March 28, 2017
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Dyanavel XR

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Dyanavel XR

DYANAVEL XR

(amphetamine) Extended-release Oral Suspension

WARNING

ABUSE AND DEPENDENCE

CNS stimulants, including DYANAVEL XR, 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

DYANAVEL XR (amphetamine) extended release oral suspension, a CNS stimulant, is an extended-release liquid formulation containing a 3.2 to1 ratio of d- to l-amphetamine.

Each 1 mL of DYANAVEL XR contains 2.5 mg of amphetamine which is the same as the amount of amphetamine (base equivalent) found in a 4 mg strength amphetamine mixed salts product.

Structural Formula

DYANAVEL XR (amphetamine) Structural Formula Illustration

DYANAVEL XR utilizes an ion exchange resin where the drug is bound to the resin (sodium polystyrene sulfonate) through an ionic binding reaction. DYANAVEL XR contains immediate release and extended-release components. The extended-release component is coated with an aqueous, pH-independent polymer. After drug release the ion-exchange resin is excreted in the feces.

Inactive Ingredients: anhydrous citric acid, bubblegum flavor, glycerin, methylparaben, modified food starch, polysorbate 80, povidone, polyvinyl acetate, propylparaben, sodium lauryl sulfate, sodium polystyrene sulfonate, sucralose, triacetin and xanthan gum.

Last reviewed on RxList: 4/25/2016
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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