Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
LISDEXAMFETAMINE DIMESYLATE (UNII: SJT761GEGS) (LISDEXAMFETAMINE - UNII:H645GUL8KJ)
Takeda Pharmaceuticals America, Inc.
LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE 10 mg
ORAL
PRESCRIPTION DRUG
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
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] .
New Drug Application
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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument