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

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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)

Հասանելի է:

Zydus Pharmaceuticals (USA) Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 accou

Ապրանքի ամփոփագիր:

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are available as: 5 mg: Hard gelatin capsules with light blue opaque cap, imprinted '1184' in black ink and light orange opaque body imprinted 'N' in black ink. NDC 70710-1184-1……………………………………………….Bottles of 100 10 mg: Hard gelatin capsules with light blue opaque cap, imprinted '1185' in black ink and light blue opaque body imprinted 'N' in black ink. NDC 70710-1185-1……………………………………………….Bottles of 100 15 mg: Hard gelatin capsules with light blue opaque cap, imprinted '1186' in black ink and white opaque body imprinted 'N' in black ink. NDC 70710-1186-1……………………………………………….Bottles of 100 20 mg: Hard gelatin capsules with light orange opaque cap, imprinted '1187' in black ink and light orange opaque body imprinted 'N' in black ink. NDC 70710-1187-1……………………………………………….Bottles of 100 25 mg: Hard gelatin capsules with light orange opaque cap, imprinted '1188' in black ink and white opaque body imprinted 'N' in black ink. NDC 70710-1188-1……………………………………………….Bottles of 100 30 mg: Hard gelatin capsules with white opaque cap, imprinted '1189' in black ink and white opaque body imprinted 'N' in black ink. NDC 70710-1189-1……………………………………………….Bottles of 100 Dispense in a tight, light-resistant container as defined in the USP. Store at 20ºC to 25ºC (68ºF to 77º F). Excursions permitted to 15ºC - 30ºC (59 - 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 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.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE
SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
CAPSULE,
EXTENDED RELEASE
ZYDUS PHARMACEUTICALS (USA) 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 EXTENDED-RELEASE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR 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, 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 Warnings 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, are
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, controlled trial in children with ADHD. (14)
Adolescents (ages 13-17): Efficacy was established in on