DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

Compra'l ara

Informació per a l'usuari (PIL)

07-01-2019

Fitxa tècnica (SPC)

07-01-2019

ingredients actius:

DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

Disponible des:

ACETRIS HEALTH, LLC

Designació comuna internacional (DCI):

DEXTROAMPHETAMINE SACCHARATE

Composición:

DEXTROAMPHETAMINE SACCHARATE 1.25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained men

Resumen del producto:

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets - Light blue to blue colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U25’ on one side and quadrisect on other side. Bottles of 100 52343-160-01 7.5 mg Tablets - Light blue to blue colored, mottled, round, convex tablets debossed with ‘U26’ on one side and quadrisect on other side. Bottles of 100 52343-161-01 10 mg Tablets - Light blue to blue colored, mottled, round, convex tablets debossed with ‘U27’ on one side and quadrisect on other side. Bottles of 100 52343-162-01 12.5 mg Tablets - Light orange to orange colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U28’ on one side and quadrisect on other side. Bottles of 100 52343-163-01 15 mg Tablets - Light orange to orange colored, mottled, round, convex tablets debossed with ‘U29’ on one side and quadrisect on other side. Bottles of 100 52343-164-01 20 mg Tablets - Light orange to orange colored, mottled, round, convex tablets debossed with ‘U30’ on one side and quadrisect on other side. Bottles of 100 52343-165-01 30 mg Tablets - are light orange to orange colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U31’ on one side and quadrisect on other side. Bottles of 100 52343-166-01 Dispense in a tight, light-resistant container as described in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with Medication Guide available at http://www.acetrishealth.com/med-guides.html Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Issued: 10/2017

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE - DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
ACETRIS HEALTH, LLC
---------- MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets CII
Rx only
Read the Medication Guide that comes with Dextroamphetamine
Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and 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 you or your child's treatment
with Dextroamphetamine Saccharate,
Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine
Sulfate Tablets and
Amphetamine Sulfate Tablets.
What is the most important information I should know about
Dextroamphetamine Saccharate,
Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine
Sulfate Tablets?
The following have been reported with use of Dextroamphetamine
Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and other
stimulant medicines.
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 Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets.
Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment
with Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and
Amphetamine Sulfate Tablets
Call your doctor right away if you or your child have

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Fitxa tècnica

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE -
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE AND
AMPHETAMINE SULFATE TABLET
ACETRIS HEALTH, LLC
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE AND
AMPHETAMINE SULFATE TABLETS CII
RX ONLY
BOXED 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 AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS
DESCRIPTION
A single-entity amphetamine product combining the neutral sulfate
salts of dextroamphetamine and
amphetamine, with the dextro isomer of amphetamine saccharate and d,
1-amphetamine aspartate
monohydrate.
EACH TABLET CONTAINS
5 MG
7.5 MG 10 MG 12.5 MG 15 MG 20 MG 30 MG
Dextroamphetamine Saccharate
1.25 mg1.875 mg2.5 mg 3.125 mg3.75 mg
5 mg
7.5 mg
Amphetamine Aspartate Monohydrate 1.25 mg1.875 mg2.5 mg 3.125 mg3.75
mg
5 mg
7.5 mg
Dextroamphetamine Sulfate, USP
1.25 mg1.875 mg2.5 mg 3.125 mg3.75 mg
5 mg
7.5 mg
Amphetamine Sulfate, USP
1.25 mg1.875 mg2.5 mg 3.125 mg3.75 mg
5 mg
7.5 mg
Total Amphetamine Base Equivalence3.13 mg 4.7 mg 6.3 mg
7.8 mg
9.4 mg 12.6 mg18.8 mg
INACTIVE INGREDIENTS
In addition, each tablet contains: colloidal silicon dioxide,
magnesium stearate, microcrystalline
cellulose, povidone, and pregelatinized starch.
COLORS
The 5 mg, 7.5 mg, and 10 mg tablets contain the color additive FD&C
Blue #1 Aluminum Lake.
The 12.5 mg, 15 mg, 20 mg, and 30 mg tablets contain the color
additive FD&C Yellow #6 Aluminum
Lake.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Amphetamines are non-catecholamine sympathomimetic amines with CNS
stimulant activity. The mode
of therapeutic action in Attention

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