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Methylphenidate 36mg ER Osm Tb (bx)

Manufacturer MALLINCKRODT 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. The extended-release tablet is designed to release the medication slowly throughout the day, providing effects for about 10-12 hours.
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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 should 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; 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.
Keep it in a dry place, away from moisture.
 Do not store your medication in a bathroom.
Keep 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 store your medication.
 Keep all medications out of reach of pets.

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 the tablet whole with water, do not chew, crush, or divide it. The tablet shell may appear in your stool, which is normal.
  • Take it once daily in the 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, supplements, and herbal products you are taking.
  • Do not stop taking this medication suddenly without consulting your doctor, as it may lead to withdrawal symptoms.
  • Store at room temperature away from moisture and heat.
  • Keep out of reach of children and secure from misuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

ADHD: Initial dose 18 mg or 36 mg once daily in the morning. May increase by 18 mg increments weekly to a maximum of 72 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial dose 18 mg orally once daily in the morning. May increase by 18 mg increments weekly to a maximum of 54 mg/day.
Adolescent: 13-17 years: Initial dose 18 mg orally once daily in the morning. May increase by 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, 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, use with caution.

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.
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. The precise mechanism by which methylphenidate produces its therapeutic effects in ADHD is not fully understood.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22% (oral)
Tmax: Biphasic: Initial peak at 1-2 hours, second peak at 6-8 hours (for OROS formulation)
FoodEffect: High-fat meal may delay Tmax by approximately 1 hour and increase Cmax by 16% and AUC by 9%.

Distribution:

Vd: 2.65 L/kg
ProteinBinding: 15% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: 3.5 hours (mean for OROS formulation)
Clearance: Not available
ExcretionRoute: Renal (90% as PPAA, 10% as unchanged drug)
Unchanged: Less than 10%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours
PeakEffect: Approximately 6-8 hours (for OROS formulation)
DurationOfAction: Approximately 10-12 hours (for OROS formulation)
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 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 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, such as pale, blue, gray, purple, or red hands, feet, or other areas
 Numbness, pain, tingling, or cold sensation in the hands or feet
Sores or wounds on the 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

Heart Problems:

If you have a heart condition or defect, inform your doctor. Sudden deaths have occurred in people with certain heart problems. Seek medical help immediately if you experience:

Chest pain
 Abnormal heartbeat
Shortness of breath
 Severe dizziness or fainting

Other Serious Side Effects:

Prolonged or painful erections (lasting more than 4 hours): Seek medical help right away to prevent long-term sexual problems.
 New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, inform your doctor.
 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 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

Common Side Effects:

Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical help 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
Difficulty sleeping
 Nose or throat irritation

Reporting Side Effects:

If you have questions about side effects or want to report any side effects, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening aggression, hostility, or irritability
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • Unusual changes in mood or behavior, especially mania
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Prolonged or painful erection (priapism) lasting more than 4 hours (seek immediate medical attention)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial to inform your doctor about the following:

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)
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 (within the last 14 days) of certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of very high blood pressure)
 Difficulty swallowing this product whole
Presence of certain gastrointestinal conditions, such as:
+ Cystic fibrosis
+ Narrowing of the GI tract or other GI problems (e.g., bowel block, small bowel disease, short gut syndrome, slow-moving esophagus or bowel tract)
+ Peritonitis
 Concurrent use of:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is essential 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 dosage of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

Until you understand 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, consult with your doctor.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Long-term 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 this medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose.

This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk of seizures with your doctor. For certain brands 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 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 some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this further.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as 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)
  • Euphoria
  • 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 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. 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, increasing anticoagulant effect.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels.
  • Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, increasing TCA levels.
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - potential for serotonin syndrome, though less common than with other stimulants.
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Moderate Interactions

  • Antihypertensive drugs - methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., antipsychotics, dopamine agonists) - potential for opposing pharmacodynamic effects.
  • Alcohol - may increase the rate of drug release from the extended-release formulation.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of dose-related increases in BP and HR, which can be clinically significant.

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 (including family history of suicide, bipolar disorder, depression)

Rationale: Risk of new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression).

Timing: Prior to initiation of treatment.

Cardiac History (including family history of sudden death or ventricular arrhythmia)

Rationale: Risk of serious cardiovascular events.

Timing: Prior to initiation of treatment.

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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; significant increases should prompt evaluation.

Action Threshold: Sustained increase in BP (>10-20 mmHg) or HR (>10-20 bpm) above baseline; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months in pediatric patients.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines); consider drug holiday or alternative treatment.

ADHD Symptom Assessment

Frequency: Regularly (e.g., monthly initially, then every 3-6 months) to assess efficacy and need for continued treatment.

Target: Improved attention, reduced hyperactivity/impulsivity.

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

Psychiatric Status

Frequency: At each visit.

Target: Absence of new or worsening psychotic, manic, or aggressive symptoms.

Action Threshold: Emergence of new or worsening symptoms; discontinue treatment immediately.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Depressed mood
  • Unexplained wounds on fingers/toes (peripheral vasculopathy)
  • Numbness, coolness, or pain in extremities
  • Priapism (prolonged and painful erections)

Special Patient Groups

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Pregnancy

Methylphenidate is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of developmental toxicity at doses much higher than human therapeutic doses.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies suggest potential for skeletal abnormalities at high doses.
Second Trimester: Limited human data; continued monitoring for fetal growth and development.
Third Trimester: Limited human data; potential for premature birth and low birth weight has been reported with stimulant use.
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor the infant for adverse effects such as agitation, insomnia, decreased weight gain, or decreased appetite.

Infant Risk: Low to moderate risk. Monitor infant for irritability, poor feeding, and sleep disturbances.
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Pediatric Use

Closely monitor growth (height and weight) in pediatric patients. Consider drug holidays or dose reductions if growth suppression is observed. Monitor for emergence or worsening of psychiatric symptoms.

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Geriatric Use

Use with caution in elderly patients, as they may be more sensitive to the effects of stimulants. Start with lower doses and titrate slowly. Monitor cardiovascular parameters closely.

Clinical Information

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Clinical Pearls

  • The OROS (Osmotic Release Oral System) formulation of methylphenidate (e.g., Concerta) is designed to provide an ascending release profile, mimicking a twice-daily dosing of immediate-release methylphenidate.
  • The tablet shell of the OROS formulation is non-absorbable and may be visible in the stool; this is normal and does not mean the medication was not absorbed.
  • Patients should be screened for cardiac abnormalities and psychiatric conditions prior to initiation of therapy.
  • Abrupt discontinuation of methylphenidate after prolonged high-dose therapy can lead to severe fatigue, depression, and sleep disturbances.
  • Risk of peripheral vasculopathy, including Raynaud's phenomenon, has been reported with stimulant use. Monitor for changes in digits.
  • Priapism (prolonged erections) is a rare but serious adverse effect that requires immediate medical attention.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, chewable, transdermal patch, liquid, other ER formulations)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER, Viloxazine ER)
  • 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 brand-name Concerta); Tier 1 (for generic methylphenidate ER)
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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. It is vital to read this guide carefully and review it again each time your prescription is refilled. 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 quantity, and the time it occurred.