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

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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)

Saatavilla:

Aurolife Pharma, LLC

INN (Kansainvälinen yleisnimi):

DEXTROAMPHETAMINE SACCHARATE

Koostumus:

DEXTROAMPHETAMINE SACCHARATE 1.25 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, 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 requiri

Tuoteyhteenveto:

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 50   13107-068-50           Bottles of 100   13107-068-01           Bottles of 250   13107-068-25           Bottles of 500   13107-068-05           Bottles of 1000   13107-068-99 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 50   13107-069-50           Bottles of 100   13107-069-01           Bottles of 250   13107-069-25           Bottles of 500   13107-069-05           Bottles of 1000   13107-069-99 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 50   13107-070-50           Bottles of 100   13107-070-01           Bottles of 250   13107-070-25           Bottles of 500   13107-070-05           Bottles of 1000   13107-070-99 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 50   13107-071-50           Bottles of 100   13107-071-01           Bottles of 250   13107-071-25           Bottles of 500   13107-071-05           Bottles of 1000   13107-071-99 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 50   13107-072-50           Bottles of 100   13107-072-01           Bottles of 250   13107-072-25           Bottles of 500   13107-072-05           Bottles of 1000   13107-072-99 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 50   13107-073-50           Bottles of 100   13107-073-01           Bottles of 250   13107-073-25           Bottles of 500   13107-073-05           Bottles of 1000   13107-073-99 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 50   13107-074-50           Bottles of 100   13107-074-01           Bottles of 250   13107-074-25           Bottles of 500   13107-074-05           Bottles of 1000   13107-074-99 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.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc 279 Princeton-Hightstown Road East Windsor, NJ-08520 Revised: 10/2018

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE - DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
Aurolife Pharma, 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.
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 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 ha

Valmisteyhteenveto

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE -
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE AND
AMPHETAMINE SULFATE TABLET
AUROLIFE PHARMA, 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,
l-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 mg
1.875 mg 2.5 mg 3.125 mg
3.75 mg
5 mg
7.5 mg
Amphetamine Aspartate
Monohydrate
1.25 mg
1.875 mg 2.5 mg 3.125 mg
3.75 mg
5 mg
7.5 mg
Dextroamphetamine
Sulfate USP
1.25 mg
1.875 mg 2.5 mg 3.125 mg
3.75 mg
5 mg
7.5 mg
Amphetamine Sulfate
USP
1.25 mg
1.875 mg 2.5 mg 3.125 mg
3.75 mg
5 mg
7.5 mg
Total amphetamine base
equivalence
3.13 mg
4.7 mg
6.3 mg
7.8 mg
9.4 mg
12.6 mg
18.8 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