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Methylphenidate 54mg 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 (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 involved in attention and impulse control. The 54mg ER Osm Tablet is designed to release the medication slowly over the day, so you usually only need to take it once in the morning.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's recommended to take this medication in the morning. However, some medications may need to be taken with food or on an empty stomach, while others have no specific requirements. If you're unsure, consult with your pharmacist for guidance on the best way to take this 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 in a dry place. Avoid storing it 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. 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 normal dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take the tablet whole with water; do not chew, crush, or divide it.
  • Can be taken with or without food.
  • Take in the morning to avoid sleep problems.
  • Avoid alcohol, as it can affect how the medication is released.
  • Maintain a healthy diet and regular exercise.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • 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 or 36 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 18-36 mg/day, titrate to effect, 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, 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. Methylphenidate is not significantly dialyzable.

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.

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 known.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22% (oral solution) to 5% (tablet) due to first-pass metabolism. For ER OROS, relative bioavailability is comparable to immediate-release.
Tmax: Biphasic: Initial peak at 1-2 hours, second peak at 6-8 hours (for OROS formulation).
FoodEffect: Minimal effect on absorption or Tmax; can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for OROS formulation, mean terminal half-life of d-methylphenidate is 6.8 hours)
Clearance: Approximately 0.43 L/hr/kg
ExcretionRoute: Primarily renal (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

Safety & Warnings

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BLACK BOX WARNING

Potential for Abuse and Dependence: 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 treatment.
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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 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. Tell your doctor if you or a family member have a history of abnormal heart rhythms or sudden death. Seek medical help immediately if you experience:

Chest pain
 Abnormal heartbeat
Shortness of breath
 Severe dizziness or fainting

Erectile Dysfunction:

If you experience a painful erection or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not having sex. If left untreated, it may lead to permanent sexual dysfunction.

Mental Health:

New or worsening behavior and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. Inform your doctor 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. Seek medical help immediately if you experience:

Hallucinations
 Changes in behavior
Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life

Serotonin Syndrome:

A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. 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 Side Effects:

Most people do not experience significant 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
 Drowsiness
Dry mouth
 Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
 Weight loss
Feeling nervous and excitable
 Trouble sleeping
* Nose or throat irritation

Reporting Side Effects:

If you have questions 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 irritability
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New or worsening tics (uncontrolled movements or sounds)
  • Unexplained numbness, pain, or discoloration in fingers or toes
  • Prolonged or painful erection (priapism, rare but serious)
  • Significant unexplained weight loss or slowed growth in children
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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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
 Certain health conditions, such as:
+ 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
 If you have ever experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (as this may lead to very high blood pressure)
 Difficulty swallowing this product 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:
+ 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. Do not initiate, stop, or adjust 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.

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, regularly have your blood work, blood pressure, and heart rate checked. 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 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 seizures while taking this medication.

For some formulations 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 adolescents, 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. It is essential 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
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dry mouth

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 sedation for severe agitation or seizures.

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.
  • Halogenated anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
  • Anticoagulants (e.g., warfarin): May decrease metabolism of coumarin anticoagulants, requiring dose adjustment.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism, requiring dose adjustment.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs): May inhibit metabolism, requiring dose adjustment. Monitor for increased antidepressant levels or serotonin syndrome with SSRIs/SNRIs.
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Moderate Interactions

  • Antihypertensive drugs: May reduce the effectiveness of antihypertensive agents.
  • Dopaminergic drugs (e.g., antipsychotics, levodopa): Potential for additive effects or antagonism.
  • Alcohol: May increase the rate of drug release from the OROS formulation, leading to a more rapid release of methylphenidate.
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Minor Interactions

  • Caffeine: May increase stimulant effects and adverse reactions.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause increases in BP and HR; screen for pre-existing cardiovascular conditions.

Timing: Prior to initiation

Height and Weight

Rationale: Monitor growth in pediatric patients.

Timing: Prior to initiation

Psychiatric History

Rationale: Screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated.

Timing: Prior to initiation

Family History of Sudden Cardiac Death/Arrhythmias

Rationale: Identify potential risk factors for serious cardiovascular events.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or every 3-6 months

Target: Within normal limits for age/sex; significant sustained increases should prompt evaluation.

Action Threshold: Sustained elevation above normal range (e.g., >95th percentile for age/sex for BP, or persistent tachycardia) should prompt dose reduction, discontinuation, or cardiovascular workup.

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory; monitor for growth suppression.

Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines) should prompt evaluation, dose adjustment, or drug holiday.

Psychiatric Status (e.g., mood, anxiety, psychotic symptoms)

Frequency: At each visit or every 3-6 months

Target: Stable mood, absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence or worsening of psychotic symptoms, mania, aggression, or severe anxiety should prompt immediate evaluation and potential discontinuation.

ADHD Symptom Control and Functional Improvement

Frequency: At each visit

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

Action Threshold: Lack of efficacy or intolerable side effects should prompt dose adjustment or consideration of alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
  • Severe anxiety or agitation
  • Unexplained weight loss
  • Tics or abnormal movements
  • Priapism (rare, but serious)

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. Studies in animals have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Data from a pregnancy registry did not show an increased risk of major congenital malformations.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations, though data are conflicting and overall risk appears low.
Second Trimester: Not specifically studied, but continued exposure could theoretically impact fetal growth.
Third Trimester: Not specifically studied, but continued exposure could theoretically impact fetal growth or lead to withdrawal symptoms in neonate.
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding. Monitor breastfed infants for agitation, insomnia, and reduced weight gain.

Infant Risk: Low to Moderate (L3). Monitor for irritability, poor feeding, and sleep disturbances.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly, as stimulants can be associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms.

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Geriatric Use

Safety and efficacy have not been established in patients over 65 years. Use with caution due to increased likelihood of cardiovascular disease, other comorbidities, and polypharmacy. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • The OROS (Osmotic Release Oral System) formulation of methylphenidate (e.g., Concerta) is designed to provide a smooth, extended release of medication over 10-12 hours, mimicking a twice-daily dosing of immediate-release methylphenidate.
  • Patients should be instructed to swallow the tablet whole with water; the tablet shell may be excreted in the stool, which is normal and does not mean the medication was not absorbed.
  • Consider a drug holiday (e.g., weekends or school breaks) for pediatric patients to assess the need for continued therapy and potentially mitigate growth suppression, though this should be discussed with the prescribing physician.
  • Careful cardiovascular screening is essential before initiating treatment, including personal and family history of cardiac disease.
  • Monitor for signs of abuse or diversion, especially in adolescents and adults, given its Schedule II classification.
  • Psychiatric adverse events, including new-onset psychosis or mania, can occur even in patients without a prior history; discontinue if such symptoms emerge.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, chewable, liquid, transdermal patch, other extended-release formulations like Aptensio XR, Jornay PM, Ritalin LA)
  • Amphetamine-based stimulants (e.g., Adderall, Vyvanse, Dexedrine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy, psychotherapy, parent training
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Cost & Coverage

Average Cost: Varies widely, typically $200-$400+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (brand), Tier 1 (generic)
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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, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.