DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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)

MAH:

Teva Pharmaceuticals USA, Inc.

INN:

DEXTROAMPHETAMINE SACCHARATE

composition:

DEXTROAMPHETAMINE SACCHARATE 1.25 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained menta

leaflet_short:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product) are supplied as follows: 5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 971 and four partial bisects on the other side debossed with 5. They are available in bottles of 100 tablets (NDC 0555-0971-02). 7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized b over 775 on one side and two partial bisects and a full score on the other side debossed with 7 | 1/2. They are available in bottles of 100 tablets (NDC 0555-0775-02). 10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 972 and two partial bisects and a full score on the other side debossed with 1 | 0. They are available in bottles of 100 tablets (NDC 0555-0972-02). 12.5 mg: Peach, oval, biconvex tablet debossed with stylized b over 776 separated by a full score on one side and four partial bisects on the other side debossed with 12 1/2. They are available in bottles of 100 tablets (NDC 0555-0776-02). 15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized b over 777 on one side and two partial bisects and a full score on the other side debossed with 1 | 5. They are available in bottles of 100 tablets (NDC 0555-0777-02). 20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 973 and two partial bisects and a full score on the other side debossed with 2 | 0. They are available in bottles of 100 tablets (NDC 0555-0973-02). 30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 974 and two partial bisects and a full score on the other side debossed with 3 | 0. They are available in bottles of 100 tablets (NDC 0555-0974-02). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Brands listed are trademarks of their respective owners. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. M 9/2023

authorization_status:

Abbreviated New Drug Application

PIL

SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE
ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
MEDICATION GUIDE
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE
AND AMPHETAMINE SULFATE
(dex" troe am fet' a meen sak' a rate, am fet' a meen a spar' tate,
dex" troe am fet' a meen sul' fate, and am fet'
sul' fate)
TABLETS (MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT) CII
What is the most important information I should know about
dextroamphetamine saccharate, amphetamine aspartate,
dextroamphetamine sulfate and amphetamine sulfate tablets?
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and amphetamine sulfate tablets may
cause serious side effects, including:
•
Abuse, misuse, and addiction. Dextroamphetamine saccharate,
amphetamine aspartate, dextroamphetamine sulfate
and amphetamine sulfate tablets 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,
dextroamphetamine sulfate and amphetamine sulfate tablets, 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, dextroamphetamine sulfate and
amphetamine sulfate tablets 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, amphetamine
aspartate, dextroamphetamine sulfate
and amphetamine sulfate tablets and will monitor you or your child
during treatment.
•
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and amphetamine
sulfate tablets may lead to physical dependence after prolonged

SPC

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS
(MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT) CII
RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS 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, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS,
CAN RESULT IN OVERDOSE AND DEATH (SEE OVERDOSAGE), AND THIS RISK IS
INCREASED WITH HIGHER DOSES OR UNAPPROVED METHODS OF ADMINISTRATION,
SUCH AS SNORTING OR INJECTION.
BEFORE PRESCRIBING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE
ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS,
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
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS TREATMENT,
REASSESS EACH PATIENT’S RISK OF ABUSE, MISUSE, AND ADDICTION AND
FREQUENTLY MONITOR FOR SIGNS AND SYMPTOMS OF ABUSE, MISUSE, AND
ADDICTION (SEE WARNINGS AND DRUG ABUSE AND DEPENDENCE).
DESCRIPTION
A single-entity amphetamine product combining the neutral sulfate
salts of
dextroamphetamine and amphetamine, with the dextro isomer of
amphetamine
saccharate and d, l-amphetamine aspartate.
EACH TABLET CONTAINS
5 MG
7.5 MG
10
MG
12.5 MG
15 MG
20 MG
30 MG
Dextroamphetamine
Saccharate
1.25
mg
1.875 mg
2.5
mg
3.125 mg
3.75
mg
5 mg
7.5 mg
Amphetamine Aspartate
Monoh