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Methylphenidate 40mg 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 2000
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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 substances in the brain that are important for attention and impulse control. The 'ER' or 'LA' means it's an extended-release form, so it works for a longer period, usually taken 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:

1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your prescription, and follow the instructions carefully.
2. Timing and Food: Take your medication in the morning. Some medications need to be taken with food, while others should be taken on an empty stomach. Check with your pharmacist to determine the best way to take your specific medication.
3. Swallowing Your Medication: Swallow your medication whole. Do not chew, break, or crush it.
4. Alternative Administration: If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce. Do not chew the mixture. Swallow it immediately, and then drink a glass of water or juice. Some products can also be mixed with yogurt. If you're unsure, read the package insert or consult with 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 Away from Moisture: Do not store your medication in a bathroom or other humid environment.

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 take in the late afternoon or evening as it may cause sleep problems.
  • Swallow the capsule whole; do not crush, chew, or divide. Some ER capsules can be opened and sprinkled on a small amount of applesauce, but check specific product instructions.
  • Avoid alcohol, as it can cause rapid release of the medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not share this medication with others, as it is a controlled substance.
  • Store 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: Not typically the first-line for adult ADHD, but can be used. Dosing is individualized.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: For children 6-12 years: Initial dose 20 mg orally once daily in the morning. May increase by 10 mg weekly to a maximum of 60 mg/day.
Adolescent: For adolescents 13-17 years: Initial dose 20 mg orally once daily in the morning. May increase by 10-20 mg weekly to a maximum of 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific 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.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-30% (due to first-pass metabolism)
Tmax: Biphasic: First peak at 1-2 hours, second peak at 4-6 hours (for Ritalin LA)
FoodEffect: High-fat meals can delay Tmax and slightly increase Cmax for some ER formulations, but overall exposure (AUC) is generally not significantly affected. Ritalin LA can be taken with or without food.

Distribution:

Vd: Approximately 2.65 L/kg
ProteinBinding: Approximately 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for Ritalin LA)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes
PeakEffect: 4-6 hours (second peak for ER formulations)
DurationOfAction: Approximately 8-10 hours (for Ritalin LA)
Confidence: Medium

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 treatment.
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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 or 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
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ 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
Difficulty controlling body movements
 Trouble 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 defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly. Seek immediate medical help if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
 If you experience a painful erection (hard penis) or an erection lasting longer than 4 hours, seek medical help right away. This can occur even when not having sex, and if left untreated, may lead to lasting sexual problems.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
+ Inform your doctor if you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide. Seek immediate medical help 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
 A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical help 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

Other Possible Side Effects

Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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

This is not an exhaustive list of possible 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 tics (uncontrolled movements or sounds)
  • New or worsening aggressive behavior or hostility
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that aren't true)
  • Manic symptoms (e.g., feeling unusually excited, irritable, or having racing thoughts)
  • Blurred vision or other vision changes
  • Prolonged or painful erections (priapism, rare but serious)
  • Unexplained numbness, tingling, or color changes in fingers or toes (Raynaud's phenomenon)
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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. Be sure to describe the allergic reaction and its symptoms.
 Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
A family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 A history of stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine the safety of taking this medication with your other treatments and health issues. Never start, stop, or change the dose of any medication without consulting your doctor first.
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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 crucial for ensuring your safety and proper care. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

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 need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

Interactions with Other Substances

Avoid consuming alcohol while taking this medication. Limit your intake of caffeine (found in tea, coffee, cola, and chocolate) as it may cause nervousness, shakiness, and a rapid heartbeat when combined with this medication. 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 with your doctor.

Allergies and Sensitivities

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

Special Considerations for Children and Teens

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

Pregnancy and Breastfeeding

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 emergency number immediately. For poison control, call 1-800-222-1222. Seek immediate medical attention. Management is primarily supportive, including gastric lavage, activated charcoal, and sedation for severe agitation or seizures.

