DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- dextroamphetamine saccha

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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)

Disponibil de la:

Bryant Ranch Prepack

INN (nume internaţional):

DEXTROAMPHETAMINE SACCHARATE

Compoziție:

DEXTROAMPHETAMINE SACCHARATE 5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 mental effort; loses things; easily distracted; forgetful.

Rezumat produs:

Product: 71335-0178 NDC: 71335-0178-2 90 TABLET in a BOTTLE NDC: 71335-0178-5 18 TABLET in a BOTTLE NDC: 71335-0178-3 30 TABLET in a BOTTLE NDC: 71335-0178-4 120 TABLET in a BOTTLE NDC: 71335-0178-1 60 TABLET in a BOTTLE

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
Bryant Ranch Prepack
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MEDICATION GUIDE
DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLETS CII
(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)
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,
dextroamphetam

Caracteristicilor produsului

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)
5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 20 MG AND 30 MG
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
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
1.875
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
In addition, each tablet for oral administration contains the
following inactive ingredients: lactose
monohydrate, magnesium stearate, microcrystalline cellulose and
pregelatinized starch.
The 5 mg, 7.5 mg, 10 mg and 12.5 mg tablets also contain FD&C Blue #2
Aluminum Lake.
The 12.5