DEXTROAMPHETAMINE SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prasco Laboratories

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.  Known hypersensitivity to amphetamine products.  During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crisis may resu

Product summary:

Dextroamphetamine Sulfate Oral Solution 5 mg/5 mL is a colorless, bubblegum flavored oral solution, available in containers of 16 fluid ounces, NDC 66993-359-57.  Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Dispense in a tight, light resistant container. 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Prasco Laboratories
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MEDICATION GUIDE
Dextroamphetamine Sulfate Oral Solution, CII
(DEX-tro-am-Fet-uh-meen-SULL-fate)
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 do 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 you healthcare provider
if you

Summary of Product characteristics

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE SOLUTION
PRASCO LABORATORIES
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DEXTROAMPHETAMINE SULFATE ORAL SOLUTION, CII
RX ONLY
WARNING
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
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 bubblegum flavor.
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 establi