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

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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)

थमां उपलब्ध:

SUNRISE PHARMACEUTICAL, INC.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) 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 organizatio

उत्पाद समीक्षा:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) are supplied as follows: 100 Tablets       Unit-of-use       NDC 11534-190-01 1000 Tablets                               NDC 11534-190-03 100 Tablets       Unit-of-use       NDC 11534-191-01 1000 Tablets                               NDC 11534-191-03 100 Tablets       Unit-of-use       NDC 11534-192-01 1000 Tablets                               NDC 11534-192-03 100 Tablets       Unit-of-use       NDC 11534-193-01 1000 Tablets                               NDC 11534-193-03 100 Tablets       Unit-of-use       NDC 11534-194-01 1000 Tablets                               NDC 11534-194-03 100 Tablets       Unit-of-use       NDC 11534-195-01 1000 Tablets                               NDC 11534-195-03 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. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Sunrise Pharmaceutical, Inc. Manufactured & Distributed By: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065 Rev. 05/2023     5358/02

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
SUNRISE PHARMACEUTICAL, INC.
----------
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets CII
(DEX-troe-am-FETuh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate,
DEX-troe-am-FET-uh-
meen SULL-fate, and am-FET-uh-meen SULL-fate)
What is the most important information I should know about
DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLETS?
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
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,
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 p

उत्पाद विशेषताएं

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
SUNRISE PHARMACEUTICAL, INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS (MIXED SALTS
OF
A SINGLE AMPHETAMINE PRODUCT) CII
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 monohydrate.
EACH TABLET CONTAINS
5 MG 7.5 MG10
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
Monohydrate