Quillichew 30mg 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.
đŸˇī¸
Drug Class
Central Nervous System Stimulant
đŸ§Ŧ
Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
🤰
Pregnancy Category
Not available
✅
FDA Approved
Dec 2015
âš–ī¸
DEA Schedule
Schedule II

Overview

â„šī¸

What is this medicine?

Quillichew ER is an extended-release chewable tablet used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by helping to increase certain natural substances in the brain that are important for attention and focus. Because it's extended-release, it works throughout the day.
📋

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 medication thoroughly 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 medication in half, consult with your doctor to determine 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. Instead, choose a dry, secure location where children and pets cannot access it. Consider using a locked box or area to prevent accidental ingestion or misuse by others. 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 attempt to catch up by taking extra doses.
💡

Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning.
  • Do not crush, chew (unless it's the chewable form), or divide other extended-release forms. Quillichew ER is designed to be chewed.
  • Avoid alcohol, as it can affect how the medication is released.
  • Maintain a healthy diet and regular sleep schedule.
  • Regular exercise can also help manage ADHD symptoms.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Not typically initiated in adults; if continued from childhood, dose should be individualized.

Condition-Specific Dosing:

ADHD: For patients transitioning from other methylphenidate products, the starting dose of Quillichew ER should be based on the current methylphenidate dose and clinical response. Max dose generally 60 mg/day.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial dose: 20 mg once daily in the morning. May increase by 10 mg or 20 mg weekly. Max dose: 60 mg/day.
Adolescent: Initial dose: 20 mg once daily in the morning. May increase by 10 mg or 20 mg weekly. Max dose: 60 mg/day.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; consider lower doses and monitor for adverse effects due to potential for increased exposure.
Dialysis: Not available; methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; consider lower doses and monitor for adverse effects due to potential for increased exposure.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic efficacy in Attention-Deficit/Hyperactivity Disorder (ADHD) is thought to be mediated through the blockade of dopamine and norepinephrine reuptake transporters in the presynaptic neuron, thereby increasing the extracellular concentrations of these monoamines in the striatum and prefrontal cortex.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not directly reported for Quillichew ER, but generally high for methylphenidate (e.g., ~30% for immediate release due to first-pass metabolism). Quillichew ER exhibits a biphasic release profile.
Tmax: Initial peak: ~1.5 hours; Second peak: ~4.5 hours (for Quillichew ER 30 mg)
FoodEffect: High-fat meal may delay Tmax by approximately 1 hour and increase Cmax by approximately 10% and AUC by approximately 15% for Quillichew ER. Can be taken with or without food, but consistency is recommended.

Distribution:

Vd: Not available (for Quillichew ER specifically, but generally large for methylphenidate, e.g., 2.65 L/kg)
ProteinBinding: 10% to 33% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3-4 hours (for Quillichew ER)
Clearance: Not available (for Quillichew ER specifically, but generally high, e.g., 0.53 L/hr/kg)
ExcretionRoute: Primarily renal (90% within 48-96 hours), with PPAA as the major metabolite.
Unchanged: <1% (methylphenidate) and ~80% (PPAA) in urine.
âąī¸

Pharmacodynamics

OnsetOfAction: Within 1-2 hours
PeakEffect: Approximately 4-5 hours
DurationOfAction: Approximately 8-10 hours

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

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.
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 sensations 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 deaths have occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly. Seek medical help immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting.

Additional Urgent Side Effects:

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 altered thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood disorders (e.g., depression, bipolar illness) or 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, 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 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.

Common Side Effects:

While many people may not experience side effects or only have mild ones, some common side effects of this medication 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 these or any other side effects bother you or persist, contact your doctor or seek medical attention.

Reporting Side Effects:

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, consult your doctor for medical advice.
🚨

Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • Numbness, tingling, or coldness in fingers or toes
  • Unexplained wounds on fingers or toes
  • New or worsening aggressive behavior or hostility
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New manic symptoms (e.g., extreme excitement, racing thoughts)
  • Uncontrolled muscle movements or tics
  • Blurred vision or other eye problems
📋

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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ 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
A history of stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as:
+ 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 treatments and health issues. Never start, stop, or change the dose of any medication without consulting your doctor.
âš ī¸

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. 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.

While taking this medication, it is recommended that you avoid consuming alcohol and limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these substances with the medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, it is crucial to discuss the use of over-the-counter (OTC) products with your doctor before taking them, as certain products such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids may increase blood pressure.

Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not exceed the prescribed dose.

This medication may increase the risk of seizures in certain individuals, particularly those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.

