Quillichew 40mg ER Chew Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of discontinuing an MAOI due to risk of hypertensive crisis.
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.
Moderate Interactions
- Antihypertensive drugs - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
- Alcohol - may increase systemic exposure of methylphenidate.
Monitoring
Baseline Monitoring
Rationale: To identify pre-existing cardiovascular conditions and monitor for stimulant-induced cardiovascular effects.
Timing: Prior to initiation of therapy
Rationale: To establish baseline for growth monitoring in pediatric patients.
Timing: Prior to initiation of therapy
Rationale: To assess risk for stimulant-induced psychiatric adverse events or exacerbation of pre-existing conditions.
Timing: Prior to initiation of therapy
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)
Routine Monitoring
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.
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.
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.
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.
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
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:
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.
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.
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
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.
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