DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE ER capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE (UNII: H527KAP6L5) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), 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, amphetamine sulfate extended-release is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The efficacy of Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 accounted for by another men

Product summary:

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules are supplied as: 30 mg Capsule: Cap: Orange opaque printed “P” in black ink and Body: White opaque printed “844” in black ink NDC 63629-2109-1, Bottles of 100 Dispense in a tight, light-resistant container as defined in the USP. Store at 20 ºC to 25º C (68º F to 77º F); excursions permitted between 15 to 30º C (59 to 86º 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, amphetamine sulfate extended-release 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, amphetamine sulfate extended-release 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, amphetamine sulfate extended-release in the household trash.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE ER-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE,
AMPHETAMINE SULFATE ER CAPSULE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
DEXTROAMPHETAMINE saccharate, AMPHETAMINE aspartate monohydrate,
DEXTROAMPHETAMINE sulfate, AMPHETAMINE sulfate extended-release
capsules CII
(dex”troe am fet’a meen, sak’a-rat, am fet’a meen,
ah-spahr’tat, mon’o-hi’drat , dex”troe am fet’a meen,
sul’fate, am fet’a meen, sul’fate extended-release) CII
Read the Medication Guide that comes with Dextroamphetamine
saccharate, amphetamine aspartate
monohydrate, dextroamphetamine sulfate, amphetamine sulfate
extended-release 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, amphetamine sulfate
extended-release.
What is the most important information I should know about
Dextroamphetamine saccharate,
amphetamine aspartate monohydrate, dextroamphetamine sulfate,
amphetamine sulfate extended-release?
Dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate,
amphetamine sulfate extended-release 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 monohydrate,
dextroamphetamine sulfate,
amphetami

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
ER- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE ER CAPSULE
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,
AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE
ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
EXTENDED-RELEASE
CAPSULES.
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (MIXED SALTS OF A
SINGLE-ENTITY
AMPHETAMINE PRODUCT) 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, AMPHETAMINE SULFATE
EXTENDED-RELEASE,
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,
amphetamine sulfate extended-release, a CNS stimulant, is indicated
for the treatment of attention deficit
hyperactivity disorder (ADHD). (1)
Children (ages 6 to 12): Efficacy was established in one 3-week
outpatient, controlled trial and one
analogue classroom, controlled trial in children with ADHD. (14)
Adolescents (ages 13 to 17): Efficacy was established in one 4-week
c