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

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Zydus Pharmaceuticals (USA) Inc.

Designació comuna internacional (DCI):

AMPHETAMINE SULFATE

Composición:

AMPHETAMINE SULFATE 1.25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are  supplied as follows: 5 mg: Blue, oval, biconvex tablet, quadrisect on one side and "N" over "950" on the other side. NDC 68382-950-01……………………………Bottles of 100 Tablets 7.5 mg: Blue, round, flat- faced, beveled edge tablet, quadrisect on one side and "N" over "951" on the other side. NDC 68382-951-01……………………………Bottles of 100 Tablets 10 mg: Blue, oval, flat-faced, beveled- edge tablet, quadrisect on one side and "N" over 952" on the other side. NDC 68382-952-01……………………………Bottles of 100 Tablets 12.5 mg: Peach, oval, biconvex tablet, quadrisect on one side and 'N" over "953" on the other side. NDC 68382-953-01……………………………Bottles of 100 Tablets 15 mg: Peach, round, flat-faced, beveled edge tablet, quadrisect on one side and "N" over 954" on the other side. NDC 68382-954-01……………………………Bottles of 100 Tablets 20 mg: Peach, oval, flat-faced, beveled-edge tablet, quadrisect on one side with "N" over" 955" on the other side. NDC 68382-955-01……………………………Bottles of 100 Tablets 30 mg: Peach, oval, biconvex tablet quadrisect on one side with "N" over "956" on the other side. NDC 68382-956-01……………………………Bottles of 100 Tablets Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Nesher Pharmaceuticals (USA) LLC. DEA Order Form Required.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
Zydus Pharmaceuticals (USA) Inc.
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SPL MEDGUIDE
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)
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,
The following have been reported with use of dextroamphetamine
saccharate, amphetamine aspartate, dextroamphetamine
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
Your doctor should check you or your child carefully for heart
problems before starting dextroamphetamine saccharate,
Your doctor should check your or your child’s blood pressure and
heart rate regularly during treatment with dextroamphetamine
Call your doctor right away if you or your child have any signs of
heart problems such as chest pain, shortness of
2. Mental (Psychiatric) Problems:
All Patients
• new or worse behavior and thought problems
• new or worse bipolar illness
• ne

Fitxa tècnica

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE AND
AMPHETAMINE SULFATE TABLET
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 AMPHETAMINES 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 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 Aspartate Monohydrate equivalent to 3.51 mg
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