Quillivant XR

What Is Quillivant XR?

Quillivant XR (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant used to treat Attention Deficit Hyperactivity Disorder (ADHD). Quillivant XR is available in generic form.

What Are Side Effects of Quillivant XR?

Common side effects of Quillivant XR include:

• decreased appetite,
• insomnia,
• nausea,
• vomiting,
• upset stomach,
• abdominal pain,
• weight loss,
• anxiety,
• dizziness,
• irritability,
• quickly changing moods,
• tics,
• eye pain,
• rash,
• the urge to scratch your skin,
• increased heart rate, and
• increased blood pressure.

Dosage for Quillivant XR

For patients 6 years of age and above, the recommended starting dose of Quillivant XR is 20 mg given orally once daily in the morning with or without food. The dosage may be increased weekly in increments of 10 mg to 20 mg per day. A daily dosage above 60 mg is not recommended.

What Drugs, Substances, or Supplements Interact with Quillivant XR?

Quillivant XR may interact with monoamine oxidase inhibitors (MAOIs). Tell your doctor all medications and supplements you use.

Quillivant XR During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Quillivant XR; it is unknown if it will affect a fetus. Premature delivery and low birth weight have been seen in mothers dependent on stimulant products such as amphetamines. Quillivant XR passes into breast milk. Breastfeeding while using Quillivant XR is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Quillivant XR.

Additional Information

Our Quillivant XR (methylphenidate hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Quillivant XR Consumer Information

Get emergency medical help if you have signs of an allergic reaction: 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 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.

Read the entire detailed patient monograph for Quillivant XR (Methylphenidate Hydrochloride Extended Release Oral Suspension, CII )

 

Quillivant XR Professional Information

SIDE EFFECTS

The following are discussed in more detail in other sections of the labeling:

• Known hypersensitivity to methylphenidate products or other ingredients of QUILLIVANT XR [see CONTRAINDICATIONS]
• Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS, DRUG INTERACTIONS]
• Drug Dependence [see BOX WARNING, WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence]
• Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
• Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
• Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Priapism [see WARNINGS AND PRECAUTIONS]
• Peripheral Vasculopathy, including Raynaud’s phenomenon [see WARNINGS AND PRECAUTIONS]
• Long-Term Suppression of Growth [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience With Other Methylphenidate Products In Children, Adolescents, And Adults With ADHD

Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia.

Clinical Trials Experience With QUILLIVANT XR In Children And Adolescents With ADHD

There is limited experience with QUILLIVANT XR in controlled trials. Based on this limited experience, the adverse reaction profile of QUILLIVANT XR appears similar to other methylphenidate extended-release products. The most common (≥2% in the QUILLIVANT XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6 to 12 years) were affect lability, excoriation, initial insomnia, tic, decreased appetite, vomiting, motion sickness, eye pain, and rash.

Table 2: Common Adverse Reactions occurring in ≥2% of subjects on QUILLIVANT XR and greater than placebo during the controlled crossover phase

Adverse reaction	QUILLIVANT XR N= 45	Placebo N= 45
Affect lability	9%	2%
Excoriation	4%	0
Initial Insomnia	2%	0
Tic	2%	0
Decreased appetite	2%	0
Vomiting	2%	0
Motion sickness	2%	0
Eye pain	2%	0
Rash	2%	0

Postmarketing Experience

The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows:

Blood and Lymphatic System Disorders: Pancytopenia, Thrombocytopenia, Thrombocytopenic purpura

Cardiac Disorders: Angina pectoris, Bradycardia, Extrasystole, Supraventricular tachycardia, Ventricular extrasystole

Eye Disorders: Diplopia, Mydriasis, Visual impairment

General Disorders: Chest pain, Chest discomfort, Hyperpyrexia

Hepatobiliary Disorders: Severe hepatocellular injury

Immune System Disorders: Hypersensitivity reactions such as Angioedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritus NEC, Rashes, Eruptions, and Exanthemas NEC

Investigations: Alkaline phosphatase increased, Bilirubin increased, Hepatic enzyme increased, Platelet count decreased, White blood cell count abnormal

Musculoskeletal, Connective Tissue and Bone Disorders: Arthralgia, Myalgia, Muscle twitching, Rhabdomyolysis

Nervous System Disorders: Convulsion, Grand mal convulsion, Dyskinesia, Serotonin syndrome in combination with serotonergic drugs

Psychiatric Disorders: Disorientation, Hallucination, Hallucination auditory, Hallucination visual, Libido changes, Mania

Urogenital System: Priapism

Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema

Vascular Disorders: Raynaud’s phenomenon

DRUG INTERACTIONS

Clinically Important Drug Interactions

MAOI Inhibitors

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.

Antihypertensive Drugs

QUILLIVANT XR may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the hypertensive drug as needed [see WARNINGS AND PRECAUTIONS].

Risperidone

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). Monitor for signs of EPS.

Drug Abuse And Dependence

Controlled Substance

QUILLIVANT XR contains methylphenidate, a Schedule II controlled substance.

Abuse

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 [see OVERDOSE].

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.

Dependence

Tolerance

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.

Dependence

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.

Read the entire FDA prescribing information for Quillivant XR (Methylphenidate Hydrochloride Extended Release Oral Suspension, CII )