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

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Camber Pharmaceuticals, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 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 organization; avoids tasks requiring sustained mental ef

Vörulýsing:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets is supplied as follows: 5 mg: White to off white round tablets with ‘T370’ debossed on one side and four partial bisects on other side. NDC 31722-155-01 bottles of 100 tablets 7.5 mg: Light blue color oval tablet, one side debossed with ‘T371’ with two partial bisects and other side with two partial bisects and one full bisect. NDC 31722-156-01 bottles of 100 tablets 10 mg: Light blue color round shaped tablet, debossed with T over 372 on one side and other side with one full bisect and two partial bisects. NDC 31722-157-01 bottles of 100 tablets 12.5 mg: Light to dark peach colored, round beveled edge tablet, debossed with “T” over “373” on one side and one full bisect and two partial bisects on other side. NDC 31722-158-01 bottles of 100 tablets 15 mg: Light to dark peach colored oval shaped tablet, debossed with ‘T374’ with two partial bisects on one side, and one full bisect and two partial bisects on other side. NDC 31722-159-01 bottles of 100 tablets 20 mg: Light to dark peach colored round tablet, debossed with T over 375 on one side and other side with one full bisect and two partial bisects. NDC 31722-163-01 bottles of 100 tablets 30 mg: Light to dark peach round, flat faced, beveled edge tablets with one full bisect and two partial bisect lines on one side, and debossed with “T” over “376” on other side. NDC 31722-164-01 bottles of 100 tablets Dispense in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 05/23

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

SULFATE, AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE
ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET
Camber Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate, and
Amphetamine Sulfate Tablets, CII
(dex” troe am fet' a meen sac cha rate, am fet' a meen a spar' tate,
dex” troe am fet' a meen sul' fate, am
fet' a meen sul' fate)
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:
Tell your healthcare provider about any mental problems you or your
child have or about a family history
of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any
new or worsening mental
symptoms or problems during treatment with dextroamphetamine
saccharate, amphetamine aspartate,
dextroamphetamine sulfate, and amphetamine sulfate tablets, especially
hearing voices, seeing or
believing things that are not real, or new manic symptoms.
What are dextroamphetamine saccharate, amphetamine aspartate,
dextroamphetamine sulfate, and
amphetamine sulfate tablets?
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate, and amphetamine
sulfate tablets are a central nervous system (CNS) stimulant
prescription medicine used for the treatment
of:
•
Attention-Deficit Hyperactivity Disorder (ADHD) in children 3 to 17
years of age.
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate, and
amphetamine sulfate tablets may help increase attention and decrease
impulsiveness and
hyperactivity in people with ADHD.
•
a sleep disorder called Narcolepsy in people 6 years and older.
It is not known if dextroamphetamine saccharate, amphetamine
aspartate, dextroamphe

Vara einkenni

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET
CAMBER PHARMACEUTICALS, INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS 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 monohydrate.
EACH TABLET CONTAINS 5 MG 7.5 MG 10
MG 12.5
MG
15 MG
20
MG 30
MG
Dextroamphetamine
Saccharat