AMPHETAMINE SULFATE- amphetamine sulfate tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Granules Pharmaceuticals Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Amphetamine sulfate tablets, USP is supplied as follows: 5 mg : White to off-white, round, biconvex, scored tablets debossed with "5" and "mg" on one side and debossed with "040" on other side. Bottles of 100 NDC 70010-040-01 10 mg : Light blue, round, biconvex, double scored tablets debossed with '1', '0', 'm' and 'g' on one side and debossed with '041' on other side. Bottles of 100 NDC 70010-041-01 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. Dispense with medication guide is also available at: https://granulespharma.com/product/amphetamine-tab/ Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Rev. 10/23

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Granules Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
https://granulespharma.com/product/amphetamine-tab/
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 tablet 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 been
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

Produkta apraksts

AMPHETAMINE SULFATE - AMPHETAMINE SULFATE TABLET
GRANULES PHARMACEUTICALS INC.
----------
AMPHETAMINE SULFATE TABLETS, USP CII
WARNING: ABUSE, MISUSE, AND ADDICTION
AMPHETAMINE SULFATE TABLET 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 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 to 6. 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:
crospovidone, silicified
microcrystalline cellulose and stearic acid. 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,