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

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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)

Fáanlegur frá:

Elite Laboratories, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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; fo

Vörulýsing:

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 │ . 30 Tablets         NDC 64850-500-30  100 Tablets       NDC 64850-500-01  500 Tablets       NDC 64850-500-05 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. 30 Tablets         NDC 64850-501-30  100 Tablets       NDC 64850-501-01  500 Tablets       NDC 64850-501-05 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. 30 Tablets         NDC 64850-502-30  100 Tablets       NDC 64850-502-01  500 Tablets       NDC 64850-502-05 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. 30 Tablets         NDC 64850-503-30  100 Tablets       NDC 64850-503-01  500 Tablets       NDC 64850-503-05 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. 30 Tablets         NDC 64850-504-30  100 Tablets       NDC 64850-504-01  500 Tablets       NDC 64850-504-05 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. 30 Tablets         NDC 64850-505-30  100 Tablets       NDC 64850-505-01  500 Tablets       NDC 64850-505-05 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. 30 Tablets         NDC 64850-506-30  100 Tablets       NDC 64850-506-01  500 Tablets       NDC 64850-506-05 Dispense in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Distributed by: Elite Laboratories, Inc. Northvale, NJ 07647 Rev. 10/23 IN0522

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE - DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
Elite Laboratories, Inc.
----------
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,

Vara einkenni

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE -
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
ELITE LABORATORIES, INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, 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, and pregelatinized
starch.
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 a co