DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE capsule, exte

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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)

Disponible des:

Granules Pharmaceuticals Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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), becaus

Resumen del producto:

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules are available as: 5 mg – Hard Gelatin Capsules, Blue Opaque Cap Printed with “G AMP XR 5 mg” and White Opaque Body Printed with ''029'' contains off-white to beige colored pellets. Bottles of 100 NDC 70010-029-01 10 mg – Hard Gelatin Capsules, Blue Opaque Cap Printed with “G AMP XR 10 mg” and White Opaque Body Printed with ''030'' contains off-white to beige colored pellets. Bottles of 100 NDC 70010-030-01 15 mg – Hard Gelatin Capsules, White Opaque Cap Printed with “G AMP XR 15 mg” and Blue Opaque Body Printed with ''031'' contains off-white to beige colored pellets. Bottles of 100 NDC 70010-031-01 20 mg – Hard Gelatin Capsules, Gold Opaque Cap Printed with “G AMP XR 20 mg” and Gold Opaque Body Printed with ''032'' contains off-white to beige colored pellets. Bottles of 100 NDC 70010-032-01 25 mg – Hard Gelatin Capsules, White Opaque Cap Printed with G AMP XR 25 mg and Gold Opaque Body Printed with ''033'' contains off-white to beige colored pellets Bottles of 100 NDC 70010-033-01 30 mg – Hard Gelatin Capsules, Gold Opaque Cap Printed with “G AMP XR 30 mg” and Orange transparent Body Printed with ''034'' contains off-white to beige colored pellets Bottles of 100 NDC 70010-034-01 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE
SULFATE AND AMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
Granules Pharmaceuticals Inc.
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SPL MEDGUIDE SECTION
Dispense with Medication Guide available at:
https://granulespharma.com/product/mixed-salt-amphetamine-er-capsule/
MEDICATION GUIDE
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE and AMPHETAMINE SULFATE
(dex″ troe am fet′ a meen sak′ a rate, am fet′ a meen as
par′ tate mon" oh hye' drate, dex″
troe am fet′ a meen sul′ fate, and am fet′ a meen sul′ fate)
EXTENDED-RELEASE CAPSULES CII
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 Capsule
has 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.
o Your healthcare provider should check you or your child’s risk for
abuse, misuse, and addiction before
starting treatment wit

Fitxa tècnica

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE
SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
CAPSULE,
EXTENDED RELEASE
GRANULES PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE
SULFATE
AND AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES (MIXED SALTS OF A
SINGLE-ENTITY
AMPHETAMINE PRODUCT) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES
(MIXED SALTS OF A SINGLE-ENTITY
AMPHETAMINE PRODUCT).
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES
(MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT), 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 ABUS