DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- dextroamphet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Lannett Company, Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 increased

Přehled produktů:

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules 5 mg - Size 3 capsule with powder blue opaque cap and natural body imprinted with “Lannett” and “0790” in black and filled with pellets. 100 count bottle                          NDC 0527-0790-37 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules 10 mg - Size 3 capsule with powder blue opaque cap and blue body imprinted with “Lannett” and “0791” in black and filled with pellets. 100 count bottle                          NDC 0527-0791-37 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules 15 mg - Size 2 capsule with white opaque cap and blue body imprinted with “Lannett” and “0792” in black and filled with pellets. 100 count bottle                          NDC 0527-0792-37 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules 20 mg - Size 2 capsule with orange opaque cap and light orange opaque body imprinted with “Lannett” and “0793” in black and filled with pellets. 100 count bottle                          NDC 0527-0793-37 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules 25 mg - Size 1 capsule with white opaque cap and light orange opaque body imprinted with “Lannett” and “0794” in black and filled with pellets. 100 count bottle                          NDC 0527-0794-37 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules 30 mg - Size 1 capsule with orange opaque cap and natural body imprinted with “Lannett” and “0795” in black and filled with pellets. 100 count bottle                          NDC 0527-0795-37 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 to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND
AMPHETAMINE ASPARTATE CAPSULE,
EXTENDED RELEASE
Lannett Company, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.lannett.com/med-guide/dextro-amp-caps
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate,
Dextroamphetamine Sulfate and Amphetamine Sulfate
(DEX-troe-am-FET-uh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate
MAN-no-HIGH-drate,
DEX-troe-am-FET-uh-meen SULL-fate and am-FET-uh-meen SULL-fate)
(mixed salts of a single-entity amphetamine product)
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 capsules 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.
•
Your healthcare provider should check you or your child’s risk for
abuse, misuse, and addiction before starting
treatment with dextroamphetamine sacchara

Charakteristika produktu

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE
SULFATE- DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE CAPSULE, EXTENDED
RELEASE
LANNETT COMPANY, 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 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 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 ADDIC