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

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE (UNII: H527KAP6L5) (AMPHETAMINE ASPARTATE - UNII:H527KAP6L5), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

Disponible des:

American Health Packaging

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 b

Resumen del producto:

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules are supplied as: 10 mg Capsule: Cap: Blue opaque printed “P” in black ink and Body: Blue opaque printed “840” in black ink Unit dose packages of 30 (5 x 6) NDC 60687-498-25 20 mg Capsule: Cap: Orange opaque printed “P” in black ink and Body: Orange opaque printed “842” in black ink Unit dose packages of 30 (5 x 6) NDC 60687-509-25 30 mg Capsule: Cap: Orange opaque printed “P” in black ink and Body: White opaque printed “844” in black ink Unit dose packages of 30 (5 x 6) NDC 60687-520-25 Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. 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.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE
SULFATE, AMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
American Health Packaging
----------
MEDICATION GUIDE
8449825/0920
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)
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, amphetamine sulfate extended-
release.
Your doct

Fitxa tècnica

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED
RELEASE
AMERICAN HEALTH PACKAGING
----------
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
out