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Methylphenidate 10mg 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 (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
Mar 1999
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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 designed to be taken by mouth, usually two or three times a day.
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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 accompanying information carefully. Take your dose 30 to 45 minutes before meals, chewing the medication thoroughly before swallowing. It is essential to take this medication with a full glass of water (at least 8 ounces or 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 are taking this medication more than once a day, ensure that your last dose is taken 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 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 your medication. Keep all medications away from pets.

Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs 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 missed dose 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, or more often than prescribed.
  • Chew the tablet thoroughly before swallowing. Do not swallow whole.
  • Take 30-45 minutes before meals for best absorption, but can be taken with food if stomach upset occurs.
  • Avoid taking doses late in the day (afternoon or evening) to prevent sleep problems.
  • Store in a safe place, out of reach of children and others, to prevent misuse or accidental overdose.
  • Do not share your medication with anyone else, as it can be dangerous and is against the law.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Limit or avoid alcohol consumption while taking this medication.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically recommended as initial therapy for adults; often extended-release formulations are preferred. If used, initial dose 5 mg twice or three times daily, titrated weekly by 5-10 mg/day. Max 60 mg/day.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 5 mg twice or three times daily, 30-45 minutes before meals. Titrate weekly by 5-10 mg/day. Max 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For ADHD in children 6 years and older: Initial 2.5 mg or 5 mg twice daily (before breakfast and lunch). Titrate weekly by 2.5-5 mg/day. Max 60 mg/day.
Adolescent: For ADHD in adolescents: Initial 5 mg twice daily (before breakfast and lunch). Titrate weekly by 5-10 mg/day. Max 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment provided; use with caution.
Moderate: No specific dose adjustment provided; use with caution.
Severe: No specific dose adjustment provided; use with caution.
Dialysis: Not well studied; use with caution and monitor for adverse effects.

Hepatic Impairment:

Mild: No specific dose adjustment provided; use with caution.
Moderate: No specific dose adjustment provided; use with caution.
Severe: No specific dose adjustment provided; use with caution.

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 exact mechanism by which it produces its therapeutic effects in ADHD is unknown.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (variable, generally good)
Tmax: Approximately 1.9 hours (chewable tablet)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Not available (widely distributed)
ProteinBinding: Approximately 15% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 2-3 hours
Clearance: Not available
ExcretionRoute: Renal (primarily as PPAA)
Unchanged: Less than 1% (as unchanged drug in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes
PeakEffect: Approximately 1-2 hours
DurationOfAction: Approximately 3-5 hours

Safety & Warnings

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BLACK BOX WARNING

WARNING: ABUSE, MISUSE, AND ADDICTION
Methylphenidate has a high potential for abuse and misuse, which can lead to a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration (e.g., snorting, injection). Before prescribing methylphenidate, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of unused drug. Monitor for signs of abuse, misuse, and addiction throughout treatment.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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 or 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 or tremors
Difficulty controlling body movements
 Trouble 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, trouble speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Sudden deaths have occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. If a family member has an abnormal heartbeat or died suddenly, also notify your doctor. Seek immediate medical attention if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
 If you experience a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical help right away. This can occur even when not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or anger
+ Hallucinations
+ Inform your doctor if you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide. Seek medical help immediately if you experience:
- Hallucinations
- Changes in behavior
- Signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life
 A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help right away 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, upset stomach, or vomiting
+ Severe headache

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 aggression, hostility, or agitation
  • New or worsening tics (uncontrolled movements or sounds)
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • Unusual changes in mood or behavior
  • Numbness, tingling, or coldness in fingers or toes
  • Unexplained wounds on fingers or toes
  • Blurred vision or other vision changes
  • Prolonged or painful erections (priapism)
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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 you experienced.
 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 had a stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
 If you are currently taking:
+ Linezolid
+ Methylene blue
If you have difficulty swallowing, discuss this with your doctor

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
 Prescription and over-the-counter (OTC) drugs
Natural products
 Vitamins
* Any health problems you are experiencing

To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication.
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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 chocolate, as combining these with the 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, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice that the medication is no longer working as well, 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, and regular growth checks may be necessary. Consult with your doctor to discuss this potential effect.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial 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)
  • 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:

In case of overdose, call your poison control center at 1-800-222-1222. If the person has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call 911.

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

  • Vasopressor agents (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.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, increasing antidepressant levels or risk of serotonin syndrome.
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Moderate Interactions

  • Antihypertensive drugs - may reduce the effectiveness of antihypertensives.
  • Dopaminergic drugs (e.g., levodopa, dopamine agonists) - may potentiate dopaminergic effects.
  • Alcohol - may increase plasma levels of methylphenidate and exacerbate adverse effects.
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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: Risk of cardiovascular adverse events (hypertension, tachycardia).

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation of therapy.

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

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

Timing: Prior to initiation of therapy.

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

Rationale: Risk of serious cardiovascular events.

Timing: Prior to initiation of therapy; consider ECG if clinically indicated.

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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/individual

Action Threshold: Sustained elevation requiring intervention or dose adjustment.

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss.

Psychiatric symptoms (e.g., agitation, anxiety, psychosis, tics, mood changes)

Frequency: At each visit

Target: Stable or improved

Action Threshold: Emergence or worsening of symptoms requiring intervention.

ADHD symptom control and functional improvement

Frequency: At each visit

Target: Improved attention, reduced hyperactivity/impulsivity

Action Threshold: Lack of efficacy or worsening symptoms.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening tics
  • Hallucinations
  • Delusional thinking
  • Mania
  • Aggression
  • Agitation
  • Anxiety
  • Insomnia
  • Loss of appetite
  • Weight loss

Special Patient Groups

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Pregnancy

Methylphenidate is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are limited data on methylphenidate use in pregnant women.

Trimester-Specific Risks:

First Trimester: Some observational studies suggest a possible increased risk of cardiac malformations with first-trimester exposure, but data are conflicting and not conclusive.
Second Trimester: No specific data on risks during the second trimester.
Third Trimester: Neonates exposed to amphetamines (a class of stimulants) during the third trimester have experienced withdrawal symptoms. Monitor neonates for signs of withdrawal (e.g., feeding difficulties, irritability, agitation).
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor breastfed infants for agitation, insomnia, and reduced weight gain. Consider risks vs. benefits.

Infant Risk: L3 (Moderate risk) - Potential for irritability, insomnia, and decreased weight gain in the infant. Consider alternative therapies or close monitoring.
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Pediatric Use

Methylphenidate chewable tablets are approved for children 6 years and older. Monitor growth (height and weight) regularly, as long-term use has been associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, tics).

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Geriatric Use

Safety and efficacy in patients over 65 years have not been established. Use with caution in elderly patients due to increased sensitivity to stimulant effects and potential for underlying cardiovascular conditions. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Methylphenidate chewable tablets are an immediate-release formulation, requiring multiple daily doses to maintain effect.
  • The chewable form can be beneficial for patients who have difficulty swallowing pills.
  • Monitor for signs of abuse and diversion, as methylphenidate is a Schedule II controlled substance.
  • Regularly assess cardiovascular status (BP, HR) and growth parameters (height, weight) in all patients, especially children.
  • Educate patients and caregivers on proper administration, storage, and disposal of the medication.
  • Consider drug holidays or dose adjustments if growth suppression or significant adverse effects occur.
  • Patients with pre-existing cardiac conditions or structural heart abnormalities should be carefully evaluated before starting methylphenidate.
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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
  • Cognitive behavioral therapy (CBT)
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Cost & Coverage

Average Cost: $50 - $200 per 30 tablets
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'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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. 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 quantity, and the time it occurred.