If you have phenylketonuria (PKU), discuss this with your doctor, as some products contain phenylalanine. Additionally, this medication may affect growth in children and teenagers; regular growth checks may be necessary. Consult with your doctor to discuss this potential effect.

It is essential to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of the medication to both you and your baby.
🆘

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)
  • Dryness of mucous membranes

What to Do:

Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Management includes supportive care, gastric lavage, activated charcoal, and sedation for severe agitation or seizures.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
🔴

Major Interactions

  • Vasopressor agents (e.g., pressor amines) - risk of increased blood pressure.
  • Halogenated anesthetics - risk of sudden blood pressure and heart rate increases during surgery.
  • Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, requiring dose adjustment.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, requiring dose adjustment.
🟡

Moderate Interactions

  • Alcohol - may lead to dose dumping of methylphenidate from extended-release formulations.
  • Antihypertensive drugs - methylphenidate may reduce the effectiveness of these drugs.
  • Dopaminergic drugs (e.g., antipsychotics, levodopa) - potential for pharmacodynamic interactions.
đŸŸĸ

Minor Interactions

  • Caffeine - additive stimulant effects.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause increases in BP and HR; screen for underlying cardiovascular conditions.

Timing: Prior to initiation of treatment.

Height and Weight

Rationale: Monitor for growth suppression in pediatric patients.

Timing: Prior to initiation of treatment.

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

Rationale: Stimulants can exacerbate or unmask psychiatric symptoms.

Timing: Prior to initiation of treatment.

📊

Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly (e.g., at each visit or every 3-6 months)

Target: Within normal limits for age/sex

Action Threshold: Persistent elevation outside normal range; consider dose reduction or discontinuation.

Height and Weight

Frequency: Every 3-6 months (pediatric patients)

Target: Normal growth trajectory

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

ADHD symptom control and adverse effects

Frequency: Regularly (e.g., at each visit)

Target: Improved ADHD symptoms with tolerable side effects

Action Threshold: Inadequate response, intolerable side effects, or emergence of new psychiatric symptoms.

Emergence of new psychiatric symptoms (e.g., psychosis, mania, aggression, tics)

Frequency: Ongoing

Target: Absence of new or worsening symptoms

Action Threshold: Prompt evaluation and potential discontinuation.

đŸ‘ī¸

Symptom Monitoring

  • Changes in mood or behavior (e.g., agitation, aggression, anxiety, depression)
  • Hallucinations or delusions
  • New or worsening tics
  • Chest pain, shortness of breath, syncope
  • Numbness, tingling, or color change in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes

Special Patient Groups

🤰

Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Data from a pregnancy registry did not show an increased risk of major congenital malformations with methylphenidate exposure.

Trimester-Specific Risks:

First Trimester: Limited human data, but some studies suggest a possible, though small, increased risk of cardiac malformations. Overall, data are conflicting and insufficient to establish a definitive risk.
Second Trimester: Not well-studied, but generally considered lower risk for structural malformations compared to first trimester.
Third Trimester: Potential for premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremor, poor feeding) have been reported with stimulant use near term.
🤱

Lactation

Methylphenidate is excreted into human milk. Monitor breastfed infants for agitation, insomnia, anorexia, and reduced weight gain. The decision to discontinue breastfeeding or discontinue the drug should take into account the importance of the drug to the mother.

Infant Risk: L3 - Moderately safe. Infant exposure is generally low, but potential for adverse effects exists. Monitor for irritability, poor feeding, and sleep disturbances.
đŸ‘ļ

Pediatric Use

Quillichew ER is approved for children aged 6 years and older. Monitor growth (height and weight) regularly, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.

👴

Geriatric Use

Safety and efficacy have not been established in geriatric patients. Use with caution in elderly patients due to increased likelihood of cardiovascular disease, other comorbidities, and polypharmacy. Start with lower doses and titrate slowly, monitoring for adverse effects.

Clinical Information

💎

Clinical Pearls

  • Quillichew ER is a chewable extended-release tablet, offering an alternative for patients who have difficulty swallowing pills.
  • Ensure patients chew the tablet thoroughly before swallowing to ensure proper extended-release properties.
  • Administer once daily in the morning to avoid interference with sleep.
  • Patients should be screened for cardiac abnormalities and psychiatric conditions prior to initiation.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Consider drug holidays if growth suppression or other significant side effects occur, under medical supervision.
🔄

Alternative Therapies

  • Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Aptensio XR, Jornay PM, Daytrana, Focalin XR)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulant medications (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy and psychotherapy for ADHD.
💰

Cost & Coverage

Average Cost: Not available per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand name, may require prior authorization)
📚

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 provides crucial information for patients. Please read this guide carefully and review it again whenever you refill your prescription. 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.