VYVANSE- lisdexamfetamine dimesylate capsule VYVANSE- lisdexamfetamine dimesylate tablet, chewable

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT761GEGS) (LISDEXAMFETAMINE - UNII:H645GUL8KJ)

Beszerezhető a:

Takeda Pharmaceuticals America, Inc.

INN (nemzetközi neve):

LISDEXAMFETAMINE DIMESYLATE

Összetétel:

LISDEXAMFETAMINE DIMESYLATE 10 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

VYVANSE® is indicated for the treatment of: - Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] - Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . Limitations of Use: - Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations (8.4)] . - 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 (5.2)] . VYVANSE is contraindicated in patients with: - Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adve

Termék összefoglaló:

VYVANSE ( lisdexamfetamine dimesylate) capsules: VYVANSE ( lisdexamfetamine dimesylate) chewable tablets: 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°F to 86°F) [see USP Controlled Room Temperature] .

Engedélyezési státusz:

New Drug Application

Betegtájékoztató

VYVANSE- LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE
Takeda Pharmaceuticals America, Inc.
----------
MEDICATION GUIDE
VYVANSE® (VI' – VANS)
(LISDEXAMFETAMINE DIMESYLATE)
CAPSULES AND CHEWABLE TABLETS, CII
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 10/2023
What is the most important information I should know about VYVANSE?
VYVANSE may cause serious side effects, including:
•
Abuse, misuse, and addiction. VYVANSE has a high chance for abuse and
misuse and may lead
to substance use problems, including addiction. Misuse and abuse of
VYVANSE, other
amphetamine containing medicines, and methylphenidate containing
medicines, can lead to
overdose and death. The risk of overdose and death is increased with
higher doses of VYVANSE
or when it is used in ways that are not approved, such as snorting or
injection.
•
Your healthcare provider should check you or your child's risk for
abuse, misuse, and addiction
before starting treatment with VYVANSE and will monitor you or your
child during treatment.
•
VYVANSE may lead to physical dependence after prolonged use, even if
taken as directed by
your healthcare provider.
•
Do not give VYVANSE to anyone else. See "What is VYVANSE?" for more
information.
•
Keep VYVANSE in a safe place and properly dispose of any unused
medicine. See "How should
I store VYVANSE?" for more information.
•
Tell your healthcare provider if you or your child have ever abused or
been dependent on alcohol,
prescription medicines, or street drugs.
•
Risks for people with serious heart disease. Sudden death has happened
in people who have heart
defects or other serious heart disease.
Your healthcare provider should check you or your child carefully for
heart problems before
starting treatment with VYVANSE. Tell your healthcare provider if you
or your child have any
heart problems, heart disease, or heart defects.
Call your healthcare provider right away or go to the nearest hospital
emergency room right away
if you or your child have any signs o

Termékjellemzők

VYVANSE- LISDEXAMFETAMINE DIMESYLATE CAPSULE
VYVANSE- LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VYVANSE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VYVANSE.
VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULES, FOR ORAL USE, CII
VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CHEWABLE TABLETS, FOR ORAL USE,
CII
INITIAL U.S. APPROVAL: 2007
WARNING: ABUSE, MISUSE, AND ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
VYVANSE HAS A HIGH POTENTIAL FOR ABUSE AND MISUSE, WHICH CAN LEAD TO
THE
DEVELOPMENT OF A SUBSTANCE USE DISORDER, INCLUDING ADDICTION. MISUSE
AND ABUSE OF
CNS STIMULANTS, INCLUDING VYVANSE, CAN RESULT IN OVERDOSE AND DEATH
(5.1, 9.2, 10):
BEFORE PRESCRIBING VYVANSE, ASSESS EACH PATIENT'S RISK FOR ABUSE,
MISUSE, AND
ADDICTION.
EDUCATE PATIENTS AND THEIR FAMILIES ABOUT THESE RISKS, PROPER STORAGE
OF THE DRUG,
AND PROPER DISPOSAL OF ANY UNUSED DRUG.
THROUGHOUT TREATMENT, REASSESS EACH PATIENT'S RISK AND FREQUENTLY
MONITOR FOR SIGNS
AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION.
RECENT MAJOR CHANGES
Boxed Warning
10/2023
Dosage and Administration (2.1)
10/2023
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.8)
10/2023
INDICATIONS AND USAGE
VYVANSE is a central nervous system (CNS) stimulant indicated for the
treatment of (1):
Attention Deficit Hyperactivity Disorder (ADHD) in adults and
pediatric patients 6 years and older
Moderate to severe binge eating disorder (BED) in adults
Limitations of Use:
Pediatric patients with ADHD younger than 6 years of age experienced
more long-term weight loss than
patients 6 years and older (8.4)
VYVANSE is not indicated 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 (5.2)
DOSAGE AND ADMINISTRATION
INDICATED
POP