DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE capsule, ext

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The efficacy of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met DSM-IV® criteria for ADHD [see Clinical Studies (14)] . A diagnosis of 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 a

Product summary:

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 5 mg: capsule with white opaque body and lime green cap (imprinted 5 mg on body and ELI-510 on cap with black ink). Capsules filled with orange pellets, bottles of 100 NDC 72162-2055-01, 30 NDC 72162-2055-03, 60 72162-2055-06, and NDC 72162-2055-09. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at room temperature, 20° to 25° C (68° to 77° F). Excursions permitted to 15° to 30° C (59° to 86° F) [see USP CONTROLLED ROOM TEMPERATURE]. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in the household trash.

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 CAPSULE, EXTENDED RELEASE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES
(DEX-troe-am-FET-uh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate,
MAN-no-HIGH-drate, DEX-
troe-am-FET-uh-meen SULL-fate, and am-FET-uh-meen SULL-fate),CII
Read the Medication Guide that comes with dextroamphetamine
saccharate, amphetamine aspartate
monohydrate, dextroamphetamine sulfate and amphetamine sulfate
extended-release capsules 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 monohydrate,
dextroamphetamine sulfate and
amphetamine sulfate extended-release capsules.
What is the most important information I should know about
dextroamphetamine saccharate, amphetamine
aspartate monohydrate, dextroamphetamine sulfate and amphetamine
sulfate extended-release capsules?
Dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate and
amphetamine sulfate extended-release capsules is a stimulant medicine.
The following have been reported
with use of 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 monohydrat

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE
SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE
CAPSULE,
EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE
SULFATE,
AND AMPHETAMINE SULFATE (MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE
PRODUCT)
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (MIXED SALTS OF A
SINGLE-ENTITY
AMPHETAMINE PRODUCT) EXTENDED-RELEASE CAPSULES.
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES,
FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 2001
WARNING: ABUSE AND DEPENDENCE
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
CNS STIMULANTS, INCLUDING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE
ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
EXTENDED-
RELEASE CAPSULES, OTHER AMPHETAMINE-CONTAINING PRODUCTS, AND
METHYLPHENIDATE,
HAVE A HIGH POTENTIAL FOR ABUSE AND DEPENDENCE (5.1, 9.3).
ASSESS THE RISK OF ABUSE PRIOR TO PRESCRIBING AND MONITOR FOR SIGNS OF
ABUSE AND
DEPENDENCE WHILE ON THERAPY (9.2, 9.3).
RECENT MAJOR CHANGES
Boxed Warning
7/2019
Dosage and Administration (2.1)
7/2019
Warnings and Precautions (5.1)
7/2019
INDICATIONS AND USAGE
Dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate and
amphetamine sulfate extended-release capsules, a CNS stimulant, is
indicated for the treatment of
attention deficit hyperactivity disorder (ADHD). (1)
Children (ages 6-12): Efficacy was established in one 3-week
outpatient, controlled trial and one
analogue classroom, controll