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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Epic Pharma, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. 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 ]. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets have not been studied in the geriatric population. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets contain amphetamine, a Schedule II controlled substance. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and 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 and PRECAUTIONS ]. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, 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. Physical Dependence Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and 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:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed Salts of a Single Entity Amphetamine Product) is supplied as follows: 5 mg: Blue, round flat-faced beveled edge tablets, debossed "є" above "339" on one side and quadrisect on the other side. They are available in bottles of 100 tablets (NDC 42806-339-01). 10 mg: Blue, round biconvex tablets, debossed “є ” above “341 ” on one side and quadrisect on the other side. They are available in bottles of 100 tablets (NDC 42806-341-01) 15 mg: Pink, oval-shaped tablets, debossed " є343" on one side and a full and partial bisect on the other side. They are available in bottles of 100 tablets (NDC 42806-343-01) 20 mg: Pink, round biconvex tablets, debossed “є ” above “344 ” on one side and quadrisect on the other side. They are available in bottles of 100 tablets (NDC 42806-344-01). 30 mg: Pink, round flat-faced beveled edge tablets, debossed "є" above "345" on one side and quadrisect on the other side. They are available in bottles of 100 tablets (NDC 42806-345-01). Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense with Medication Guide available at: www.epic-pharma.com/medguide/Dextroamp-Saccharate-Amp-Asparate-Dextroamp-Sulfate-Amp-Sulfate-Tablet.pdf Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev.09/2023 MF339REV09/2023 OE2729

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
Epic Pharma, LLC
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.epic-pharma.com/medguide/Dextroamp-Saccharate-
Amp-Asparate-Dextroamp-Sulfate-Amp-Sulfate-Tablet.pdf
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets, CII
(DEX-troe-am-FET-uh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate,
DEX-troe-am-FET-uh-meen SULL-fate, and am-FET-uh-meen SULL-fate)
What is the most important information I should know about
dextroamphetamine saccharate,
amphetamine aspartate, dextroamphetamine sulfate and amphetamine
sulfate tablets?
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and
amphetamine sulfate tablets may cause serious side effects, including:
•
Abuse, misuse, and addiction. Dextroamphetamine saccharate,
amphetamine aspartate,
dextroamphetamine sulfate and amphetamine sulfate tablets have a high
chance for abuse and
misuse and may lead to substance use problems, including addiction.
Misuse and abuse of
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and
amphetamine sulfate tablets, 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 dextroamphetamine saccharate,
amphetamine aspartate,
dextroamphetamine sulfate and 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 dextroamphetamine saccharate,
amphetamine
aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets
and will monitor you or
your child during treatment.
o
De

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
EPIC PHARMA, LLC
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS
RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and 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
Dextroamphetamine
saccharate, amphetamine aspartate, dextroamphetamine sulfate and
amphetamine
sulfate tablets, 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 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 dextroamphetamine saccharate, amphetamine aspartate,
dextroamphetamine sulfate and 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 (seeWARNINGSandDRUG
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
15 MG
20 MG
30 MG
Dextroamphetamine
Saccharate
1.25 mg
2. 5 mg
3.75 mg
5 mg
7.5 mg
Amphetamine Aspartate
Monohydrate
1.25 mg
2. 5 mg
3.75 mg
5 mg
7.5 mg
Dextroamphetamine
Sulfate, USP
1.25 mg
2. 5 mg
3.