Quillivant XR 25mg/5ml Susp 120ml

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic efficacy in 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 experience 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
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. Sudden deaths have occurred in people with certain 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 experience a painful erection or an erection that lasts longer than 4 hours, seek medical help right away. This can occur even when you are not having sex. If left untreated, it may lead to permanent sexual dysfunction.

Mental Health:

New or worsening behavioral and mood changes, such as changes in thinking, anger, and 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. If you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, seek medical help immediately.

Serotonin Syndrome:

A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. 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, seek medical help immediately.

Other Side Effects:

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor:

Dizziness or headache
Drowsiness
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous and excitable
Trouble sleeping
* Nose or throat irritation

Reporting Side Effects:

If you have questions about side effects or want to report a side effect, 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, 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

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 needs to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without consulting your doctor first.

Important Information to Share with Your Healthcare Team

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 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 other products) and chocolate, as combining these substances with this 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
* Certain natural products or aids

Potential Risks and Side Effects

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 some individuals, particularly those with a history of seizures. Discuss your risk of seizures with your doctor.

In rare cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns.

Pregnancy and Breastfeeding

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

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

• Pressor agents (e.g., decongestants, tricyclic antidepressants) - risk of hypertensive crisis.
• Halogenated anesthetics - risk of sudden blood pressure and heart rate increases during surgery.
• Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome.

• Anticoagulants (e.g., coumarin) - methylphenidate may inhibit their metabolism, increasing bleeding risk.
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - methylphenidate may inhibit their metabolism, increasing serum levels.
• Antihypertensive drugs - methylphenidate may reduce their effectiveness.
• Dopaminergic drugs (e.g., antipsychotics, dopamine agonists) - potential for pharmacodynamic antagonism or additive effects.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hostility
• Psychotic symptoms (e.g., hallucinations, delusions)
• Manic symptoms (e.g., elevated mood, grandiosity, decreased need for sleep)
• Suicidal ideation
• Unexplained wounds on fingers or toes (peripheral vasculopathy)
• Numbness, coolness, or pain in extremities (Raynaud's phenomenon)

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 or preterm birth with methylphenidate exposure.

Methylphenidate is excreted into human milk. Monitor breastfed infants for agitation, insomnia, anorexia, and reduced weight gain. Consider 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.

Approved for children 6 years and older. Monitor growth (height and weight) regularly, as long-term use has been associated with 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 increased sensitivity to adverse effects, particularly cardiovascular effects, and potential for comorbidities and polypharmacy.

• Quillivant XR is an extended-release liquid formulation, which can be beneficial for patients who have difficulty swallowing pills or prefer a liquid.
• Ensure proper shaking (10 seconds) and accurate measurement with the provided oral dispenser to ensure consistent dosing.
• The biphasic release profile provides an initial rapid effect followed by sustained release, aiming for once-daily dosing convenience.
• Always assess for pre-existing cardiac conditions and psychiatric disorders before initiating therapy due to potential risks.
• Educate patients and caregivers about the potential for abuse and the importance of secure storage.
• Regularly monitor blood pressure, heart rate, and growth parameters, especially in children.

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

If your symptoms or health issues persist or worsen, it's 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 valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate 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 amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.