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Quillichew ER

Quillichew ER(Methylphenidate Hydrochloride Extended-release Chewable Tablets) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Quillichew ER Side Effects Center

What Is QuilliChew ER?

QuilliChew ER (methylphenidate hydrochloride) extended-release chewable tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

What Are Side Effects of QuilliChew ER?

Common side effects of QuilliChew ER include:

Dosage for QuilliChew ER

For patients 6 years and above, the recommended starting dose of QuilliChew ER is 20 mg given orally once daily in the morning.

What Drugs, Substances, or Supplements Interact with QuilliChew ER?

QuilliChew ER may interact with monoamine oxidase inhibitors (MAOIs). Tell your doctor all medications and supplements you or your child uses.

QuilliChew ER During Pregnancy and Breastfeeding

During pregnancy, QuilliChew ER should be used only if prescribed. It is unknown if it would affect a fetus. QuilliChew ER passes into breast milk. It is unknown if it would affect a nursing infant. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking QuilliChew ER.

Additional Information

Our QuilliChew ER (methylphenidate hydrochloride) extended-release chewable tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Quillichew ER 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 Quillichew ER (Methylphenidate Hydrochloride Extended-release Chewable Tablets)

 

Quillichew ER 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 QuilliChew ER [see CONTRAINDICATIONS]
  • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS, DRUG INTERACTIONS]
  • Drug Dependence [see BOXED 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]
  • Risks in Phenylketonuria [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 QuilliChew ER In Children With ADHD

There is limited experience with QuilliChew ER in controlled trials. The safety data in this section is based on data from a laboratory classroom study conducted in 90 pediatric subjects (ages 6 to 12 years) with ADHD. The study consisted of a 6-week dose optimization period, followed by a randomized, double-blind, parallel group treatment period with the individually optimized dose of QuilliChew ER or placebo.

The most common (≥2% in the QuilliChew ER group and greater than placebo) adverse reactions reported in the double-blind, randomized, placebo-controlled phase in patients optimized to doses of QuilliChew ER 20 to 60 mg/day are described in Table 1.

Table 1: Common Adverse Reactions Occurring in ≥2% of Subjects on QuilliChew ER and Greater than Placebo During the Double-Blind Period of the ADHD Laboratory Classroom Study

Adverse reaction QuilliChew ER
N= 42 n (%)		 Placebo
N= 44 n (%)
Decreased appetite 1 (2.4) 0 (0)
Aggression 1 (2.4) 0 (0)
Emotional poverty 1 (2.4) 0 (0)
Nausea 1 (2.4) 0 (0)
Headache 1 (2.4) 0 (0)
Weight decreased 1 (2.4) 0 (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 QuilliChew ER 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

QuilliChew ER 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

QuilliChew ER contains methylphenidate, a Schedule II controlled substance.

Abuse

CNS stimulants including QuilliChew ER, 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 OVERDOSAGE].

To reduce the abuse of CNS stimulants including QuilliChew ER, 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 [see HOW SUPPLIED/Storage And Handling], monitor for signs of abuse while on therapy, and re-evaluate the need for QuilliChew ER 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 QuilliChew ER.

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 QuilliChew ER. 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 Quillichew ER (Methylphenidate Hydrochloride Extended-release Chewable Tablets)

&Copy; Quillichew ER Patient Information is supplied by Cerner Multum, Inc. and Quillichew ER Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.