DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Patient Information leaflet
(PIL)
29-05-2020
Summary of Product characteristics
(SPC)
29-05-2020
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:
Lannett Company, Inc.
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; for
Product summary:
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as follows: 5 mg: A blue, oval, flat-faced, beveled-edge tablet debossed with “e” over “500” separated by a full score on one side and a full score on the other side debossed with 5 │ . 100 Tablets NDC 0527-1500-37 500 Tablets NDC 0527-1500-41 7.5 mg: A blue, oval, flat-faced, beveled-edge tablet debossed with “e” over “501” separated by a full score on one side and two partial bisects and a full score on the other side debossed with 7 │ 1/2. 100 Tablets NDC 0527-1501-37 500 Tablets NDC 0527-1501-41 10 mg: A blue, flat-faced, beveled-edge tablet debossed with “e” over “502” separated by a full score on one side and two partial bisects and a full score on the other side debossed with 1 │ 0. 100 Tablets NDC 0527-1502-37 500 Tablets NDC 0527-1502-41 12.5 mg: A peach, oval biconvex tablet debossed with “e” over “503” separated by a full score on one side and four partial bisects on the other side debossed with 12 1/2. 100 Tablets NDC 0527-1503-37 500 Tablets NDC 0527-1503-41 15 mg: A peach, oval, flat-faced, beveled-edge tablet debossed with “e” over “504” separated by a full score on one side and two partial bisects and a full score on the other side debossed with 1 │ 5. 100 Tablets NDC 0527-1504-37 500 Tablets NDC 0527-1504-41 20 mg: A peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with “e” over “505” and two partial bisects and a full score on the other side debossed with 2 │ 0. 100 Tablets NDC 0527-1505-37 500 Tablets NDC 0527-1505-41 30 mg: A peach, oval, biconvex tablet with two partial bisects on one side debossed with “e” over “506” and two partial bisects and a full score on the other side debossed with 3 │ 0. 100 Tablets NDC 0527-1506-37 500 Tablets NDC 0527-1506-41 Dispense in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Rev. 09/22 IN0535
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
Lannett Company, Inc.
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MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets (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), CII
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,
dex
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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
LANNETT COMPANY, INC.
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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
1.875mg
2.5 mg
3.125mg
3.75 mg
5 mg
7.5 mg
Amphetamine Aspartate Monohydrate
1.25 mg
1.875mg
2.5 mg
3.125mg
3.75 mg
5 mg
7.5 mg
Dextroamphetamine Sulfate, USP
1.25 mg
1.875mg
2.5 mg
3.125mg
3.75 mg
5 mg
7.5 mg
Amphetamine Sulfate, USP
1.25 mg
1.875mg
2.5 mg
3.125mg
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: compressible sugar, magnesium stearate,
maltodextrin, microcrystalline
cellulose, sodium saccharin, pregelatinized starch, and other
ingredients.
COLORS: Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and
Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue
#1 Aluminum Lake.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and
Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain
FD&C Yellow #6 Aluminum
Lake as
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