DEXTROAMPHETAMINE SULFATE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)

Saadav alates:

Novel Laboratories, Inc.

INN (Rahvusvaheline Nimetus):

DEXTROAMPHETAMINE SULFATE

Koostis:

DEXTROAMPHETAMINE SULFATE 5 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Dextroamphetamine Sulfate Tablets USP are indicated for: 1.         Narcolepsy. 2.         Attention Deficit Disorder with Hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy

Toote kokkuvõte:

Dextroamphetamine Sulfate Tablets, USP are available as: 5 mg: Peach, round, flat-faced, beveled-edge, scored tablet. Debossed with "n" on the scored side and "870"on the other side. Available in bottles of: 30 NDC 40032-870-03 100 NDC 40032-870-01 1000 NDC 40032-870-10 10 mg: Pink, round, flat-faced, beveled-edge, scored tablet. Debossed with "n" on the scored side and "871" on the other side. Available in bottles of: 30 NDC 40032-871-03 100 NDC 40032-871-01 1000 NDC 40032-871-10 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. DEA Order Form Required. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI8710000103 Rev. 04/2017

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Novel Laboratories, Inc.
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MEDICATION GUIDE
DEXTROAMPHETAMINE SULFATE (DEX-troe-am-FET-uh-meen SULL-fate) TABLETS
USP, CII
Read the Medication Guide that comes with Dextroamphetamine Sulfate
Tablets 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
Sulfate Tablets.
Revised: 12/2017
Document Id: 522d3dbb-521e-4d0b-9d95-dee25e3bd83c
34391-3
Set id: 9f0426b4-ecf2-4345-b1cf-c5f48832126b
Version: 5
Effective Time: 20171222
Novel Laboratories, Inc.

Toote omadused

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE TABLET
NOVEL LABORATORIES, INC.
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RX ONLY
WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE
PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-
THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE
PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS.
DESCRIPTION
Dextroamphetamine sulfate, USP is the dextro isomer of the compound
_d,l_-amphetamine sulfate, a
sympathomimetic amine of the amphetamine group. Chemically,
dextroamphetamine is d-alpha-
methylphenethylamine, and is present in all forms of dextroamphetamine
sulfate, USP as the neutral
sulfate. The structural formula is as follows:
(C H N) ·H SO Molecular Weight: 368.49
INACTIVE INGREDIENTS
Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate,
Microcrystalline Cellulose and
Povidone.
The 5 mg also contains D&C yellow no. 10, Iron oxide yellow and Iron
oxide red.
The 10 mg also contains FD&C yellow no. 6 aluminium lake and FD&C red
no. 40 aluminium lake.
CLINICAL PHARMACOLOGY
Amphetamines are non-catecholamine, sympathomimetic amines with CNS
stimulant activity. Peripheral
actions include elevations of systolic and diastolic blood pressures
and weak bronchodilator and
respiratory stimulant action.
There is neither specific evidence which clearly establishes the
mechanism whereby amphetamines
produce mental and behavioral effects in children, nor conclusive
evidence regarding how these effects
relate to the condition of the central nervous system.
PHARMACOKINETICS
9
13
2
2
4
The pharmacokinetics of the tablet and sustained-release capsule were
compared in 12 healthy subjects.
The extent of bioavailability of the sustained-release capsule was
similar compared to the immediate-
release tablet. Following administration of three 5 mg tablets,
ave