Quillivant XR 25mg/5ml Susp 180ml

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effect in Attention Deficit Hyperactivity Disorder (ADHD) is thought to be due 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.

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, 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. Sudden deaths have occurred in people with certain heart problems. Tell your doctor if you or a family member have a history of abnormal heart rhythms or sudden death. Seek immediate medical attention if you experience:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Other Serious Side Effects:

Painful or prolonged erections (lasting more than 4 hours): Seek medical help right away to avoid long-term 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 health conditions, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical help if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life
Serotonin syndrome: A potentially life-threatening condition that may occur when taking this medication with certain other drugs. Seek medical help right away 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:

Many people may not experience any side effects or only minor ones. However, if you notice any of the following side effects, contact your doctor or seek medical help 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, 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.

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)
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 experienced a stroke
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug 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 inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

Your doctor and pharmacist will help determine if it is safe to take this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without consulting your doctor first.

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 to ensure your safety and proper care. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

Precautions to Take While Using This Medication

Until you know how this medication affects you, avoid driving and engaging in activities that require you to be alert. 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, particularly in individuals with a history of seizures. Discuss your risk with your doctor.

Special Considerations for Children, Teens, and Pregnant or Breastfeeding Women

This medication may affect growth in children and teens. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to weigh the benefits and risks to you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)

• Halogenated Anesthetics (risk of sudden blood pressure and heart rate increases during surgery)
• Vasopressor Agents (may potentiate pressor effects)
• Coumarin Anticoagulants (may increase prothrombin time)
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone - may inhibit metabolism, requiring dose adjustment)
• Tricyclic Antidepressants (e.g., imipramine, desipramine - may inhibit metabolism, requiring dose adjustment)
• Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., fluoxetine, paroxetine - may inhibit metabolism, requiring dose adjustment)

• Alcohol (may increase the release rate of methylphenidate from extended-release formulations)
• Antihypertensive Drugs (may reduce the effectiveness of antihypertensive drugs)

• Caffeine (additive stimulant effects)

• Chest pain
• Shortness of breath
• Syncope
• Unexplained weakness
• Numbness
• Coldness in extremities (Raynaud's phenomenon)
• New or worsening tics/Tourette's syndrome
• New or worsening aggressive behavior
• Hallucinations
• Delusional thinking
• Manic symptoms
• Suicidal ideation
• Blurred vision
• Priapism (rare, prolonged erections)

Based on animal reproduction studies, 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. Consider risks of untreated ADHD during pregnancy.

Methylphenidate is excreted into human milk. Monitor breastfed infants for agitation, insomnia, anorexia, and reduced weight gain. Weigh the developmental and health benefits of breastfeeding along with the mother’s clinical need for Quillivant XR and any potential adverse effects on the breastfed infant.

Quillivant XR is FDA-approved for ADHD in children 6 years and older and adolescents. Monitor growth (height and weight) regularly due to potential for 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 likelihood of cardiovascular disease and other comorbidities. Start with lower doses and titrate slowly.

• Quillivant XR is an extended-release oral suspension, providing a convenient liquid option for patients who have difficulty swallowing pills.
• Ensure patients or caregivers are properly instructed on how to measure the dose accurately using the provided oral dosing dispenser.
• Shake the bottle vigorously for at least 10 seconds before each use to ensure uniform suspension.
• The extended-release formulation provides approximately 12 hours of symptom control, typically allowing for once-daily morning dosing.
• Monitor for cardiovascular changes (BP, HR) and growth parameters (height, weight) regularly, especially in pediatric patients.
• Educate patients and families about the potential for psychiatric side effects (e.g., anxiety, agitation, psychosis) and to report any new or worsening symptoms immediately.
• Consider a drug holiday if growth suppression is observed or if long-term treatment is being re-evaluated.

• Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse)
• Non-stimulants (e.g., Strattera (atomoxetine), Intuniv (guanfacine ER), Kapvay (clonidine ER))
• Behavioral therapy
• Cognitive behavioral therapy (CBT)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 patient fact sheet that provides crucial information. It is vital to 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, do not hesitate to consult 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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.