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Methylphenidate 36mg ER Tb (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 is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are important for attention and impulse control. The 'ER' means Extended-Release, so it works over a longer period, and '24h' means it's designed to last for about 24 hours, typically taken once a day.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication in the morning, as directed. Some medications need to be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication. When taking your medication, swallow the tablet whole - do not chew, break, or crush it.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. It's crucial to store your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep your medication safe. Remember to keep all medications out of reach of pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning. Do not crush, chew, or divide the extended-release tablet.
  • Maintain a healthy diet and regular exercise, especially for children, to support overall health and growth.
  • Ensure adequate sleep, as stimulants can sometimes interfere with sleep if taken too late in the day.
  • Avoid alcohol, as it can affect the release of the medication and increase side effects.
  • Store medication securely to prevent misuse or diversion, as it is a controlled substance.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 36 mg orally once daily in the morning
Dose Range: 18 - 72 mg

Condition-Specific Dosing:

ADHD: Initial dose 18-36 mg once daily; titrate in 18 mg increments weekly to a maximum of 72 mg/day based on response and tolerability.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial dose 18 mg orally once daily in the morning for children 6-12 years old; titrate in 18 mg increments weekly to a maximum of 54 mg/day.
Adolescent: Initial dose 18 mg orally once daily in the morning for adolescents 13-17 years old; titrate in 18 mg increments weekly to a maximum of 72 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended; use with caution.
Severe: Use with caution; consider lower starting doses and slower titration due to potential for increased exposure to metabolites. Monitor for adverse effects.
Dialysis: Not available; methylphenidate is extensively metabolized, and dialysis is unlikely to significantly remove the parent drug.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended; use with caution.
Severe: Use with caution; consider lower starting doses and slower titration due to potential for altered metabolism. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in ADHD are thought to be mediated through the blockade of dopamine and norepinephrine reuptake transporters in the presynaptic neuron, thereby increasing the extracellular concentrations of these monoamines in the striatum and prefrontal cortex. This leads to enhanced neurotransmission in brain regions associated with attention, executive function, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-28% (due to first-pass metabolism)
Tmax: Biphasic for typical ER formulations: initial peak at 1-2 hours, second peak at 6-8 hours. For a 24h formulation, Tmax may be later (e.g., 10-13 hours for specific 24h formulations like Jornay PM).
FoodEffect: Food generally does not affect the extent of absorption (AUC) but may delay Tmax for some ER formulations. For 24h formulations, food effect can vary by specific product.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for the active drug, methylphenidate, from ER formulations). The inactive metabolite (r-PPAA) has a longer half-life of about 7-8 hours.
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (90% as metabolites, 1% as unchanged drug)
Unchanged: Less than 1% of the dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for initial release from ER formulation)
PeakEffect: Approximately 6-8 hours (for second peak of ER formulation). For a 24h formulation, peak effect may be later, e.g., 10-13 hours.
DurationOfAction: Approximately 24 hours (as specified by the product name '24h'). Note: Most common methylphenidate ER formulations (e.g., Concerta) have a duration of 10-12 hours.

Safety & Warnings

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BLACK BOX WARNING

WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including methylphenidate, other methylphenidate products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
 Joint pain
Purple patches on the skin or mouth
 Changes in eyesight or eye pain, swelling, or redness
Seizures
 Shakiness
Trouble controlling body movements
 Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
 Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
 Numbness, pain, tingling, or cold feeling 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, changes in balance, drooping on one side of the face, or blurred vision
Sudden deaths have 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 medical help immediately if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
 If you experience a painful erection (priapism) or an erection that lasts longer than 4 hours, seek medical help right away. This can occur even when you are not having sex, and if left untreated, may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
+ Depression
+ Thoughts of suicide
+ Nervousness
+ Emotional instability
+ Anxiety
+ Lack of interest in life
Inform your doctor if you or a family member has a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide.
 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
+ 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

While many people may not experience any side effects or only minor ones, it is essential to be aware of the following potential side effects:

Dizziness or headache
 Drowsiness
Dry mouth
 Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
 Weight loss
Feeling nervous or excitable
 Trouble sleeping
* Nose or throat irritation

If you experience any of these side effects or any other unusual symptoms, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can 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 agitation.
  • New psychotic symptoms (e.g., hearing voices, believing things that aren't true).
  • New manic symptoms (e.g., extreme energy, racing thoughts, decreased need for sleep).
  • Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes (Raynaud's phenomenon).
  • Prolonged or painful erection (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:

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)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever experienced a stroke
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
 Difficulty swallowing this product whole
Presence of certain gastrointestinal conditions, including:
+ Cystic fibrosis
+ Narrowing of the gastrointestinal (GI) tract
+ Other GI problems, such as bowel block, small bowel disease, short gut syndrome, or slow-moving esophagus or bowel tract
+ Peritonitis
 Concurrent use of certain medications, including:
+ Linezolid
+ Methylene blue

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 to ensure safe use of this medication. Do not initiate, stop, or modify 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. Regularly monitor your blood work, blood pressure, and heart rate as advised by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult with your doctor.

While taking this medication, it is recommended to avoid consuming alcohol and limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances with the 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 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 the medication is not working as well as it previously did, contact your doctor. Do not exceed 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.

