AMPHETAMINE SULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Amphetamine Sulfate (UNII: 6DPV8NK46S) (Amphetamine - UNII:CK833KGX7E)

Available from:

SpecGx LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amphetamine sulfate tablets are 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

Product summary:

Amphetamine Sulfate Tablets USP are supplied as follows: 5 mg: White, round tablet, debossed "M" on one side, and "5" with a score on the other side in bottles of 100 tablets, NDC 0406-1219-01. 10 mg: Blue, round tablet, debossed "M" on one side, and "10" with double scores on the other side in bottles of 100 tablets, NDC 0406-1220-01. 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. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt. Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA Revised: 10/2023 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20A13.pdf or by calling 1-800-778-7898 for alternate delivery options.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SpecGx LLC
----------
MEDICATION GUIDE
Amphetamine Sulfate Tablets, CII
(am fet’ a meen sul’ fate)
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
overdose 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 defects.
Call your healthcare provider right away or go to the nearest hospital
emergency room right away if you or
your child have

Summary of Product characteristics

AMPHETAMINE SULFATE- AMPHETAMINE SULFATE TABLET
SPECGX 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 is a sympathomimetic amino of the amphetamine
group. It is a
white, odorless crystalline powder. It has a slightly bitter taste.
Its solutions are acid to
litmus, having a pH of 5.0 to 8.0. 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.
Each tablet also contains the following inactive ingredients:
crospovidone, silicified
microcrystalline cellulose, silicon dioxide, and stearic acid. The 10
mg tablet also contains
FD&C Blue #1.
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 excita