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

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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)

Dostupné s:

Lannett Company, Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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 0527-5510-37 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 10 mg: capsules with blue body and blue cap (imprinted 10 mg on body and ELI-511 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 0527-5511-37 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 15 mg: capsule with white opaque body and green cap (imprinted 15 mg on body and ELI-512 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 0527-5512-37 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 20 mg: capsule with white opaque body and light pink cap (imprinted 20 mg on body and ELI-513 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 0527-5513-37 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 25 mg: capsules with pink body and pink cap (imprinted 25 mg on body and ELI-514 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 0527-5514-37 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 30 mg: capsules with white opaque body and dark pink cap (imprinted 30 mg on body and ELI-515 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 0527-5515-37 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.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE,
AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE
Lannett Company, Inc.
----------
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 monohydra

Charakteristika produktu

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE
SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE CAPSULE, EXTENDED
RELEASE
LANNETT COMPANY, INC.
----------
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,
contr