AMPHETAMINE SULFATE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

Verfügbar ab:

Ascend Laboratories, LLC

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Amphetamine sulfate tablet is indicated for: - Narcolepsy - Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. - Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other

Produktbesonderheiten:

Amphetamine sulfate tablets, USP are supplied as follows: 5 mg: White, round, biconvex tablet, debossed “AS” on one side and ‘’5’’ with a functional score on other side in bottles of 100 tablets, NDC 67877-710-01. 10 mg: Blue, round biconvex tablet, debossed “AS” on one side and “10” with a functional double score on the other side in bottles of 100 tablets, NDC 67877-711-01. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a well closed container, as defined in the USP. Manufactured by: Alkem Laboratories Fenton, MO. 63026 Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: December, 2021

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

AMPHETAMINE SULFATE - AMPHETAMINE SULFATE TABLET
Ascend Laboratories, LLC
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MEDICATION GUIDE
Amphetamine Sulfate (am fet' a meen sul' fate) Tablets, USP CII
Read this Medication Guide before you or your child starts taking
amphetamine sulfate tablets and each time
you get a refill. There may be new information. This information does
not take the place of talking to your
doctor about you or your child's treatment.
What is the most important information I should know about amphetamine
sulfate tablets?
Amphetamine sulfate tablets are a stimulant medicine. Some people have
had the following problems when
taking stimulant medicines such as amphetamine sulfate tablets:
1. Heart-related problems :
•
sudden death in people who have heart problems or heart defects
•
stroke and heart attack in adults
•
increased blood pressure and heart rate
Tell your doctor if you or your child has any heart problems, heart
defects, high blood pressure, or a family
history of these problems.
Your doctor should check you or your child carefully for heart
problems before starting amphetamine sulfate
tablets.
Your doctor should check you or your child's blood pressure and heart
rate regularly during treatment with
amphetamine sulfate tablets.
Call your doctor right away if you or your child have any signs of
heart problems such as chest pain,
shortness of breath, or fainting while taking amphetamine sulfate
tablets.
2. Mental (Psychiatric) problems including:
In children, teenagers, and adults:
•
new or worse behavior and thought problems
•
new or worse bipolar illness
•
new or worse aggressive behavior or hostility
In Children and Teenagers who have psychiatric problems, new psychotic
symptoms such as:
•
hearing voices
•
seeing things that are not real
•
believing things that are not true
•
being suspicious
•
new manic symptoms
Tell your doctor about any mental problems you or your child have, or
about a family history of suicide,
bipolar illness, or depression.
Call your doctor right away if you or your child

Fachinformation

AMPHETAMINE SULFATE - AMPHETAMINE SULFATE TABLET
ASCEND LABORATORIES, LLC
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WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID
TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-
THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE
PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS.
DESCRIPTION
Amphetamine Sulfate, USP is a sympathomimetic amino of the amphetamine
group. It is
a white to off-white odourless crystalline powder. It has a slightly
bitter taste. Its
solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely
soluble in water and
slightly soluble in alcohol.
Each tablet, for oral administration contains 5 mg or 10 mg of
amphetamine sulfate,
USP. Each tablet also contains the following inactive ingredients:
crospovidone, silicified
microcrystalline cellulose and magnesium stearate. The 10 mg tablet
also contains FD&C
Blue #1 aluminum lake.
Structural Formula:
CLINICAL PHARMACOLOGY
Amphetamines are non-catecholamine, sympathomimetic amines with CNS
stimulant
activity. Peripheral actions include elevations of systolic and
diastolic blood pressures,
and weak bronchodilator, and respiratory stimulant action.
Amphetamine, as the racemic form, differs from dextroamphetamine in a
number of
ways. The l-isomer is more potent than the d-isomer in cardiovascular
activity, but much
less potent in causing CNS excitatory effects. The racemic mixture
also is less effective
as an appetite suppressant when compared to dextroamphetamine. There
is neither
specific evidence which clearly establishes the mechanism whereby
amphetamines
produce mental and behavioral effects in children, nor conclusive
evidence regarding
how those effects relate to the condition of the central nervous
system.
Drugs in this class used in obesity are commonly known as "anorectics"
or
"