DEXTROAMPHETAMINE SULFATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)

Dostupno od:

KVK-Tech, Inc.

INN (International ime):

DEXTROAMPHETAMINE SULFATE

Sastav:

DEXTROAMPHETAMINE SULFATE 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Dextroamphetamine Sulfate Tablets USP are indicated for: 1. Narcolepsy. 2. Attention Deficit Disorder with Hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). Controlled Substance Dextroamphetamine sulfate is a Schedule II controlled substance. Abuse Dextroamphetamine sulfate has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see WARNINGS). Dextroamphetamine 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 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. Dependence Physical Dependence Dextroamphetamine 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 sulfate include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Dextroamphetamine 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).

Proizvod sažetak:

Dextroamphetamine Sulfate Tablets USP are available as: 5 mg: Peach, round, flat face, beveled edge tablets, debossed "K" above bisect “65” on one side and plain on the other side, packaged as follows: NDC #: 10702-065-03 Bottle of 30 tablets NDC #: 10702-065-06 Bottle of 60 tablets NDC #: 10702-065-01 Bottle of 100 tablets 10 mg: Pink, round, flat face, beveled edge tablets, debossed "K" above bisect “66” on one side and plain on the other side, packaged as follows: NDC #: 10702-066-03 Bottle of 30 tablets NDC #: 10702-066-06 Bottle of 60 tablets NDC #: 10702-066-01 Bottle of 100 tablets Store at 20° to 25°C (68° to 77°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. DEA Order Form Required. Manufactured by: KVK-TECH, INC. 110 Terry Dr. Newtown, PA 18940-1850 Manufacturer's code: 10702 Item ID #: 6109/11 01/2024

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

KVK-Tech, Inc.
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MEDICATION GUIDE
DEXTROAMPHETAMINE SULFATE
TABLETS USP, CII
(DEX-TROE-AM-FET-UH-MEEN SULL-
FATE)
What is the most important information I should know about
Dextroamphetamine Sulfate Tablets?
Dextroamphetamine Sulfate Tablets may cause serious side effects,
including:
Abuse misuse, and addiction. Dextroamphetamine Sulfate Tablets has a
high chance for abuse and misuse
and may lead to substance use problems, including addiction. Misuse
and abuse of dextroamphetamine
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 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 sulfate tablets and will
monitor you or your child during
treatment.
dextroamphetamine sulfate tablets may lead to physical dependence
after prolonged use, even if taken as
directed by your healthcare provider.
Do not give dextroamphetamine sulfate tablets to anyone else. See
“What is dextroamphetamine sulfate
tablets?” for more information.
Keep dextroamphetamine sulfate tablets in a safe place and properly
dispose of any unused medicine. See
“How should I store dextroamphetamine sulfate tablets?” for more
information.
Tell your healthcare provider if you or your child have ever abused or
been dependent on alcohol,
prescription medicines, or street drugs.
Risks 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
treatment with dextroamphetamine sulfate tablets. Tell your healthcare
provider if you or your child have
any heart problems, heart diseases, or heart defects.
Call your healthcare prov

Svojstava lijeka

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE TABLET
KVK-TECH, INC.
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DEXTROAMPHETAMINE SULFATE TABLETS USP, CII
RX ONLY
WARNING
Dextroamphetamine 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 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 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 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
Dextroamphetamine sulfate, USP is the dextro isomer of the compound
_d_, _l_-
amphetamine sulfate, a sympathomimetic amine of the amphetamine group.
Chemically,
dextroamphetamine is _d_-alpha-methylphenethylamine, and is present in
all forms of
dextroamphetamine sulfate, USP as the neutral sulfate. The structural
formula is as
follows:
INACTIVE INGREDIENTS
Magnesium stearate, microcrystalline cellulose, and silicon dioxide.
The 5 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C
red no. 40
aluminum lake.
The 10 mg tablet also contains FD&C red no. 40 aluminum lake and FD&C
yellow no. 6
aluminum lake.
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.
There is neither specific evidence which clearly establishes the
mechanism whereby
amphetamines produce mental and behavioral effects in children, nor
conclusi