April 28, 2017
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Adzenys XR-ODT

"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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Adzenys XR-ODT

ADZENYS XR-ODT
(amphetamine) Extended-release Orally Disintegrating Tablets

WARNING

ABUSE AND DEPENDENCE

CNS stimulants, including ADZENYS XR-ODT, other amphetamine-containing products, and methylphenidate, 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, and Drug Abuse And Dependence].

DRUG DESCRIPTION

ADZENYS XR-ODT (amphetamine extended-release orally disintegrating tablet) contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant.

The labeled strengths reflect the amount of amphetamine base in ADZENYS XR-ODT whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products.

Structural Formula:

ADZENYS XR-ODT (amphetamine extended-release orally disintegrating tablets) Structural Formula Illustration

C9H13N       MW 135.21

ADZENYS XR-ODT is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing.

ADZENYS XR-ODT also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid Copolymer Type A, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol.

Last reviewed on RxList: 1/23/2017
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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