"The US Food and Drug Administration (FDA) has approved an amphetamine extended-release orally disintegrating tablet (Adzenys XR-ODT) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older. A"...
(amphetamine) Extended-release Orally Disintegrating Tablets
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].
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.
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.
Additional Adzenys XR-ODT Information
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