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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE (UNII: H527KAP6L5) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

Available from:

STAT RX USA LLC

INN (International Name):

DEXTROAMPHETAMINE SACCHARATE

Composition:

DEXTROAMPHETAMINE SACCHARATE 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets is 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 are available as: 5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 971 and four partial bisects on the other side debossed with 5 . Available in bottles of: 7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized b over 775 on one side and two partial bisects and a full score on the other side debossed with 7│½ . Available in bottles of: 10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 972 and two partial bisects and a full score on the other side debossed with 1│0 . Available in bottles of: 12.5 mg: Peach, oval, biconvex tablet debossed with stylized b over 776 separated by a full score on one side and four partial bisects on the other side debossed with 12│½. Available in bottles of: 15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized b over 777 on one side and two partial bisects and a full score on the other side debossed with 1│5 . Available in bottles of: 20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 973 and two partial bisects and a full score on the other side debossed with 2│0 . Available in bottles of: 30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 974 and two partial bisects and a full score on the other side debossed with 3│0 . Available in bottles of: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE - DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SUFLATE TABLET
STAT RX USA LLC
----------
MEDICATION GUIDE
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS
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 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 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 any signs of
heart problems such as

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE -
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE AND
AMPHETAMINE SUFLATE TABLET
STAT RX USA LLC
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CII
(THREE MEDICATION GUIDES ATTACHED)
ISS. 10/2009
11001546
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.
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
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 contains the following inactive ingredients:
colloidal silicon dioxide,
compressible sugar, corn starch, magnesium stearate, microcrystalline
cellulose and saccharin sodium.
The 5, 7.5 and 10 mg also contain FD&C blue no.1 aluminum lake.
The 12.5, 15, 20 and 30 mg also contain FD&C yellow no. 6 aluminum
lake.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Amphetamines are non-catecholamine sympathomimetic amines with CNS
stimulant activity. The mode
of therapeutic action in Attention De