DEXTROAMPHETAMINE SULFATE solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Mikart, LLC

INN (Medzinárodný Name):

DEXTROAMPHETAMINE SULFATE

Zloženie:

DEXTROAMPHETAMINE SULFATE 5 mg in 5 mL

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 sympa

Prehľad produktov:

Dextroamphetamine Sulfate Oral Solution 5 mg/5 mL is a colorless, bubblegum flavored oral solution, available in containers of 16 fluid ounces, NDC 46672-646-16. Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Dispense in a tight, light resistant container. Manufactured by: Mikart, Inc. Atlanta, Georgia 30318 Manufactured for: Outlook Pharmaceuticals Inc. Cincinnati, OH 45209 Code 983Z00 Rev. 09/16

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE SOLUTION
Mikart, LLC
----------
MEDICATION GUIDE
D extroamphetamine 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
your chil

Súhrn charakteristických

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE SOLUTION
MIKART, LLC
----------
PRESCRIBING INFORMATION
DEXTROAMPHETAMINE SULFATE ORAL SOLUTION, 5 MG/5 ML CII
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
Dextroamphetamine 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 r