Quillivant XR is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Quillivant XR extended-release oral suspension is used to treat attention deficit hyperactivity disorder (ADHD). The extended-release oral suspension formulation releases methylphenidate into your body throughout the day.

Quillivant XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Quillivant XR is safe and effective in children under 6 years of age.

You should not use Quillivant XR if you have glaucoma, tics or Tourette's syndrome, or severe anxiety, tension, or agitation.

Do not use Quillivant XR if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Methylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Methylphenidate may be habit-forming, Misuse can cause addiction, overdose, or death.. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems - chest pain, feeling light-headed or short of breath; signs of psychosis - paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems - unexplained wounds on your fingers or toes.

Take Quillivant XR exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your dose needs may change if you switch to a different brand, strength, or form of methylphenidate. Avoid medication errors by using only the medicine your doctor prescribes.

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Never share this medicine with another person. Keep the medicine where others cannot get to it. Selling or giving away Quillivant XR is against the law.

To prevent sleep problems, take this medicine in the morning.

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.

Measure liquid Quillivant XR oral suspension with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Tell your doctor if you have a planned surgery.

Your doctor will need to check your progress on a regular basis. Tell any doctor who treats you that you are using Quillivant XR.

Store at room temperature away from moisture and heat.

Keep your medicine in a place where no one can use it improperly.

Usual Adult Dose for Attention Deficit Disorder:

Initial Dose: 20 mg orally once a day in the morning. Titrate in increments of 10 to 20 mg weekly until a well-tolerated, therapeutic dose is achieved.
Maximum Dose: 60 mg/day.

Usual Pediatric Dose for Attention Deficit Disorder:

6 years or older:
Initial Dose: 20 mg orally once a day in the morning. Titrate in increments of 10 to 20 mg weekly until a well-tolerated, therapeutic dose is achieved.
Maximum Dose: 60 mg/day.

Do not use Quillivant XR if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

You may not be able to use Quillivant XR if you are allergic to methylphenidate, or if you have:

• glaucoma;

• a personal or family history of tics (muscle twitches) or Tourette's syndrome; or

• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

To make sure Quillivant XR is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• motor tics (muscle twitches) or Tourette's syndrome;

• blood circulation problems in the hands or feet;

• seizures or epilepsy;

• problems with the esophagus, stomach, or intestines;

• an abnormal brain wave test (EEG); or

• drug or alcohol addiction.

Tell your doctor if you are pregnant or breastfeeding.

Quillivant XR is not approved for use by anyone younger than 6 years old.

Use the medicine as soon as you can, but skip the missed dose if it is later than 6:00 p.m. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate could be fatal.

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how Quillivant XR will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction to Quillivant XR: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of heart problems - chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis - hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;

• signs of circulation problems - numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or

• penis erection that is painful or lasts 4 hours or longer (rare).

Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate.

Common Quillivant XR side effects may include:

• excessive sweating;

• mood changes, feeling nervous or irritable, sleep problems (insomnia);

• fast heart rate, pounding heartbeats or fluttering in your chest, increased blood pressure;

• loss of appetite, weight loss;

• dry mouth, nausea, stomach pain; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with methylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.