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

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE (UNII: H527KAP6L5) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

Tilgjengelig fra:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

Dextroamphetamine saccharate

Sammensetning:

Dextroamphetamine saccharate 1.25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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).

Produkt oppsummering:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg, green, round, flat faced beveled edge tablet debossed with ‘MP441’ and two partial bisects on one side and plain on the other side Bottles of 100 NDC 57664-641-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 7.5 mg, green, oval, biconvex tablet debossed with ‘MP442’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-642-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 10 mg, green, round, biconvex tablet debossed with ‘MP443’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-643-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 12.5 mg, yellow, round-shaped, flat face beveled edge tablet, debossed with ‘MP444’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-644-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 15 mg, yellow, oval-shaped, biconvex tablet, debossed with ‘MP445’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-645-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 20 mg, yellow, round-shaped, biconvex tablet, debossed with ‘MP446’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-646-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 30 mg, yellow, round, flat faced beveled edge tablet, debossed with ‘MP447’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-647-08 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND
AMPHETAMINE SULFATE TABLET
Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate, Amphetamine
Sulfate
(DEX-troe-am-FET-uh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate,
DEX-troe-am-FET-uh-meen SULL-fate, am-FET-uh-meen SULL-fate)
Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
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 has 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 Dextroamphetamine saccharate, amphetamine aspartate,
dextroamphetamine sulfate and amphetamine
sulfate

Preparatomtale

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS (MIXED SALTS OF
A
SINGLE ENTITY AMPHETAMINE PRODUCT) (CII)
RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
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. 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 (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, I-amphetamine aspartate.
EACH TABLET
CONTAINS
5 MG
7.5 MG 10
MG
12.5
MG
15 MG 20
MG
30
MG
Dextroamphetamine Saccharate 1.25
mg
1.875
mg
2.5
mg
3.125
mg
3.75
mg
5 mg
7.5
mg
Amphetamine Aspartate