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QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR is available in a 25 mg per 5 mL (5 mg per mL) extended-release oral suspension.
Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1.
QUILLIVANT XR® (methylphenidate hydrochloride) – Structural Formula Illustration
Methylphenidate HCl is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.
QUILLIVANT XR also contains the following 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.
Before starting or refilling a Quillivant XR prescription, read the medication guide included with your pills, as it may be updated with new information.
This guide should not replace a conversation with your doctor, who has a holistic view of your or your child’s medical history, other diagnoses, and other prescriptions. If you have questions, ask your doctor or pharmacist before you begin taking the medication.
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. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Drug Abuse And Dependence
QUILLIVANT XR contains methylphenidate, a Schedule II controlled substance.
CNS stimulants including QUILLIVANT XR, other methylphenidate-containing products, and amphetamines have a high potential for abuse. Abuse is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving.
Signs and symptoms of CNS stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Abusers of CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which can result in overdose and death .
To reduce the abuse of CNS stimulants including QUILLIVANT XR, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for QUILLIVANT XR use.
Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) can occur during chronic therapy with CNS stimulants including QUILLIVANT XR.
Physical dependence (a state of adaptation manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) can occur in patients treated with CNS stimulants including QUILLIVANT XR. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
As with all medications, follow your Quillivant XR prescription instructions exactly. Quillivant XR is the only liquid, extended-release methylphenidate product available. It is especially useful for the one-third of children who can’t swallow pills and for people of any age who need very low doses of methylphenidate medication.
Quillivant XR is a liquid formulation that releases the first dose of methylphenidate in 45 minutes and slowly keeps working for up to 12 hours. It is taken once daily in the morning with or without food. Shake the bottle well for at least 10 seconds, and then measure the medicine with the included syringe. The time-release formulation is designed to maintain a steady level of medication in your body throughout the day.
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 titrated weekly in increments of 10 mg to 20 mg. Daily dosages above 60 mg have not been studied and are not recommended.
The optimal dosage varies patient by patient. It is not determined by age, weight, or height, but rather by how a person metabolizes the medication, and the condition treated. Your doctor may adjust your daily dosage until you or your child experiences the best response — that is, the lowest dosage at which you experience the greatest improvement in symptoms without side effects.
During treatment, your doctor may periodically ask you to stop taking your Quillivant XR so that he or she can monitor ADHD symptoms; check vital statistics including blood, heart, and blood pressure; or evaluate height and weight. If any problems are found, your doctor may recommend discontinuing treatment.
Some patients report developing a tolerance to Quillivant XR after long-term use. If you notice that your dosage is no longer controlling your symptoms, talk to your doctor to plan a course of action.
Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; or to dexmethylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood circulation problems (such as Raynaud’s disease), glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts), personal/family history of uncontrolled muscle movements (motor tics, Tourette’s syndrome), overactive thyroid (hyperthyroidism), seizure disorder.
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
If used for a long time, this drug may affect a child’s growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend briefly stopping the medication from time to time. Check the child’s weight and height regularly, and consult your doctor or pharmacist for more details.
Older adults may be more sensitive to the side effects of this drug, especially trouble sleeping, weight loss, or chest pain.
During pregnancy, methylphenidate should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Consult your doctor before breast-feeding.
The most common side effects of Quillivant XR are as follows: decreased appetite, weight loss, nausea, stomach pain, dry mouth, vomiting, trouble sleeping, anxiety, nervousness, restlessness, mood swings, agitation, irritability, dizziness, shaking, blurred vision, increased blood pressure, fast heart beat, increased sweating, and fever.
Other serious side effects include slowing of growth in children, seizures, priapism and eyesight changes or blurred vision.
If side effects are bothersome, or do not go away, talk to your doctor. Most people taking this medication do not experience any of these side effects.
Report to your doctor any heart-related problems or a family history of heart and blood pressure problems. Patients with structural cardiac abnormalities and other serious heart problems have experienced sudden death, stroke, heart attack, and increased blood pressure while taking Quillivant XR.
Stimulants can increase blood pressure and heart rate. Physicians should monitor these vital signs closely during treatment. Call your doctor immediately if you or your child experiences warning signs such as chest pain, shortness of breath, or fainting while taking Quillivant XR.
Also disclose to your physician all mental health issues including any family history of suicide, bipolar illness, tics, or depression. Quillivant XR may create new or exacerbate existing behavior problems, bipolar illness, or Tourette’s syndrome. The FDA recommends evaluating patients for bipolar disorder, tics, and Tourette’s syndrome prior to stimulant administration, which can cause psychotic or manic symptoms in children and teenagers. Call your doctor immediately if you or your child experiences new or worsening mental health symptoms including hallucinations or sudden suspicions.
Discuss circulation problems with your doctor before taking Quillivant XR, which has been known to cause numbness, coolness, or pain in fingers or toes, including Raynaud’s phenomenon. Report to your doctor any new blood-flow problems, pain, skin color changes, or sensitivities to temperature while taking Quillivant XR.
Stimulants like Quillivant XR have a high potential for abuse and addiction, especially among people who do not have ADHD. It is a “Schedule II Stimulant,” a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse. Other Schedule II drugs include Dexedrine, Ritalin, and cocaine. People with a history of drug abuse should use caution when trying this medication. Taking the medication exactly as prescribed can reduce the potential for abuse.
The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.
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