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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascent Pharmaceuticals, Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 mental ef

Product summary:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets is supplied as follows: 5 mg: White to off white round tablets with ‘T370’ debossed on one side and four partial bisects on other side. NDC 43602-370-01 bottles of 100 tablets NDC 43602-370-05 bottles of 500 tablets 7.5 mg: Light blue color oval tablet, one side debossed with ‘T371’ with two partial bisects and other side with two partial bisects and one full bisect. NDC 43602-371-01 bottles of 100 tablets NDC 43602-371-05 bottles of 500 tablets 10 mg: Light blue color round shaped tablet debossed with T over 372 on one side and other side with one full bisect and two partial bisects. NDC 43602-372-01 bottles of 100 tablets NDC 43602-372-05 bottles of 500 tablets 12.5 mg: Light to dark peach colored, round beveled edge tablet, debossed with “T” over “373” on one side and one full bisect and two partial bisects on other side. NDC 43602-373-01 bottles of 100 tablets NDC 43602-373-05 bottles of 500 tablets 15 mg: Light to dark peach colored oval shaped tablet, debossed with ‘T374’ with two partial bisects on one side, and one full bisect and two partial bisects on other side. NDC 43602-374-01 bottles of 100 tablets NDC 43602-374-05 bottles of 500 tablets 20 mg: Light to dark peach colored round tablet, debossed with T over 375 on one side and other side with one full bisect and two partial bisects. NDC 43602-375-01 bottles of 100 tablets NDC 43602-375-05 bottles of 500 tablets 30 mg: Light to dark peach round, flat faced, beveled edge tablets with one full bisect and two partial bisect lines on one side, and debossed with “T” over “376” on other side. NDC 43602-376-01 bottles of 100 tablets NDC 43602-376-05 bottles of 500 tablets Dispense in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Rev: 04/21

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND
AMPHETAMINE SULFATE TABLET
Ascent Pharmaceuticals, Inc
----------
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets CII
(dex troe am fet' a meen sac cha rate, am fet' a meen a spar' tate,
dex troe am fet' a meen sul' fate, am fet' a
meen sul' fate)
Rx only
Read the Medication Guide that comes with dextroamphetamine
saccharate, amphetamine aspartate,
dextroamphetamine sulfate, and amphetamine sulfate tablets 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 childs treatment with
dextroamphetamine saccharate, amphetamine
aspartate, dextroamphetamine sulfate, 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 childs blood pressure and heart
rate regularly during treatment with
dextroamphetamine saccharate, amphetamine aspartate, dex

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET
ASCENT PHARMACEUTICALS, INC
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS CII
RX ONLY
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
* 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg
Amphetamine Aspartate (Anhydrous) as supplied
† 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755
mg
Amphetamine Aspartate (Anhydrous) as supplied
‡ 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg
Amphetamine
†
‡
§
¶
#
Þ
Aspartate (Anhydrous) as supplied
§ 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925
mg
Amphetamine Aspartate (Anhydrous) as supplied
¶ 3.75 mg of Amphetamine Aspartate Mo