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

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

ANI Pharmaceuticals, Inc.

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 capsule administration is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/othermedications/ . Risk Summary

Bidhaa muhtasari:

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 5 mg are hard gelatin capsules, green opaque cap and clear body, printed “AMG” on cap and “277” on body, which are supplied as follows: Bottles of 100     NDC 43975-277-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 10 mg are hard gelatin capsules, green opaque cap and body, printed “AMG” on cap and “278” on body, which are supplied as follows: Bottles of 100     NDC 43975-278-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 15 mg are hard gelatin capsules, green opaque cap and white opaque body, printed “AMG” on cap and “279” on body, which are supplied as follows: Bottles of 100     NDC 43975-279-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 20 mg are hard gelatin capsules, pink opaque cap and body, printed “AMG” on cap and “280” on body, which are supplied as follows: Bottles of 100     NDC 43975-280-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 25 mg are hard gelatin capsules, pink opaque cap and white opaque body, printed “AMG” on cap and “281” on body, which are supplied as follows: Bottles of 100     NDC 43975-281-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules 30 mg are hard gelatin capsules, pink opaque cap and clear body, printed “AMG” on cap and “282” on body, which are supplied as follows: Bottles of 100     NDC 43975-282-10 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). [see USP CONTROLLED ROOM TEMPERATURE].

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE
SULFATE AND AMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
ANI Pharmaceuticals, Inc.
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MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate,
Dextroamphetamine Sulfate,
and Amphetamine Sulfate Extended-Release Capsules CII
(DEX-troe-am-FET-a-meen sak-uh-reyt, am-fet-uh-meen ah-spahr-teyt
mon-uh-hahy-dreyt, DEX-troe-
am-FET-a-meen suhl-feyt, and am-fet-uh-meen suhl-feyt extended-release
capsules)
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.
o
Your healthcare provider should check you or your child’s risk for
abuse, misuse, and
addiction before starting treatment with Dextroamphetamine Saccharate,
Amphetamine
Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine
Sulfate Exte

Tabia za bidhaa

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE
SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
CAPSULE,
EXTENDED RELEASE
ANI PHARMACEUTICALS, INC.
----------
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 (MIXED SALTS OF A
SINGLE-ENTITY
AMPHETAMINE PRODUCT) 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)
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 10/2023
Indications and Usage (1) 10/2023
Dosage and Administration (2.1, 2.2, 2.7) 10/2023
Contraindications (4) 10/2023
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.7, 5.9) 10/2023
INDICATIONS AND USAGE
Dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate, and
amphetamine sulfate extended-release capsules, a CNS stimulant, is
indicated for the treatment of