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Methylphenidate 36mg ER Osm Tablet

Manufacturer TRIGEN LABORATORIES 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 Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Not available
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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 medicine slowly throughout the day, so you typically 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 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.
 Check with your pharmacist to determine if your medication should be taken with food or on an empty stomach, as this may vary depending on the specific drug.
Swallow your medication whole, without chewing, breaking, or crushing it.

Storing and Disposing of Your Medication

To maintain the quality 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 exactly as prescribed, usually once daily in the morning.
  • Swallow the tablet whole with water; do not chew, crush, or divide it.
  • The tablet shell may appear in your stool; this is normal and does not mean the medication was not absorbed.
  • Avoid alcohol, as it can cause the medication to be released too quickly.
  • Maintain a regular sleep schedule, as this medication can cause insomnia.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
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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. Titrate weekly in 18 mg increments. Max: 72 mg/day.
Dose Range: 18 - 72 mg

Condition-Specific Dosing:

ADHD: Initial: 18 mg orally once daily in the morning. Titrate weekly in 18 mg increments. 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. Titrate weekly in 18 mg increments. Max: 54 mg/day.
Adolescent: 13-17 years: Initial: 18 mg orally once daily in the morning. Titrate weekly in 18 mg increments. Max: 72 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 accumulation of metabolites.
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 therapeutic effect in ADHD is thought to be related to its ability to increase dopamine and norepinephrine levels in the prefrontal cortex, improving attention, focus, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (variable, depends on formulation)
Tmax: Biphasic release: Initial peak at 1-2 hours, second peak at 6-8 hours (for OROS formulation)
FoodEffect: Food does not significantly affect the extent of absorption (AUC) of methylphenidate ER, but may delay Tmax by approximately 1 hour.

Distribution:

Vd: 2.65 L/kg (d-methylphenidate)
ProteinBinding: 10-33%
CnssPenetration: Yes

Elimination:

HalfLife: 3.5 hours (d-methylphenidate), 6.8 hours (l-methylphenidate) for ER formulation
Clearance: Not available
ExcretionRoute: Renal (90% as PPAA, 1% unchanged)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER formulation)
PeakEffect: Biphasic: 1-2 hours and 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 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, such as pale, blue, gray, purple, or red hands, feet, or other areas
 Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
 Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex interest
 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:

Painful erection (hard penis) or an erection lasting longer than 4 hours (seek medical help immediately to avoid lasting sex problems)
 New or worsening behavior and mood changes, such as:
+ Hallucinations
+ Changes in thinking or behavior
+ Depression
+ Thoughts of suicide
+ Nervousness
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Serotonin syndrome, a potentially life-threatening condition that may occur when taking 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 serious side effects, but some may occur. If you experience 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
Feeling sleepy
 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 about side effects or want to report a side effect, 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 agitation
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New or worsening tics or unusual movements
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Blurred vision or other vision changes
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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
 Presence of any of the following gastrointestinal conditions:
+ Cystic fibrosis
+ Narrowing of the gastrointestinal (GI) tract
+ Bowel block
+ Small bowel disease
+ Short gut syndrome
+ Slow-moving esophagus or bowel tract
+ Peritonitis
* Concurrent use of certain medications, including 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 drugs, natural products, and vitamins, as well as any existing health problems. 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. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult with your doctor.

While taking this medication, it is recommended that you 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, it is crucial to discuss 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. Consult with your doctor to determine if you are at a higher risk of experiencing seizures while taking this medication.

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. However, if you have questions or concerns, discuss them 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.

It is essential to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of taking 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
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dryness of mucous membranes

What to Do:

Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Management includes supportive care, maintaining circulation and respiration, and controlling hyperpyrexia and convulsions.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis
  • Concurrent use with halogenated anesthetics - risk of sudden blood pressure and heart rate increase
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Major Interactions

  • Vasopressors (e.g., phenylephrine, pseudoephedrine) - enhanced pressor effect
  • Antihypertensive agents (e.g., guanethidine, clonidine) - methylphenidate may reduce their effectiveness
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - theoretical risk of serotonin syndrome
  • Warfarin - methylphenidate may inhibit metabolism, increasing INR and bleeding risk
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - methylphenidate may inhibit metabolism, increasing levels
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Moderate Interactions

  • Alcohol - may alter release rate of ER formulations, leading to dose dumping
  • Caffeine - additive stimulant effects
  • Tricyclic Antidepressants (TCAs) - potential for increased TCA levels
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Minor Interactions

  • Not available

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.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Growth suppression has been reported in pediatric patients.

Timing: Prior to initiation of therapy (pediatric).

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

Rationale: To assess risk for psychiatric adverse events.

Timing: Prior to initiation of therapy.

Cardiac History (including family history of sudden death, arrhythmias)

Rationale: To assess risk for serious cardiovascular events.

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

Action Threshold: Persistent elevation above normal range; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months (pediatric)

Target: Normal growth trajectory

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

Psychiatric Symptoms (e.g., new or worsening aggression, hostility, mania, psychosis)

Frequency: At each visit

Target: Stable or improved

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

ADHD Symptom Control

Frequency: 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
  • Palpitations
  • New or worsening aggression
  • Hostility
  • Psychotic symptoms (hallucinations, delusions)
  • Manic symptoms (agitation, irritability, rapid speech)
  • Severe headache
  • Blurred vision
  • Numbness or weakness in limbs
  • Unexplained wounds on fingers or toes (Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Data from observational studies of methylphenidate use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are potential risks to the fetus from exposure to CNS stimulants, such as premature birth and low birth weight. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: No clear evidence of increased risk of major birth defects.
Second Trimester: Potential for premature birth and low birth weight.
Third Trimester: Potential for premature birth and low birth weight; withdrawal symptoms in neonates if exposed near term.
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Lactation

Methylphenidate is excreted into human milk. Limited data suggest that methylphenidate levels in breast milk are low and infant exposure is minimal. Monitor breastfed infants for agitation, insomnia, anorexia, or reduced weight gain. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for methylphenidate and any potential adverse effects on the breastfed infant.

Infant Risk: Low to moderate risk (L3)
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Pediatric Use

Safety and effectiveness established in pediatric patients 6 to 17 years of age. Long-term effects on growth (weight and height) should be monitored. Not recommended for children under 6 years of age.

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Geriatric Use

Safety and effectiveness in patients over 65 years of age have not been established. Use with caution due to potential for increased sensitivity to stimulant effects and higher prevalence of cardiovascular disease.

Clinical Information

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Clinical Pearls

  • The OROS (Osmotic Release Oral System) formulation of methylphenidate ER (e.g., Concerta) is designed to provide a smooth, extended release of medication over 10-12 hours, mimicking a twice-daily dosing regimen with a single morning dose.
  • Patients should be advised that the tablet shell may be visible in their stool, which is a normal part of the OROS delivery system and does not mean the medication was not absorbed.
  • Monitor for signs of stimulant-induced psychosis or mania, especially in patients with a history of psychiatric disorders.
  • Growth suppression is a concern in pediatric patients; regular monitoring of height and weight is crucial. Drug holidays may be considered if growth deceleration is significant.
  • Cardiovascular monitoring (BP, HR) is essential due to the risk of dose-related increases. Pre-existing cardiac conditions should be thoroughly evaluated before initiation.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of storing the medication securely.
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Alternative Therapies

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

Average Cost: $150 - $400 per 30 tablets (generic 36mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or 4 (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 provides crucial information about its use. 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, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.