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

  • Vasopressors (may potentiate pressor effects)
  • Halogenated Anesthetics (risk of sudden blood pressure and heart rate increases during surgery)
  • Anticoagulants (e.g., warfarin - may inhibit metabolism, increasing levels)
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone - may inhibit metabolism, increasing levels)
  • Tricyclic Antidepressants (TCAs - e.g., imipramine, desipramine - may inhibit metabolism, increasing levels)
  • Selective Serotonin Reuptake Inhibitors (SSRIs - potential for serotonin syndrome, though less common than with amphetamines)
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Moderate Interactions

  • Antihypertensives (may reduce the hypotensive effect of these drugs)
  • Dopaminergic drugs (e.g., levodopa, bromocriptine - potential for additive effects)
  • Alcohol (may accelerate release of methylphenidate from some ER formulations, leading to dose dumping)
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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 (hypertension, tachycardia).

Timing: Prior to initiation of treatment.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation of treatment.

Psychiatric History (e.g., tics, psychosis, bipolar disorder)

Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new ones.

Timing: Prior to initiation of treatment.

Cardiac History (e.g., family history of sudden death, structural cardiac abnormalities)

Rationale: Risk of serious cardiovascular events.

Timing: Prior to initiation of treatment (consider ECG if clinically indicated).

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Target: Within normal limits for age/individual.

Action Threshold: Sustained elevation requiring intervention or discontinuation.

Height and Weight

Frequency: Every 3-6 months (pediatric patients).

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric Symptoms (e.g., tics, aggression, anxiety, psychosis, mania)

Frequency: At each visit.

Target: Absence or control of symptoms.

Action Threshold: Emergence or worsening of symptoms.

ADHD Symptom Control and Functional Improvement

Frequency: At each visit.

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

Action Threshold: Lack of efficacy or worsening of ADHD symptoms.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening tics
  • Aggression
  • Hostility
  • New psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, grandiosity, decreased need for sleep)
  • Severe anxiety or agitation
  • Unexplained weight loss
  • Blurred vision
  • Priapism (rare, but serious)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data from observational studies suggest a possible increased risk of cardiac malformations and other congenital malformations with first-trimester exposure.

Trimester-Specific Risks:

First Trimester: Possible increased risk of cardiac malformations (e.g., ventricular septal defect) and other congenital malformations based on some observational studies, though data are conflicting and confounding factors exist.
Second Trimester: Not well-studied, but generally considered lower risk for major malformations compared to first trimester.
Third Trimester: Risk of premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremor, poor feeding) have been reported with stimulant use near term.
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Lactation

Methylphenidate is excreted into breast milk. Monitor breastfed infants for adverse reactions such as agitation, insomnia, anorexia, or reduced weight gain. Weigh the developmental and health benefits of breastfeeding along with the mother’s clinical need for methylphenidate and any potential adverse effects on the breastfed infant.

Infant Risk: Low to moderate risk. Monitor for irritability, poor feeding, and sleep disturbances. Long-term effects on neurodevelopment are unknown.
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Pediatric Use

Approved for ADHD in 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 and tics.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Methylphenidate ER (LA) capsules typically provide 8-10 hours of symptom control, making them suitable for once-daily morning dosing.
  • Patients should be screened for cardiac abnormalities and psychiatric conditions (e.g., bipolar disorder, psychosis, tics) prior to initiation.
  • Monitor blood pressure and heart rate regularly, as stimulants can cause dose-related increases.
  • Growth suppression is a concern in pediatric patients; monitor height and weight and consider drug holidays if growth is significantly affected.
  • High potential for abuse and dependence; assess risk and monitor for signs of misuse.
  • Advise patients not to crush or chew extended-release capsules to avoid dose dumping and potential overdose.
  • Some formulations allow sprinkling contents on applesauce for patients who have difficulty swallowing capsules whole.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., Concerta, Daytrana, Focalin XR, Quillivant XR, Adhansia XR, Aptensio XR, Jornay PM)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine, Zenzedi)
  • Non-stimulants (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree), Bupropion (Wellbutrin))
  • Behavioral therapy and psychotherapy
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Cost & Coverage

Average Cost: Varies widely, e.g., $150-$400+ per 30 capsules (40mg ER)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generic often Tier 1 or 2, brand Tier 3)
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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 resource for patients. 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, 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.