DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

Tillgänglig från:

Sandoz Inc

INN (International namn):

DEXTROAMPHETAMINE SACCHARATE

Sammansättning:

DEXTROAMPHETAMINE SACCHARATE 1.25 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. In patients known to be hypersensitive to amphetamine, or other components of mixed salts of a single entity amphetamine product. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products (see ADVERSE REACTIONS). Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis (see WARNINGS and Drug Interactions). Mixed salts of a single entity amphetamine product contains amphetamine, a Schedule II controlled substance. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see WARNINGS and PRECAUTIONS). Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and 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. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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).

Produktsammanfattning:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product), for oral administration, are available as: 5 mg Dark blue, round, biconvex tablets, debossed “E ” over “84” on one side and double-bisected on the other side and supplied as: NDC 0185-2098-01 bottles of 100 10 mg Dark blue, round, biconvex tablets, debossed “E ” over “111” on one side and double-bisected on the other side and supplied as: NDC 0185-0842-01 bottles of 100 20 mg Dark orange, round, biconvex tablets, debossed “E ” over “401” on one side and double-bisected on the other side and supplied as: NDC 0185-0853-01 bottles of 100 30 mg Dark orange, round, biconvex tablets, debossed “E ” over “404” on one side and double-bisected on the other side and supplied as: NDC 0185-2099-01 bottles of 100 Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. Keep tightly closed. Store at 20°C to 25°C (68°F to 77°F) (See USP Controlled Room Temperature). KEEP OUT OF THE REACH OF CHILDREN . Distributed by Sandoz Inc., Princeton, NJ 08540 1325A00 Revised: 10/2023

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE
SULFATE AND AMPHETAMINE
SULFATE TABLET
Eon Labs, Inc.
----------
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII
(dex-troe-am-FET-ah-meen)
What is the most important information I should know about mixed
salts of a single entity amphetamine product?
Mixed salts of a single entity amphetamine product may cause serious
side effects, including:
•
Abuse, misuse, and addiction. Mixed salts of a single entity
amphetamine product has a high chance for abuse and misuse and
may lead to substance use problems, including addiction. Misuse
and abuse of mixed salts of a single entity amphetamine product,
other amphetamine containing medicines, and methylphenidate
containing medicines, can lead to overdose and death. The risk of
overdose and death is increased with higher doses of mixed salts
of a single entity amphetamine product 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 mixed
salts of a single entity amphetamine product and will monitor you
or your child during treatment.
o
Mixed salts of a single entity amphetamine product may lead to
physical dependence after prolonged use, even if taken as directed
by your healthcare provider.
o
Do not give mixed salts of a single entity amphetamine product to
anyone else. See “What is mixed salts of a single entity
amphetamine product?” for more information.
o
Keep mixed salts of a single entity amphetamine product in a safe
place and properly dispose of any unused medicine. See “How
should I store mixed salts of a single entity amphetamine
product?” for more information.
o
Tell your healthcare provider if you or your child have ever
abused or been dependent on alcohol, prescription medicines, or

Produktens egenskaper

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE
SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
EON LABS, INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS
(MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT)
RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and amphetamine sulfate 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 dextroamphetamine
saccharate,
amphetamine aspartate, dextroamphetamine sulfate and 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 dextroamphetamine saccharate, amphetamine
aspartate,
dextroamphetamine sulfate and amphetamine sulfate, 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 dextroamphetamine saccharate, amphetamine aspartate,
dextroamphetamine sulfate and amphetamine sulfate 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
A single-entity amphetamine product combining the neutral sulfate
salts of
dextroamphetamine and amphetamine, with the dextro isomer of
amphetamine
saccharate and d, l-amphetamine aspartate monohydrate.
EACH TABLET
CONTAINS
5 MG
10 MG 20 MG 30 MG
Dextroamphetamine
Saccharate
1.25 mg
2.5 mg 5 mg
7.5 mg
Amphetamine
Aspartate Monohydrate
1.25 mg
2.5 mg 5 mg
7.5 mg
Dextroamphetamine
1.25 mg
2.5