DEXTROAMPHETAMINE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Tris Pharma Inc

Designación común internacional (DCI):

DEXTROAMPHETAMINE SULFATE

Composición:

DEXTROAMPHETAMINE SULFATE 5 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Dextroamphetamine sulfate oral solution is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years 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 crisis may result). D

Resumen del producto:

Dextroamphetamine Sulfate Oral Solution 5 mg/5 mL is a colorless, bubble gum flavored oral solution. It is available in 16 fluid ounces (473 mL) bottles, NDC 27808-085-01. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Manufactured by Tris Pharma, Inc. Monmouth Junction, NJ 08852 www.trispharma.com LB8255 Rev. 09 Revised: 09/2023

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Tris Pharma Inc
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MEDICATION GUIDE
Dextroamphetamine Sulfate Oral Solution, CII 5 mg/5 mL
(DEX-troe-am-FET-a-meen SUL-fate)
Rx Only
What is the most important information I should know about
Dextroamphetamine Sulfate Oral Solution?
Dextroamphetamine Sulfate Oral Solution may cause serious side
effects, including:
•
Abuse, misuse, and addiction. Dextroamphetamine Sulfate Oral Solution
has a high chance for
abuse and misuse and may lead to substance use problems, including
addiction. Misuse and abuse
of Dextroamphetamine Sulfate Oral Solution, 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 Oral
Solution 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
Oral Solution and
will monitor you or your child during treatment.
•
Dextroamphetamine Sulfate Oral Solution may lead to physical
dependence after
prolonged use, even if taken as directed by your healthcare provider.
•
Do not give Dextroamphetamine Sulfate Oral Solution to anyone else.
See “What is
Dextroamphetamine Sulfate Oral Solution?” for more information.
•
Keep Dextroamphetamine Sulfate Oral Solution in a safe place and
properly dispose of
any unused medicine. See “How should I store Dextroamphetamine
Sulfate Oral
Solution?” 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 Oral Solution. Tell your
health

Ficha técnica

DEXTROAMPHETAMINE- DEXTROAMPHETAMINE SOLUTION
TRIS PHARMA INC
----------
DEXTROAMPHETAMINE SULFATE ORAL SOLUTION CII, 5 MG/5 ML RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
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, 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 as the neutral sulfate.
Structural Formula:
Dextroamphetamine sulfate, USP is a colorless, bubble gum flavored
oral solution. Each
5 mL (1 teaspoonful) of dextroamphetamine sulfate oral solution
contains 5 mg of
dextroamphetamine sulfate. Inactive ingredients consist of anhydrous
citric acid,
benzoic acid, bubble gum flavor, purified water, sodium citrate
anhydrous, sodium
saccharin, and sorbitol solution.
CLINICAL PHARMACOLOGY
Amphetamines are noncatecholamine, 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 that clearly establishes the
mechanism where