April 28, 2017
Recommended Topic Related To:

Quillichew ER

"The US Food and Drug Administration (FDA) has approved a chewable tablet form of extended-release methylphenidate (QuilliChew ER, Pfizer Inc) for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older, the compa"...

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Quillichew ER

QUILLICHEW ER™
(methylphenidate hydrochloride) Extended-Release Chewable Tablets

WARNING

ABUSE AND DEPENDENCE

CNS stimulants, including QuilliChew ER, 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 [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence].

DRUG DESCRIPTION

QuilliChew ER (methylphenidate hydrochloride extended-release chewable tablets) is available in three dosage strengths -20 mg, 30 mg and 40 mg. The dosage strengths are expressed in terms of methylphenidate hydrochloride equivalents; however only 15% of methylphenidate is present as methylphenidate hydrochloride salt. The remaining 85% is present as methylphenidate ionically-bound to the sulfonate groups of sodium polystyrene sulfonate particles. QuilliChew ER contains approximately 30% immediate release and 70% extended release methylphenidate.

The QuilliChew ER extended-release chewable tablets are cherry flavored.

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.

Figure 1. Methylphenidate HCl Structure

QUILLICHEW ER™ (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.

QuilliChew ER also contains the following inactive ingredients: aspartame [see WARNINGS AND PRECAUTIONS], cherry flavor, citric acid, crospovidone, D&C red #30 (for 30 mg strength), D&C red #7 (for 40 mg strength), guar gum, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl acetate, polyvinyl alcohol, povidone, silicon dioxide, sodium polystyrene sulfonate, talc, triacetin, xanthan gum.

Last reviewed on RxList: 3/8/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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