DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, 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)

Available from:

Avera McKennan Hospital

INN (International Name):

DEXTROAMPHETAMINE SACCHARATE

Composition:

DEXTROAMPHETAMINE SACCHARATE 1.25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE
SULFATE AND AMPHETAMINE SULFATE TABLET
AVERA MCKENNAN HOSPITAL
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE
SULFATE, AMPHETAMINE SULFATE TABLETS CII
(MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT)
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.
The structural formula is:
C H N MW=135.21
EACH TABLET CONTAINS
.........................................................
5 MG
10 MG
20 MG
30 MG
Dextroamphetamine Saccharate ........... 1.25 mg
2.5 mg
5 mg
7.5 mg
Amphetamine Aspartate Monohydrate.. 1.25 mg
2.5 mg
5 mg
7.5 mg
Dextroamphetamine Sulfate USP.........
1.25 mg
2.5 mg
5 mg
7.5 mg
Amphetamine Sulfate USP...................
1.25 mg
2.5 mg
5 mg
7.5 mg
Total amphetamine base equivalence... 3.13 mg
6.3 mg
12.6 mg
18.8 mg
In addition each tablet for oral administration contains the following
inactive ingredients: lactose
monohydrate, pregelatinized starch (corn) and magnesium stearate.
In addition dextroamphetamine saccharate, amphetamine aspartate
monohydrate, dextroamphetamine
9
13
sulfate, amphetamine sulfate tablets (Mixed Salts of a Single Entity
Amphetamine Product) 5 mg and 10
mg contain FD&C blue No. 1 aluminum lake and the 20 mg and 30 mg
contain FD&C yellow No.