Active Ingredient: methylphenidate hydrochloride
Inactive Ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinol, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide.
Quillivant XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Quillivant XR in a safe place to prevent misuse and abuse. Selling or giving away Quillivant XR may harm others, and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
WARNING: ABUSE AND DEPENDENCE
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.
Tell your doctor if you are are breastfeeding or plan to breast feed. Quillivant XR passes into your breast milk. You and your doctor should decide if you will take Quillivant XR or breast feed.
Quillivant XR is prescription medication used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Quillivant XR should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Before starting Quillivant XR tell your or your child’s doctor about all health conditions (or a family history of) including:
- heart problems, heart defects, high blood pressure
- mental problems including psychosis, mania, bipolar illness, or depression
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breast feed
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Quillivant XR will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.
1. Heart-related problems:
- sudden death in patients who have heart problems or heart defects
- stroke and heart attack in adults
- increased blood pressure and heart rate
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.Your doctor should check you or your child carefully for heart problems before starting Quillivant XR.Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with Quillivant XR.Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Quillivant XR.
2. Mental (Psychiatric) problems:All Patients
- new or worse behavior and thought problems
- new or worse bipolar illness
Children and Teenagers
- new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Quillivant XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
Quillivant XR should not be taken if you or your child:
- are allergic to methylphenidate hydrochloride, or any of the ingredients in Quillivant XR.
- are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
The recommended starting dose of Quillivant XR for patients 6 years and above is 20 mg once daily in the morning. The dose may be increased by 10 mg to 20 mg each week. Daily doses above 60 mg have not been studied and are not recommended.
See “Drug Precautions” section for information on reported heart and mental problems.
Other serious side effects include:
- slowing of growth (height and weight) in children
Common side effects include:
- decreased appetite
- weight loss
- nausea
- stomach pain
- dry mouth
- vomiting
- trouble sleeping
- anxiety
- nervousness
- restlessness
- mood swings
- agitation
- irritability
- dizziness
- shaking (tremor)
- blurred vision
- increased blood pressure
- fast heart beat
- increased sweating
- fever
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Quillivant XR there are no specific foods that you must exclude from your diet when receiving Quillivant XR.
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Quillivant XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Quillivant XR.
Your doctor will decide whether Quillivant XR can be taken with other medicines.
Especially tell your doctor if you or your child takes:
- anti-depression medicines including MAOIs
- cold or allergy medicines that contain decongestants
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking Quillivant XR without talking to your doctor first.
If you take too much Quillivant XR, call your local Poison Control Center or seek emergency medical attention right away.
- Take Quillivant XR exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
- Take Quillivant XR once each day in the morning. Quillivant XR is an extended-release suspension. It releases medicine into your body throughout the day.
- 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.
- 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 doctor may stop Quillivant XR treatment for awhile to check ADHD symptoms.
- Your doctor 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.
- Store Quillivant XR in a safe place at 59°F to 86°F (15°C to 30°C).
- Keep Quillivant XR and all medicines out of the reach of children.
Quillivant XR (generic: methylphenidate) is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in people over 6 years old. Quillivant XR belongs to a group of drugs called central nervous system (CNS) stimulants, which change the amounts of natural compounds in the brain.
This medication comes in a liquid form and is taken once a day in the morning, with or without food.
Common side effects of Quillivant XR include decreased appetite, weight loss, and nausea. Quillivant XR can cause dizziness.