DEXTROAMPHETAMINE SULFATE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

SpecGx LLC

INN (Διεθνής Όνομα):

DEXTROAMPHETAMINE SULFATE

Σύνθεση:

DEXTROAMPHETAMINE SULFATE 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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). Dex

Περίληψη προϊόντος:

Each Dextroamphetamine Sulfate Tablet USP (5 mg) contains dextroamphetamine sulfate 5 mg. It is available as triangle shaped, white to off white tablet debossed with a number “5” and a bisect on one side and an “M” in a box on the other.          Bottles of 100 ........................NDC 0406-8958-01 Each Dextroamphetamine Sulfate Tablet USP (10 mg) contains dextroamphetamine sulfate 10 mg. It is available as diamond shaped, white to off white tablet debossed with a number “10” and a partial quadrisect on one side and an “M” in a box on the other.          Bottles of 100 ........................NDC 0406-8959-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers with a child-resistant closure as defined in the USP. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 09/2023 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20D10.pdf or by calling 1-800-778-7898 for alternate delivery options.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

SpecGx LLC
----------
MEDICATION GUIDE
Dextroamphetamine Sulfate Tablets USP,
CII
(DEX-troe-am-FET-uh-meen SULL-fate)
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 are
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 healthcare
provider if you or your child have
any heart problems, heart disease,
or heart defects.
C

Αρχείο Π.Χ.Π.

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE TABLET
SPECGX LLC
----------
DEXTROAMPHETAMINE SULFATE TABLETS USP
5 MG AND 10 MG
RX ONLY
CII
WARNING: ABUSE, MISUSE, AND ADDICTION
DEXTROAMPHETAMINE SULFATE TABLETS HAVE 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 TABLETS, 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 TABLETS, 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
TABLETS 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 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. The structural
formula is as follows:
Each tablet, for oral administration, contains dextroamphetamine
sulfate USP, 5 mg or
10 mg. Each tablet also contains the following inactive ingredients:
microcrystalline
cellulose, povidone, silicon dioxide, and stearic acid.
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 evidence which clearly establishes the
mechanism whereby
amphetamines produce mental and behavioral effects in children, nor
concl