Methylphenidate 2.5mg Chewable Tabs

Manufacturer RISING Active Ingredient Methylphenidate Chewable 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 is used to treat narcolepsy.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
Category C
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FDA Approved
Aug 1955
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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. This chewable tablet form is often used for children or those who have difficulty swallowing pills.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Take this medication 30 to 45 minutes before meals, chewing it well before swallowing. It is essential to take this medication with a full glass of water (at least 8 ounces/240 mL) to prevent it from swelling and potentially blocking your throat, which could lead to choking. If you have concerns, discuss them with your doctor.

If you take this medication more than once a day, ensure that you take the last dose before 6 PM.

Storing and Disposing of Your Medication

Store this medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom. Keep the 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 safeguard the medication. Keep all medications away from pets.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, do not take the medication after 6 PM. If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less of it or take it more often than prescribed.
  • Chew the tablet thoroughly before swallowing.
  • Take the last dose of the day before 6 PM to avoid sleep problems (insomnia).
  • Avoid alcohol, as it can increase side effects.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor height and weight in children.
  • Store medication securely to prevent misuse or abuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically initiated with 2.5mg chewable tabs; adult dosing usually starts at 5mg IR BID/TID or equivalent ER.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Initial: 5 mg orally twice or three times daily (immediate-release). May increase by 5-10 mg weekly. Max: 60 mg/day. (Note: 2.5mg chewable is a very low dose, typically for titration or pediatric use).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial (â‰Ĩ6 years): 2.5 mg orally twice daily (e.g., Methylin chewable) before breakfast and lunch. May increase by 2.5-5 mg weekly. Max: 60 mg/day. Dosing is highly individualized.
Adolescent: Initial (â‰Ĩ6 years): 2.5 mg orally twice daily (e.g., Methylin chewable) before breakfast and lunch. May increase by 2.5-5 mg weekly. Max: 60 mg/day. Dosing is highly individualized.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended; use with caution.
Moderate: No specific adjustment recommended; use with caution due to limited data.
Severe: No specific adjustment recommended; use with caution due to limited data.
Dialysis: Not available; caution advised.

Hepatic Impairment:

Mild: No specific adjustment recommended; use with caution.
Moderate: No specific adjustment recommended; use with caution due to limited data.
Severe: No specific adjustment recommended; use with caution due to limited data.

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 believed to be related to the increased availability of dopamine and norepinephrine in the prefrontal cortex, improving attention, focus, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: 22-65% (variable due to first-pass metabolism)
Tmax: 1-2 hours (immediate-release formulations)
FoodEffect: Food can delay Tmax and decrease Cmax, but generally does not significantly affect AUC for immediate-release formulations. For chewable tablets, food may slightly delay absorption.

Distribution:

Vd: 2.65 L/kg
ProteinBinding: 10-15%
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: 2-4 hours (immediate-release)
Clearance: Not readily available for specific rate, but rapid.
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1% (as unchanged drug)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (immediate-release)
PeakEffect: 1-2 hours (immediate-release)
DurationOfAction: 3-5 hours (immediate-release)
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 PATIENTS FOR SIGNS OF ABUSE AND DEPENDENCE WHILE ON 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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin with or without fever
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting or yellow skin and 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 or tremors
Difficulty controlling body movements
Uncontrollable sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Changes in sex drive
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor.

Heart Problems:

If you experience any signs of heart problems, such as chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting, seek medical help immediately.

Erectile Dysfunction:

If you experience a painful erection or an erection lasting longer than 4 hours, seek medical attention right away. Delayed treatment may lead to permanent sexual dysfunction.

Mental Health Changes:

New or worsening behavioral and mood changes, such as altered thinking, anger, or 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 help immediately if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

Serotonin Syndrome:

A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or 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 resolve:

Dizziness or headache
Drowsiness
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Nervousness or excitability
Sleep disturbances
Nose or throat irritation

This is not an exhaustive list of potential side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or 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.
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true).
  • New manic symptoms (e.g., extreme high mood, increased energy, racing thoughts).
  • Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes (Raynaud's phenomenon).
  • Blurred vision or other vision changes.
  • Uncontrolled muscle movements or tics.
  • Severe headache.
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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 to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
Previous stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue
* Difficulty swallowing, as this may require special consideration

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. They will help determine if it is safe to take this medication with your existing treatments and health status. 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. 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, 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 use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you find 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 certain individuals, particularly those with a history of seizures. Discuss your risk of seizures with your doctor. In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks. Consult with your doctor to determine the best course of action.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Vomiting
  • Agitation
  • Tremors
  • Hyperreflexia
  • Muscle twitching
  • Convulsions (may be followed by coma)
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (very high fever)
  • Tachycardia (fast heart rate)
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension (high blood pressure)
  • Mydriasis (dilated pupils)
  • Dry mouth and mucous membranes

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and may include gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).

