Quillivant XR 25mg/5ml Susp 150ml

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic efficacy in 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.

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 immediately or seek emergency 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
Uncontrollable 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 death has occurred in people with certain heart problems or defects. If you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor.

Heart Problems:

If you experience any signs of heart problems, such as chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting, seek medical help immediately.

Erectile Dysfunction:

If you have a painful erection or an erection that lasts longer than 4 hours, seek medical attention right away. This can lead to permanent sexual dysfunction if left untreated.

Mental Health Changes:

New or worsening behavior 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 health conditions, such as depression or bipolar disorder, or if 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, or anxiety.

Serotonin Syndrome:

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, 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, or severe headache.

Other 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
Difficulty sleeping
Nose or throat irritation

Reporting Side Effects:

If you have questions about side effects or want to report any, contact your doctor or the FDA at 1-800-332-1088 or 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. 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
+ 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 certain medications, such as:
+ Linezolid
+ Methylene blue

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 whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before undergoing surgery, discuss this with your doctor.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. As directed by your doctor, regularly have your blood work, blood pressure, and heart rate checked. 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 to 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, reducing its effectiveness. If you find that the medication is no longer working as well as it should, 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. Discuss your risk of seizures with your doctor.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to discuss this potential effect.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of this medication to both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOIs (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., coumarin, warfarin): May decrease metabolism of anticoagulants, increasing bleeding risk.
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of these drugs, increasing plasma concentrations.
• Antidepressants (e.g., tricyclic antidepressants, SSRIs): May inhibit metabolism of some antidepressants, increasing plasma concentrations. Caution with serotonergic drugs due to risk of serotonin syndrome.
• Dopaminergic drugs (e.g., antipsychotics, levodopa): May antagonize effects of antipsychotics or potentiate effects of dopaminergic drugs.

• Antihypertensive drugs: May reduce the effectiveness of antihypertensive agents.
• Alcohol: May increase systemic exposure of methylphenidate and lead to dose dumping of extended-release formulations.

• Not specifically identified as minor, but general caution with other CNS stimulants.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening psychotic symptoms (e.g., hallucinations, delusional thinking)
• New or worsening manic symptoms (e.g., euphoria, irritability, pressured speech)
• Aggressive behavior or hostility
• Anxiety
• Depression
• Tics or Tourette's syndrome exacerbation
• Growth deceleration
• Weight loss
• Peripheral vasculopathy (e.g., Raynaud's phenomenon)

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of developmental toxicity at doses higher than human therapeutic doses. There are limited data from human observational studies.

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 use in children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms.

Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to adverse effects, especially cardiovascular effects. Generally not recommended unless benefits clearly outweigh risks.

• Quillivant XR is an extended-release formulation, providing once-daily dosing convenience for up to 12 hours of effect.
• Always shake the bottle vigorously for at least 10 seconds before each use to ensure uniform suspension.
• Use the provided oral dosing syringe for accurate measurement; household spoons are not accurate.
• Patients should be advised that the medication can be taken with or without food, but a high-fat meal may delay the onset of action.
• Regular monitoring of blood pressure, heart rate, and growth parameters (in children) is crucial.
• Educate patients and caregivers about the signs of serious cardiovascular and psychiatric adverse events and when to seek medical attention.
• Consider drug holidays or dose adjustments if growth suppression is observed in pediatric patients.
• Due to its Schedule II classification, strict prescribing and dispensing regulations apply.

• Other methylphenidate formulations (e.g., Concerta, Daytrana, Ritalin LA, Focalin XR, Quillichew ER, Aptensio XR, Jornay PM)
• 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.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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 receive a refill of this medication. If you have any questions or concerns about this medication, consult 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.