Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)
Novel Laboratories, Inc.
DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE 5 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
Novel Laboratories, Inc. ---------- 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. Прочитайте повний документ
DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE TABLET NOVEL LABORATORIES, INC. ---------- 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 Прочитайте повний документ