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.
  • Anticoagulants (e.g., warfarin) - may inhibit metabolism, increasing anticoagulant effect.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels.
  • Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, increasing TCA levels and potential for adverse effects.
  • SSRIs (e.g., fluoxetine, paroxetine) - theoretical risk of serotonin syndrome, though less common than with other stimulants.
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Moderate Interactions

  • Antihypertensives - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., levodopa) - theoretical risk of pharmacodynamic interaction.
  • Alcohol - may increase plasma levels of methylphenidate and lead to more rapid absorption of some extended-release formulations (dose dumping).
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Minor Interactions

  • Caffeine - additive stimulant effects.

Monitoring

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Baseline Monitoring

Complete Medical History and Physical Exam

Rationale: To identify pre-existing cardiovascular conditions, psychiatric disorders, or other contraindications/precautions.

Timing: Prior to initiation of therapy.

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 (Pediatric Patients)

Rationale: To monitor for potential growth suppression.

Timing: Prior to initiation of therapy.

Psychiatric Status Assessment

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

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; monitor for significant increases.

Action Threshold: Sustained elevation (e.g., >10-15 mmHg increase in BP or >10-20 bpm increase in HR) warrants further evaluation and potential dose adjustment or discontinuation.

Height and Weight (Pediatric Patients)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration or weight loss warrants evaluation and potential drug holiday or alternative therapy.

Psychiatric Status

Frequency: At each visit.

Target: Stable mood, absence of new or worsening psychotic/manic symptoms.

Action Threshold: Emergence of new psychotic symptoms, mania, aggression, or severe anxiety/agitation warrants immediate evaluation and potential discontinuation.

ADHD Symptom Control

Frequency: At each visit.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Severe anxiety
  • Agitation
  • Unexplained weight loss
  • Insomnia
  • Tics or dyskinesias

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Data are conflicting regarding increased risk of congenital malformations (specifically cardiac). Monitor for fetal growth restriction.

Trimester-Specific Risks:

First Trimester: Some studies suggest a small increased risk of cardiac malformations (e.g., atrial septal defects) with first-trimester exposure, while others do not. Data are limited and inconsistent.
Second Trimester: Potential for fetal growth restriction.
Third Trimester: Potential for fetal growth restriction; neonatal withdrawal symptoms (e.g., jitteriness, feeding difficulties) if used close to delivery.
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Lactation

Methylphenidate is excreted into breast milk. Monitor breastfed infants for agitation, insomnia, decreased appetite, or poor weight gain. Use with caution, or consider alternative if possible.

Infant Risk: L3 (Moderately safe) - Monitor infant for adverse effects. Consider using the lowest effective dose and avoiding nursing at peak drug levels.
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor closely for growth suppression (height and weight), cardiovascular effects (BP, HR), and psychiatric adverse events. Dosing is highly individualized and titrated based on response and tolerability.

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Geriatric Use

Safety and efficacy in patients over 65 years have not been established. Use with caution due to potential for increased sensitivity to stimulant effects, higher prevalence of cardiovascular disease, and polypharmacy. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Methylphenidate 2.5mg chewable tablets are a very low dose, often used for initial titration in sensitive patients or young children, or for fine-tuning doses.
  • Dosing is highly individualized; titration is crucial to find the optimal balance between efficacy and side effects.
  • Administer doses early in the day to minimize insomnia.
  • Monitor for cardiovascular changes (BP, HR) and growth suppression (in children) regularly.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Be aware of potential psychiatric adverse events, including new-onset psychosis or mania, and aggression.
  • Chewable tablets must be chewed thoroughly before swallowing.
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Alternative Therapies

  • Other CNS Stimulants (e.g., Amphetamine salts, Lisdexamfetamine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150+ per 30 tablets (2.5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.