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Methylphenidate 30mg ER (la) Caps

Manufacturer MAYNE 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
May 2000
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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 chemicals in the brain that are involved in attention and impulse control. The extended-release (ER) capsule is designed to release the medication slowly throughout the day, so you usually only need to take it 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:

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 medication.
3. Swallowing Your Medication: Swallow the 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, consult the package insert or talk to your pharmacist.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

1. Store at Room Temperature: Keep your medication at room temperature, away from light and moisture.
2. Protect from Children and Pets: Store your medication in a secure location where children and pets cannot access it. Consider using a locked box or area to prevent accidental ingestion.
3. Keep 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 the capsule whole with water; do not crush, chew, or divide it.
  • Take it consistently at the same time each morning, with or without food.
  • Avoid alcohol, as it can cause the medication to be released too quickly.
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
  • Report any new or worsening heart problems, mental health changes, or circulation problems in fingers/toes.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

ADHD: Initial: 20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max: 60 mg/day.
Narcolepsy: Not typically indicated for narcolepsy in ER formulation; immediate-release is preferred. If used, dose titration would be similar to ADHD but off-label.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial: 20 mg orally once daily in the morning. May increase by 10 mg weekly. Max: 60 mg/day.
Adolescent: 13-17 years: Initial: 20 mg orally once daily in the morning. May increase by 10-20 mg weekly. Max: 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended. Use with caution due to potential for accumulation of metabolites.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended. Use with caution due to potential for altered metabolism.
Confidence: Medium

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 22-25% (due to first-pass metabolism)
Tmax: Biphasic: First peak at 1-2 hours, second peak at 4-5 hours (for ER formulations)
FoodEffect: High-fat meal may delay Tmax by approximately 2.5 hours and increase Cmax by 25-30% for some ER formulations, but overall absorption is not significantly affected. Should be taken consistently with or without food.

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 can be longer due to extended release)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Renal (primarily as PPAA)
Unchanged: Less than 1% (as unchanged drug)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER formulations)
PeakEffect: Approximately 4-5 hours (for ER formulations)
DurationOfAction: Approximately 8-10 hours (for ER formulations)

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 patients 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
 Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
 Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
 Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
 Muscle pain or weakness, dark urine, or difficulty urinating
Changes in sex drive
 Weakness on one side of the body, trouble speaking or thinking, balance problems, drooping on one side of the face, or blurred vision

Heart Problems: Important Warning

Sudden deaths have occurred in people with certain heart problems or defects. Inform your doctor if you have any heart condition or defect. Also, let your doctor know if a family member has an abnormal heartbeat or has 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 or prolonged erections (lasting more than 4 hours): Seek medical help right away to avoid long-term 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 has a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide.
 Call your doctor immediately if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life

Serotonin Syndrome: A Potentially Life-Threatening Condition

This medication can cause a severe and potentially deadly condition called serotonin syndrome when taken with certain other medications. Seek medical help right away 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 notice 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
Drowsiness
 Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
 Heartburn
Weight loss
 Feeling nervous and excitable
Trouble sleeping
 Nose or throat irritation

Reporting Side Effects

If you have questions 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 (signs of heart problems)
  • Numbness, coolness, or pain in fingers or toes (signs of circulation problems)
  • New or worsening aggression, hostility, or irritability
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New or worsening tics (uncontrolled movements or sounds)
  • Unexplained fever, muscle stiffness, or confusion (signs of neuroleptic malignant syndrome-like reaction)
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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 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 (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 Previous medical events, such as a 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 inform your doctor and pharmacist about all your medications, including:

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

Your doctor will assess the safety of taking this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

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.

Precautions and Warnings

Until you know how this medication affects you, avoid driving and other activities that require your full attention.
 As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring.
You may need to undergo certain heart tests before starting this medication. If you have any questions or concerns, discuss them with your doctor.
 It is recommended to avoid consuming alcohol while taking this medication.
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.

Interactions with Other Medications

If you have high blood pressure, consult your doctor before taking any 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

Long-Term Use and Tolerance

If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same effect. This is known as tolerance. If you notice that the medication is no longer working as well, contact your doctor. Do not take more than the prescribed dose.

Seizure Risk

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.

Effects on Children and Teens

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this with your doctor.

Pregnancy and Breast-Feeding

If you are pregnant, plan to become pregnant, or are breast-feeding, 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)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dryness of mucous membranes

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally 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

  • Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - risk of increased blood pressure.
  • Halogenated anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery.
  • Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, requiring dose adjustment.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, requiring dose adjustment.
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Moderate Interactions

  • Antihypertensive agents - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., levodopa) - theoretical risk of pharmacodynamic interaction.
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Minor Interactions

  • Alcohol - may accelerate the release of methylphenidate from extended-release formulations, leading to a more rapid absorption and higher peak exposure.

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 (Pediatric)

Rationale: CNS stimulants have been associated with growth suppression in children.

Timing: Prior to initiation of therapy.

Cardiac History and Family History of Sudden Death/Arrhythmias

Rationale: To identify patients at risk for cardiac events.

Timing: Prior to initiation of therapy.

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

Rationale: To assess risk of exacerbation of psychiatric conditions or emergence of new symptoms.

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 (Pediatric)

Frequency: Every 3-6 months

Target: Normal growth trajectory

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

Psychiatric Symptoms (e.g., agitation, aggression, hallucinations, mania, tics)

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

Target: Absence of new or worsening symptoms

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

ADHD Symptom Control

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

Target: Improved attention, reduced hyperactivity/impulsivity

Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • New or worsening aggression
  • Hallucinations
  • Delusional thinking
  • Mania
  • New or worsening tics
  • Numbness, coolness, or pain in digits (Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Methylphenidate is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use 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, but continued exposure could theoretically impact fetal growth.
Third Trimester: Potential for withdrawal symptoms in the neonate if exposed late in pregnancy (e.g., tremors, irritability, feeding difficulties).
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding (L3 - Moderately safe). Monitor breastfed infants for agitation, insomnia, and decreased weight gain.

Infant Risk: Low to moderate risk. Monitor for irritability, poor feeding, and sleep disturbances. Consider using the lowest effective dose and monitoring infant weight.
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Pediatric Use

Not recommended for children under 6 years of age due to lack of established safety and efficacy. Growth suppression (weight and/or height) has been reported with long-term use; monitor growth regularly. Psychiatric adverse events (e.g., psychosis, mania) can occur.

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Geriatric Use

Use with caution in elderly patients, as they may be more sensitive to the effects of CNS stimulants, particularly cardiovascular effects. Start with lower doses and titrate slowly. Not typically indicated for ADHD in this population unless diagnosed in childhood and continued into old age.

Clinical Information

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Clinical Pearls

  • Methylphenidate ER (LA) capsules can be opened and the beads sprinkled on a small amount of applesauce for patients who have difficulty swallowing, but the beads should not be chewed.
  • Take in the morning to avoid insomnia.
  • Monitor for signs of abuse and diversion, especially in patients with a history of substance abuse.
  • Consider drug holidays (e.g., weekends, school breaks) in pediatric patients to mitigate potential growth suppression and assess continued need for medication.
  • Patients should be advised to avoid alcohol due to the potential for dose dumping with some ER formulations.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, transdermal patch, chewable ER, liquid ER)
  • Amphetamine-based stimulants (e.g., Adderall, Vyvanse, Dexedrine)
  • Non-stimulant medications (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy, psychotherapy, educational interventions
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Cost & Coverage

Average Cost: $150 - $400 per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand-name ER formulations); Tier 1 (for generic ER formulations)
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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 provides crucial information 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, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.