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

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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)

Beschikbaar vanaf:

Oryza Pharmaceuticals Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) 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 ]. Controlled Substance Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets contains 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 samenvatting:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as follows: 5 mg: Light blue to blue, round, flat-faced beveled edge tablet debossed with F1 on one side and quadrisect on the other side. 100 tablets                                Unit of use                           NDC 72516-016-01 7.5 mg: Light blue to blue, round, flat-faced beveled edge tablet debossed with F2 on one side and quadrisect on the other side. 100 tablets                                Unit of use                           NDC 72516-015-01 10 mg: Light blue to blue, round, flat-faced beveled edge tablet debossed with F3 on one side and quadrisect on the other side. 100 tablets                               Unit of use                           NDC 72516-014-01 15 mg: Light yellow to beige, round, flat-faced beveled edge tablet debossed with F5 on one side and quadrisect on the other side. 100 tablets                               Unit of use                           NDC 72516-013-01 20 mg: Light yellow to beige, round, flat-faced beveled edge tablet debossed with F6 on one side and quadrisect on the other side. 100 tablets                              Unit of use                            NDC 72516-012-01 30 mg: Light yellow to beige, round, flat-faced beveled edge tablet debossed with F7 on one side and quadrisect on the other side. 100 tablets                             Unit of use                             NDC 72516-011-01 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE
ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
Oryza Pharmaceuticals Inc.
----------
MEDICATION GUIDE
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 as -PAR-tate,
DEX-troe-amFET-uh-meen
SULL-fate, 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 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.
•
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.
•
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and
amphetamine sulfate tablets may lead to physical dependence after
prolonged use, even if
taken as directed by your healthcare provide

Productkenmerken

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
ORYZA PHARMACEUTICALS INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS 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 WARNINGSAND 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
7.5 MG 10 MG15 MG 20 MG 30 MG
Dextroamphetamine Saccharate
1.25
mg
1.875 mg2.5 mg3.75 mg5 mg
7.5 mg
Amphetamine Aspartate
Monohydrate
1.25
mg
1.875 mg2.5 mg3.75 mg5 mg
7.5 mg
Dextroamphetamine S