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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

CorePharma, LLC

INN (International Name):

AMPHETAMINE SULFATE

Composition:

AMPHETAMINE SULFATE 1.875 mg

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. 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 effort; loses things; easily distracted; forgetful.

Product summary:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg: Blue, round, compressed tablets, debossed cor over 130 on one side and Quadrisect on the other side. In bottles of 100 tablets     (NDC 64720-130-10) Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 7.5 mg: Blue, oval, compressed tablets, debossed cor 1 31 on one side and Bisect on the other side. In bottles of 100 tablets     (NDC 64720-131-10) Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 10 mg: Blue, round, compressed tablets, debossed cor over 132 on one side and Quadrisect on the other side. In bottles of 100 tablets     (NDC 64720-132-10) Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 12.5 mg: Purple, round, compressed tablets, debossed cor over 133 on one side and Bisect on the other side. In bottles of 100 tablets     (NDC 64720-133-10) Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 15 mg: Pink, oval, compressed tablets, debossed cor 134 on one side and Bisect on the other side. In bottles of 100 tablets     (NDC 64720-134-10) Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 20 mg: Pink, round, compressed tablets, debossed cor over 135 on one side and Quadrisect on the other side. In bottles of 100 tablets     (NDC 64720-135-10) Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 30 mg: Pink, round, compressed tablets, debossed cor over 136 on one side and Quadrisect on the other side. In bottles of 100 tablets     (NDC 64720-136-10) Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature). Protect from moisture. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. LB# 910-01 Rev. September, 2016 Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 For additional copies of the printed patient information/medication guide, please visit www.corepharma.com or call 1-800-850-2719.

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
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
CorePharma, LLC
----------
MEDICATION GUIDE
DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLETS CII
(DEX-troe-am-FET-uh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate,
DEX-troe-am-FET-uh-meen
SULL-fate, and am-FET-uh-meen SULL-fate)
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 child’s 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 an

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
COREPHARMA, LLC
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS
(MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT)
5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 20 MG AND 30 MG
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
In addition, each tablet for oral administration contains the
following in