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ADZENYS XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older
This is Extended-Release Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side),
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 number of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of the active ingredients in these products.
The ADZENYS XR-ODT Structural Formula Illustration: C9H13N MW 135.21
It 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.
This may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient.
ADZENYS XR-ODT should be taken as follows:
-The tablet should remain in the blister pack until the patient is ready to take it.
-The patient or caregiver should use dry hands to open the blister.
-Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet.The tablet should not be pushed through the foil.
-As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue.
-The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing.
-The tablet will disintegrate in saliva so that it can be swallowed.
So, store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]