Quillivant XR 25mg/5ml Susp 60ml

Manufacturer TRIS PHARMA Active Ingredient Methylphenidate Extended- Release Oral Suspension(meth il FEN i date) Pronunciation KWIL-i-vant EKS-AR (meth-il-FEN-i-date)
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System Stimulant
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Pharmacologic Class
Dopamine and Norepinephrine Reuptake Inhibitor
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Pregnancy Category
Not available
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FDA Approved
Sep 2012
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Quillivant XR is an extended-release liquid medicine used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It helps improve focus, attention, and control over impulsive behaviors by affecting certain chemicals in the brain.
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How to Use This Medicine

To take this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Take your dose in the morning, with or without food. Before each use, shake the bottle for at least 10 seconds to ensure the contents are well mixed. Verify that the medication is in liquid form; if it remains a powder, return it to the pharmacist as it should not be used.

When measuring your dose, use the provided measuring device. If one is not included, consult your pharmacist for an appropriate measuring tool to accurately measure your medication.

To maintain the medication's effectiveness, store it at room temperature, away from direct light and in a dry location. Avoid storing it in a bathroom.

If you miss a dose, contact your doctor for guidance on the best course of action to take.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning. Do not take in the afternoon or evening as it may cause sleep problems.
  • Shake the bottle well for at least 10 seconds before each use.
  • Measure the dose accurately using the provided oral dosing syringe.
  • Do not stop taking this medication suddenly without talking to your doctor, as it may cause withdrawal symptoms.
  • Avoid alcohol consumption, as it may cause the medication to be released too quickly.
  • Store at room temperature, away from light and moisture. Do not freeze.
  • Keep out of reach of children and pets due to abuse potential.

Dosing & Administration

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Adult Dosing

Standard Dose: Not indicated for initial treatment in adults; however, if continued from childhood, dose should be individualized. Max 60 mg/day.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Initial dose 20 mg orally once daily in the morning. May increase by 10-20 mg weekly to a maximum of 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial dose 20 mg orally once daily in the morning for patients 6-12 years of age. May increase by 10-20 mg weekly to a maximum of 60 mg/day.
Adolescent: Initial dose 20 mg orally once daily in the morning for patients 13-17 years of age. May increase by 10-20 mg weekly to a maximum of 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.
Dialysis: Not available; methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in ADHD are 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. This leads to enhanced neurotransmission in areas of the brain associated with attention, impulse control, and executive function.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-25% (due to first-pass metabolism)
Tmax: Approximately 6.5-10.5 hours (biphasic absorption, initial peak at 1-2 hours, second peak at 6-8 hours)
FoodEffect: High-fat meal may delay Tmax by approximately 2.5 hours and increase Cmax by about 25%.

Distribution:

Vd: Approximately 2.65 L/kg
ProteinBinding: Approximately 15% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5-6.4 hours (for methylphenidate), 2.9 hours (for d-methylphenidate)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (90% as PPAA, 1% as unchanged drug)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: Approximately 45-60 minutes
PeakEffect: Approximately 6-8 hours
DurationOfAction: Approximately 10-12 hours

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Quillivant XR, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy. Misuse of CNS stimulants may cause sudden death and serious cardiovascular adverse events.
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Side Effects

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 medical attention immediately:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or 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 (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold feeling 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 any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Erectile Dysfunction:

If you experience a painful erection (hard penis) 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 lasting sexual problems and impotence.

Mental Health Changes:

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 or mood problems, 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
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 severe and 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
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 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 and 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.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (seek immediate medical attention)
  • New or worsening aggressive behavior or hostility
  • New psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New manic symptoms (e.g., extreme high mood, increased energy, racing thoughts)
  • Unexplained wounds on fingers or toes, or changes in skin color (Raynaud's phenomenon)
  • Prolonged or painful erections (priapism, seek immediate medical attention)
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Before Using This Medicine

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. Be sure to describe the allergic reaction you experienced, including any 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 any of the following medications:
+ 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 need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

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, have regular blood tests, blood pressure checks, and heart rate monitoring. You may need to undergo certain heart tests before starting this medication; if you have questions, consult 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 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 and potentially requiring higher doses to achieve the same effect. If you notice the medication is no longer working as well, contact your doctor. Do not exceed 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 children and teenagers, this medication may affect growth in some cases, requiring regular growth checks; consult your doctor about this potential effect.

