DEXTROAMPHETAMINE SULFATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Teva Pharmaceuticals USA, Inc.

DCI (Dénomination commune internationale):

DEXTROAMPHETAMINE SULFATE

Composition:

DEXTROAMPHETAMINE SULFATE 5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Dextroamphetamine Sulfate Tablets are indicated for: - Narcolepsy . - 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). D

Descriptif du produit:

Dextroamphetamine Sulfate Tablets, USP are available as: 5 mg: Peach, round, flat-faced, beveled-edge, scored tablet, debossed with 952/5 on the scored side and stylized b on the other side. Available in bottles of 100 (NDC: 0555-0952-02). 10 mg: Pink, round, flat-faced, beveled-edge, scored tablet, debossed with 953/10 on the scored side and stylized b on the other side. Available in bottles of 100 (NDC: 0555-0953-02). Store at 20º to 25ºC (68º to 77ºF) [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. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. H 9/2023

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

Teva Pharmaceuticals USA, Inc.
----------
Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Dextroamphetamine Sulfate
(dex" troe am fet' uh meen sul' fate)
Tablets, USP CII
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 have 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 healthca

Résumé des caractéristiques du produit

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
DEXTROAMPHETAMINE SULFATE TABLETS, USP CII
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 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:
(C H N) ∙H SO M.W. 368.49
INACTIVE INGREDIENTS
Calcium sulfate, colloidal silicon dioxide, compressible sugar, corn
starch, magnesium
stearate, and microcrystalline cellulose. The 5 mg also contains D&C
yellow no. 10
aluminum lake and FD&C red no. 40 aluminum lake. The 10 mg also
contains FD&C red
9
13
2
2
4
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 evide