For some formulations of this medication, you may notice the tablet shell in your stool, which is a normal occurrence and not a cause for concern. If you have 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 adolescents, this medication may affect growth in some cases, and regular growth checks may be necessary. Consult with your doctor to discuss this potential effect.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the 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)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth

What to Do:

In case of suspected overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for cardiovascular and CNS effects.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant 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): May potentiate pressor effects, leading to severe hypertension.
  • Halogenated anesthetics (e.g., halothane, isoflurane): Risk of sudden blood pressure and heart rate increases during surgery.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort): Potential for serotonin syndrome, though less direct than amphetamines.
  • Antipsychotics (e.g., haloperidol, risperidone): May antagonize the effects of methylphenidate or exacerbate psychotic symptoms.
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Moderate Interactions

  • Antihypertensive drugs: Methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Coumarin anticoagulants (e.g., warfarin): May increase prothrombin time; monitor INR.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of these drugs, increasing their serum concentrations.
  • Tricyclic Antidepressants (TCAs): May increase plasma concentrations of TCAs, leading to increased cardiovascular risk.
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Minor Interactions

  • Alcohol: May accelerate the release rate of methylphenidate from some ER formulations, leading to dose dumping.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Methylphenidate can cause dose-related increases in BP and HR. Baseline assessment is crucial to identify pre-existing cardiovascular conditions or risks.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Stimulants can cause growth suppression in pediatric patients. Baseline measurements are needed for growth monitoring.

Timing: Prior to initiation of therapy.

Psychiatric History and Status

Rationale: To screen for pre-existing bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy.

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To identify potential underlying 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, and after dose adjustments.

Target: Within normal limits for age; individualize based on patient's baseline.

Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex/height or significant increase from baseline); consider dose reduction, discontinuation, or cardiology referral.

Height and Weight

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

Target: Consistent growth trajectory for children; stable weight for adults.

Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines) or clinically significant weight loss; consider drug holiday or alternative therapy.

ADHD Symptom Control and Functional Improvement

Frequency: At each visit, especially after dose adjustments.

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

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

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

Frequency: At each visit.

Target: Absence of new or worsening symptoms.

Action Threshold: New onset or significant worsening of symptoms; consider discontinuation or psychiatric consultation.

Abuse/Diversion Risk

Frequency: Ongoing assessment at each visit.

Target: No signs of abuse or diversion.

Action Threshold: Signs of abuse or diversion; implement risk mitigation strategies.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening anxiety
  • Agitation
  • Psychotic symptoms (hallucinations, delusions)
  • Manic symptoms (elevated mood, decreased need for sleep, racing thoughts)
  • Aggression
  • Tics or dyskinesias
  • Blurred vision
  • Priapism (rare)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of developmental toxicity at high doses. Human data are limited but do not suggest a major teratogenic risk. However, there are reports of cardiovascular malformations and other birth defects with first-trimester exposure, though causality is not established. Neonates exposed to amphetamines or methylphenidate during pregnancy may experience withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Limited data; some observational studies suggest a possible small increase in risk of cardiac malformations, but findings are inconsistent. Consider risks vs. benefits.
Second Trimester: Less data available; focus on monitoring maternal health and fetal growth.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., agitation, tremors, feeding difficulties) if used close to delivery. Monitor for preterm birth and low birth weight.
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Lactation

Methylphenidate is excreted into breast milk in small amounts. The relative infant dose (RID) is generally low (around 0.2-1.6%). Monitor breastfed infants for adverse effects such as irritability, insomnia, or poor weight gain. Use with caution, especially in neonates or preterm infants. Non-stimulant alternatives may be preferred.

Infant Risk: L3 (Moderately Safe - Limited controlled studies in women; risk of non-serious adverse effects or no adverse effects in infants. Weigh benefits vs. risks.)
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) carefully due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms. Cardiovascular monitoring is essential.

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Geriatric Use

Use with caution in elderly patients, as they may be more sensitive to the effects of stimulants, particularly cardiovascular and psychiatric adverse effects. Start with lower doses and titrate slowly. Not typically indicated for ADHD in this population unless symptoms persist from childhood.

Clinical Information

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Clinical Pearls

  • The '24h' extended-release formulation is designed for once-daily dosing, providing symptom control throughout the day and into the evening. This can be beneficial for patients who need evening coverage or have difficulty remembering midday doses.
  • Unlike some other methylphenidate ER formulations (e.g., Concerta), some 24h formulations (e.g., Jornay PM) are designed to be taken in the evening, with a delayed release to provide morning effect. Confirm specific product instructions.
  • Patients should be advised not to crush, chew, or divide the extended-release tablets, as this can lead to rapid release of the entire dose and increased side effects.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial due to potential cardiovascular and growth-related adverse effects.
  • Careful psychiatric screening is necessary before initiation, as stimulants can exacerbate pre-existing psychotic or manic conditions.
  • Educate patients and families about the potential for abuse and dependence, and the importance of secure storage.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, other extended-release, transdermal patch, liquid suspension)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulant medications (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy and psychotherapy (often used in conjunction with pharmacotherapy for ADHD)
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Cost & Coverage

Average Cost: $150 - $400 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization for brand-name or specific ER formulations)
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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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult 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 details about the medication taken, the quantity, and the time it occurred.