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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

NDC: 71335-1081-1: 60 Tablets in a BOTTLE NDC: 71335-1081-2: 90 Tablets in a BOTTLE NDC: 71335-1081-3: 30 Tablets in a BOTTLE

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
Bryant Ranch Prepack
----------
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 hav

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
BRYANT RANCH PREPACK
----------
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