Quillivant XR

What is Quillivant XR?

• Quillivant XR (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

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What are the uses of this medicine?

• QUILLIVANT XR is a central nervous system stimulant prescription medicine.
• QUILLIVANT XR is a liquid medicine that you take by mouth.
• It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
• QUILLIVANT XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

How does this medicine work?

• Methylphenidate (meth" il fen' i date) is a piperidine derivative that is structurally related to amphetamine which acts as a central nervous system (CNS) sympathomimetic stimulant, probably by causing release of norepinephrine at CNS nerve terminals promoting neurotransmission.
• Methylphenidate may also affect dopaminergic neurotransmission.
• Therapy with methylphenidate has been shown to increase cognitive abilities and improve psychological functioning and performance in children and adults with suspected attention deficit disorders.
• It has a paradoxical calming action in children with hyperactivity.
• Methylphenidate is also used in the therapy of narcolepsy.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known to be hypersensitive to methylphenidate, or other components of QUILLIVANT XR.
• treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI),

What drug interactions can this medicine cause?

• Do not administer QUILLIVANT XR concomitantly with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment. Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis.
• QUILLIVANT XR may decrease the effectiveness of drugs used to treat hypertension.
• Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS).

Is this medicine FDA approved?

• Methylphenidate was initially approved for use in the United States in 1955 and its indications have been broadened to include children above the age of 6 and adolescents with attention deficit disorder.

How should this medicine be used?

• Prior to treating children, adolescents, and adults with CNS stimulants including QUILLIVANT XR, assess for the presence of cardiac disease.
• Before administering the dose, VIGOROUSLY SHAKE the bottle of QUILLIVANT XR for at least 10 seconds, to ensure that the proper dose is administered.

Recommended dosage:

• For patients 6 years and above, recommended starting dose is 20 mg given orally once daily in the morning.
• Dosage may be increased weekly in increments of 10 mg to 20 mg per day.
• Daily dosage above 60 mg is not recommended.

Administration:

• Take QUILLIVANT XR exactly as prescribed. Your health care provider may adjust the dose, if needed, until it is right for you or your child. During dose adjustment, you or your child may still have ADHD symptoms.
• QUILLIVANT XR should be used with the oral dosing dispenser provided with the product. If the oral dosing dispenser is missing or not provided, please contact your pharmacist for a replacement.
• Check and make sure that the QUILLIVANT XR bottle contains liquid medicine. If QUILLIVANT XR is in powder form, do not use it. Return it to your pharmacist.
• Check and make sure that the bottle adapter was fully inserted into the bottle by the pharmacist. If the bottle adapter is not fully inserted, insert the adapter into the bottle.
• Take QUILLIVANT XR 1 time each day in the morning. QUILLIVANT XR is an extended-release suspension. It releases medicine into your body throughout the day.
• QUILLIVANT XR can be taken with or without food. Taking QUILLIVANT XR with food may shorten the time it takes for the medicine to start working.
• From time to time, your health care provider may stop QUILLIVANT XR treatment for a while to check ADHD symptoms.
• Your health care provider may do regular checks of the blood, heart, and blood pressure while taking QUILLIVANT XR.
• Children should have their height and weight checked often while taking QUILLIVANT XR. QUILLIVANT XR treatment may be stopped if a problem is found during these check-ups.
• In case of poisoning call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.
• If a dose is missed, you or your child should talk to your health care provider about dosing.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release oral suspension (after reconstitution with water): 25 mg per 5 mL (5 mg per mL).

This medicine is available in fallowing brand namesː QUILLIVANT XR

What side effects can this medication cause?

The most common side effects of this medicine include:

• decreased appetite
• trouble sleeping
• nausea
• vomiting
• indigestion
• stomach pain
• weight loss
• anxiety
• dizziness
• irritability
• mood swings
• fast heart beat
• increased blood pressure

QUILLIVANT XR may cause serious side effects, including:

• Heart-related problems
• Mental (Psychiatric) problems
• Circulation problems in fingers and toes
• painful and prolonged erections (priapism)

What special precautions should I follow?

• Sudden death has been reported in association with CNS stimulants at recommended doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
• CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.
• Use of CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar disorder prior to QUILLIVANT XR use.
• Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.
• CNS stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
• CNS stimulants, including QUILLIVANT XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
• CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor height and weight at appropriate intervals in pediatric patients.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis.

Treatment of overdosage:

• Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice on the management of overdosage with methylphenidate.

Can this medicine be used in pregnancy?

• There are limited published studies and small case series that report on the use of methylphenidate in pregnant women; however, the data are insufficient to inform any drug-associated risks.

Can this medicine be used in children?

• The safety and effectiveness of QUILLIVANT XR have been established in pediatric patients ages 6 to 17 years
• Safety and efficacy in pediatric patients below the age of 6 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: methylphenidate hydrochloride
• Inactive Ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide.

Who manufactures and distributes this medicine?

Distributed by: Next wave 30%

Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ

What should I know about storage and disposal of this medication?

• Store QUILLIVANT XR in a safe place at 59°F to 86°F (15°C to 30°C).

• Dailymed label info on Quillivant XR
• FDA Quillivant XR

Quillivant XR Resources
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