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Methylphenidate 18mg ER Tabs (24h)

Manufacturer KREMERS URBAN Active Ingredient Methylphenidate Extended- Release Tablets(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
Aug 2000
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Methylphenidate extended-release 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. This medication is designed to release slowly over 24 hours, so it's usually taken once a day in the morning to help with focus and reduce hyperactivity throughout the 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 guidelines:

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.
 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.
Swallow your medication whole, without chewing, breaking, or crushing it.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

 Store it at room temperature, protected from light.
Keep it in a dry place, away from moisture.
 Do not store your medication in a bathroom.
Keep your medication in a safe and secure location, out of the reach of children and pets. Consider using a locked box or area to store your medication.
 Keep all medications away from pets to avoid accidental ingestion.

What to Do If You Miss a Dose

If you miss a dose of your medication:
Skip the missed dose 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 dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Do not crush, chew, or divide the extended-release tablets; swallow them whole.
  • Maintain a healthy diet and regular sleep schedule.
  • Engage in regular physical activity.
  • Avoid alcohol, as it may affect the release of the medication.
  • 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: 18 mg orally once daily in the morning. May increase by 18 mg increments weekly. Max: 72 mg/day.
Dose Range: 18 - 72 mg

Condition-Specific Dosing:

ADHD: Initial: 18 mg orally once daily in the morning. May increase by 18 mg increments weekly. Max: 72 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial: 18 mg orally once daily in the morning. May increase by 18 mg increments weekly. Max: 54 mg/day.
Adolescent: 13-17 years: Initial: 18 mg orally once daily in the morning. May increase by 18 mg increments weekly. Max: 72 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, monitor for adverse effects.
Moderate: No specific dose adjustment recommended, monitor for adverse effects.
Severe: Use with caution; no specific dose adjustment recommended, monitor for adverse effects.
Dialysis: Not available; methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, monitor for adverse effects.
Moderate: No specific dose adjustment recommended, monitor for adverse effects.
Severe: Use with caution; no specific dose adjustment recommended, 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 22-28% (due to first-pass metabolism)
Tmax: Biphasic: Initial peak at 1-2 hours, second peak at 6-8 hours (for OROS formulation)
FoodEffect: High-fat meal can delay the initial peak and increase overall exposure (AUC) by about 15-20% for some ER formulations (e.g., Concerta), but does not affect the overall duration of action.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate, but ER formulation provides extended duration)
Clearance: 0.40 L/hr/kg
ExcretionRoute: Renal (approximately 78-90% as PPAA, <1% as unchanged drug)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: Biphasic: 1-2 hours and 6-8 hours
DurationOfAction: Approximately 10-12 hours (for 24h ER formulations, the drug release is designed to last up to 12-16 hours, providing symptom control throughout the day)

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 while on 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: 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
 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 a family history of abnormal heart rhythms or sudden death, inform your doctor and seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting

Additional Warnings

 If you experience a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical help right away to avoid potential long-term sexual dysfunction
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations, have been reported; if you or a family member have a history of mental health conditions, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor and seek help if you experience hallucinations, changes in behavior, or mood changes like depression, suicidal thoughts, nervousness, or anxiety
 A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs; seek medical help immediately if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache

Common Side Effects

Most people do not experience severe side effects, but some may encounter mild or moderate side effects. If you experience any of the following, contact your doctor or seek medical help 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

This is not an exhaustive list of potential 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 heart problems or high blood pressure
  • New or worsening mental problems (e.g., hallucinations, delusions, mania, aggression)
  • New or worsening tics (uncontrolled movements or sounds)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Prolonged or painful erections (priapism, rare but serious)
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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.
 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
 Personal history of:
+ Stroke
+ Use of specific medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure
Difficulty swallowing the medication whole
 History of gastrointestinal (GI) problems, including:
+ Cystic fibrosis
+ Narrowing of the GI tract or other GI conditions like bowel block, small bowel disease, short gut syndrome, or slow-moving esophagus or bowel tract
+ Peritonitis
* Current use of certain medications, such as linezolid or methylene blue

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, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose 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 chocolate, as combining these with the medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, it is crucial to discuss with your doctor before using 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, and certain natural products or aids.

Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice that the medication is no longer working as well, 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. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.

For certain brands of this medication, you may notice the tablet shell in your stool. This is a normal occurrence and not a cause for concern. However, if you have any questions, consult with your doctor.

If you are undergoing x-rays near the abdominal area, inform your doctor that you are taking this medication.

