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)

现在购买

资料单张 (PIL)

30-01-2023

产品特点 (SPC)

30-01-2023

有效成分:

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)

可用日期:

NorthStar RxLLC

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 mental eff

產品總結:

Dextroamphetamine Saccharate, amphetamine aspartate monohydrate, Dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets - Light blue to blue colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U25’ on one side and quadrisect on other side. Bottles of 100 16714-948-01 7.5 mg Tablets - Light blue to blue colored, mottled, round, convex tablets debossed with ‘U26’ on one side and quadrisect on other side. Bottles of 100 16714-949-01 10 mg Tablets - Light blue to blue colored, mottled, round, convex tablets debossed with ‘U27’ on one side and quadrisect on other side. Bottles of 100 16714-950-01 12.5 mg Tablets - Light orange to orange colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U28’ on one side and quadrisect on other side. Bottles of 100 16714-951-01 15 mg Tablets - Light orange to orange colored, mottled, round, convex tablets debossed with ‘U29’ on one side and quadrisect on other side. Bottles of 100 16714-952-01 20 mg Tablets - Light orange to orange colored, mottled, round, convex tablets debossed with ‘U30’ on one side and quadrisect on other side. Bottles of 100 16714-953-01 30 mg Tablets - are light orange to orange colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U31’ on one side and quadrisect on other side. Bottles of 100 16714-954-01 Dispense in a tight, light-resistant container as described in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with Medication Guide available at www.northstarrxllc.com/products or call 1-800-206-7821 Manufactured for: Northstar Rx LLC, Memphis, TN 38141. Manufactured by: Corepharma LLC, Middlesex, NJ 08846 Issued: 08/2022

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
NorthStar RxLLC
---------- MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets CII
Rx only
Read the Medication Guide that comes with Dextroamphetamine
Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and 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 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.
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, Dextroamphetamine
Sulfate and Amphetamine
Sulfate Tablets
Call your doctor right away if you or your child have any

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产品特点

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE -
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
NORTHSTAR RXLLC
----------
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, 1-amphetamine aspartate monohydrate.
EACH TABLET CONTAINS
5 MG
7.5
MG
10
MG
12.5
MG
15 MG20 MG30 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
INACTIVE INGREDIENTS
In addition, each tablet contains: colloidal silicon dioxide,
magnesium stearate,
microcrystalline cellulose, povidone, and pregelatinized starch.
COLORS
The 5 mg, 7.5 mg, and 10 mg tablets contain the color additive FD&C
Blue #1 Aluminum
Lake.
The 12.5 mg, 15 mg, 20 mg, and 30 mg tablets contain the color
additive FD&C Yellow
#6 Aluminum Lake.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Amphetamines are non-catecholamine sympathomimetic amines with CNS
stimulant
activity. The mode of therapeutic action in A

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