AMPHETAMINE SULFATE- amphetamine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals NY LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amphetamine sulfate tablets, USP 5 mg and 10 mg are indicated for: 1. Narcolepsy 2. 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. 3. 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

Product summary:

Amphetamine Sulfate Tablets USP, 5 mg are supplied as white, round biconvex tablets, plain on one side, and ‘5’ with score on the other side. They are available as follows: Bottles of 100:                        NDC 69238-1563-1 Amphetamine Sulfate Tablets USP, 10 mg are supplied as blue, round biconvex tablets, plain on one side, and ‘10’ with double scores on the other side. They are available as follows: Bottles of 100:                        NDC 69238-1564-1 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: Amneal Pharmaceuticals of New York, LLC Brookhaven, NY 11719 Rev. 10-2023-06 Dispense with Medication Guide available at: documents.amneal.com/mg/amphetamine-tab.pdf

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMPHETAMINE SULFATE- AMPHETAMINE TABLET
Amneal Pharmaceuticals NY LLC
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
documents.amneal.com/mg/amphetamine-tab.pdf
Amphetamine (am FET a meen) Sulfate Tablets CII
What is the most important information I should know about amphetamine
sulfate tablets?
Amphetamine sulfate tablets may cause serious side effects, including:
•
Abuse, misuse, and addiction. Amphetamine sulfate tablets have a high
chance for abuse and
misuse and may lead to substance use problems, including addiction.
Misuse and abuse of
amphetamine sulfate tablets, other amphetamine-containing medicines,
and methylphenidate, can
lead to overdose and death. The risk of overdosage and death is
increased with higher doses of
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 amphetamine sulfate tablets
and will monitor you
or your child during treatment.
•
Amphetamine sulfate tablets may lead to physical dependence after
prolonged use, even if
taken as directed by your healthcare provider.
•
Do not give amphetamine sulfate tablets to anyone else. See “What
are amphetamine
sulfate tablets?” for more information.
•
Keep amphetamine sulfate tablets in a safe place and properly dispose
of unused medicine.
See “How should I store amphetamine sulfate tablets?” for more
information.
•
Tell your healthcare provider if you or your child have ever abused or
been dependent on
alcohol, prescription medicines, or street drugs.
•
Risks for people with serious heart disease. Sudden death has happened
in people who have heart
defects or other serious heart disease. Your healthcare provider
should check you or your child
carefully for heart problems before starting amphetamine sulfate
tablets. Tell your healthcare
provider if you or your child have any heart problems, heart disease,
or heart de

Summary of Product characteristics

AMPHETAMINE SULFATE- AMPHETAMINE TABLET
AMNEAL PHARMACEUTICALS NY LLC
----------
AMPHETAMINE SULFATE TABLETS, USP CII
WARNING: ABUSE, MISUSE, AND ADDICTION
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
AMPHETAMINE SULFATE, 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 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 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
Amphetamine sulfate, USP is a sympathomimetic amino of the amphetamine
group. It is
a white powder. It has a slightly bitter taste. Its solutions are acid
to litmus, having a pH
of 5 to 8. It is freely soluble in water, slightly soluble in alcohol
and practically insoluble in
ether.
Each tablet, for oral administration contains 5 mg or 10 mg of
amphetamine sulfate,
USP. Each tablet also contains the following inactive ingredients:
colloidal silicon dioxide,
crospovidone, microcrystalline cellulose, stearic acid, and talc. 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, b