vision or other vision changes
  • Uncontrolled tics or muscle movements
  • Severe headache
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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 circumstances 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.
 Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
Family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (as this may lead to very high blood pressure)
 Current use of:
+ Linezolid
+ Methylene blue
* Rare hereditary conditions, including:
+ Glucose-galactose malabsorption
+ Fructose intolerance
+ Sucrase-isomaltase deficiency (note: some products contain sucrose)

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine the safety of taking this medication with your existing treatments and conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & 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. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may also need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these 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 use or high doses 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 notice that this medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose.

This medication may increase the risk of seizures in 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, so consult with your doctor. If you are pregnant, plan to become pregnant, or are breastfeeding, 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)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dry mouth

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Management is primarily supportive, including gastric lavage, activated charcoal, and sedation for severe agitation or seizures. Monitor vital signs and cardiac rhythm.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
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Major Interactions

  • Vasopressors (e.g., phenylephrine, epinephrine, dopamine) - risk of hypertensive crisis
  • Halogenated Anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery
  • Antipsychotics (e.g., haloperidol, risperidone) - potential for opposing effects or exacerbation of tics
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - theoretical risk of serotonin syndrome (though less common than with amphetamines)
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Moderate Interactions

  • Anticoagulants (e.g., warfarin) - may inhibit metabolism, increasing anticoagulant effect
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels
  • Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, increasing TCA levels
  • Antihypertensives - may reduce the hypotensive effect of these drugs
  • Alcohol - may increase plasma levels of methylphenidate and lead to dose dumping with 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: Risk of cardiovascular adverse events (e.g., hypertension, tachycardia)

Timing: Prior to initiation

Height and Weight

Rationale: Risk of growth suppression in pediatric patients

Timing: Prior to initiation

Psychiatric History (including family history of sudden death or serious cardiac disease)

Rationale: Risk of exacerbating pre-existing psychiatric conditions or unmasking new ones; identify cardiac risk factors

Timing: Prior to initiation

ECG (if clinically indicated)

Rationale: To screen for underlying cardiac abnormalities in patients with cardiac risk factors or concerning symptoms

Timing: Prior to initiation (if indicated)

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each dose adjustment and at least every 3-6 months

Target: Within normal limits for age

Action Threshold: Persistent elevation above 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 treatment

ADHD Symptom Control

Frequency: Regularly (e.g., monthly initially, then every 3-6 months)

Target: Improved attention, reduced hyperactivity/impulsivity

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

Emergence/Worsening of Psychiatric Symptoms (e.g., psychosis, mania, aggression, anxiety)

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

Target: Absence of new or worsening symptoms

Action Threshold: New onset or worsening; consider discontinuation or psychiatric evaluation

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Depressed mood
  • Tics or dyskinesias
  • Numbness, coolness, or pain in digits (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes

Special Patient Groups

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Pregnancy

Methylphenidate is Pregnancy Category C. Studies in animals have shown adverse effects on fetal development at doses several times the human dose. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations (e.g., atrial septal defects) based on some observational studies, though data are conflicting and overall risk appears low.
Second Trimester: Limited data, generally considered lower risk than first trimester for structural malformations.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms (e.g., agitation, tremor, poor feeding) in the neonate if used close to delivery.
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Lactation

Methylphenidate is excreted into human milk. The relative infant dose is low (0.2-0.7%), and adverse effects in breastfed infants are generally not expected. However, monitor the infant for agitation, insomnia, or poor weight gain. Use with caution.

Infant Risk: L3 (Moderate risk) - Monitor for irritability, insomnia, decreased appetite, or poor weight gain. Consider alternative if infant shows adverse effects.
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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 increased sensitivity to stimulant effects and higher prevalence of cardiovascular conditions. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Methylphenidate ER (LA) capsules contain two types of beads: immediate-release and extended-release, providing a bimodal release profile.
  • Patients should be advised to swallow the capsule whole. If swallowing is difficult, the capsule may be opened and the beads sprinkled onto a small amount of applesauce and consumed immediately.
  • Consider a drug holiday (e.g., weekends or school breaks) to assess the need for continued therapy and to mitigate potential growth suppression, though this should be discussed with a healthcare provider.
  • Monitor for signs of diversion or abuse, especially in adolescents and young adults.
  • Patients with pre-existing cardiac conditions or structural heart abnormalities should generally not use methylphenidate.
  • Be aware of the potential for Raynaud's phenomenon (peripheral vasculopathy) and priapism, though rare.
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Alternative Therapies

  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse)
  • Other methylphenidate formulations (e.g., Concerta, Focalin XR, Daytrana patch)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
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Cost & Coverage

Average Cost: $50 - $200 per 30 capsules (10mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or 4 (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 your safety, 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, we encourage you to discuss them with 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.