DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- dextroamphet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Eon Labs, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the foll

Product summary:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), for oral administration, are available as: 5 mg: Dark blue, round, flat face, bevel edge tablets, debossed “E ” over “84” on one side and double-bisected on the other side and supplied as: NDC 0185-0084-01 bottles of 100 10 mg: Dark blue, round, biconvex tablets, debossed “E ” over “111” on one side and double-bisected on the other side and supplied as: NDC 0185-0111-01 bottles of 100 20 mg: Dark orange, round, biconvex tablets, debossed “E ” over “401” on one side and double-bisected on the other side and supplied as: NDC 0185-0401-01 bottles of 100 30 mg: Dark orange, round, flat faced tablets, debossed “E ” over “404” on one side and double-bisected on the other side and supplied as: NDC 0185-0404-01 bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. Keep tightly closed. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE
AND AMPHETAMINE SULFATE TABLET
Eon Labs, Inc.
----------
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII (Mixed
Salts of a Single Entity
Amphetamine Product)
(dex-troe-am-FET-ah-meen)
Read the Medication Guide that comes with Mixed Salts of a Single
Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product.
What is the most important information I should know about Mixed Salts
of a Single Entity
Amphetamine Product?
The following have been reported with use of Mixed Salts of a Single
Entity Amphetamine Product 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 Mixed Salts of a
Single Entity Amphetamine Product.
Your doctor should check your or your child’s blood pressure and
heart rate regularly during treatment
with Mixed Salts of a Single Entity Amphetamine Product.
Call your doctor right away if you or your child have any signs of
heart problems such as chest pain,
shortness of breath, or fainting while taking Mixed Salts of a Single
Entity Amphetamine Product.
2. Mental (Psychiatric) Problems:
All Patients
• new or worse behavior and thought problems
• new or worse bipolar illness
• new or worse aggressi

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE
SULFATE AND AMPHETAMINE SULFATE TABLET
EON LABS, INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE AND
AMPHETAMINE SULFATE TABLETS CII
(MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT)
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.
The structural formula is:
C H N MW=135.21
EACH TABLET CONTAINS
5 MG
10 MG
20 MG
30 MG
Dextroamphetamine Saccharate
1.25 mg
2.5 mg
5 mg
7.5 mg
Amphetamine Aspartate Monohydrate
1.25 mg
2.5 mg
5 mg
7.5 mg
Dextroamphetamine Sulfate USP
1.25 mg
2.5 mg
5 mg
7.5 mg
Amphetamine Sulfate USP
1.25 mg
2.5 mg
5 mg
7.5 mg
Total amphetamine base equivalence
3.13 mg
6.3 mg
12.6 mg
18.8 mg
In addition each tablet for oral administration contains the following
inactive ingredients: lactose
monohydrate, pregelatinized starch (corn) and magnesium stearate.
In addition dextroamphetamine saccharate, amphetamine aspartate,
dextroamphetamine sulfate and
9
13
amphetamine sulfate tablets (Mixed Salts of a Single Entity
Amphetamine Product) 5 mg and 10 mg
contain FD&C blue No. 1 aluminum lake and the 20 mg and 30 mg contain
FD&C yellow No. 6
aluminum lake as color additives.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Amphetamines are non-catecholamine sympathomimetic amin