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Methylphenidate 27mg 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 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 over the day, so it's usually taken once in the morning.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the morning. It's essential to check with your pharmacist to determine if this medication should be taken with food or on an empty stomach, as this may vary.

When taking your medication, swallow the tablet whole. Do not chew, break, or crush it, as this can affect its efficacy.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep your medication in a safe and secure location, out of reach of children and pets. Consider using a locked box or area to prevent unauthorized access. This will help prevent accidents and ensure your medication is taken only as prescribed.

Missing 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 crush, chew, or divide it.
  • 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.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • Maintain a healthy diet and regular sleep schedule.
  • For children, monitor growth (height and weight) regularly.
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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 by 18 mg increments. Max: 72 mg/day.
Dose Range: 18 - 72 mg

Condition-Specific Dosing:

ADHD: Initial: 18 mg or 36 mg orally once daily in the morning. Titrate weekly by 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 by 18 mg increments. Max: 54 mg/day.
Adolescent: 13-17 years: Initial 18 mg orally once daily in the morning. Titrate weekly by 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 well studied. Use with caution and monitor for adverse effects.

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 therapeutic effect in ADHD is thought to be related to increased dopamine and norepinephrine activity in the prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22% to 25% (due to first-pass metabolism)
Tmax: Biphasic: Initial peak at 1-2 hours, second peak at 6-8 hours (for ER formulation)
FoodEffect: Food does not significantly affect the extent of absorption (AUC) but may delay Tmax by approximately 1 hour.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for ER formulation)
Clearance: Approximately 0.40 L/hr/kg
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: Less than 1% (in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER formulation)
PeakEffect: Approximately 6-8 hours (for ER formulation)
DurationOfAction: Approximately 10-12 hours (for ER formulation)

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

Important Side Effects to Report to Your Doctor 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, 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 vision 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. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek medical attention immediately if you experience any signs of heart problems, such as:

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 Changes

New or worsening behavioral and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental health conditions, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical attention 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 attention 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

While many people may not experience any side effects or only minor side effects, some common side effects include:

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

If you experience any of these side effects or any other side effects that bother you or do not go away, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening aggressive behavior or hostility
  • New or worsening thoughts of harming yourself or others
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • Unexplained numbness, tingling, or coldness in fingers or toes
  • Prolonged or painful erection (priapism)
  • Unexplained fever, muscle stiffness, or severe confusion (signs of neuroleptic malignant syndrome)
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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 circumstances to ensure safe treatment:

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

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. This will help ensure that it is safe to take this medication with your other treatments. Never start, stop, or adjust the dose of any medication without consulting your doctor.
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Precautions & Cautions

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

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may also need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

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

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

Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not take more than the prescribed dose.

This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.

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

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

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

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. 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 (very high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth and mucous membranes

What to Do:

Seek immediate medical attention or call a poison control center. Call 1-800-222-1222. 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 (risk of hypertensive crisis)
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Major Interactions

  • Vasopressors (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
  • Antihypertensive drugs - may reduce the effectiveness of antihypertensives
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - theoretical risk of serotonin syndrome
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Moderate Interactions

  • Coumarin 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) - may inhibit metabolism, increasing TCA levels
  • Dopaminergic drugs (e.g., bupropion, levodopa) - additive effects, increased risk of adverse reactions
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Minor Interactions

  • Alcohol - may increase the rate of drug release from the extended-release formulation

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause dose-related increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Stimulants are associated with growth suppression in pediatric patients.

Timing: Prior to initiation of therapy (especially in pediatric patients).

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

Rationale: Stimulants can exacerbate pre-existing psychiatric conditions or induce new psychotic/manic symptoms.

Timing: Prior to initiation of therapy.

Cardiovascular History (including family history of sudden death or arrhythmias)

Rationale: To identify patients at higher risk for stimulant-related 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: Maintain within normal limits for age/baseline.

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg SBP/DBP or >10-20 bpm HR) warrant dose reduction or discontinuation.

Height and Weight

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

Target: Maintain normal growth trajectory (pediatric).

Action Threshold: Significant growth deceleration or weight loss may require dose adjustment or drug holiday.

ADHD Symptom Control

Frequency: Regularly, at each follow-up visit.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.

Psychiatric Status (e.g., emergence of new or worsening psychotic/manic symptoms, aggression, anxiety, depression)

Frequency: At each visit.

Target: Stable mood and behavior.

Action Threshold: Emergence of severe psychiatric symptoms warrants immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • New or worsening manic symptoms (e.g., elevated mood, grandiosity, decreased need for sleep)
  • Aggression or hostility
  • Anxiety or agitation
  • Depressed mood or suicidal ideation
  • Unexplained weight loss
  • Slowed growth (in children)
  • Priapism (rare, but serious)

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. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown some evidence of developmental toxicity at maternally toxic doses.

Trimester-Specific Risks:

First Trimester: Limited human data. Animal studies suggest potential for skeletal abnormalities at high doses.
Second Trimester: Limited human data.
Third Trimester: Limited human data. Potential for premature birth and low birth weight has been reported with stimulant use during pregnancy.
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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 breastfed infants for agitation, insomnia, and reduced weight gain.

Infant Risk: Low to moderate risk. 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) carefully. Long-term effects on growth are not fully established but some studies suggest a temporary slowing of growth rate. Monitor for emergence of psychiatric symptoms.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • The osmotic-release oral system (OROS) tablet (e.g., Concerta) is designed to be taken whole and should not be crushed, chewed, or divided. The outer shell of the tablet may appear in the stool, which is normal and does not mean the medication was not absorbed.
  • Methylphenidate ER should be taken once daily in the morning to avoid interference with sleep.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and diversion.
  • Consider drug holidays (e.g., weekends or school breaks) in pediatric patients to assess the need for continued therapy and to potentially mitigate growth suppression, though this should be discussed with a healthcare provider.
  • Patients with pre-existing cardiac conditions or structural heart abnormalities should generally not use stimulants.
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Alternative Therapies

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

Average Cost: $200 - $600 per 30 tablets (generic ER)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generic often Tier 1 or 2, brand Tier 3)
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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 patient fact sheet that provides important information. 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, and the time it occurred.