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

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 both 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 immediately (e.g., 1-800-222-1222 in the US). Seek emergency medical attention. Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis)
  • Patients with marked anxiety, tension, and agitation
  • Patients with glaucoma
  • Patients with tics or Tourette's syndrome (or family history of Tourette's syndrome)
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Major Interactions

  • Vasopressors (e.g., phenylephrine, epinephrine, norepinephrine) - risk of hypertensive crisis
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
  • Antipsychotics (e.g., haloperidol, chlorpromazine) - may antagonize effects of methylphenidate or exacerbate psychotic symptoms
  • Anticoagulants (e.g., warfarin) - may inhibit metabolism of anticoagulants, increasing bleeding risk
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of anticonvulsants, increasing serum levels
  • Antihypertensive drugs - methylphenidate may reduce the effectiveness of drugs used to treat hypertension
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Moderate Interactions

  • Alcohol (may accelerate the release rate of methylphenidate from some ER formulations, leading to dose dumping)
  • Tricyclic Antidepressants (TCAs) - may increase plasma levels of TCAs
  • Dopaminergic drugs (e.g., levodopa) - potential for additive effects or antagonism
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To establish baseline and identify pre-existing cardiovascular conditions; stimulants can increase BP and HR.

Timing: Prior to initiation of therapy

Height and Weight

Rationale: To establish baseline for growth monitoring, especially in pediatric patients.

Timing: Prior to initiation of therapy

Psychiatric History and Status

Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis, severe anxiety) that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To identify potential cardiac risks.

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: Within normal limits for age/sex; monitor for sustained increases

Action Threshold: Sustained increase >10-20 mmHg systolic/diastolic or HR >10-20 bpm above baseline; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months in children and adolescents

Target: Normal growth trajectory

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

ADHD Symptom Control

Frequency: At each visit

Target: Improved focus, reduced impulsivity/hyperactivity

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

Psychiatric Status (e.g., emergence of new psychotic or manic symptoms, severe anxiety, aggression, tics)

Frequency: At each visit

Target: Stable mood, absence of new psychiatric symptoms

Action Threshold: Emergence of new or worsening psychiatric symptoms; consider dose reduction, discontinuation, or psychiatric consultation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening tics
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Aggression
  • Unexplained wounds on fingers/toes (Raynaud's phenomenon)
  • Priapism (rare)

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 to methylphenidate, but these findings are inconsistent.

Trimester-Specific Risks:

First Trimester: Possible increased risk of cardiac malformations (e.g., ventricular septal defects), though data are inconsistent and limited.
Second Trimester: No specific data indicating increased risk of malformations; potential for fetal growth restriction.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms in the neonate (e.g., agitation, tremor, feeding difficulties) if used close to delivery.
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Lactation

L3 (Moderately Safe). Methylphenidate is excreted into breast milk in small amounts. Monitor breastfed infants for adverse effects such as agitation, insomnia, poor feeding, or decreased weight gain. Consider using the lowest effective dose and monitoring infant closely.

Infant Risk: Low to moderate. Potential for irritability, insomnia, decreased appetite, or weight loss in the infant. Risk is generally considered low with careful monitoring.
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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 (e.g., psychosis, mania, aggression, tics).

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Geriatric Use

Use with caution in elderly patients. Start with lower doses and titrate slowly due to increased sensitivity to stimulant effects and potential for comorbidities (e.g., cardiovascular disease, glaucoma). Monitor blood pressure and heart rate closely.

Clinical Information

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Clinical Pearls

  • Methylphenidate ER tablets (e.g., Concerta) are designed to be swallowed whole and should not be crushed, chewed, or divided, as this can lead to rapid release of the entire dose (dose dumping) and increased side effects.
  • The outer shell of some ER tablets (e.g., Concerta) may appear in the stool; this is normal and does not mean the medication was not absorbed.
  • Administer in the morning to avoid insomnia.
  • Titrate dose slowly (weekly increments) to achieve optimal efficacy with minimal side effects.
  • Consider drug holidays (e.g., weekends, school breaks) if appropriate, to assess ongoing need for medication and potentially mitigate growth suppression, but discuss with prescriber.
  • Educate patients and caregivers about the potential for abuse and the importance of secure storage.
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Alternative Therapies

  • Other CNS stimulants (e.g., amphetamine salts - Adderall, Vyvanse; dextroamphetamine - Dexedrine)
  • Non-stimulants (e.g., atomoxetine - Strattera; guanfacine ER - Intuniv; clonidine ER - Kapvay)
  • Behavioral therapy, psychotherapy, educational interventions
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Cost & Coverage

Average Cost: $150 - $400+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for generic); Tier 3 or Tier 4 (for brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, seek immediate medical attention or call your local poison control center. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred, as this information is crucial for receiving appropriate care.