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

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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)

Fáanlegur frá:

Rhodes Pharmaceuticals L.P.

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. 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 effort; loses things; easily distracted; forgetful

Vörulýsing:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets are available as: 5 mg : A blue, round flat-faced beveled edge tablet debossed 'RP' over '21' on one side and quadrisect on the other side, supplied as follows: 100 Tablets    NDC 42858-721-01 7.5 mg : A blue, round flat-faced beveled edge tablet debossed 'RP' over '22' on one side and quadrisect on the other side, supplied as follows: 100 Tablets    NDC 42858-722-01 10 mg : A blue, round biconvex tablet debossed 'RP' over '23' on one side and quadrisect on the other side, supplied as follows: 100 Tablets    NDC 42858-723-01 12.5 mg : A peach, round flat-faced beveled edge tablet debossed 'RP' over '24' on one side and quadrisect on the other side, supplied as follows: 100 Tablets    NDC 42858-724-01 15 mg : A peach, round flat-faced beveled edge tablet debossed 'RP' over '25' on one side and quadrisect on the other side, supplied as follows: 100 Tablets    NDC 42858-725-01 20 mg : A peach, round biconvex tablet debossed 'RP' over '26' on one side and quadrisect on the other side, supplied as follows: 100 Tablets    NDC 42858-726-01 30 mg : A peach, round flat faced beveled edge tablet debossed 'RP' over '27' on one side and quadrisect on the other side, supplied as follows: 100 Tablets    NDC 42858-727-01 Dispense in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE
SULFATE, AND AMPHETAMINE
SULFATE TABLET
Rhodes Pharmaceuticals L.P.
----------
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate, and
Amphetamine Sulfate Tablets, CII
(dex'' troe am fet' a meen sak' a rate, am fet' a meen as par' tate,
dex'' troe am fet' a meen sul' fate, and 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:
•
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 use, even if
taken as dir

Vara einkenni

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE
SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET
RHODES PHARMACEUTICALS L.P.
----------
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 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, 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
Saccharate
1.25
mg
1.875
mg
2.5
mg
3.125
mg
3.75
mg
5 mg
7.5
mg
Amphetamine
Aspartate
Monohydrate
1.25
mg