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

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)

可用日期:

American Health Packaging

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Dextroamphetamine saccharate, amphetamine aspartate, 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 requiring sustained me

產品總結:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets is supplied as follows: 10 mg: Light blue color round shaped tablet, debossed with T over 372 on one side and other side with one full bisect and two partial bisects. Unit dose packages of 30 (5 x 6) NDC 60687-644-25 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. DEA Order Form Required.

授权状态:

Abbreviated New Drug Application

资料单张

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND
AMPHETAMINE SULFATE TABLET
American Health Packaging
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MEDICATION GUIDE
8464425/1121
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets CII
(dex" troe am fet' a meen sac cha rate, am fet' a meen a spar' tate,
dex" troe am fet' a meen sul' fate, am fet' a
meen sul' fate)
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

产品特点

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET
AMERICAN HEALTH PACKAGING
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS CII
8464425/1121
RX ONLY
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.
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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
1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg
Amphetamine Aspartate
(Anhydrous) as supplied
1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg
Amphetamine
Aspartate (Anhydrous) as supplied
2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg
Amphetamine Aspartate
(Anhydrous) as supplied
3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg
Amphetamine
Aspartate (Anhydrous) as supplied
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INACTIVE INGREDIEN