Home â€ē Medicine

Methylphenidate 18mg ER Osm Tablets

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.
🏷ī¸
Drug Class
Central Nervous System Stimulant
đŸ§Ŧ
Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
🤰
Pregnancy Category
Category C
✅
FDA Approved
Aug 2000
⚖ī¸
DEA Schedule
Schedule II

Overview

ℹī¸

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, so you typically only need to take it once in the morning.
📋

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.
💡

Lifestyle & Tips

  • Take the tablet whole with water, do not crush, chew, or divide it. It has a special coating that allows for extended release.
  • Take it in the morning, usually before or after breakfast, to avoid interference with sleep.
  • Maintain a regular sleep schedule, as stimulants can affect sleep.
  • Eat regular, healthy meals, as appetite suppression can occur.
  • Avoid alcohol, as it can affect the release of the medication and increase side effects.
  • Store at room temperature away from moisture and heat.
💊

Available Forms & Alternatives

Available Strengths:

Dosing & Administration

👨‍⚕ī¸

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.
đŸ‘ļ

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.
⚕ī¸

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, as 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

đŸ”Ŧ

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 of action in ADHD is not fully understood.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-25% (due to first-pass metabolism)
Tmax: Biphasic: 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) but may delay Tmax.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate), 2.5 hours (for PPAA)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (90% as PPAA, <1% as unchanged drug)
Unchanged: <1%
⏱ī¸

Pharmacodynamics

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

Safety & Warnings

⚠ī¸

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.
⚠ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
 Joint pain
Purple patches on the skin or mouth
 Changes in 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 skin
 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 has died suddenly, notify your doctor. Seek medical help immediately if you experience any signs of heart problems, such as:

Chest pain
 Abnormal heartbeat
Shortness of breath
 Severe dizziness or fainting

Other Serious Side Effects:

If you experience a painful erection (priapism) or an erection that lasts longer than 4 hours, seek medical help immediately. This can occur even when you are not having sex, and if left untreated, may lead to permanent sexual dysfunction.
 If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience:
+ Hallucinations
+ Changes in behavior or mood
+ Signs of depression, such as thoughts of suicide, nervousness, emotional ups and downs, or lack of interest in life
A severe and 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 serious side effects, and many people have no side effects or only minor side effects. However, 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.
🚨

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
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • New manic symptoms (e.g., extreme energy, racing thoughts)
  • Unexplained wounds on fingers or toes (Raynaud's phenomenon)
  • Prolonged or painful erection (priapism)
  • Blurred vision or other vision changes
📋

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
 Previous medical events, such as a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (Note: Combining these medications can lead to 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 crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to your doctor and pharmacist. They will help you determine the safety of taking this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
⚠ī¸

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 and are taking this medication, 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. 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 of the abdominal area, inform your doctor that you are taking this medication.

In some cases, this medication may affect growth in children and teenagers. 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. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Vomiting
  • Agitation
  • Tremors
  • Hyperreflexia
  • Muscle twitching
  • Convulsions
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately. Seek emergency medical attention.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
🔴

Major Interactions

  • Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - risk of hypertensive crisis
  • 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
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may increase plasma levels of antidepressants or methylphenidate
🟡

Moderate Interactions

  • Clonidine, Guanfacine (alpha-2 adrenergic agonists) - potential for additive cardiovascular effects, though some co-prescribing occurs for ADHD
  • Antihypertensive agents - methylphenidate may reduce the effectiveness of these drugs
⚠ī¸

Confidence Interactions

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia)

Timing: Prior to initiation

Height and Weight

Rationale: Risk of growth suppression in pediatric patients

Timing: Prior to initiation

Psychiatric History (e.g., bipolar disorder, psychosis, tics)

Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new ones

Timing: Prior to initiation

Cardiac History (e.g., structural cardiac abnormalities, family history of sudden cardiac death)

Rationale: Risk of serious cardiovascular events

Timing: Prior to initiation

📊

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

Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex or clinically significant increase) warrants investigation/intervention.

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory

Action Threshold: Significant deviation from growth curve warrants investigation/intervention.

ADHD Symptom Control

Frequency: At each visit

Target: Improved attention, reduced hyperactivity/impulsivity

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

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

Frequency: At each visit

Target: Absence of new or worsening symptoms

Action Threshold: Any new or worsening psychiatric symptoms warrant immediate evaluation and potential discontinuation.

👁ī¸

Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Anxiety
  • Depression
  • Tics
  • Blurred vision
  • Priapism (rare)

Special Patient Groups

🤰

Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data are limited, but some studies suggest a possible association with cardiac malformations when used in the first trimester, though findings are inconsistent.

Trimester-Specific Risks:

First Trimester: Limited data, some studies suggest a small increased risk of cardiac malformations (e.g., atrial septal defects, ventricular septal defects) but findings are inconsistent and overall risk appears low.
Second Trimester: No specific increased risks identified.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms (e.g., tremors, irritability) in the neonate if used close to delivery.
🤱

Lactation

L3 (Moderate risk). Methylphenidate is excreted into breast milk. Monitor breastfed infants for agitation, insomnia, decreased weight gain, or decreased appetite. Consider alternative therapies or temporary discontinuation of breastfeeding.

Infant Risk: Agitation, insomnia, decreased weight gain, decreased appetite. Long-term effects unknown.
đŸ‘ļ

Pediatric Use

Closely monitor growth (height and weight) in pediatric patients, as long-term use has been associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.

👴

Geriatric Use

Use with caution in elderly patients, generally not recommended due to increased risk of cardiovascular adverse events and other comorbidities. Start with lower doses and titrate slowly, if used.

Clinical Information

💎

Clinical Pearls

  • The OROS (Osmotic Release Oral System) formulation of methylphenidate ER is designed to provide a smooth, ascending release profile, mimicking twice-daily dosing with a single morning dose.
  • Tablets should be swallowed whole with water and should not be chewed, crushed, 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.
  • Take in the morning to avoid insomnia. If a dose is missed, it should generally be skipped rather than taken later in the day.
  • Patients should be screened for cardiac abnormalities and psychiatric conditions prior to initiation.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and diversion.
🔄

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)
💰

Cost & Coverage

Average Cost: $150 - $400 per 30 tablets (generic ER)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generic often Tier 1 or 2, brand Tier 3 or 4)
📚

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, and do not take medication prescribed to someone else. This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is important to 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, 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.