Drugplain

QuilliChew ER 30 mg/1

methylphenidate hydrochloride · TABLET, CHEWABLE, EXTENDED RELEASE · NextWave Pharmaceuticals, Inc

No Recall HistoryCurrently in Shortage
Plain English

Quillichew ER is a chewable extended-release tablet containing methylphenidate, a stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD) in children and adults. This prescription medication is designed to provide symptom relief throughout the day in a formulation that can be chewed rather than swallowed whole.

Key Facts

Brand Name
QuilliChew ER
Generic Name
methylphenidate hydrochloride
NDC Code (Product)
24478-075
Manufacturer
NextWave Pharmaceuticals, Inc
Strength
30 mg/1
Dosage Form
TABLET, CHEWABLE, EXTENDED RELEASE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
NDA207960
Marketing Start
04/18/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,137 reports
headache401 reports
off label use379 reports
anxiety365 reports
fatigue349 reports
nausea325 reports
toxicity to various agents316 reports
product substitution issue282 reports
drug abuse274 reports
somnolence267 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE QuilliChew ER is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 ) ]. Limitations of Use The use of QuilliChew ER is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ) , Use in Specific Populations ( 8.4 ) ]. QuilliChew ER is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). ( 1 ) Limitations of Use The use of QuilliChew ER is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).

Dosage & Administration

2 DOSAGE AND ADMINISTRATION QuilliChew ER may be taken with or without food. ( 2.1 ) For patients 6 years and above, recommended starting dose is 20 mg given orally once daily in the morning. Dosage may be titrated weekly in increments of 10 mg, 15 mg or 20 mg per day. Daily dosage above 60 mg is not recommended. ( 2.1 ) 2.1 Pretreatment Screening Prior to treating patients with QuilliChew ER, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ]. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating QuilliChew ER [see Warnings and Precautions (5.10) ]. 2.2 Recommended Dosage The recommended starting dosage of QuilliChew ER for patients 6 years and above is 20 mg once daily orally in the morning. The dose may be titrated up or down weekly in increments of 10 mg, 15 mg or 20 mg. The 10 mg and 15 mg doses can each be achieved by breaking in half the functionally scored 20 mg and 30 mg tablets, respectively. Daily doses above 60 mg have not been studied and are not recommended. As with…

Contraindications

4 CONTRAINDICATIONS Known hypersensitivity to methylphenidate or product components. ( 4.1 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days. ( 4.2 , 7.1 ) 4.1 Hypersensitivity to Methylphenidate or other Components of QuilliChew ER QuilliChew ER is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of QuilliChew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions ( 6.2 ) ] . 4.2 Monoamine Oxidase Inhibitors QuilliChew ER is contraindicated during concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI), because of the risk of hypertensive crisis [see Drug Interactions ( 7.1 ) ].

Drug Interactions

7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7 ) 7.1 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 (5.3) ]. Halogenated Anesthetics Concomitant use of halogenated anesthetics and QuilliChew ER may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of QuilliChew ER in patients being treated with anesthetics on the day of surgery. Risperidone Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both me…

Adverse Reactions

6 A DVERSE REACTIONS 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 (4.1) ] • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4.2) , Drug Interactions (7.1) ] • Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2 , 9.3 )] • Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] • Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] • Priapism [see Warnings and Precautions (5.5) ] • Peripheral Vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions (5.6) ] • Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.7) ] • Risks in Phenylketonuria [see Warnings and Precautions (5.8) ] • Acute Angle Closure Glaucoma [see Warnings and Precautions (5.9) ] • Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.10) ] • Motor and Verbal Tic…

Frequently Asked Questions

What is QuilliChew ER used for?

Quillichew ER is a chewable extended-release tablet containing methylphenidate, a stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD) in children and adults. This prescription medication is designed to provide symptom relief throughout the day in a formulation that can be chewed rather than swallowed whole.

Is QuilliChew ER a controlled substance?

Yes, QuilliChew ER is classified as CII under the DEA Controlled Substances Act.

What is the generic name for QuilliChew ER?

The generic name for QuilliChew ER is methylphenidate hydrochloride. There are 11 other brand versions of methylphenidate hydrochloride.

What is the NDC code for QuilliChew ER 30 mg/1?

The NDC (National Drug Code) for QuilliChew ER 30 mg/1 is 24478-075, listed by NextWave Pharmaceuticals, Inc.

Product NDC

24478-075

Package NDC

24478-075-01

Other QuilliChew ER Dosages

Other Methylphenidate Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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