DEXTROAMPHETAMINE SULFATE- dextroamphetamine sulfate solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Avadel Generics, LLC

Designació comuna 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, emotionally 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. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympatho

Resumen del producto:

Dextroamphetamine Sulfate Oral Solution 5 mg/5 mL is a colorless, bubblegum flavored oral solution, available in containers of 16 fluid ounces, NDC 76181-002-25. Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Dispense in a tight, light resistant container. Manufactured for: Avadel Generics, LLC Chesterfield, MO 63005 Code 983D00 Rev. 05/17

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE SOLUTION
Avadel Generics, LLC
----------
MEDICATION GUIDE
Dextroamphetamine Sulfate Oral Solution, 5 mg/5 mL CII
(DEX-troe-am-FET-uh-meen SULL-fate)
Read the Medication Guide that comes with Dextroamphetamine Sulfate
Oral Solution before you or your
child starts taking it and each time you get a refill. There may be
new information. This Medication Guide
does not take the place of talking to your doctor about your or your
child’s treatment with
Dextroamphetamine Sulfate Oral Solution.
What is the most important information I should know about
Dextroamphetamine Sulfate
Oral Solution?
The following have been reported with use of Dextroamphetamine Sulfate
Oral Solution and other stimulant
medicines.
1. Heart-related problems :
•
Sudden death in patients who have heart problems or heart defects
•
Stroke and heart attack in adults
•
Increased blood pressure and heart rate
Tell your doctor if you or your child have any heart problems, heart
defects, high blood pressure, or a family
history of these problems.
Your doctor should check you or your child carefully for heart
problems before starting Dextroamphetamine
Sulfate Oral Solution.
Your doctor should check your or your child’s blood pressure and
heart rate regularly during treatment with
Dextroamphetamine Sulfate Oral Solution.
Call your doctor right away if you or your child has any signs of
heart problems such as chest pain, shortness
of breath, or fainting while taking Dextroamphetamine Sulfate Oral
Solution.
2. Mental (Psychiatric) problems :
All Patients
•
new or worse behavior and thought problems
•
new or worse bipolar illness
•
new or worse aggressive behavior or hostility
Children and Teenagers
•
new psychotic symptoms (such as hearing voices, believing things that
are not true, are suspicious) or
new manic symptoms
Tell your doctor about any mental problems you or your child have, or
about a family history of suicide,
bipolar illness, or depression.
Call your doctor right away if you or

Fitxa tècnica

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE SOLUTION
AVADEL GENERICS, LLC
----------
WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE
PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-
THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE
PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS.
DESCRIPTION
Detroamphetamine sulfate 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 Oral Solution is a colorless, bubblegum
flavored oral solution. Each
teaspoonful (5 mL) of Dextroamphetamine Sulfate Oral Solution contains
5 mg of dextroamphetamine
sulfate. Inactive ingredients consist of benzoic acid, citric acid
anhydrous, purified water, sodium
citrate hydrous, sodium saccharin, sorbitol solution, and artificial
bubble gum flavor.
CLINICAL PHARMACOLOGY
Amphetamines are noncatecholamine, sympathomimetic amines with CNS
stimulant activity. Peripheral
actions include elevations of systolic and diastolic blood pressures
and weak bronchdilator and
respiratory stimulant action.
There is neither specific evidence that clearly establishes the
mechanism whereby amphetamines
produce mental and behavioral effects in children, nor conclusive
evidence regarding how these effects
relate to the condition of the central nervous system.
PHARMACOKINETICS
Ingestion of 10 mg of dextroamphetamine sulfate in oral solution form
by healthy volunteers produced
an average peak dextroamphetamine blood level of 33.2 ng/mL. The
half-life was 11.75 hours. The
average urinary recovery was 38% in 48 hours.
In 12 healthy subjects, the rate and exten