Quillichew 40mg ER Chew Tablets

Manufacturer TRIS PHARMA Active Ingredient Methylphenidate Extended- Release 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 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
Dec 2015
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Quillichew ER is a chewable tablet that helps improve focus, attention, and control over impulsive behavior in people with Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the morning, chewing the tablet well before swallowing. You can take it with or without food, but be sure to drink a full glass of water. If you have any questions about breaking your tablet in half, consult with your doctor to confirm if this is acceptable.

Storing and Disposing of Your Medication

Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom, and instead, choose a dry location. It's essential to store your medication in a secure place where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep your medication safe. Remember to keep all medications out of reach of pets.

Missing a Dose

If you miss a dose, skip it 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 one.
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Lifestyle & Tips

  • Take Quillichew ER once daily in the morning, with or without food. Chewing the tablet thoroughly before swallowing is important.
  • Do not crush, cut, or dissolve the tablet in liquid, as this can affect its extended-release properties (beyond chewing as directed).
  • Avoid taking the medication in the late afternoon or evening to prevent sleep problems.
  • Store the medication securely to prevent misuse or abuse.
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements.
  • Limit or avoid alcohol consumption while taking this medication.

Dosing & Administration

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Adult Dosing

Standard Dose: Not specifically approved for adults; however, methylphenidate ER is used in adults. Dosing is individualized based on patient response and tolerability. Typical maximum dose for methylphenidate ER is 60 mg/day.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Individualized titration, typically starting with lower doses and increasing weekly.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6 to 12 years of age: Initial dose of 20 mg once daily in the morning. Dosage may be titrated weekly in increments of 10 mg or 20 mg to a maximum of 60 mg/day.
Adolescent: For adolescents 13 to 17 years of age: Initial dose of 20 mg once daily in the morning. Dosage may be titrated weekly in increments of 10 mg or 20 mg to a maximum of 60 mg/day.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic efficacy in ADHD is thought to be related to its ability to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: 22-65% (variable)
Tmax: Approximately 5.1 hours (for Quillichew ER)
FoodEffect: A high-fat meal can delay Tmax by approximately 1.5 hours, increase Cmax by 19%, and increase AUC by 16%.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for Quillichew ER)
Clearance: Not readily quantifiable due to extensive first-pass metabolism
ExcretionRoute: Urine (primarily as ritalinic acid)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: Approximately 5-6 hours
DurationOfAction: Up to 10 hours

Safety & Warnings

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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 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 eyesight 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, 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, 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:

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 lasting longer than 4 hours, seek medical attention immediately. If left untreated, this can lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
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, inform your doctor. 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

Serotonin Syndrome:

A potentially life-threatening condition called serotonin syndrome can 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 severe 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 go away:

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

Reporting Side Effects:

If you have questions about side effects or want to report any side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (especially during exercise)
  • New or worsening aggressive behavior or hostility
  • New or worsening tics (uncontrolled repetitive movements or sounds)
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • Feeling unusually suspicious or paranoid
  • Unexplained numbness, pain, or discoloration in fingers or toes
  • Unexplained weight loss or slowed growth in children
  • Severe headache or blurred vision
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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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
A family history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced 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)
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

Important Information to Share with Your Healthcare Providers

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial for ensuring your safety and proper care, especially if you are scheduled to have surgery. Be sure to discuss your surgery plans with your doctor.

Precautions to Take While Using This Medication

Until you know how this medication affects you, avoid driving and engaging in activities that require your full attention. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

Interactions with Other Substances

Avoid consuming alcohol while taking this medication. Limit your intake of caffeine (found in tea, coffee, cola, and chocolate) as it may cause nervousness, shakiness, and a rapid heartbeat when combined with this medication.

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
* Certain natural products or aids

Potential Risks and Side Effects

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 take more than 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.