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

Overdose Symptoms:

  • Vomiting
  • Agitation
  • Tremors
  • Hyperreflexia
  • Muscle twitching
  • Convulsions (may be followed by coma)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dry mouth

What to Do:

Call 911 or your local poison control center immediately (e.g., 1-800-222-1222). Seek emergency medical attention. Management includes supportive care, maintaining circulation and respiration, external cooling for hyperpyrexia, and benzodiazepines for severe agitation or convulsions.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis)
  • Halogenated anesthetics (risk of sudden blood pressure and heart rate increases during surgery)
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Major Interactions

  • Vasopressors (e.g., phenylephrine, pseudoephedrine) - enhanced pressor effect
  • Antihypertensives (e.g., guanethidine, clonidine) - reduced hypotensive effect
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - theoretical risk of serotonin syndrome
  • Antipsychotics (e.g., haloperidol, chlorpromazine) - may inhibit metabolism of methylphenidate, or methylphenidate may antagonize effects of antipsychotics
  • Anticoagulants (e.g., warfarin) - may prolong prothrombin time
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of these drugs
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Moderate Interactions

  • Alcohol (may accelerate release of methylphenidate from extended-release formulations, leading to dose dumping)
  • Caffeine (additive stimulant effects)
  • Acidifying agents (e.g., ascorbic acid, ammonium chloride) - may decrease absorption of methylphenidate
  • Alkalinizing agents (e.g., sodium bicarbonate, antacids) - may increase absorption of methylphenidate
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Complete Medical History and Physical Exam

Rationale: To identify pre-existing cardiovascular conditions (e.g., structural cardiac abnormalities, cardiomyopathy, serious arrhythmia, coronary artery disease) or psychiatric conditions (e.g., bipolar disorder, psychosis) that may contraindicate or require caution with stimulant use.

Timing: Prior to initiation of therapy

Blood Pressure and Heart Rate

Rationale: Stimulants can cause increases in blood pressure and heart rate.

Timing: Prior to initiation of therapy

Height and Weight

Rationale: To monitor for potential growth suppression in pediatric patients.

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood Pressure and Heart Rate

Frequency: Regularly (e.g., at each visit or every 3-6 months)

Target: Within normal limits for age

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm heart rate) warrant further evaluation and potential dose adjustment or discontinuation.

Height and Weight

Frequency: Every 3-6 months in pediatric patients

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration or weight loss may require drug holiday or alternative treatment.

Psychiatric Status (e.g., emergence or worsening of psychotic or manic symptoms, aggression, anxiety, depression)

Frequency: Regularly (e.g., at each visit)

Target: Stable or improved psychiatric symptoms

Action Threshold: New or worsening psychiatric symptoms warrant immediate evaluation and potential discontinuation.

ADHD Symptom Control

Frequency: Regularly (e.g., at each visit)

Target: Improved attention, reduced impulsivity/hyperactivity

Action Threshold: Lack of efficacy or intolerable side effects may require dose adjustment or change in therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • Unexplained fainting
  • New or worsening aggression
  • Hallucinations
  • Delusional thinking
  • Mania
  • Severe anxiety
  • Depressed mood
  • Tics or abnormal movements
  • Numbness, coolness, or pain in digits (Raynaud's phenomenon)
  • Priapism (prolonged or painful erections)

Special Patient Groups

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Pregnancy

There are no adequate and well-controlled studies of methylphenidate in pregnant women. Available data from published observational studies and postmarketing reports have not identified a clear drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, methylphenidate use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but no consistent pattern of major birth defects observed.
Second Trimester: Not specifically studied, but generally considered lower risk for major malformations.
Third Trimester: Potential for premature birth and low birth weight. Neonates exposed to amphetamines (a class of drugs with similar pharmacology) during the third trimester have been reported to have withdrawal symptoms.
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Lactation

Methylphenidate is excreted into human milk. There are limited data on the effects of methylphenidate on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Quillivant XR and any potential adverse effects on the breastfed infant from Quillivant XR or from the underlying maternal condition. Monitor breastfed infants for agitation, insomnia, anorexia, and reduced weight gain.

Infant Risk: Low to moderate risk (L3). Potential for irritability, poor feeding, and sleep disturbances in the infant.
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Pediatric Use

Approved for use in pediatric patients 6 years of age and older. Monitor growth (height and weight) regularly. Long-term effects on growth are not fully established but some studies suggest a temporary slowing of growth rate. Psychiatric adverse events (e.g., psychosis, mania) can occur.

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Geriatric Use

Safety and effectiveness in geriatric patients have not been established. Use with caution due to increased likelihood of cardiovascular disease and other comorbidities. Generally not recommended for initial treatment in this population.

Clinical Information

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Clinical Pearls

  • 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 of the bottle (at least 10 seconds) before each dose to ensure uniform suspension and accurate dosing.
  • Use the provided oral dosing syringe for accurate measurement; household spoons are not accurate.
  • The extended-release nature means it's typically dosed once daily in the morning, providing symptom control throughout the school/work day.
  • Monitor for signs of abuse and diversion, as methylphenidate is a Schedule II controlled substance.
  • Educate patients and caregivers about potential cardiovascular and psychiatric side effects, and when to seek medical attention.
  • Consider drug holidays for pediatric patients to assess growth and symptom control, if clinically appropriate and supervised by a physician.
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Alternative Therapies

  • Other extended-release methylphenidate formulations (e.g., Concerta, Ritalin LA, Daytrana, Aptensio XR, Jornay PM)
  • Immediate-release methylphenidate (e.g., Ritalin, Methylin)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine)
  • Non-stimulant medications for ADHD (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
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Cost & Coverage

Average Cost: Varies widely, typically $200-$400 per 60ml bottle
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand-name, often requires prior authorization)
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General Drug Facts

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 amount, and the time it occurred.