Quillichew 20mg ER Chew Tablets

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in Attention Deficit Hyperactivity Disorder (ADHD) are thought to be mediated through the blockade of norepinephrine and dopamine reuptake into the presynaptic neuron and increasing the release of these monoamines into the extraneuronal space. This leads to increased concentrations of norepinephrine and dopamine in the synaptic cleft, enhancing neurotransmission in brain regions associated with attention and behavior.

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
+ 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 vision or eye pain, swelling, or redness
Seizures
Shakiness
Trouble controlling body movements
Difficulty 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, 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 defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly. 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
+ 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 immediate medical attention if you experience:
- Hallucinations
- Changes in behavior
- Signs of mood changes, including 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 immediate medical attention 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

Other Possible Side Effects

While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following:

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

If you experience any of these side effects or any other unusual symptoms, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 a new medication
Stopping a medication
Changing the dose of any medication

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 other products) and chocolate, as combining these with the medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, it is crucial to discuss with your doctor the use of 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, where the medication becomes less effective, and higher doses may be required to achieve the same effect. 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. 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. In children and teenagers, this medication may affect growth in some cases, and regular growth checks may be necessary. Consult with your doctor to discuss this further.

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

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy (risk of hypertensive crisis)

• Vasopressor agents (e.g., phenylephrine, pseudoephedrine): May potentiate pressor effects.
• Halogenated anesthetics (e.g., halothane, isoflurane): Risk of sudden blood pressure and heart rate increases during surgery.

• Anticoagulants (e.g., warfarin): May increase prothrombin time; monitor INR.
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May alter plasma concentrations; monitor levels.
• Antidepressants (e.g., tricyclic antidepressants, SSRIs): May inhibit metabolism of TCAs, increasing plasma levels; caution with SSRIs due to potential for serotonin syndrome.
• Antihypertensive drugs: May reduce the effectiveness of antihypertensive medications.

• Alcohol: May alter the release rate of methylphenidate from ER formulations; avoid concomitant use.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening psychotic symptoms (e.g., hallucinations, delusions)
• Manic symptoms (e.g., elevated mood, increased energy, decreased need for sleep)
• Aggressive behavior
• Anxiety
• Depression
• Suicidal ideation
• Motor or vocal tics
• Unexplained weight loss
• Growth deceleration

Category C. Studies in animals have shown adverse effects on fetal development at doses higher than human therapeutic doses. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for agitation, insomnia, and reduced weight gain.

Approved for children 6 years and older. Monitor growth (height and weight) carefully, as stimulants can be associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.

Safety and efficacy have not been established in geriatric patients. Use with caution due to increased sensitivity to adverse effects, particularly cardiovascular effects. Consider lower initial doses and slower titration.

• Quillichew ER is a chewable tablet, which can be beneficial for patients who have difficulty swallowing pills.
• Ensure patients chew the tablet thoroughly before swallowing to ensure proper extended-release properties.
• Administer in the morning to avoid insomnia. The extended-release formulation provides effects for up to 10-12 hours.
• Regularly monitor blood pressure, heart rate, and growth parameters (height and weight) in pediatric patients.
• Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
• Screen for pre-existing cardiac conditions and psychiatric disorders before initiating therapy.
• Avoid concomitant use with MAOIs due to the risk of hypertensive crisis.

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

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information about its use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.