DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED-REL

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

Beszerezhető a:

Rhodes Pharmaceuticals L.P.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules administration is contraindicated in patients: - known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6.2)]. - taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increa

Termék összefoglaló:

Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20ºC to 25°C (68°F to 77ºF) [see USP Controlled Room Temperature].

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED-
RELEASE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE CAPSULE, EXTENDED
RELEASE
Rhodes Pharmaceuticals L.P.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Rev.:
10/2023
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate,
Dextroamphetamine Sulfate,
and Amphetamine Sulfate extended-release capsules, CII
(DEX-troe am FET-uh-meen Sack-uh-rate/ am-FET-uh-meen as-PAR-tate
MAH-no-HIGH-drate/ DEX-
troe-am-FET-uh-meen SULL-fate/am-FET-uh-meen-SULL-fate)
What is the most important information I should know about
dextroamphetamine saccharate,
amphetamine aspartate monohydrate, dextroamphetamine sulfate, and
amphetamine sulfate extended-
release capsules?
Dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate, and
amphetamine sulfate extended-release capsules may cause serious side
effects, including:
•
Abuse, misuse, and addiction. Dextroamphetamine saccharate,
amphetamine aspartate
monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
extended-release capsules
have a high chance for abuse and misuse and may lead to substance use
problems, including
addiction. Misuse and abuse of dextroamphetamine saccharate,
amphetamine aspartate
monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
extended-release capsules,
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
dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate,
and amphetamine sulfate extended-release capsules 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 dextroamphetamine saccharate,

Termékjellemzők

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE
SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE
ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
RHODES PHARMACEUTICALS L.P.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE
SULFATE
AND AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE
ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE
EXTENDED-RELEASE
CAPSULES.
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES,
FOR ORAL USE. CII
INITIAL U.S. APPROVAL: 2001
WARNING: ABUSE, MISUSE, AND ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES
HAVE 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 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES, CAN
RESULT IN OVERDOSE AND DEATH (5.1, 9.2, 10):
BEFORE PRESCRIBING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE
EXTENDED-
RELEASE CAPSULES, 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 MAJ