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Methylphenidate 5mg Chewable Tabs

Manufacturer RISING PHARMACEUTICALS 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
Dopamine and Norepinephrine Reuptake Inhibitor
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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) and narcolepsy. It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. This chewable tablet form is designed to be chewed thoroughly before swallowing.
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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's 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, be sure to take your last dose before 6 PM.

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 this medication out of the reach of children and pets, and consider storing it in a locked box or secure area to prevent unauthorized access.

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. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs.

What to Do If You Miss a Dose

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

  • Take exactly as prescribed by your doctor. Do not take more or less than directed.
  • Chew the tablet thoroughly before swallowing. Do not swallow whole.
  • Take the last dose early enough in the day (e.g., before 6 PM) to avoid sleep problems.
  • Avoid alcohol while taking this medication.
  • Store in a safe place to prevent misuse or abuse.
  • 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.
  • For children, monitor height and weight regularly.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically the starting formulation for adults; often 5-20 mg BID/TID for immediate-release formulations.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Initial: 5 mg BID or TID, preferably 30-45 minutes before meals. Adjust weekly in 5-10 mg increments. Max: 60 mg/day.
Narcolepsy: Initial: 10 mg BID or TID. Adjust weekly in 5-10 mg increments. Max: 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial (≥6 years): 5 mg BID or TID, preferably 30-45 minutes before meals. Adjust weekly in 5-10 mg increments. Max: 60 mg/day.
Adolescent: Initial (≥6 years): 5 mg BID or TID, preferably 30-45 minutes before meals. Adjust weekly in 5-10 mg increments. Max: 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; monitor for adverse effects. No specific dose adjustment recommended due to extensive hepatic metabolism.
Dialysis: Not well studied; use with caution. Methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; monitor for adverse effects. Methylphenidate is primarily metabolized by carboxylesterase 1A1.
Confidence: Medium

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The therapeutic effects in ADHD are believed to be due to increased dopamine and norepinephrine activity in the prefrontal cortex, improving attention, impulse control, and executive function.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 30% (due to first-pass metabolism)
Tmax: 1-2 hours (for immediate-release oral formulations)
FoodEffect: Food may delay Tmax and decrease Cmax slightly, but overall extent of absorption (AUC) is generally not significantly affected for immediate-release formulations. Chewable tablets are designed to be chewed and swallowed.

Distribution:

Vd: Approximately 2.65 L/kg
ProteinBinding: 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: 2-3 hours (for immediate-release formulations)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 1-2 hours
DurationOfAction: 3-5 hours (for immediate-release formulations)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, 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: dark urine, fatigue, decreased appetite, stomach pain or upset, 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
Difficulty controlling body movements
 Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
 Restlessness
Changes in skin color (pale, blue, gray, purple, or red) on 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

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

Additional Urgent Side Effects:

 Painful or prolonged erections (lasting more than 4 hours); if not treated promptly, this can lead to lasting sexual problems
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations; if you or a family member have a history of mental health conditions, such as depression or bipolar disorder, inform your doctor
 Serotonin syndrome, a potentially life-threatening condition, can occur when taking this medication with certain other drugs; seek medical help if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or irregular heartbeat, flushing, muscle twitching or stiffness, seizures, shivering, excessive sweating, severe diarrhea, stomach upset, or vomiting

Common Side Effects:

While many people may not experience side effects or only have mild ones, some common side effects include:

Dizziness or headache
 Drowsiness
Dry mouth
 Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
 Weight loss
Feeling nervous or excitable
 Difficulty sleeping
* Nose or throat irritation

If any of these side effects or others bother you or persist, contact your doctor for advice. 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 aggression, hostility, or irritability.
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true).
  • New or worsening manic symptoms (e.g., extreme energy, racing thoughts).
  • Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
  • Unexplained weight loss or significant decrease in appetite.
  • Blurred vision or other vision changes.
  • New or worsening tics (uncontrolled movements or sounds).
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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, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
 Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever experienced a stroke
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to 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 other medications and health conditions. 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. Before undergoing surgery, discuss your treatment with your doctor.

To ensure your safety, avoid driving and other 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 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 to avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances 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 or high-dose use of this medication may lead to tolerance, reducing its effectiveness. If you experience a decrease in the medication's effectiveness, 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. 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 monitor growth and development.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to 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 (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 at 1-800-222-1222. Treatment is generally supportive, including 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) - risk of hypertensive crisis. Do not use within 14 days of MAOI discontinuation.
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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.
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - potential for 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) - potential for additive dopaminergic effects.
  • Alcohol - may increase plasma levels of methylphenidate and lead to dose dumping with extended-release formulations (less relevant for chewable IR).
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Minor Interactions

  • Caffeine - additive stimulant effects.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: To monitor for growth suppression, especially in pediatric patients.

Timing: Prior to initiation of therapy.

Cardiac History and Physical Exam

Rationale: To screen for pre-existing cardiac conditions that may contraindicate stimulant use.

Timing: Prior to initiation of therapy.

Psychiatric History (including family history of tics/Tourette's, bipolar disorder, psychosis)

Rationale: To identify risk factors for psychiatric adverse events.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or at least every 3-6 months.

Target: Within normal limits for age; monitor for sustained increases.

Action Threshold: Sustained elevation above baseline or age-appropriate norms; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months in children and adolescents.

Target: Normal growth trajectory.

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

Psychiatric Symptoms (e.g., agitation, anxiety, psychosis, mania, tics)

Frequency: At each visit.

Target: Absence of new or worsening symptoms.

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

ADHD Symptom Control

Frequency: At each visit.

Target: Improved attention, reduced impulsivity/hyperactivity.

Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative treatment.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • New or worsening tics
  • Unexplained weight loss
  • Sleep disturbances

Special Patient Groups

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Pregnancy

Methylphenidate is classified as Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Data from observational studies have not suggested an increase in overall major birth defects or a consistent pattern of specific major birth defects with methylphenidate exposure during the first trimester. However, some studies suggest a possible small increase in cardiac malformations.

Trimester-Specific Risks:

First Trimester: Possible small increase in cardiac malformations (e.g., atrial septal defects, ventricular septal defects) based on some observational studies, though overall risk of major birth defects not consistently increased.
Second Trimester: Limited data; potential for fetal growth restriction.
Third Trimester: Limited data; potential for withdrawal symptoms in neonate if exposed near term (e.g., agitation, tremor, poor feeding).
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Lactation

Methylphenidate is excreted into human breast milk. The relative infant dose (RID) is estimated to be low (around 0.2-1.7% of the maternal weight-adjusted dose). Monitor breastfed infants for adverse reactions such as agitation, insomnia, decreased appetite, or poor weight gain. Use with caution, and consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for methylphenidate and any potential adverse effects on the breastfed infant.

Infant Risk: L3 (Moderate risk). Potential for irritability, poor feeding, and sleep disturbances in the infant. Monitor closely.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) carefully due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).

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Geriatric Use

Safety and efficacy in patients over 65 years have not been established. Use with caution due to increased sensitivity to adverse effects (e.g., cardiovascular, psychiatric). Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Chewable tablets must be chewed thoroughly before swallowing; do not swallow whole.
  • Immediate-release methylphenidate has a short duration of action (3-5 hours), requiring multiple daily doses.
  • Consider a 'drug holiday' (e.g., weekends or school breaks) for pediatric patients to assess baseline symptoms, reduce tolerance, and potentially mitigate growth suppression, but this should be discussed with a healthcare provider.
  • Educate patients and caregivers about the potential for abuse and the importance of secure storage.
  • Always assess for pre-existing cardiac conditions and psychiatric comorbidities before initiating stimulant therapy.
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Alternative Therapies

  • Other CNS stimulants (e.g., amphetamine salts, lisdexamfetamine, dexmethylphenidate)
  • Non-stimulants (e.g., atomoxetine, guanfacine ER, clonidine ER)
  • Behavioral therapy (often used in conjunction with pharmacotherapy for ADHD)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150 per 30 tablets (5mg chewable)
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 your safety, never share your medication with others or take someone else's medication. When you receive this medication, you will also get a Medication Guide, which is a detailed patient information sheet. Please read this guide carefully and review it again whenever you refill your prescription. 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 information about the overdose, including the medication taken, the amount, and the time it occurred.