"The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of "...
VYVANSE® is indicated for the treatment of:
- Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies]
- Moderate to Severe Binge Eating Disorder (BED) [see Clinical Studies].
Limitation of Use
VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established [see WARNINGS AND PRECAUTIONS].
DOSAGE AND ADMINISTRATION
General Instructions For Use
Take VYVANSE by mouth in the morning with or without food; avoid afternoon doses because of the potential for insomnia. VYVANSE may be administered in one of the following ways:
- Swallow VYVANSE capsules whole, or
- Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder. The contents should be mixed until completely dispersed. Consume the entire mixture immediately. It should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed. Do not take anything less than one capsule per day, and a single capsule should not be divided.
Dosage For Treatment Of ADHD
The recommended starting dose is 30 mg once daily in the morning in patients ages 6 and above. Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum dose of 70 mg/day. Patients may be maintained on their optimal dose [see Clinical Studies].
Dosage For Treatment Of Moderate To Severe BED
The recommended starting dose is 30 mg/day to be titrated in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50 to 70 mg/day. The maximum dose is 70 mg/day [see Clinical Studies]. Discontinue VYVANSE if binge eating does not improve.
Important Information Prior To Dosing
Prior to treating children, adolescents, and adults with CNS stimulants, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS AND PRECAUTIONS].
To reduce the abuse of CNS stimulants including VYVANSE, assess the risk of abuse, prior to prescribing. After prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for VYVANSE use [see WARNINGS AND PRECAUTIONS, Drug Abuse and Dependence].
Dosage In Patients With Renal Impairment
In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m²), the maximum dose should not exceed 50 mg/day. In patients with end stage renal disease (ESRD, GFR < 15 mL/min/1.73 m²), the maximum recommended dose is 30 mg/day [see Use in Specific Populations].
Dosage Modifications Due To Drug Interactions
Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust VYVANSE dosage accordingly [see DRUG INTERACTIONS].
Dosage Forms And Strengths
Capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg)
Capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg)
Capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg)
Capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg)
Capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg)
Capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg)
Capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg)
VYVANSE capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg), bottles of 100, NDC 59417-101-10
VYVANSE capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg), bottles of 100, NDC 59417-102-10
VYVANSE capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg), bottles of 100, NDC 59417-103-10
VYVANSE capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg), bottles of 100, NDC 59417-104-10
VYVANSE capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg), bottles of 100, NDC 59417-105-10
VYVANSE capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg), bottles of 100, NDC 59417-106-10
VYVANSE capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg), bottles of 100, NDC 59417-107-10
Storage And Handling
Dispense in a tight, light-resistant container as defined in the USP.
Store at room temperature, 20°C to 25° C (68°F to 77° F). Excursions permitted between 15°C and 30° C (59 to 86° F) [see USP Controlled Room Temperature].
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired VYVANSE by a medicine take-back program.
Manufactured for: Shire US Inc., Wayne, PA 19087. Revised January 2015
Last reviewed on RxList: 2/5/2015
This monograph has been modified to include the generic and brand name in many instances.
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