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

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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)

Tilgængelig fra:

Bryant Ranch Prepack

INN (International Name):

DEXTROAMPHETAMINE SACCHARATE

Sammensætning:

DEXTROAMPHETAMINE SACCHARATE 5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product) 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 menta

Produkt oversigt:

NDC: 63629-3731-1: 60 Tablets in a BOTTLE NDC: 63629-3731-2: 90 Tablets in a BOTTLE NDC: 63629-3731-3: 30 Tablets in a BOTTLE NDC: 63629-3731-4: 120 Tablets in a BOTTLE NDC: 63629-3731-5: 18 Tablets in a BOTTLE

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
(dex" troe am fet' a meen sak' a rate, am fet' a meen a spar' tate,
dex" troe am fet' a meen sul' fate, and am
fet' a meen sul' fate)
TABLETS (MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT) 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�

Produktets egenskaber

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
BRYANT RANCH PREPACK
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS
(MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT) CII
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.
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 Equivalent
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
3.75 mg of Amphetamine Asparta