AMPHETAMINE SULFATE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Solco Healthcare US, LLC

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Amphetamine sulfate tablets, USP, are indicated for: Controlled Substance Amphetamine sulfate tablets contain amphetamine, a Schedule II controlled substance. Abuse Amphetamine sulfate tablets have 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 activit

Tóm tắt sản phẩm:

Amphetamine sulfate tablets, USP, are supplied as follows: 5 mg: White, round, convex tablet, uppers scored and debossed "5" on the left side, lowers debossed "S" in bottles of 100 tablets with child-resistant closure, NDC 43547-457-10. 10 mg: White, round, convex tablet, uppers are double crossed scored and debossed "1" on the lower left corner and "0" on the lower right corner, lowers debossed "S" in bottles of 100 tablets with child-resistant closure, NDC 43547-458-10. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15o C and 30o C (59o F and 86o F). [see USP Controlled Room Temperature.] Dispense in a well-closed container, as defined in the USP. Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/amphetamine-tablets.pdf Manufactured by: Prinston Laboratories Charlotte, NC 28206, USA Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised: 09/2023 9040380-06

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

Solco Healthcare US, LLC
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MEDICATION GUIDE
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/amphetamine-tablets.pdf
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.
o
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 your child
during treatment.
o
Amphetamine sulfate tablets may lead to physical dependence after
prolonged use, even if taken
as directed by your healthcare provider.
o
Do not give amphetamine sulfate tablets to anyone else. See “What
are amphetamine sulfate
tablets?” for more information.
o
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.
o
Tell your healthcare provider if you or your child have ever abused or
been dependent on
alcohol, prescription medicines, or street drugs.
•
Risk 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

Đặc tính sản phẩm

AMPHETAMINE SULFATE- AMPHETAMINE SULFATE TABLET
SOLCO HEALTHCARE US, 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 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,
magnesium stearate, silicified microcrystalline cellulose, and stearic
acid.
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 m