dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate- Dextroamphetamine Sacch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Patient Information leaflet (PIL)

27-03-2007

Summary of Product characteristics (SPC)

27-03-2007

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:

Mutual Pharmaceutical Company

INN (International Name):

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

Pharmaceutical form:

TABLET

Composition:

1.25 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, round, green, double-scored, debossed MP 441 on one side; the other side plain Bottles of 100 NDC 53489-564-01 Bottles of 250 NDC 53489-564-03 Bottles of 500 NDC 53489-564-05 Bottles of 1000 NDC 53489-564-10 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 7.5 mg, oval, green, double-scored, debossed MP 442 on one side; the other side plain Bottles of 100 NDC 53489-565-01 Bottles of 250 NDC 53489-565-03 Bottles of 500 NDC 53489-565-05 Bottles of 1000 NDC 53489-565-10 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 10 mg, round, green, double-scored, debossed MP 443 on one side; the other side plain Bottles of 100 NDC 53489-566-01 Bottles of 250 NDC 53489-566-03 Bottles of 500 NDC 53489-566-05 Bottles of 1000 NDC 53489-566-10 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 12.5 mg, round, yellow, double-scored, debossed MP 444 on one side; the other side plain Bottles of 100 NDC 53489-567-01 Bottles of 250 NDC 53489-567-03 Bottles of 500 NDC 53489-567-05 Bottles of 1000 NDC 53489-567-10 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 15 mg, oval, yellow, double-scored, debossed MP 445 on one side; the other side plain Bottles of 100 NDC 53489-568-01 Bottles of 250 NDC 53489-568-03 Bottles of 500 NDC 53489-568-05 Bottles of 1000 NDC 53489-568-10 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 20 mg, round, yellow, double-scored, debossed MP 446 on one side; the other side plain Bottles of 100 NDC 53489-569-01 Bottles of 250 NDC 53489-569-03 Bottles of 500 NDC 53489-569-05 Bottles of 1000 NDC 53489-569-10 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 30 mg, round, yellow, double-scored, debossed MP 447 on one side; the other side plain Bottles of 100 NDC 53489-570-01 Bottles of 250 NDC 53489-570-03 Bottles of 500 NDC 53489-570-05 Bottles of 1000 NDC 53489-570-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Patient Information leaflet

SULFATE, AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE
ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET
Mutual Pharmaceutical Company
----------
MEDICATION GUIDE
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE TABLETS CII
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.
Revised: 3/2007
Document Id: 0D9F4440-9ECD-7EF5-D84E-EC41B763CAC4
Set id: F0FC4960-8262-48E1-805C-DAE63FD045B0
Version: 1
Effective Time: 20070327
Mutual Pharmaceutical Company

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Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE, AND
AMPHETAMINE SULFATE TABLET
MUTUAL PHARMACEUTICAL COMPANY
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS
RX ONLY
CII
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
NONTHERAPEUTIC 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
1.25 mg
1.875 mg
2.5 mg
3.125 mg
3.75 mg
5 mg
7.5 mg
Amphetamine
Sulfate
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 inactive ingredients: crospovidone,
magnesium stearate, microcrystalline cellulose, povidone,
pregelatinized starch. The 5 mg, 7.5 mg and
10 mg tablets contain D&C Yellow #10 Aluminum Lake and FD&C Blue #1
Aluminum Lake. The 12.5
mg, 15 mg, 20 mg, and 30 mg tablets contain D&C Yellow #10 Aluminum
Lake.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Amphetamines are non-catecholamine sympathomimetic amines with CNS
stimulant activity. The mode
of therapeutic action in

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