Special Considerations

If you have phenylketonuria (PKU), consult with your doctor, as some products contain phenylalanine. This medication may affect growth in children and teenagers, requiring regular growth checks. Discuss this with your doctor.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of discontinuing an MAOI due to risk of hypertensive crisis.
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Major Interactions

  • Vasopressor agents (e.g., phenylephrine, epinephrine) - risk of potentiating pressor effects.
  • Halogenated anesthetics (e.g., halothane, isoflurane) - risk of sudden increases in blood pressure and heart rate during surgery.
  • Coumarin anticoagulants (e.g., warfarin) - may increase prothrombin time; monitor coagulation parameters.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may alter plasma concentrations of these drugs; monitor levels.
  • Tricyclic antidepressants (TCAs) - may inhibit metabolism of TCAs, leading to increased plasma levels; monitor for adverse effects.
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Moderate Interactions

  • Antihypertensive drugs - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Alcohol - may increase systemic exposure of methylphenidate.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To identify pre-existing cardiovascular conditions and monitor for stimulant-induced cardiovascular effects.

Timing: Prior to initiation of therapy

Height and Weight

Rationale: To establish baseline for growth monitoring in pediatric patients.

Timing: Prior to initiation of therapy

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

Rationale: To assess risk for stimulant-induced psychiatric adverse events or exacerbation of pre-existing conditions.

Timing: Prior to initiation of therapy

Electrocardiogram (ECG)

Rationale: Consider if patient has a history of cardiac disease or significant family history of sudden cardiac death.

Timing: Prior to initiation of therapy (if indicated)

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or every 3-6 months

Target: Within normal limits for age/sex

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant investigation and potential dose adjustment or discontinuation.

Height and Weight

Frequency: Every 3-6 months in pediatric patients

Target: Consistent growth along percentile curves

Action Threshold: Significant growth deceleration or weight loss warrants investigation and potential dose adjustment or drug holiday.

ADHD Symptom Control

Frequency: At each visit

Target: Improved focus, reduced impulsivity/hyperactivity

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

Emergence of Psychiatric Symptoms (e.g., agitation, psychosis, mania, 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.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Unexplained fainting
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • New or worsening manic symptoms (e.g., elevated mood, increased energy, decreased need for sleep)
  • New or worsening aggressive behavior or hostility
  • New or worsening tics or Tourette's syndrome symptoms
  • Unexplained weight loss
  • Severe headache
  • Blurred vision

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations (e.g., ventricular septal defects) based on some observational studies, though data are conflicting and overall risk appears low.
Second Trimester: No specific risks identified beyond general stimulant effects.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms (e.g., agitation, tremor, poor feeding) in neonates if exposed late in pregnancy.
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Lactation

L3 (Moderate risk). Methylphenidate is excreted into breast milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for adverse effects.

Infant Risk: Potential for irritability, agitation, poor feeding, or poor weight gain in the infant. Monitor infant for signs of adverse effects.
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Pediatric Use

Approved for children 6 years of age and older. Monitor growth (height and weight) regularly, as stimulants have been associated with modest growth suppression. Assess for emergence of tics or psychiatric symptoms.

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Geriatric Use

Safety and efficacy have not been established in geriatric patients. Not typically used in this population. Use with caution due to increased sensitivity to sympathomimetic effects and potential for cardiovascular adverse events.

Clinical Information

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Clinical Pearls

  • Quillichew ER is a chewable extended-release tablet, making it a suitable option for patients who have difficulty swallowing traditional pills.
  • Ensure patients understand that the tablet must be chewed thoroughly before swallowing to ensure proper extended-release delivery.
  • Administer in the morning to minimize the risk of insomnia.
  • Individualize dosing based on patient response and tolerability, starting with a low dose and titrating gradually.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Regularly monitor blood pressure, heart rate, and growth parameters (in children) throughout treatment.
  • Be vigilant for new or worsening psychiatric symptoms, including psychosis, mania, and aggression.
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Alternative Therapies

  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulant medications (e.g., Atomoxetine [Strattera], Guanfacine ER [Intuniv], Clonidine ER [Kapvay])
  • Behavioral therapy and other psychosocial interventions for ADHD
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Cost & Coverage

Average Cost: Varies widely by strength, quantity, and pharmacy per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred 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. This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.