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:

Sun Pharmaceutical Industries, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amphetamine sulfate tablets, USP 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 drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. - Known hypersensitivity to amphetamine products. - During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). Controlled Substance Amphetamine sulfate tablets contains amphetamine, a Schedule II controlled substance. Abuse Amphetamine sulfate tablets has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see WARNINGS). Amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. 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. Dependence Physical Dependence amphetamine sulfate tablets may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including amphetamine sulfate tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Amphetamine sulfate tablets may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Product summary:

Amphetamine sulfate tablets, USP are supplied as follows: 5 mg: White to mottled off-white, flat face beveled edge tablet, bisect scored on one side, debossed with “062" on other side in bottles of 100 tablets, NDC 57664-062-88. 10 mg: Blue to mottled light blue, flat face beveled edge tablet, quadrisect scored on one side and debossed with “075” on other side in bottles of 100 tablets, NDC 57664-075-88. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 5245406 Rev. 09/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AMPHETAMINE SULFATE- AMPHETAMINE SULFATE TABLET
Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Amphetamine Sulfate Tablets, USP, 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 has 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 is
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 defects or
other heart 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 heal

Summary of Product characteristics

AMPHETAMINE SULFATE- AMPHETAMINE SULFATE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
AMPHETAMINE SULFATE TABLETS, USP, CII
WARNING: ABUSE, MISUSE, AND ADDICTION
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
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, odorless 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,
povidone, silicified microcrystalline cellulose and stearic acid. The
10 mg tablet also
contains FD&C Blue #1.
Structural Formula:
1. C
H
N
SO
MW 368.4 9
18
28
2
4
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 cardiovascul